dr. med. gabriele siegler - newconceptoncology gmbh · •75 % caput •20 % corpus ... •ca 19-9...

Pankreaskarzinom Weiterbildungskurs 06122017

Dr med Gabriele Siegler Med Klinik 5

HaumlmatologieOnkologie

Klinikum Nuumlrnberg

(Leiter Prof Dr M Wilhelm)

Von Furfur - Krebs in Deutschland 2012 CC-BY-SA 40 httpscommonswikimediaorgwindexphpcurid=47147008

Epidemiologie

Epidemiologie

bull bdquoDeadliest Cancerldquo = houmlchte krebsspez Mortalitaumlt 5-JUumlR 6-8

bull Inzidenz 10-14100000 Einwohner

bull Mittleres Erkrankungsalter 70-75 Jahre

bull 2030 zweithaumlufigste Todesursache nach Lunge

Allgemeines

1-Jahres-Uumlberleben ca 25

5 Jahres-Uuml ca 6-8

WARUM

bull Bei Diagnose nicht mehr resektabel

bull metastastiert schnell

bull fruumlhes Lokalrezidiv

bull Relativ Strahlen- und chemoresistent

Symptome

bull Schmerzloser Ikterus bull Diffuse abdominelle Beschwerden

Ruumlckenschmerzen Steatorrhoe Verschlechterung eines Diabetes mellitus ua

bull Paraneoplastische Syndrome ndash Thormbophilie ndash Thrombophlebitis migrans ndash Pannikulitis nodularis

bull Abh v Metastasenlokalisation

Exokrines PC

bull 75 Caput bull 20 Corpus bull 5 Cauda

Histologien bull Duktales Adeno-Ca (ca 95 )

ndash adenosquamoumlses Ca ndash muzinoumlses nichtzystisches Ca ndash anaplastisches (undifferenziertes) Ca

bull Azinuszell-Ca = azinaumlres Ca bull Muzinoumlse Zystadeno-Ca = zyst Adeno-Ca

Praumlkanzerosen

bull PanIN pankreatische intraepitheliale Neoplasie

bull MCN muzinoumlse cystische Neoplasie

bull IPMN intraduktale papillaumlre muzinoumlse Neoplasie

Pathogenese

bull Duktale Epithelzelle

Modern Pathology (2002) 15 441ndash447 (2002)

Mutational Landscape

Nature 2015 Feb 26 518(7540) 495ndash501

Involvierte Gene Tumorsuppressorgene TP53 SMAD4 CDKN2A BRCA1 BRCA2 PALB2 ua Onkogene ERBB2 MET FGFR1 CDK6 PIK3R3 PIK3CA ua

-gt Antreiber der Glykolyse increased glucose uptake and lactate production

Haoqiang Ying et al Genes Dev 201630355-385

copy 2016 Ying et al Published by Cold Spring Harbor Laboratory Press

gt 90 KRAS-Mutation



Stroma-Immun-Reaktionen

Tumorzellen

sezernieren

TGFβ CXCL5 and

GM-CSF

-gt Mobilisation von

immunsuppressiven

myeloischen Zellen

und T reg Zellen

Risikofaktoren

bull Metabolisches Syndrom

bull Adipositas per magna

bull Rauchen

bull Diabetes mellitus

bull Chron Pankreatitis

bull 2-3 familiaumlre PC mind 2 Verwandte 1 Grades

hereditaumlre Syndrome Keimbahnmutationen

bull FAMMMFAMMMPC ndash familiaumlres atypisches multiples Muttermal- und

Melanom - Pankreaskarzinom ndash Syndrom ndash Keimbahnmutation im CDKNRA-Gen

bull Peutz-Jeghers ndash Keimbahnmutationen im STK11 -Gen

bull hereditaumlres Mamma- und Ovarial-Ca ndash Keimbahnmutationen im BRCA- oder PALB2-Gen

bull hereditaumlre Pankreatitis ndash Keimbahnmutationen im PRSS1 oder SPINK1Gen

Tumorpraumldispositions-Syndrome

bull FAP

bull HNPCC (Keimbahnmutation im APC-Gen)

bull Ataxia teleangiectasia

bull Mismatchreparaturdefekte

ProphylaxeFruumlherkennung

bull Nikotinkarenz halbiert das Risiko

bull Keine gesicherte Fruumlherkennung

bull CA19-9-Screening senkt nicht die krebsspez Mortalitaumlt

bull jaumlhrliche Kontrollen diskutieren (Evidenz) 10 Jahre vor Erstdiagnose des Verwandten ndash Vorsorgeprogramm der FaPaCa der DKH

FaPaCa Nationale Fallsammlung familiaumlres Pankreaskarzinom

httpwwwfapacadearzt-infhtml

Diagnostik

bull Sono Abdomen

bull Falls nicht eindeutig CTMRT-Abdomen

bull Ca 19-9 CEA

bull Histologie bei neoadjuvanten oder palliativen Konzepten obligat

Staging

bull Sono Abdomen bull CTMRT-Abdomen mit KM vor geplanter

Operation bull CT-Thorax vor geplanter Operation (neu) bull CA 19-9 und CEA vor jeder Tumortherapie

(Operation Bestrahlung medikamentoumlse Tumortherapie)

bull Endosonographie fakultativ bull PET Option bei unklaren Raumforderungen (nur

bei unklaren pulmonalen Rf zugelassen) bull Laparoskopie Option vor geplanter Operation

Klassifikation

bull TNM-Einteilung wenig aussagekraumlftig

Therapie- und Prognose-entscheidende Einteilung

bull Primaumlr resektabel

bull Primaumlr irresektabel = lokal fortgeschritten

bull metastasiert

TNM (AJCC Version 7)

Primaumlrtumor bull T1 lt 2cm auf Pankreas begrenzt bull T2 gt 2cm auf Pankreas begrenz bull T3 Pankreas uumlberschreitend ohne Kontakt zum Tr Coeliacus

oder zur A mes Sup bull T4 mit Kontakt zum Tr Coeliacus oder zur A mes Sup

(irresektabel)

Regionale Lymphknoten bull N0 keine bull N1 vorhanden

Fernmetastasen bull M0 kein Fernmetastasen bull M1 Fernmetastasen

TNM (AJCC Version 8) guumlltig ab Januar 2018

Primaumlrtumor bull T1 lt 2cm

ndash T1a lt 05 cm ndash T1b 05-1cm ndash T1c 1-2cm

bull T2 2-4cm bull T3 gt 4cm bull T4 mit Kontakt zum Tr Coeliacus oder zur A mes Sup Oder A

hepatica comm

Regionale Lymphknoten bull N0 keine

bull N1 1-3 Lmphknoten bull N2 mind 4 Lymphknoten


AJCC Version 8

bull St IA T1 N0 M0

bull St IB T2 N0 M0

bull St IIA T3 N0 M0

bull St IIB T1 T2 T3 N1 M0

bull St III T1 T2 T3 N2 M0

T4 jedes N M0

bull St IV jedes T jedes N M1

Copyright copy 2017 Wolters Kluwer Health Inc All rights reserved Published by Lippincott Williams amp Wilkins Inc 2

FIGURE 3

Multi-institutional Validation Study of the American Joint Commission on Cancer (8th Edition) Changes for T and N Staging in Patients With Pancreatic Adenocarcinoma Allen Peter Kuk Deborah Castillo Carlos Basturk Olca Wolfgang Christopher MD PhD Cameron John Lillemoe Keith Ferrone Cristina Morales-Oyarvide Vicente MD MPH He Jin MD PhD Weiss Matthew Hruban Ralph Gonen Mithat Klimstra David Mino-Kenudson Mari Annals of Surgery 265(1)185-191 January 2017 DOI 101097SLA0000000000001763

FIGURE 3 Overall survival by T-stage of 525 patients who underwent resection for node-negative pancreatic cancer stratified by proposed AJCC 8th edition criteria (training set only)


FIGURE 4


FIGURE 4 Overall survival by number of positive nodes for all patients who underwent a R0 resection (training set n = 1551) stratified by proposed AJCC 8th edition criteria


FIGURE 4

Does Size Matter in Pancreatic Cancer Reappraisal of Tumour Dimension as a Predictor of Outcome Beyond the TNM Marchegiani Giovanni Andrianello Stefano Malleo Giuseppe De Gregorio Lucia Scarpa Aldo Mino-Kenudson Mari Maggino Laura Ferrone Cristina Lillemoe Keith Bassi Claudio Castillo Carlos Salvia Roberto Annals of Surgery 266(1)142-148 July 2017 DOI 101097SLA0000000000001837

FIGURE 4 Kaplan-Meier survival curves for PDAC size stratified by N status 1 20 mmN0 4 gt20 mmN1

Gillen et al PLoS Med 2010 Apr 7 (4)

Wo stehen wir heute

Therapie des Pankreas-Karzinoms

- und sie bewegt sich doch

bull Neoadjuvante Therapie

bull Beeinflussung des Tumor-Mikroenvironment (desmoplastisches Stroma)

bull Zielgerichtete Therapien (kras p53 etc)

bull Metastasenresektion bei Oligometastasierung

Primaumlr resektables PC

Neoadjuvante Therapie

Adjuvante Chemotherapie

Operation

bull Pylorus-erhaltende Teilresektion

bull Duodenopankreatektomie nach Whipple

bull Totale Pankreasresektion wwwwikimediade

CAVE prauml-OP

Gallengangsstent vermeiden

da deutlich erschwerte OP-Bedingungen und

R0-Resektion unwahrscheinlicher

R0-Resektion

bull CRM-Status prognostisch entscheidend

OP-Ziel

bull CRM negativ mikroskopisch kein Nachweis von Tumorzellen im circumferentiellen Resesktionsrand bis zu 1 mm

copy 2013 Lippincott Williams amp Wilkins Inc Published by Lippincott Williams amp Wilkins Inc 2

FIGURE 3

Pancreatic Ductal Adenocarcinoma Is There a Survival Difference for R1 Resections Versus Locally Advanced Unresectable Tumors What Is a True R0 Resection Konstantinidis Ioannis Warshaw Andrew Allen Jill Blaszkowsky Lawrence Castillo Carlos Deshpande Vikram Hong Theodore Kwak Eunice Lauwers Gregory Ryan David Wargo Jennifer Lillemoe Keith Ferrone Cristina Annals of Surgery 257(4)731-736 April 2013 DOI 101097SLA0b013e318263da2f

FIGURE 3 Patients undergoing an R1 resection had an improved overall survival compared with those with LA unresectable tumors (median survival of 14 vs 11 months P lt 0001)


Pancreatic Cancer Surgery The New R-status Counts Strobel Oliver Hank Thomas Hinz Ulf Bergmann Frank Schneider Lutz Springfeld Christoph MD PhD Jager Dirk Schirmacher Peter Hackert Thilo Buchler Markus Annals of Surgery 265(3)565-573 March 2017 DOI 101097SLA0000000000001731

FIGURE 2 Resection margin status and survival Kaplan-Meier curves for postresection survival in (A) all patients stratified into the three margin status groups (B) R1 cases stratified according to the location of the positive margins Includes transection margins of the pancreatic neck bile duct duodenumstomach and small bowel Includes anterior posterior medial and uncinate margins Patients alive at their last follow-up are censored (I)

ESPAC-3-Kollektiv R0-Status entscheidend

Gesamtkollektiv CRM+ nur sign Schlechteres DFS

Subgruppe hinterer Resektionsrad CRM+ signifikant schlechteres DFS + OS

Ghan

eh e

t al

A

nnS

urg

20

17 DOI 101

097S

LA0

000000000002557


bull Rezidivrisiko signifikant erhoumlht bei ndash G3

ndash N

ndash PS 1

ndash Tumorgroumlszlige

ndash R1 Hinterrand oder alle Raumlnder CRM+

Ghaneh et al AnnSurg 2017 DOI 101097SLA0000000000002557

Neoadjuvanz

bull Einige retrospektive vielversprechende Daten ndash Groszlige Angst vor Progress waumlhrend

Neoadjuvanz (unberechtigt)

ndash Kein erhoumlhtes Risiko operativ und postoperativ

bull Phase IIIII-Studien laufen rekrutieren aber langsam (NEPAFOX NEOPA ua)

Thesen

bull Sequenztherapie koumlnnte Chemotherapieresistenz uumlberwinden

bull Stroma wird durch nabPacli verringert und Gemcitabine bzw FOLFIRINOX dringt besser zum Tumor vor

OS (stage I amp II) NAT vs UR

Presented By Massimo Falconi at 2017 ASCO Annual Meeting

Neoadjuvanz vs primaumlre OP

OS (stage I amp II) NAT vs UR + adjuvant TX



ADJUVANTE THERAPIE


PFS () OS () Studie

5FULV vs BSC 21 vs 8 P=0009

ESPAC-1

Gem vs BSC 134 vs 67 p=lt0001

207 vs 104 P=001

CONKO-001

5FULV vs Gem 141 vs 143 23 vs 236 ns

ESPAC-3

Gem +- Erlotinib 116 vs 116 265 vs 246 ns

CONKO-005

Gem +- Cape 280 vs 255 P=0032

ESPAC-4

Slide 20

Presented By John Neoptolemos at 2016 ASCO Annual Meeting

ESPAC-4 adjuvant Gemcitabine +- Capecitabine

(Phase III)

Hintergrund bis ESPAC3 medianes Uumlberleben immer unter 24 Monate (egal ob Gem oder 5-FU) Gemcitabine 1000 mgqm d1815 R 29 Capecitabine 1650 mgqm d1-14 6 Zyklen Einschlusskriterien R0 + R1 (lt1mm) WHO lt 2 M0

Reported Toxicity


Survival by Treatment


Slide 16


Adjuvant Gemcitabin +- Capecitabine

bull Pro ndash R0 N0 deutlicher OS-Vorteil

bull Contra ndash 7 Hand-Fuss-Syndrom IIIdegIVdeg ndash Kaum Benefit bei R1 undoder N+ ndash Off-lable ndash Studie bdquounsauberldquo dokumentiert (CRM

Follow up)

Resectable PC Treatment Guidelines

Presented By E Chiorean at 2016 ASCO Annual Meeting

Alternative Fakten

Adjuvante Radiochemotherapie

PFS () OS () Studie

BSC vs RT + 5FU (nur T1-2 N0-1a)

37 vs 38 ns

41 vs 51 ns

Klinkenbiijl 1999

BSC vs RT+5FU 20 vs 10 P=005

ESPAC-1

Gem +- RT 12 vs 11 ns

24 vs 24 ns

EORTC-40013-22012FFCD-9203GERCOR

RT5FU vs RTGem

18 vs 22 ns

US IntergroupRT

OG 9704

Kein gesicherter Stellenwert

Adjuvante Therapie

1 Gemcitabine +-Capecitabin

2 5-FU gilt als gleichwertig aber mehr Nebenwirkungen als Gemcitabin

3 Kein gesicherter Stellenwert der Radiotherapie

Lokal fortgeschrittenes PC

Borderline-resektabel (LBPC)

Primaumlr irresektabel (LAUPC)

Borderline-Kriterien nach NCCN 22017

Quelle Seufferlein et al Dtsch Arztebl Int 2014 111(22) 396-402

Definition LAPC

X Aussagekraumlftige

Bildgebung (Spiral-CT mit KM

mind 3mm Schichten)

NE

OL

AP

-Ko

llektiv

-gt Identifizierung von

Studienpatienten in

interdisziplinaumlren

Tumorboards

Intergroup Criteria for clinical staging of localized PC (Katz M et al ASCO 2014)

Definition from surgical standpoints


Kriterien aus chirugischer Sicht

BRPC Treatment Guidelines


Fakt ist leiderhellip bull Noch keine Phase III-Daten

bull Zumeist retrospektive Daten

bull Mehrere Phase I und II-Ergebnisse (ohne Kontrollarm oder kleine Fallzahl)

bull Gepoolte Daten ndash Unterschiedliche Chemo-Strahlenprotokolle

ndash Unterschiedliche Borderline-Kriterien

ndash Definition R0

Borderline resektabel (LBPC)

bull Neoadjuvante Therapie im Rahmen von Studien (off lable)

bull Bei zumindest stabiler Erkrankung chirurgische Exploration anstreben

PRIMAumlR IRRESEKTABLES PC LAUPC

LAUPC Treatment Guidelines NCCN ASCO


Slide 26


Conclusions Multi-D Tumor Boards


(Radio-)Chemotherapie bei lokal fortgeschrittenen PC

PFS OS StudieQuelle

RT+CisF vs Gem 14 vs 32 P=0025

86 vs 13 P=003

Chauffert AnnOnc 2008

Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011

Gem +- RT 4 Mo Induktion Gem-haltige Chemo

12 vs 104 152 vs 165

LAP07 Hammel Jama 2016

Gem +- Erlotinib

99 vs 84

119 vs 136


Sek irresektables oder metastasiertes PC

Palliative Erstlinie

Ansprechen PFS OS StudieQuelle

5FULV vs BSC 6 vs 2 60 vs 25 Plt 001

Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002

43 vs 56 Burris 1997

Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004

71 vs 62 Cunningham JCO 2009

Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX

Oxaliplatin 85 mgqm 2h Tag 1 Irinotecan 180 mgqm 90 Min Tag 1 Folinsaumlure 400 mgqm 120 Min Tag 1 5-FU 400 mgqm Bolus Tag 1 5-FU 2400 mgqm 46 h Tag 1 Wiederholung Tag 15

FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825

uumlberwiegend franzoumlsische Zentren

Altersmedian 61 Jahre

FOLFIRINOX Original Oxaliplatin 85 mgqm 2h Tag 1 Irinotecan 180 mgqm 90 Min Tag 1 Folinsaumlure 400 mgqm 120 Min Tag 1 5-FU 400 mgqm Bolus Tag 1 5-FU 2400 mgqm 46 h Tag 1 Wiederholung Tag 15 Modifiziertes FOLFIRINOX 85 Oxaliplatin 75 Irinotecan Kein 5FU-Bolus 5-FU 2400 mgqm Oder 75 Irinotecan 25 5-FU Bolus

Mod FOLFIRINOX

bull Kein prospektiver Studienvergleich

bull Aumlhnliches PFS und OS in einarmigen Studien

bull ZB Cancer Lett 2017 Oct 1040622-26 doi 101016jcanlet201707012 Epub 2017 Jul 17 PFS 103 vs 7 Monate 325 Ansprechen

bull (Chinesen)

Mod FOLFIRINOX = FOLFIRINOX

Overall survival Progression-free survival

Median OS

6 mo 12 mo 18 mo Median PFS

6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62

Br J Cancer 2016 Mar 29 114(7) 809ndash812

Prospektive Studie mit direktem Vergleich FOLFIRINOX vs Mod Mod 75 Irinotecan 75 5FU Bolus

NAB-PACLITAXELGEMCITABIN

nabPaclitaxel

bull nanoparticle albumin bound paclitaxel bull Paclitaxel an Albumin-Nanopartikel einer

mittleren Groumlszlige von ungefaumlhr 130 Nanometer gebunden

bull Besser vertraumlglich wie Paclitaxel kaum Hypersensitivitaumltsreaktionen keine Praumlmedikation obligat

bull Lineare Pharmakokinetik besseres Verteilungsvolumen

bull Hauptnebenwirkung reversible Knochenmarkstoxizitaumlt Polyneuropathie

73

Gemcitabin

bull 2prime2prime-Difluordesoxycytidin bull Nucleosidanalogon von Cytidin bull Abbruch der DNA-Synthese bull Prodrug bull Renale Elimination bull Wirksamkeit von Dosis und Infusionsdauer

abhaumlngig bull Nebenwirkungen allergische Reaktionen

grippale Symptomatik KM-Toxizitaumlt

74

FOLFIRINOX

OS 111 vs 68 Mo PFS 64 vs 33 Mo

nabPacGem OS 85 vs 67 Mo PFS 55 vs 37 Mo

N Engl J Med 2011 3641817-1825 N Engl J Med 2013 3691691-1703

Mehr Patienten West- und Osteuropa uumlberwiegend franzoumlsische Zentren

Palliative Zweitlinie


BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008

CONKO Pelzer EJCA 2011

5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010

CONKO-003 Oettle JCO 2013

5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012

NAPOLI-1 Wang-Gilliam JCO 2016

5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002

PANCREOX Gill JCO2016

Benefit fuumlr 5FULV + nalIrinotecan


Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan

bull Liposomales Irinotecan

bull Laumlngere Halbwertszeit

bull Houmlhere Gewebekonzentration moumlglich als bei Irinotecan

bull Verlaumlngerte Aktivitaumltszeit in Tumorzellen

bull Kein direkter Studienvergleich mit Irinotecan

NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w

5-FULV 2000200 mgqm 4xw 6w

Nal-Iri 80 mgqm +

5-FULV 2400400 mgqm 2w

Prim Endpunkt OS Sek Endpunkte PFS TTF OR CA19-9-Ansprechen

NAPOLI-1 Zwischenauswertung

Nal-Iri +5-FULV (n=117)

5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05

Wang-Gilliam et al J Clin Oncol 34 2016 (suppl Abstr 4126)

Updated overall survival (OS) analysis of NAPOLI-1

Phase 3 study of nanoliposomal irinotecan (nal-IRI MM-398) with or without 5-fluorouracil and leucovorin (5-FULV) vs 5-FULV in metastatic pancreatic cancer (mPAC) previously treated with

gemcitabine (gem)-based therapy

Haupt-Nebenwirkungen Neutropenie Diarrhoe Erbrechen Fatigue

Schlussfolgerung der Autoren bull signifikanter Uumlberlebensvorteil fuumlr nal-IRI+5-FULV

bull Neuer Standard fuumlr Gem-vorbehnadelte mPAC


Effect of baseline carbohydrate antigen 19-9 (CA19-9) level on overall survival (OS) in

NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)

nal-IRI +5-FULV (n = 115)

76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)

HR for Death (95 CI)

112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)

J Clin Oncol 34 2016 (suppl Abstr e15740)

PEGPH20

Hyaluronan um Tumor -gt erhoumlhter interstitieller Druck -gt Kompression Gefaumlszlige -gt red Wirkstofftransport PEGPH20 degradiert HA -gt Wirkspiegel steigen

HALO-202

Randomized Phase 2 Study of

PEGPH20 Plus nab-Paclitaxel Gemcitabine (PAG)

vs nab-Paclitaxel Gemcitabine (AG) in Patients with Untreated Metastatic Pancreatic Ductal

Adenocarcinoma

Hingorani et al JClin Oncol 35 2017 (suppl abstr 4008)

Ansprechraten


PFS


PFS-Subgruppe


Exploratory Endpoint Overall Survival in HA-High (Combined Stages 1 amp 2)


Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE

Supportive Therapien

bull Antikoagulation mit niedermolekularem Heparin fuumlhrt sowohl in der Primaumlr- als auch Sekundaumlrprophylaxe zu signifikant weniger thromboembolischen Ereignissen jedoch kaum zu einer Uumlberlebensverbesserung

bull S3-Leitlinie bdquokannldquo-Empfehlung

bull Misteltherapie bdquokannldquo-Empfehlung

ZUSAMMENFASSUNG

httpswwwonkopediacomdeonkopediaguidelinespankreaskarzinomviewhtmlindexhtmlID0EFLAE

DGHO-Therapieleitlinie Stand Juli 2017

htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E

Von Furfur - Krebs in Deutschland 2012 CC-BY-SA 40 httpscommonswikimediaorgwindexphpcurid=47147008

Epidemiologie

Epidemiologie





Allgemeines



WARUM





Symptome





Exokrines PC





Praumlkanzerosen




Pathogenese




Nature 2015 Feb 26 518(7540) 495ndash501





gt 90 KRAS-Mutation




Tumorzellen

sezernieren

TGFβ CXCL5 and

GM-CSF


immunsuppressiven

myeloischen Zellen

und T reg Zellen

Risikofaktoren



bull Rauchen











bull FAP











Diagnostik

bull Sono Abdomen


bull Ca 19-9 CEA


Staging






Klassifikation





bull metastasiert




(irresektabel)







hepatica comm




AJCC Version 8

bull St IA T1 N0 M0

bull St IB T2 N0 M0




T4 jedes N M0



FIGURE 3




FIGURE 4




FIGURE 4




Wo stehen wir heute










Operation




CAVE prauml-OP




R0-Resektion


OP-Ziel



FIGURE 3









Ghan

eh e

t al

A

nnS

urg

20

17 DOI 101

097S

LA0

000000000002557



ndash N

ndash PS 1




Neoadjuvanz





Thesen









ADJUVANTE THERAPIE


PFS () OS () Studie


ESPAC-1


207 vs 104 P=001

CONKO-001


ESPAC-3


CONKO-005

Gem +- Cape 280 vs 255 P=0032

ESPAC-4

Slide 20



(Phase III)


Reported Toxicity




Slide 16





Follow up)



Alternative Fakten


PFS () OS () Studie


37 vs 38 ns

41 vs 51 ns

Klinkenbiijl 1999


ESPAC-1


24 vs 24 ns


RT5FU vs RTGem

18 vs 22 ns

US IntergroupRT

OG 9704


Adjuvante Therapie









Definition LAPC



mind 3mm Schichten)

NE

OL

AP

-Ko

llektiv


Studienpatienten in


Tumorboards












ndash Definition R0







Slide 26





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E

Epidemiologie





Allgemeines



WARUM





Symptome





Exokrines PC





Praumlkanzerosen




Pathogenese




Nature 2015 Feb 26 518(7540) 495ndash501





gt 90 KRAS-Mutation




Tumorzellen

sezernieren

TGFβ CXCL5 and

GM-CSF


immunsuppressiven

myeloischen Zellen

und T reg Zellen

Risikofaktoren



bull Rauchen











bull FAP











Diagnostik

bull Sono Abdomen


bull Ca 19-9 CEA


Staging






Klassifikation





bull metastasiert




(irresektabel)







hepatica comm




AJCC Version 8

bull St IA T1 N0 M0

bull St IB T2 N0 M0




T4 jedes N M0



FIGURE 3




FIGURE 4




FIGURE 4




Wo stehen wir heute










Operation




CAVE prauml-OP




R0-Resektion


OP-Ziel



FIGURE 3









Ghan

eh e

t al

A

nnS

urg

20

17 DOI 101

097S

LA0

000000000002557



ndash N

ndash PS 1




Neoadjuvanz





Thesen









ADJUVANTE THERAPIE


PFS () OS () Studie


ESPAC-1


207 vs 104 P=001

CONKO-001


ESPAC-3


CONKO-005

Gem +- Cape 280 vs 255 P=0032

ESPAC-4

Slide 20



(Phase III)


Reported Toxicity




Slide 16





Follow up)



Alternative Fakten


PFS () OS () Studie


37 vs 38 ns

41 vs 51 ns

Klinkenbiijl 1999


ESPAC-1


24 vs 24 ns


RT5FU vs RTGem

18 vs 22 ns

US IntergroupRT

OG 9704


Adjuvante Therapie









Definition LAPC



mind 3mm Schichten)

NE

OL

AP

-Ko

llektiv


Studienpatienten in


Tumorboards












ndash Definition R0







Slide 26





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E

Allgemeines



WARUM





Symptome





Exokrines PC





Praumlkanzerosen




Pathogenese




Nature 2015 Feb 26 518(7540) 495ndash501





gt 90 KRAS-Mutation




Tumorzellen

sezernieren

TGFβ CXCL5 and

GM-CSF


immunsuppressiven

myeloischen Zellen

und T reg Zellen

Risikofaktoren



bull Rauchen











bull FAP











Diagnostik

bull Sono Abdomen


bull Ca 19-9 CEA


Staging






Klassifikation





bull metastasiert




(irresektabel)







hepatica comm




AJCC Version 8

bull St IA T1 N0 M0

bull St IB T2 N0 M0




T4 jedes N M0



FIGURE 3




FIGURE 4




FIGURE 4




Wo stehen wir heute










Operation




CAVE prauml-OP




R0-Resektion


OP-Ziel



FIGURE 3









Ghan

eh e

t al

A

nnS

urg

20

17 DOI 101

097S

LA0

000000000002557



ndash N

ndash PS 1




Neoadjuvanz





Thesen









ADJUVANTE THERAPIE


PFS () OS () Studie


ESPAC-1


207 vs 104 P=001

CONKO-001


ESPAC-3


CONKO-005

Gem +- Cape 280 vs 255 P=0032

ESPAC-4

Slide 20



(Phase III)


Reported Toxicity




Slide 16





Follow up)



Alternative Fakten


PFS () OS () Studie


37 vs 38 ns

41 vs 51 ns

Klinkenbiijl 1999


ESPAC-1


24 vs 24 ns


RT5FU vs RTGem

18 vs 22 ns

US IntergroupRT

OG 9704


Adjuvante Therapie









Definition LAPC



mind 3mm Schichten)

NE

OL

AP

-Ko

llektiv


Studienpatienten in


Tumorboards












ndash Definition R0







Slide 26





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E

Symptome





Exokrines PC





Praumlkanzerosen




Pathogenese




Nature 2015 Feb 26 518(7540) 495ndash501





gt 90 KRAS-Mutation




Tumorzellen

sezernieren

TGFβ CXCL5 and

GM-CSF


immunsuppressiven

myeloischen Zellen

und T reg Zellen

Risikofaktoren



bull Rauchen











bull FAP











Diagnostik

bull Sono Abdomen


bull Ca 19-9 CEA


Staging






Klassifikation





bull metastasiert




(irresektabel)







hepatica comm




AJCC Version 8

bull St IA T1 N0 M0

bull St IB T2 N0 M0




T4 jedes N M0



FIGURE 3




FIGURE 4




FIGURE 4




Wo stehen wir heute










Operation




CAVE prauml-OP




R0-Resektion


OP-Ziel



FIGURE 3









Ghan

eh e

t al

A

nnS

urg

20

17 DOI 101

097S

LA0

000000000002557



ndash N

ndash PS 1




Neoadjuvanz





Thesen









ADJUVANTE THERAPIE


PFS () OS () Studie


ESPAC-1


207 vs 104 P=001

CONKO-001


ESPAC-3


CONKO-005

Gem +- Cape 280 vs 255 P=0032

ESPAC-4

Slide 20



(Phase III)


Reported Toxicity




Slide 16





Follow up)



Alternative Fakten


PFS () OS () Studie


37 vs 38 ns

41 vs 51 ns

Klinkenbiijl 1999


ESPAC-1


24 vs 24 ns


RT5FU vs RTGem

18 vs 22 ns

US IntergroupRT

OG 9704


Adjuvante Therapie









Definition LAPC



mind 3mm Schichten)

NE

OL

AP

-Ko

llektiv


Studienpatienten in


Tumorboards












ndash Definition R0







Slide 26





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E

Exokrines PC





Praumlkanzerosen




Pathogenese




Nature 2015 Feb 26 518(7540) 495ndash501





gt 90 KRAS-Mutation




Tumorzellen

sezernieren

TGFβ CXCL5 and

GM-CSF


immunsuppressiven

myeloischen Zellen

und T reg Zellen

Risikofaktoren



bull Rauchen











bull FAP











Diagnostik

bull Sono Abdomen


bull Ca 19-9 CEA


Staging






Klassifikation





bull metastasiert




(irresektabel)







hepatica comm




AJCC Version 8

bull St IA T1 N0 M0

bull St IB T2 N0 M0




T4 jedes N M0



FIGURE 3




FIGURE 4




FIGURE 4




Wo stehen wir heute










Operation




CAVE prauml-OP




R0-Resektion


OP-Ziel



FIGURE 3









Ghan

eh e

t al

A

nnS

urg

20

17 DOI 101

097S

LA0

000000000002557



ndash N

ndash PS 1




Neoadjuvanz





Thesen









ADJUVANTE THERAPIE


PFS () OS () Studie


ESPAC-1


207 vs 104 P=001

CONKO-001


ESPAC-3


CONKO-005

Gem +- Cape 280 vs 255 P=0032

ESPAC-4

Slide 20



(Phase III)


Reported Toxicity




Slide 16





Follow up)



Alternative Fakten


PFS () OS () Studie


37 vs 38 ns

41 vs 51 ns

Klinkenbiijl 1999


ESPAC-1


24 vs 24 ns


RT5FU vs RTGem

18 vs 22 ns

US IntergroupRT

OG 9704


Adjuvante Therapie









Definition LAPC



mind 3mm Schichten)

NE

OL

AP

-Ko

llektiv


Studienpatienten in


Tumorboards












ndash Definition R0







Slide 26





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E

Praumlkanzerosen




Pathogenese




Nature 2015 Feb 26 518(7540) 495ndash501





gt 90 KRAS-Mutation




Tumorzellen

sezernieren

TGFβ CXCL5 and

GM-CSF


immunsuppressiven

myeloischen Zellen

und T reg Zellen

Risikofaktoren



bull Rauchen











bull FAP











Diagnostik

bull Sono Abdomen


bull Ca 19-9 CEA


Staging






Klassifikation





bull metastasiert




(irresektabel)







hepatica comm




AJCC Version 8

bull St IA T1 N0 M0

bull St IB T2 N0 M0




T4 jedes N M0



FIGURE 3




FIGURE 4




FIGURE 4




Wo stehen wir heute










Operation




CAVE prauml-OP




R0-Resektion


OP-Ziel



FIGURE 3









Ghan

eh e

t al

A

nnS

urg

20

17 DOI 101

097S

LA0

000000000002557



ndash N

ndash PS 1




Neoadjuvanz





Thesen









ADJUVANTE THERAPIE


PFS () OS () Studie


ESPAC-1


207 vs 104 P=001

CONKO-001


ESPAC-3


CONKO-005

Gem +- Cape 280 vs 255 P=0032

ESPAC-4

Slide 20



(Phase III)


Reported Toxicity




Slide 16





Follow up)



Alternative Fakten


PFS () OS () Studie


37 vs 38 ns

41 vs 51 ns

Klinkenbiijl 1999


ESPAC-1


24 vs 24 ns


RT5FU vs RTGem

18 vs 22 ns

US IntergroupRT

OG 9704


Adjuvante Therapie









Definition LAPC



mind 3mm Schichten)

NE

OL

AP

-Ko

llektiv


Studienpatienten in


Tumorboards












ndash Definition R0







Slide 26





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E

Pathogenese




Nature 2015 Feb 26 518(7540) 495ndash501





gt 90 KRAS-Mutation




Tumorzellen

sezernieren

TGFβ CXCL5 and

GM-CSF


immunsuppressiven

myeloischen Zellen

und T reg Zellen

Risikofaktoren



bull Rauchen











bull FAP











Diagnostik

bull Sono Abdomen


bull Ca 19-9 CEA


Staging






Klassifikation





bull metastasiert




(irresektabel)







hepatica comm




AJCC Version 8

bull St IA T1 N0 M0

bull St IB T2 N0 M0




T4 jedes N M0



FIGURE 3




FIGURE 4




FIGURE 4




Wo stehen wir heute










Operation




CAVE prauml-OP




R0-Resektion


OP-Ziel



FIGURE 3









Ghan

eh e

t al

A

nnS

urg

20

17 DOI 101

097S

LA0

000000000002557



ndash N

ndash PS 1




Neoadjuvanz





Thesen









ADJUVANTE THERAPIE


PFS () OS () Studie


ESPAC-1


207 vs 104 P=001

CONKO-001


ESPAC-3


CONKO-005

Gem +- Cape 280 vs 255 P=0032

ESPAC-4

Slide 20



(Phase III)


Reported Toxicity




Slide 16





Follow up)



Alternative Fakten


PFS () OS () Studie


37 vs 38 ns

41 vs 51 ns

Klinkenbiijl 1999


ESPAC-1


24 vs 24 ns


RT5FU vs RTGem

18 vs 22 ns

US IntergroupRT

OG 9704


Adjuvante Therapie









Definition LAPC



mind 3mm Schichten)

NE

OL

AP

-Ko

llektiv


Studienpatienten in


Tumorboards












ndash Definition R0







Slide 26





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E


Nature 2015 Feb 26 518(7540) 495ndash501





gt 90 KRAS-Mutation




Tumorzellen

sezernieren

TGFβ CXCL5 and

GM-CSF


immunsuppressiven

myeloischen Zellen

und T reg Zellen

Risikofaktoren



bull Rauchen











bull FAP











Diagnostik

bull Sono Abdomen


bull Ca 19-9 CEA


Staging






Klassifikation





bull metastasiert




(irresektabel)







hepatica comm




AJCC Version 8

bull St IA T1 N0 M0

bull St IB T2 N0 M0




T4 jedes N M0



FIGURE 3




FIGURE 4




FIGURE 4




Wo stehen wir heute










Operation




CAVE prauml-OP




R0-Resektion


OP-Ziel



FIGURE 3









Ghan

eh e

t al

A

nnS

urg

20

17 DOI 101

097S

LA0

000000000002557



ndash N

ndash PS 1




Neoadjuvanz





Thesen









ADJUVANTE THERAPIE


PFS () OS () Studie


ESPAC-1


207 vs 104 P=001

CONKO-001


ESPAC-3


CONKO-005

Gem +- Cape 280 vs 255 P=0032

ESPAC-4

Slide 20



(Phase III)


Reported Toxicity




Slide 16





Follow up)



Alternative Fakten


PFS () OS () Studie


37 vs 38 ns

41 vs 51 ns

Klinkenbiijl 1999


ESPAC-1


24 vs 24 ns


RT5FU vs RTGem

18 vs 22 ns

US IntergroupRT

OG 9704


Adjuvante Therapie









Definition LAPC



mind 3mm Schichten)

NE

OL

AP

-Ko

llektiv


Studienpatienten in


Tumorboards












ndash Definition R0







Slide 26





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E




gt 90 KRAS-Mutation




Tumorzellen

sezernieren

TGFβ CXCL5 and

GM-CSF


immunsuppressiven

myeloischen Zellen

und T reg Zellen

Risikofaktoren



bull Rauchen











bull FAP











Diagnostik

bull Sono Abdomen


bull Ca 19-9 CEA


Staging






Klassifikation





bull metastasiert




(irresektabel)







hepatica comm




AJCC Version 8

bull St IA T1 N0 M0

bull St IB T2 N0 M0




T4 jedes N M0



FIGURE 3




FIGURE 4




FIGURE 4




Wo stehen wir heute










Operation




CAVE prauml-OP




R0-Resektion


OP-Ziel



FIGURE 3









Ghan

eh e

t al

A

nnS

urg

20

17 DOI 101

097S

LA0

000000000002557



ndash N

ndash PS 1




Neoadjuvanz





Thesen









ADJUVANTE THERAPIE


PFS () OS () Studie


ESPAC-1


207 vs 104 P=001

CONKO-001


ESPAC-3


CONKO-005

Gem +- Cape 280 vs 255 P=0032

ESPAC-4

Slide 20



(Phase III)


Reported Toxicity




Slide 16





Follow up)



Alternative Fakten


PFS () OS () Studie


37 vs 38 ns

41 vs 51 ns

Klinkenbiijl 1999


ESPAC-1


24 vs 24 ns


RT5FU vs RTGem

18 vs 22 ns

US IntergroupRT

OG 9704


Adjuvante Therapie









Definition LAPC



mind 3mm Schichten)

NE

OL

AP

-Ko

llektiv


Studienpatienten in


Tumorboards












ndash Definition R0







Slide 26





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E




Tumorzellen

sezernieren

TGFβ CXCL5 and

GM-CSF


immunsuppressiven

myeloischen Zellen

und T reg Zellen

Risikofaktoren



bull Rauchen











bull FAP











Diagnostik

bull Sono Abdomen


bull Ca 19-9 CEA


Staging






Klassifikation





bull metastasiert




(irresektabel)







hepatica comm




AJCC Version 8

bull St IA T1 N0 M0

bull St IB T2 N0 M0




T4 jedes N M0



FIGURE 3




FIGURE 4




FIGURE 4




Wo stehen wir heute










Operation




CAVE prauml-OP




R0-Resektion


OP-Ziel



FIGURE 3









Ghan

eh e

t al

A

nnS

urg

20

17 DOI 101

097S

LA0

000000000002557



ndash N

ndash PS 1




Neoadjuvanz





Thesen









ADJUVANTE THERAPIE


PFS () OS () Studie


ESPAC-1


207 vs 104 P=001

CONKO-001


ESPAC-3


CONKO-005

Gem +- Cape 280 vs 255 P=0032

ESPAC-4

Slide 20



(Phase III)


Reported Toxicity




Slide 16





Follow up)



Alternative Fakten


PFS () OS () Studie


37 vs 38 ns

41 vs 51 ns

Klinkenbiijl 1999


ESPAC-1


24 vs 24 ns


RT5FU vs RTGem

18 vs 22 ns

US IntergroupRT

OG 9704


Adjuvante Therapie









Definition LAPC



mind 3mm Schichten)

NE

OL

AP

-Ko

llektiv


Studienpatienten in


Tumorboards












ndash Definition R0







Slide 26





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E

Risikofaktoren



bull Rauchen











bull FAP











Diagnostik

bull Sono Abdomen


bull Ca 19-9 CEA


Staging






Klassifikation





bull metastasiert




(irresektabel)







hepatica comm




AJCC Version 8

bull St IA T1 N0 M0

bull St IB T2 N0 M0




T4 jedes N M0



FIGURE 3




FIGURE 4




FIGURE 4




Wo stehen wir heute










Operation




CAVE prauml-OP




R0-Resektion


OP-Ziel



FIGURE 3









Ghan

eh e

t al

A

nnS

urg

20

17 DOI 101

097S

LA0

000000000002557



ndash N

ndash PS 1




Neoadjuvanz





Thesen









ADJUVANTE THERAPIE


PFS () OS () Studie


ESPAC-1


207 vs 104 P=001

CONKO-001


ESPAC-3


CONKO-005

Gem +- Cape 280 vs 255 P=0032

ESPAC-4

Slide 20



(Phase III)


Reported Toxicity




Slide 16





Follow up)



Alternative Fakten


PFS () OS () Studie


37 vs 38 ns

41 vs 51 ns

Klinkenbiijl 1999


ESPAC-1


24 vs 24 ns


RT5FU vs RTGem

18 vs 22 ns

US IntergroupRT

OG 9704


Adjuvante Therapie









Definition LAPC



mind 3mm Schichten)

NE

OL

AP

-Ko

llektiv


Studienpatienten in


Tumorboards












ndash Definition R0







Slide 26





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E








bull FAP











Diagnostik

bull Sono Abdomen


bull Ca 19-9 CEA


Staging






Klassifikation





bull metastasiert




(irresektabel)







hepatica comm




AJCC Version 8

bull St IA T1 N0 M0

bull St IB T2 N0 M0




T4 jedes N M0



FIGURE 3




FIGURE 4




FIGURE 4




Wo stehen wir heute










Operation




CAVE prauml-OP




R0-Resektion


OP-Ziel



FIGURE 3









Ghan

eh e

t al

A

nnS

urg

20

17 DOI 101

097S

LA0

000000000002557



ndash N

ndash PS 1




Neoadjuvanz





Thesen









ADJUVANTE THERAPIE


PFS () OS () Studie


ESPAC-1


207 vs 104 P=001

CONKO-001


ESPAC-3


CONKO-005

Gem +- Cape 280 vs 255 P=0032

ESPAC-4

Slide 20



(Phase III)


Reported Toxicity




Slide 16





Follow up)



Alternative Fakten


PFS () OS () Studie


37 vs 38 ns

41 vs 51 ns

Klinkenbiijl 1999


ESPAC-1


24 vs 24 ns


RT5FU vs RTGem

18 vs 22 ns

US IntergroupRT

OG 9704


Adjuvante Therapie









Definition LAPC



mind 3mm Schichten)

NE

OL

AP

-Ko

llektiv


Studienpatienten in


Tumorboards












ndash Definition R0







Slide 26





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E








Diagnostik

bull Sono Abdomen


bull Ca 19-9 CEA


Staging






Klassifikation





bull metastasiert




(irresektabel)







hepatica comm




AJCC Version 8

bull St IA T1 N0 M0

bull St IB T2 N0 M0




T4 jedes N M0



FIGURE 3




FIGURE 4




FIGURE 4




Wo stehen wir heute










Operation




CAVE prauml-OP




R0-Resektion


OP-Ziel



FIGURE 3









Ghan

eh e

t al

A

nnS

urg

20

17 DOI 101

097S

LA0

000000000002557



ndash N

ndash PS 1




Neoadjuvanz





Thesen









ADJUVANTE THERAPIE


PFS () OS () Studie


ESPAC-1


207 vs 104 P=001

CONKO-001


ESPAC-3


CONKO-005

Gem +- Cape 280 vs 255 P=0032

ESPAC-4

Slide 20



(Phase III)


Reported Toxicity




Slide 16





Follow up)



Alternative Fakten


PFS () OS () Studie


37 vs 38 ns

41 vs 51 ns

Klinkenbiijl 1999


ESPAC-1


24 vs 24 ns


RT5FU vs RTGem

18 vs 22 ns

US IntergroupRT

OG 9704


Adjuvante Therapie









Definition LAPC



mind 3mm Schichten)

NE

OL

AP

-Ko

llektiv


Studienpatienten in


Tumorboards












ndash Definition R0







Slide 26





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E

Staging






Klassifikation





bull metastasiert




(irresektabel)







hepatica comm




AJCC Version 8

bull St IA T1 N0 M0

bull St IB T2 N0 M0




T4 jedes N M0



FIGURE 3




FIGURE 4




FIGURE 4




Wo stehen wir heute










Operation




CAVE prauml-OP




R0-Resektion


OP-Ziel



FIGURE 3









Ghan

eh e

t al

A

nnS

urg

20

17 DOI 101

097S

LA0

000000000002557



ndash N

ndash PS 1




Neoadjuvanz





Thesen









ADJUVANTE THERAPIE


PFS () OS () Studie


ESPAC-1


207 vs 104 P=001

CONKO-001


ESPAC-3


CONKO-005

Gem +- Cape 280 vs 255 P=0032

ESPAC-4

Slide 20



(Phase III)


Reported Toxicity




Slide 16





Follow up)



Alternative Fakten


PFS () OS () Studie


37 vs 38 ns

41 vs 51 ns

Klinkenbiijl 1999


ESPAC-1


24 vs 24 ns


RT5FU vs RTGem

18 vs 22 ns

US IntergroupRT

OG 9704


Adjuvante Therapie









Definition LAPC



mind 3mm Schichten)

NE

OL

AP

-Ko

llektiv


Studienpatienten in


Tumorboards












ndash Definition R0







Slide 26





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E

Klassifikation





bull metastasiert




(irresektabel)







hepatica comm




AJCC Version 8

bull St IA T1 N0 M0

bull St IB T2 N0 M0




T4 jedes N M0



FIGURE 3




FIGURE 4




FIGURE 4




Wo stehen wir heute










Operation




CAVE prauml-OP




R0-Resektion


OP-Ziel



FIGURE 3









Ghan

eh e

t al

A

nnS

urg

20

17 DOI 101

097S

LA0

000000000002557



ndash N

ndash PS 1




Neoadjuvanz





Thesen









ADJUVANTE THERAPIE


PFS () OS () Studie


ESPAC-1


207 vs 104 P=001

CONKO-001


ESPAC-3


CONKO-005

Gem +- Cape 280 vs 255 P=0032

ESPAC-4

Slide 20



(Phase III)


Reported Toxicity




Slide 16





Follow up)



Alternative Fakten


PFS () OS () Studie


37 vs 38 ns

41 vs 51 ns

Klinkenbiijl 1999


ESPAC-1


24 vs 24 ns


RT5FU vs RTGem

18 vs 22 ns

US IntergroupRT

OG 9704


Adjuvante Therapie









Definition LAPC



mind 3mm Schichten)

NE

OL

AP

-Ko

llektiv


Studienpatienten in


Tumorboards












ndash Definition R0







Slide 26





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E




(irresektabel)







hepatica comm




AJCC Version 8

bull St IA T1 N0 M0

bull St IB T2 N0 M0




T4 jedes N M0



FIGURE 3




FIGURE 4




FIGURE 4




Wo stehen wir heute










Operation




CAVE prauml-OP




R0-Resektion


OP-Ziel



FIGURE 3









Ghan

eh e

t al

A

nnS

urg

20

17 DOI 101

097S

LA0

000000000002557



ndash N

ndash PS 1




Neoadjuvanz





Thesen









ADJUVANTE THERAPIE


PFS () OS () Studie


ESPAC-1


207 vs 104 P=001

CONKO-001


ESPAC-3


CONKO-005

Gem +- Cape 280 vs 255 P=0032

ESPAC-4

Slide 20



(Phase III)


Reported Toxicity




Slide 16





Follow up)



Alternative Fakten


PFS () OS () Studie


37 vs 38 ns

41 vs 51 ns

Klinkenbiijl 1999


ESPAC-1


24 vs 24 ns


RT5FU vs RTGem

18 vs 22 ns

US IntergroupRT

OG 9704


Adjuvante Therapie









Definition LAPC



mind 3mm Schichten)

NE

OL

AP

-Ko

llektiv


Studienpatienten in


Tumorboards












ndash Definition R0







Slide 26





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E





hepatica comm




AJCC Version 8

bull St IA T1 N0 M0

bull St IB T2 N0 M0




T4 jedes N M0



FIGURE 3




FIGURE 4




FIGURE 4




Wo stehen wir heute










Operation




CAVE prauml-OP




R0-Resektion


OP-Ziel



FIGURE 3









Ghan

eh e

t al

A

nnS

urg

20

17 DOI 101

097S

LA0

000000000002557



ndash N

ndash PS 1




Neoadjuvanz





Thesen









ADJUVANTE THERAPIE


PFS () OS () Studie


ESPAC-1


207 vs 104 P=001

CONKO-001


ESPAC-3


CONKO-005

Gem +- Cape 280 vs 255 P=0032

ESPAC-4

Slide 20



(Phase III)


Reported Toxicity




Slide 16





Follow up)



Alternative Fakten


PFS () OS () Studie


37 vs 38 ns

41 vs 51 ns

Klinkenbiijl 1999


ESPAC-1


24 vs 24 ns


RT5FU vs RTGem

18 vs 22 ns

US IntergroupRT

OG 9704


Adjuvante Therapie









Definition LAPC



mind 3mm Schichten)

NE

OL

AP

-Ko

llektiv


Studienpatienten in


Tumorboards












ndash Definition R0







Slide 26





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E

AJCC Version 8

bull St IA T1 N0 M0

bull St IB T2 N0 M0




T4 jedes N M0



FIGURE 3




FIGURE 4




FIGURE 4




Wo stehen wir heute










Operation




CAVE prauml-OP




R0-Resektion


OP-Ziel



FIGURE 3









Ghan

eh e

t al

A

nnS

urg

20

17 DOI 101

097S

LA0

000000000002557



ndash N

ndash PS 1




Neoadjuvanz





Thesen









ADJUVANTE THERAPIE


PFS () OS () Studie


ESPAC-1


207 vs 104 P=001

CONKO-001


ESPAC-3


CONKO-005

Gem +- Cape 280 vs 255 P=0032

ESPAC-4

Slide 20



(Phase III)


Reported Toxicity




Slide 16





Follow up)



Alternative Fakten


PFS () OS () Studie


37 vs 38 ns

41 vs 51 ns

Klinkenbiijl 1999


ESPAC-1


24 vs 24 ns


RT5FU vs RTGem

18 vs 22 ns

US IntergroupRT

OG 9704


Adjuvante Therapie









Definition LAPC



mind 3mm Schichten)

NE

OL

AP

-Ko

llektiv


Studienpatienten in


Tumorboards












ndash Definition R0







Slide 26





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E


FIGURE 3




FIGURE 4




FIGURE 4




Wo stehen wir heute










Operation




CAVE prauml-OP




R0-Resektion


OP-Ziel



FIGURE 3









Ghan

eh e

t al

A

nnS

urg

20

17 DOI 101

097S

LA0

000000000002557



ndash N

ndash PS 1




Neoadjuvanz





Thesen









ADJUVANTE THERAPIE


PFS () OS () Studie


ESPAC-1


207 vs 104 P=001

CONKO-001


ESPAC-3


CONKO-005

Gem +- Cape 280 vs 255 P=0032

ESPAC-4

Slide 20



(Phase III)


Reported Toxicity




Slide 16





Follow up)



Alternative Fakten


PFS () OS () Studie


37 vs 38 ns

41 vs 51 ns

Klinkenbiijl 1999


ESPAC-1


24 vs 24 ns


RT5FU vs RTGem

18 vs 22 ns

US IntergroupRT

OG 9704


Adjuvante Therapie









Definition LAPC



mind 3mm Schichten)

NE

OL

AP

-Ko

llektiv


Studienpatienten in


Tumorboards












ndash Definition R0







Slide 26





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E


FIGURE 4




FIGURE 4




Wo stehen wir heute










Operation




CAVE prauml-OP




R0-Resektion


OP-Ziel



FIGURE 3









Ghan

eh e

t al

A

nnS

urg

20

17 DOI 101

097S

LA0

000000000002557



ndash N

ndash PS 1




Neoadjuvanz





Thesen









ADJUVANTE THERAPIE


PFS () OS () Studie


ESPAC-1


207 vs 104 P=001

CONKO-001


ESPAC-3


CONKO-005

Gem +- Cape 280 vs 255 P=0032

ESPAC-4

Slide 20



(Phase III)


Reported Toxicity




Slide 16





Follow up)



Alternative Fakten


PFS () OS () Studie


37 vs 38 ns

41 vs 51 ns

Klinkenbiijl 1999


ESPAC-1


24 vs 24 ns


RT5FU vs RTGem

18 vs 22 ns

US IntergroupRT

OG 9704


Adjuvante Therapie









Definition LAPC



mind 3mm Schichten)

NE

OL

AP

-Ko

llektiv


Studienpatienten in


Tumorboards












ndash Definition R0







Slide 26





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E


FIGURE 4




Wo stehen wir heute










Operation




CAVE prauml-OP




R0-Resektion


OP-Ziel



FIGURE 3









Ghan

eh e

t al

A

nnS

urg

20

17 DOI 101

097S

LA0

000000000002557



ndash N

ndash PS 1




Neoadjuvanz





Thesen









ADJUVANTE THERAPIE


PFS () OS () Studie


ESPAC-1


207 vs 104 P=001

CONKO-001


ESPAC-3


CONKO-005

Gem +- Cape 280 vs 255 P=0032

ESPAC-4

Slide 20



(Phase III)


Reported Toxicity




Slide 16





Follow up)



Alternative Fakten


PFS () OS () Studie


37 vs 38 ns

41 vs 51 ns

Klinkenbiijl 1999


ESPAC-1


24 vs 24 ns


RT5FU vs RTGem

18 vs 22 ns

US IntergroupRT

OG 9704


Adjuvante Therapie









Definition LAPC



mind 3mm Schichten)

NE

OL

AP

-Ko

llektiv


Studienpatienten in


Tumorboards












ndash Definition R0







Slide 26





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E


Wo stehen wir heute










Operation




CAVE prauml-OP




R0-Resektion


OP-Ziel



FIGURE 3









Ghan

eh e

t al

A

nnS

urg

20

17 DOI 101

097S

LA0

000000000002557



ndash N

ndash PS 1




Neoadjuvanz





Thesen









ADJUVANTE THERAPIE


PFS () OS () Studie


ESPAC-1


207 vs 104 P=001

CONKO-001


ESPAC-3


CONKO-005

Gem +- Cape 280 vs 255 P=0032

ESPAC-4

Slide 20



(Phase III)


Reported Toxicity




Slide 16





Follow up)



Alternative Fakten


PFS () OS () Studie


37 vs 38 ns

41 vs 51 ns

Klinkenbiijl 1999


ESPAC-1


24 vs 24 ns


RT5FU vs RTGem

18 vs 22 ns

US IntergroupRT

OG 9704


Adjuvante Therapie









Definition LAPC



mind 3mm Schichten)

NE

OL

AP

-Ko

llektiv


Studienpatienten in


Tumorboards












ndash Definition R0







Slide 26





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E










Operation




CAVE prauml-OP




R0-Resektion


OP-Ziel



FIGURE 3









Ghan

eh e

t al

A

nnS

urg

20

17 DOI 101

097S

LA0

000000000002557



ndash N

ndash PS 1




Neoadjuvanz





Thesen









ADJUVANTE THERAPIE


PFS () OS () Studie


ESPAC-1


207 vs 104 P=001

CONKO-001


ESPAC-3


CONKO-005

Gem +- Cape 280 vs 255 P=0032

ESPAC-4

Slide 20



(Phase III)


Reported Toxicity




Slide 16





Follow up)



Alternative Fakten


PFS () OS () Studie


37 vs 38 ns

41 vs 51 ns

Klinkenbiijl 1999


ESPAC-1


24 vs 24 ns


RT5FU vs RTGem

18 vs 22 ns

US IntergroupRT

OG 9704


Adjuvante Therapie









Definition LAPC



mind 3mm Schichten)

NE

OL

AP

-Ko

llektiv


Studienpatienten in


Tumorboards












ndash Definition R0







Slide 26





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E

CAVE prauml-OP




R0-Resektion


OP-Ziel



FIGURE 3









Ghan

eh e

t al

A

nnS

urg

20

17 DOI 101

097S

LA0

000000000002557



ndash N

ndash PS 1




Neoadjuvanz





Thesen









ADJUVANTE THERAPIE


PFS () OS () Studie


ESPAC-1


207 vs 104 P=001

CONKO-001


ESPAC-3


CONKO-005

Gem +- Cape 280 vs 255 P=0032

ESPAC-4

Slide 20



(Phase III)


Reported Toxicity




Slide 16





Follow up)



Alternative Fakten


PFS () OS () Studie


37 vs 38 ns

41 vs 51 ns

Klinkenbiijl 1999


ESPAC-1


24 vs 24 ns


RT5FU vs RTGem

18 vs 22 ns

US IntergroupRT

OG 9704


Adjuvante Therapie









Definition LAPC



mind 3mm Schichten)

NE

OL

AP

-Ko

llektiv


Studienpatienten in


Tumorboards












ndash Definition R0







Slide 26





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E

R0-Resektion


OP-Ziel



FIGURE 3









Ghan

eh e

t al

A

nnS

urg

20

17 DOI 101

097S

LA0

000000000002557



ndash N

ndash PS 1




Neoadjuvanz





Thesen









ADJUVANTE THERAPIE


PFS () OS () Studie


ESPAC-1


207 vs 104 P=001

CONKO-001


ESPAC-3


CONKO-005

Gem +- Cape 280 vs 255 P=0032

ESPAC-4

Slide 20



(Phase III)


Reported Toxicity




Slide 16





Follow up)



Alternative Fakten


PFS () OS () Studie


37 vs 38 ns

41 vs 51 ns

Klinkenbiijl 1999


ESPAC-1


24 vs 24 ns


RT5FU vs RTGem

18 vs 22 ns

US IntergroupRT

OG 9704


Adjuvante Therapie









Definition LAPC



mind 3mm Schichten)

NE

OL

AP

-Ko

llektiv


Studienpatienten in


Tumorboards












ndash Definition R0







Slide 26





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E


FIGURE 3









Ghan

eh e

t al

A

nnS

urg

20

17 DOI 101

097S

LA0

000000000002557



ndash N

ndash PS 1




Neoadjuvanz





Thesen









ADJUVANTE THERAPIE


PFS () OS () Studie


ESPAC-1


207 vs 104 P=001

CONKO-001


ESPAC-3


CONKO-005

Gem +- Cape 280 vs 255 P=0032

ESPAC-4

Slide 20



(Phase III)


Reported Toxicity




Slide 16





Follow up)



Alternative Fakten


PFS () OS () Studie


37 vs 38 ns

41 vs 51 ns

Klinkenbiijl 1999


ESPAC-1


24 vs 24 ns


RT5FU vs RTGem

18 vs 22 ns

US IntergroupRT

OG 9704


Adjuvante Therapie









Definition LAPC



mind 3mm Schichten)

NE

OL

AP

-Ko

llektiv


Studienpatienten in


Tumorboards












ndash Definition R0







Slide 26





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E







Ghan

eh e

t al

A

nnS

urg

20

17 DOI 101

097S

LA0

000000000002557



ndash N

ndash PS 1




Neoadjuvanz





Thesen









ADJUVANTE THERAPIE


PFS () OS () Studie


ESPAC-1


207 vs 104 P=001

CONKO-001


ESPAC-3


CONKO-005

Gem +- Cape 280 vs 255 P=0032

ESPAC-4

Slide 20



(Phase III)


Reported Toxicity




Slide 16





Follow up)



Alternative Fakten


PFS () OS () Studie


37 vs 38 ns

41 vs 51 ns

Klinkenbiijl 1999


ESPAC-1


24 vs 24 ns


RT5FU vs RTGem

18 vs 22 ns

US IntergroupRT

OG 9704


Adjuvante Therapie









Definition LAPC



mind 3mm Schichten)

NE

OL

AP

-Ko

llektiv


Studienpatienten in


Tumorboards












ndash Definition R0







Slide 26





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E



ndash N

ndash PS 1




Neoadjuvanz





Thesen









ADJUVANTE THERAPIE


PFS () OS () Studie


ESPAC-1


207 vs 104 P=001

CONKO-001


ESPAC-3


CONKO-005

Gem +- Cape 280 vs 255 P=0032

ESPAC-4

Slide 20



(Phase III)


Reported Toxicity




Slide 16





Follow up)



Alternative Fakten


PFS () OS () Studie


37 vs 38 ns

41 vs 51 ns

Klinkenbiijl 1999


ESPAC-1


24 vs 24 ns


RT5FU vs RTGem

18 vs 22 ns

US IntergroupRT

OG 9704


Adjuvante Therapie









Definition LAPC



mind 3mm Schichten)

NE

OL

AP

-Ko

llektiv


Studienpatienten in


Tumorboards












ndash Definition R0







Slide 26





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E

Neoadjuvanz





Thesen









ADJUVANTE THERAPIE


PFS () OS () Studie


ESPAC-1


207 vs 104 P=001

CONKO-001


ESPAC-3


CONKO-005

Gem +- Cape 280 vs 255 P=0032

ESPAC-4

Slide 20



(Phase III)


Reported Toxicity




Slide 16





Follow up)



Alternative Fakten


PFS () OS () Studie


37 vs 38 ns

41 vs 51 ns

Klinkenbiijl 1999


ESPAC-1


24 vs 24 ns


RT5FU vs RTGem

18 vs 22 ns

US IntergroupRT

OG 9704


Adjuvante Therapie









Definition LAPC



mind 3mm Schichten)

NE

OL

AP

-Ko

llektiv


Studienpatienten in


Tumorboards












ndash Definition R0







Slide 26





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E

Thesen









ADJUVANTE THERAPIE


PFS () OS () Studie


ESPAC-1


207 vs 104 P=001

CONKO-001


ESPAC-3


CONKO-005

Gem +- Cape 280 vs 255 P=0032

ESPAC-4

Slide 20



(Phase III)


Reported Toxicity




Slide 16





Follow up)



Alternative Fakten


PFS () OS () Studie


37 vs 38 ns

41 vs 51 ns

Klinkenbiijl 1999


ESPAC-1


24 vs 24 ns


RT5FU vs RTGem

18 vs 22 ns

US IntergroupRT

OG 9704


Adjuvante Therapie









Definition LAPC



mind 3mm Schichten)

NE

OL

AP

-Ko

llektiv


Studienpatienten in


Tumorboards












ndash Definition R0







Slide 26





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E







ADJUVANTE THERAPIE


PFS () OS () Studie


ESPAC-1


207 vs 104 P=001

CONKO-001


ESPAC-3


CONKO-005

Gem +- Cape 280 vs 255 P=0032

ESPAC-4

Slide 20



(Phase III)


Reported Toxicity




Slide 16





Follow up)



Alternative Fakten


PFS () OS () Studie


37 vs 38 ns

41 vs 51 ns

Klinkenbiijl 1999


ESPAC-1


24 vs 24 ns


RT5FU vs RTGem

18 vs 22 ns

US IntergroupRT

OG 9704


Adjuvante Therapie









Definition LAPC



mind 3mm Schichten)

NE

OL

AP

-Ko

llektiv


Studienpatienten in


Tumorboards












ndash Definition R0







Slide 26





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E


PFS () OS () Studie


ESPAC-1


207 vs 104 P=001

CONKO-001


ESPAC-3


CONKO-005

Gem +- Cape 280 vs 255 P=0032

ESPAC-4

Slide 20



(Phase III)


Reported Toxicity




Slide 16





Follow up)



Alternative Fakten


PFS () OS () Studie


37 vs 38 ns

41 vs 51 ns

Klinkenbiijl 1999


ESPAC-1


24 vs 24 ns


RT5FU vs RTGem

18 vs 22 ns

US IntergroupRT

OG 9704


Adjuvante Therapie









Definition LAPC



mind 3mm Schichten)

NE

OL

AP

-Ko

llektiv


Studienpatienten in


Tumorboards












ndash Definition R0







Slide 26





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E



(Phase III)


Reported Toxicity




Slide 16





Follow up)



Alternative Fakten


PFS () OS () Studie


37 vs 38 ns

41 vs 51 ns

Klinkenbiijl 1999


ESPAC-1


24 vs 24 ns


RT5FU vs RTGem

18 vs 22 ns

US IntergroupRT

OG 9704


Adjuvante Therapie









Definition LAPC



mind 3mm Schichten)

NE

OL

AP

-Ko

llektiv


Studienpatienten in


Tumorboards












ndash Definition R0







Slide 26





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E

Reported Toxicity




Slide 16





Follow up)



Alternative Fakten


PFS () OS () Studie


37 vs 38 ns

41 vs 51 ns

Klinkenbiijl 1999


ESPAC-1


24 vs 24 ns


RT5FU vs RTGem

18 vs 22 ns

US IntergroupRT

OG 9704


Adjuvante Therapie









Definition LAPC



mind 3mm Schichten)

NE

OL

AP

-Ko

llektiv


Studienpatienten in


Tumorboards












ndash Definition R0







Slide 26





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E



Slide 16





Follow up)



Alternative Fakten


PFS () OS () Studie


37 vs 38 ns

41 vs 51 ns

Klinkenbiijl 1999


ESPAC-1


24 vs 24 ns


RT5FU vs RTGem

18 vs 22 ns

US IntergroupRT

OG 9704


Adjuvante Therapie









Definition LAPC



mind 3mm Schichten)

NE

OL

AP

-Ko

llektiv


Studienpatienten in


Tumorboards












ndash Definition R0







Slide 26





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E





Follow up)



Alternative Fakten


PFS () OS () Studie


37 vs 38 ns

41 vs 51 ns

Klinkenbiijl 1999


ESPAC-1


24 vs 24 ns


RT5FU vs RTGem

18 vs 22 ns

US IntergroupRT

OG 9704


Adjuvante Therapie









Definition LAPC



mind 3mm Schichten)

NE

OL

AP

-Ko

llektiv


Studienpatienten in


Tumorboards












ndash Definition R0







Slide 26





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E



Alternative Fakten


PFS () OS () Studie


37 vs 38 ns

41 vs 51 ns

Klinkenbiijl 1999


ESPAC-1


24 vs 24 ns


RT5FU vs RTGem

18 vs 22 ns

US IntergroupRT

OG 9704


Adjuvante Therapie









Definition LAPC



mind 3mm Schichten)

NE

OL

AP

-Ko

llektiv


Studienpatienten in


Tumorboards












ndash Definition R0







Slide 26





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E


PFS () OS () Studie


37 vs 38 ns

41 vs 51 ns

Klinkenbiijl 1999


ESPAC-1


24 vs 24 ns


RT5FU vs RTGem

18 vs 22 ns

US IntergroupRT

OG 9704


Adjuvante Therapie









Definition LAPC



mind 3mm Schichten)

NE

OL

AP

-Ko

llektiv


Studienpatienten in


Tumorboards












ndash Definition R0







Slide 26





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E

Adjuvante Therapie









Definition LAPC



mind 3mm Schichten)

NE

OL

AP

-Ko

llektiv


Studienpatienten in


Tumorboards












ndash Definition R0







Slide 26





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E






Definition LAPC



mind 3mm Schichten)

NE

OL

AP

-Ko

llektiv


Studienpatienten in


Tumorboards












ndash Definition R0







Slide 26





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E











ndash Definition R0







Slide 26





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E







Slide 26





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E





PFS OS StudieQuelle


86 vs 13 P=003


Gem +- RT 60 vs 67 111 vs 92 P=0017

Loumlhrer JCO 2011


12 vs 104 152 vs 165


Gem +- Erlotinib

99 vs 84

119 vs 136






Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E





Gimelius 1996

5FU vs Gem 0 vs 54 10 vs 22 P=0002


Gem +- Cap 191 vs 124 P=003

53 vs 38 P= 004


Gem vs FOLFIRINOX

91 vs 316 Plt0001

35 vs 64 Plt0001

68 vs 111 Plt0001

PRODIGE4ACCORD11

Gem +- Cap 437 vs 176 P=0001

62 vs 53 P=008

103 vs 75 P=006

Lee 2017

Gem +- Oxa 268 vs 173 P=004

58 vs 37 P=004

90 vs 71

Gem +- nabPacli

23 vs 7 Plt0001

55 vs 37 Plt 0001

85 vs 67 Plt0001

vonHoff NEJM 2013

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E

FOLFIRINOX


FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E

FOLFIRINOX

FOLFIRINOX

OS 111 vs 68 Mo

PFS 64 vs 33 Mo

N Engl J Med 2011 3641817-1825




Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E


Mod FOLFIRINOX




bull (Chinesen)



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E



Median OS


6 mo 12 mo 18 mo

Metastatic (37 pts)

102 mo

81 38 22 61 mo 54 14 9

LAPC (29 pts)

266 mo

100 86 62 178 mo 97 69 62




nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E


nabPaclitaxel






73

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E

Gemcitabin




74

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E

FOLFIRINOX







BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E



BSC vs 5FULVOx

0 vs 0 23 vs 48 P=0008


5FULV+- Ox

0 vs 0 29 vs 20 P=0019

59 vs 33 P=0010


5FULV +- nalIri

16 vs 1 Plt00001

31 vs 15 P=00001

61 vs 42 P=0012


5FULV+-Ox 132 vs 85 31 vs 29 61 vs 99 P=002




Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E


Neue Substanzen

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E

NAL-IRINOTECAN

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E

nalIrinotecan






NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E

NAPOLI-1

Met PC

Gem vorbehandelt

N=417

Nal-Iri 120 mgqm 3w


Nal-Iri 80 mgqm +





5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E



5-FULV (n=119)

OS 62 Mo 42 Mo HR 075 P=00417

6-Mo-Uumlberleben

53 38

12-Mo-Uumlberleben

26 16

Nal-Iri (n=151)

5-FULV (n=149)

OS 49 Mo 42 Mo HR 108 P=05










NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E









NAPOLI-1

CA19-9 level (UmL)

Q1 lt 120

Q2 120 to lt 1549

Q3 1542 to lt 12815

Q4 ge 12815

Median OS mo (n)


76 (n = 27) 67 (n = 35) 61 (n = 27) 46 (n = 26)

5-FULV (n = 103)

72 (n = 31) 61 (n = 25) 38 (n = 21) 19 (n = 26)


112 (057 222)

074 (037 148)

043 (022 084)

035 (019 064)


PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E

PEGPH20


HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E

HALO-202




Adenocarcinoma


Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E

Ansprechraten


PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E

PFS


PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E

PFS-Subgruppe




Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E



Gesamtuumlberleben

Slide 10


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E


SUPPORTIVE THERAPIE





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E





ZUSAMMENFASSUNG



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E



htt

ps

ww

wo

nkop

edia

com

deo

nkop

edia

gui

deline

spa

nkre

askar

zino

m

vi

ew

htm

lin

dexh

tml

ID

0E

FLA

E

dr. med. gabriele siegler - newconceptoncology gmbh · •75 % caput •20 % corpus ... •ca 19-9...

Documents