highlights in management of gastrointestinal cancer. current management of esofageal cancer. dott....
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Highlights in management of gastrointestinal cancer.
Current management of esofageal cancer.
Dott. Salvatore Tumolo
U.O. Oncologia (Pordenone)
Roma, 11-12 aprile 2008
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Epidemiologia Colpisce il sesso maschile (Rapporto M: F 2-4:1)
Più alta percentuale di incidenza nei maschi (15/100.000) in Calvados (FR), Hong Kong, Giappone
Più alta percentuale di incidenza nelle femmine (5/100.000) in Bombay, Shangai e Scozia
Negli USA incidenza più alta negli Afro-Americani maschi (12/100.000) che nei maschi bianchi (6/100.000)
In Italia (2001) ci sono 1.869 nuovi casi nei maschi e 602 nuovi casi nelle femmine (ca. 4/100.000)
(Rosso S, Epi. Prev. 2004)
Le regioni più colpite tra i maschi sono Trentino (13.5/100.000), Valle D’Aosta (11.3/100.000) , FVG (10.8/100.000) e Veneto (10.3/100.000)
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Cancro dell’Esofago: Sopravvivenza nei Paesi Europei
OS a 1 anno 31,1/36,4 M/FOS a 5 anni 7,4/10,3
Eurocare-3 study Ann Oncol S5; v81, 2003
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NEOPLASIE ESOFAGEEDimensione del Problema
USA12.000-18.000 nuovi casi/anno14.550 nuovi casi/2006 (stima)13.770 decessi/2006 (stima)
American Cancer Society 2006AIRC 2005Bonadonna G. ‘03Parkin 2001Verdecchia A. ‘01
ITALIA2.000 nuovi casi/anno(4 casi/100.000 abitanti)
Mondo Occidentale410.000 casi/anno (4.1%)
Istotipo prevalente: 1) Adenocarcinoma; 2) Forme squamose 7^-9^ posto nell’ incidenza neoplastica globale Tasso di mortalità: elevato
TT
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Hofstetter et al, Ann Surg, 2002
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Studi diagnostici nel carcinoma dell’esofago
Accuratezza
EUS >80% su T
circa 70% su N
CT per le metastasi a distanza
PET 90% per le metastasi a distanza
Broncoscopia per neoplasie sopra il livello della carena
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Classificazione TNM (1)
Tumore primitivo (T)
TX il tumore primitivo non può essere determinato
T0 non evidenza del tumore primitivo
Tis carcinoma in situ
T1 il tumore invade la lamina propria o la sottomucosa
T2 il tumore invade la muscolare propria
T3 il tumore invade l’avventizia
T4 il tumore invade le strutture adiacenti
Linfonodi regionali (N)
NX i linfonodi regionali non possono essere determinati
N0 non metastasi nei linfonodi regionali
N1 metastasi nei linfonodi regionali
Metastasi a distanza (M)
MX le metastasi a distanza non possono essere determinate
M0 non metastasi a distanza
M1 metastasi a distanza
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Classificazione TNM (2)
Tumori dell’esofago toracico inferiore
M1a metastasi nei linfonodi celiaci
M1b altre metastasi a distanza
Tumori dell’esofago toracico medio
M1a non applicabile*
M1b linfonodi non regionali o altre metastasi a distanza
Tumori dell’esofago toracico superiore
M1a metastasi nei linfonodi cervicali
M1b altre metastasi a distanza
*Per le neoplasie dell’esofago toracico medio si impiega solo M1b poiché in questi tumori la prognosi In caso di metastasi a livello di linfonodi non regionali è sovrapponibile a tumori con altri sitimetastatici a distanza.
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NEOPLASIE ESOFAGEE - STADIAZIONE
UICC-TNM 2002
Palliazione
IntentoCurativo
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S. Swisher, 2008
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Trattamenti
Stadio Trattamento
convenzionale
Trattamenti
In fase di studio
0 chirurgia?
I Chirurgia o Radioterapia
II chirurgia chemioterapia+radioterapia +/- successiva chirurgia
III resezione del T chemioterapia+radioterapia +/- successiva chirurgia
IV palliazione:
- Posizionamento di stent/dilatazione endoscopica
- Radioterapia palliativa
- Chemioterapia
- Laser/elettrocoagulazione
-nuovi agenti chemioterapici- nuove schedule di combinazione
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Generalpopulation
GERDsymptoms
Barrett’sesophagus
DysplasiaAdeno-
carcinoma
GERD-metaplasia-dysplasia-carcinoma model
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NEOPLASIE ESOFAGEE I TRATTAMENTI CON INTENTO RADICALE
(forme potenzialmente resecabili):
Il Ruolo della Chirurgia
“Esophageal cancer is often a systemic disease for which surgical cure is impossible.
It is the stage of the tumor & its biologicalbehaviour at the time of diagnosis, not the size of
the specimen or the # of LFN resected, that determinesurvival in the vast majority of patients”
Orringer, Ann Surg 1999 – World J Surg 2001
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NEOPLASIE ESOFAGEE I TRATTAMENTI CON INTENTO RADICALE
(forme potenzialmente resecabili):
Il Ruolo della Chirurgia
Trattamento di elezione (early stage; esofago toracico)
ma…. Il 60% dei pts è inoperabile alla diagnosi (T/N bulky; età; PS; comorbidità)
Chirurgia demolitiva (soprattutto per l’esofago cervicale: SVV con Radioterapia sovrapponibili alla chirurgia);
L’estensione della linfoadenectomia è dibattuta;
Risultati Chirurgia esclusiva nelle forme resecabili (indipendentemente dalla sede):
SVV 5aa del 5-30%; Mortalità perioperatoria < 10%
Rosenberg ’81-’89; Kelsen DP ’90; ISDE CC ‘95Hirai ’00;Law, Wong ’01; Bonavina ’04; Wright CD ‘05
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TRIALS RANDOM RT-CT vs RT alone TRIALS RANDOM seq RT-CT vs RT alone
La Revisione della Letteratura
NEOPLASIE ESOFAGEE I TRATTAMENTI CON INTENTO RADICALE
la RT +/- CHEMIO esclusiva
RTOG 85-01
La Radio-chemioterapia concomitante è un’evidenza clinica !!
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RTOG 85-01
Week 1 5 8 11
5-FU 1000 mg/m2 x 4 d CDDP 75 mg/m2 d 1
RT 50 Gy
RT 64 GyJCO 97/JAMA 99
RISULTATI CONFERMATI DA ECOG TRIAL (Smith TJ ’98) !!!
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INT 0123 – Schema: intensificazione dose RT(RTOG 94-05)
S
T
R
A
T
I
F
Y
Weight loss> or < 10%
Tumor size< or > 5 cm
HistologyAdenoSquamous
R
A
N
D
O
M
I
Z
E
5-FU/CDDP X 4 + 64.8 Gy
5-FU/CDDP X 4 + 50.4 Gy
NEOPLASIE ESOFAGEE I TRATTAMENTI CON INTENTO RADICALE
la RT +/- CHEMIO esclusiva
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%
A L
I V
E
0
25
50
75
100
MONTHS FROM RANDOMIZATION0 6 12 18 24 30 36
///// // / //////
/ ////
/ / /// // / /
/ / //// // / /
/ ///// / /////
// //
//// / / / / /
//// / // / /////// // / /
INT 0123SVV
64.8 Gy
50.4 Gy
MEDIAN 2-YR50.4 Gy 17.6 M 38%64.8 Gy 12.9 M 29%
p=0.14 (log-rank)
50.4 Gy
64.8 Gy
109
107
59
42
24
17
6
6
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Chirurgia vs. RT-CT esclusiva
Chirurgia RT-CT(INT 0133) (RTOG 85-01)
SVV mediana 18 mesi 14 mesi
SVV 5 aa 20% 27%
Ripresa locale 31% + 30%* 45%
* 30% : R1-2
NEOPLASIE ESOFAGEE I TRATTAMENTI CON INTENTO RADICALE
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FFCD 9102 – Proc ASCO 2002
• 445 pts: 5-FU/CDDP/RT x 2 (46 Gy o 30 Gy split course)
Chirurgia• 259 pts
5-FU/CDDP/RT x 2 x 3 (20 Gy o 15 Gy split course)
• Mediana (18 vs. 19 m) e 2 aa SVV (34% vs. 40%)
NEOPLASIE ESOFAGEE I TRATTAMENTI CON INTENTO RADICALE
Chirurgia vs. RT-CT esclusiva
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NEOPLASIE ESOFAGEE I TRATTAMENTI CON INTENTO RADICALE
Chirurgia vs. RT-CT esclusiva
Trial Prospettico Randomizzato Multicentrico CURE(FORME SQUAMOSE)
(Chinese University Research Group for Esophageal Cancer):
Esofagectomia definitiva
RT-CT concomitante esclusiva +/- Chir. salvataggio5FU 200 mg/mq/die gg1-42 + CDDP 60 mg/mq gg 1 e 22Range dose totale RT_ 50-60 Gy (fx convenzionale)
Chiu PWY ; J. of Gastrointestinal Surgery 9 (6) 2005
RISULTATI PRELIMINARI: no differenze in DFS & SVV
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NEOPLASIE ESOFAGEE I TRATTAMENTI CON INTENTO RADICALE
la RT +/- CHEMIO esclusiva
Summary:
RT-CT concomitante > RT-CT sequenziale; RT-CT concomitante con schemi CDDP-based; Intensificazione di dose RT: no vantaggi (Dose standard: 50 Gy) Studi di confronto CH vs RT-CT esclusiva: - No sufficienti Trials randomizzati - CL & SVV sovrapponibili Risultati Trial prospettico random cinese (CURE): - conferma sovrapponibilità risultati preliminari per CL, DFS, SVV
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NEOPLASIE ESOFAGEE I TRATTAMENTI CON INTENTO RADICALE
(forme potenzialmente resecabili-forme non resecabili):
Le terapie neoadiuvanti
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Randomized: 440 ptsAdenocarcinoma: 55%Squamous cell CA: 45%
Surgery Cisplatin +5-FU x 3
Surgery
Cisplatin + 5-FU x 2
Median survival: 16.1 mos
1 yr survival: 60%
2 yr survival: 37%
Median survival: 14.9 mos
1 yr survival: 59%
2 yr survival: 35%
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Trial Randomizzati RT pre-op
Dose SVV 5 aa (%)Casistiche # (Gy) Chirurgia RT P
Launois 109 40 10 10 nsArnott 175 20 17 9 nsHuang 160 40 25 46 ?Mei 206 40 30 35 nsGignoux 229 33 8 10 nsNygaard* 186 35 5 18 0.009
* Associazione con chemioterapia
NEOPLASIE ESOFAGEE I TRATTAMENTI CON INTENTO
RADICALE(forme potenzialmente resecabili-
forme non resecabili): RT +/- CT pre-op
Stadio II-III TNM
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Michigan University RT-CT pre-op
Esofagectomia transjatale
100 Pts(75% Adeno)
Preop 5-FU/CDDP Vinblastina x 2 45 Gy (1.5 Gy BID)
Stadio II-III TNM
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Follow-up Mediano: 8 aa SVV RT-CT pre-op ChirurgiaMediana 16.9 M 17.6 M
SVV 3 aa 30% 15%
Ripresa locale 19% 42% JCO 2001
Michigan University RT-CT pre-op
Stadio II-III TNM
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RT-CT pre-op l’esperienza di Walsh
Chirurgia
113 Pts (100% Adeno)
Preop 5-FU/CDDP X 2 + concomitante 40 Gy
(2.67 Gy/Fx)
NEJM 1996
Stadio II-III TNM
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Pre-opSVV RT-CT Chirurgia
Mediana 16 M 11 M
3 aa 32% 6%
(p=0.01)
RT-CT pre-op l’esperienza di Walsh
Stadio II-III TNM
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RT-CT pre-op (EORTC)
Chirurgia
282 Pts. Formesquamose
Preop 3.7 Gy x 5 2 wks 3.7 Gy x 5 CDDP (80 mg/m2 gg -2 0) NEJM 1998
Stadio II-III TNM
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Follow-up mediano: 55 mesi
SVV RT-CT pre-op ChirurgiaMediana 19 M 19 M
DFS 3 aa 40% 20%
3 aa Overall 36% 36%
RT-CT pre-op (EORTC)
Stadio II-III TNM
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Gruppo di Studio Neoplasie Esofagee
SEOUL-COREA
102 pts Forme squamose
CHIRURGIA
Preop CDDP gg1; 5-FU gg 2-5+ RT conc. 45.6 Gy (1.2 Gy BID)CDDP/5-FU x 3 postop
• Follow-up mediano: 25 mesi• SVV mediana: 28 vs. 27 m (preop vs. Chir.)
Lee et al Proc ASCO 2003
Stadio II-III TNM
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Terapia neoadiuvante nel carcinoma dell’esofago
Vantaggio sulla OS a 3 anni Aumento della mortalità postop.
Fiorica F et al: Gut 2004,53;925
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RT-CT pre-op vs Chir.Metanalisi
Altre Metanalisi confermano un beneficio in termini di CL, DFS e OS della
RT-CT PRE-OP vs Chirurgia esclusiva
J.D. Urschel ’03; F. Fiorica ’04; B.H. Burmeister ’05; S.E. Greer ‘05
Stadio II-III TNM
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NEOPLASIE ESOFAGEE I TRATTAMENTI CON INTENTO RADICALE
(forme potenzialmente resecabili-forme non resecabili):
Le terapie neoadiuvantiSummary:
Chemio pre-op vs Chirurgia: NO differenze statistiche (NS)
3 TRIAL Random RT-CT pre-op vs Chir.: > SVV in RT-CT preop con significatività statistica (Walsh; Urba; Nygaard) 1 TRIAL Random RT-CT pre-op vs Chir.: > CL & SVV senza significatività statistica (Michigan University Trial) 3 TRIAL Random RT-CT pre-op vs Chir.: SVV sovrapponibili (EORTC; COREANO; AUSTRALIANO) LIMITI di alcuni TRIAL Random RT-CT pre-op vs Chir: Basse dosi RT e/o Schedule di trattamento non convenzionali METANALISI RT-CT pre-op vs Chir.: > CL; DFS; SVV in RT-CT (Am J. Surg. ’02; Urschel ’03; Fiorica ’04; Burmeister ’05; Greer ’05)
Stadio II-III TNM
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NEOPLASIE ESOFAGEE I TRATTAMENTI CON INTENTO RADICALE
(forme potenzialmente resecabili-forme non resecabili):
Le terapie neoadiuvanti
Stadio II-III TNM
RT-CT PRE-OP:
IL VALORE DELLA p CR !!
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NEOPLASIE ESOFAGEE
ESOFAGO CERVICALEStadi I-II-III TNM; PS (Karnofsky)
E’ comune l’approccio conservativo !!RT-CT definitiva 50-50.4 Gy + 5FU & CDDPbased schedule
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STADIO INCCN NCI BCCA
CCOP
*(solo potenzialmente curabili e resecabili M0)
NEOPLASIE ESOFAGEE
ESOFAGO TORACICO PS (Karnofsky); valut. operab.
1) Chirurgia2) RT-CT escl.*3) RT-CT neoad*
*50-50.4 Gy5FU-CDDP
1) Chirurgia 1) Chirurgia 1) Chirurgia
T1 N0 M0
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NCCN NCI BCCA CCOP
*Under clinical evaluation
NEOPLASIE ESOFAGEE
ESOFAGO TORACICO PS (Karnofsky); val. operab.
Stage IIAT2, N0, M0 T3, N0, M0 Stage IIBT1, N1, M0 T2, N1, M0
1) Chirurgia2) RT-CT escl.*3) RT-CT neoad*
4) RT-CT post-op** N+; R1; R2
*50-50.4 Gy5FU-CDDP
** 5FU-based
1) Chirurgia2) RT-CT +/- CH*
1) Chirurgia2) RT-CT escl.*
* T1-3 N1 piccoli
1) ChirurgiaT inf. alla carena
2) RT-CT preop*T sup. alla carena:Clearance CH difficControindic. CHRifiuto pz alla CH
* Protocollo GIEFUP
*50-50.4 Gy5FU-CDDP
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NCCN NCI BCCA CCOP
*Under clinical evaluation
NEOPLASIE ESOFAGEE
ESOFAGO TORACICO PS (Karnofsky); val. operab.
1) Chirurgia2) RT-CT escl.*3) RT-CT neoad*4) RT-CT post-op** N+; R1; R2 (**5FU)
5) RT-CT escl.* T4 o Best Supportive Care*50-50.4 Gy5FU-CDDP
1) Chirurgia T32) RT-CT +/- CH*
1) Chirurgia2) RT-CT escl.*
* T1-3 N1 piccoli
1) ChirurgiaT inf. alla carena
2) RT-CT preop*T sup. alla carena:Clearance CH difficControindic. CHRifiuto pz alla CH
* Protocollo GIEFUP
Stage IIIT3, N1, M0 T4, any N, M0
All newly diagnosed patients should be considered candidates for therapies and clinical trials comparing various treatment modalities.
*50-50.4 Gy5FU-CDDP
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STADIO IV (T1-T4 N0-N1 M1)
1. Stent esofageo per via endoscopica2. RT +/- intubazione e dilatazione endoluminale3. BRT-HDR endoluminale per la palliazione della
disfagia4. Elettrocoagulazione endoluminale5. Chemioterapia per M+6. Terapia di supporto esclusiva
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Efficacia terapeutica di agenti singoli nelle neoplasie esofagee
Farmaco No. pazienti Tipo istologico
RC + RP (%)
Bleomicina 80 S 15
Fluorouracile 13
26
S
S
85
16
Mitomicina 31 S 35
Vinorelbina 152 S 28
Cisplatino 131
15*
S
S
21
73
Paclitaxel 51
14
S/A
S/A
32
0
A: adenocarcinoma; RC: risposta completa; RP: risposta parziale; S: carcinoma a cellule squamose.
* neoadiuvante
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Response rates in adenocarcinoma vs
squamous cell carcinoma of the esophagus
Trials No. of patients Response rates (%)
AC SCC AC SCC
Paclitaxel (single agent) 32 18 34 28
5-FU+IFN (two trials)* 24 31 29 26
CDDP+MG+VBL 18 11 33 64
CDDP+5-FU+IFN 15 11 33 73
CDDP+5-FU+Pac 30 30 47 50
CDDP+Pac 27 10 37 60
CDDP+CPT-11 11 6 55 50
CDDP+VP-16 27 65 48 48
All trials 184 182 39 46
*Preoperative trial
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Associazioni chemioterapiche
Combinazione No. Pazienti
Tipo
istologico
RC+RP (%)
• Cisplatino+ bleomicina•Cisplatino+bleomicina+vindesina•Cisplatino+bleomicina+methotrexate•Cisplatino+mitoguazone+vindesina•Cisplatino+fluorouracile•Cisplatino+vinorelbina•Cisplatino+etoposide•Paclitaxel (in 3h)+cisplatino ogni 2 wks•Paclitaxel (in 3h)+cisplatino+fluorouracile ogni 4wks•Irinotecan+cisplatino ogni wk x4, ogni 6 wks•Irinotecan+cisplatino ogni wk x4, ogni 6 wks•Docetaxel+irinotecan ogni 3 wks•Mitomicina+cisplatino+fluoruracile
vs•Epirubicina+cisplatino+fluorouracile
17
51
40
20
82
71
65
51
60
35
25
46
285
289
S
S
S
S
S
S
S
S/A
S/A
S/A
A
A
A/G
A/G
17
31
30
40
35
34
48
43
48 (56% S, 46% A)
57 (66% S, 52% A)
51
26
46% A, 38% G
44% A, 36% G
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No increase in RO resection ratePath CR: 2.5%No increase in survival
Kelsen, NEJM, 1998
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6% increase in R0 Resection Rate
Path CR: 4%
6% increase in 5 yr survival (2008)
MRC Trial, Lancet, 2002
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Cunningham, NEJM, 2006
Log rank p-value=0.009No increase in Ro resection ratePath CR=0%13% increase in 5-yr survival
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Thirion, ASCO, 2007
Absolute benefitat 5 years:4.3%
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MDACC Esophageal Database
p=0.29No increase in RO resection ratePath CR: 2%No increase in 3 yr survival
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2008
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No increase in RO resection ratePath CR: 28%Trend: 14% 3yr survival increase
Urba, JCO, 2001
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21% increase in RO resection ratePath CR: 16%No increase in 3yr survival
Burmeister, Lancet Onc, 2005
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Perspectives
• Target therapies
• Radiosensitizers
• Genetic markers
• Functional imaging
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CHEMIOTERAPICI CONVENZIONALI RADIOSENSIBILIZZANTI
• CISPLATINO• 5FU• MYTOMICINA
ASSOCIATI ALLA RT
INCREMENTO DEL “RESPONSE RATE”
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Nuovi farmaci
TAXANI IRINOTECAN GEMCITABINA VINORELBINA OXALIPLATINO
Esistono studi sulla tossicità attività in associaz.
con DDP e/o FU//RT
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Oxaliplatino
OX/5FU/FO testato nelle neoplasie del colon-retto in studi fase II-III
< Tox ematologica, renale, neurologica rispetto cDDP
Effetto radiosensibilizzante su linee cellulari
Associazione con 5FU ic/RT nell’ Adk retto avanzato
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Razionale dello studio30-90% delle neoplasie esofagee sovraesprimono il
recettore EGFR
L’espressione del recettore EGFR sembra correlato ad una cattiva prognosi
Terapie con Anticorpi anti-EGFR si sono dimostrate efficaci in pazienti con Ca esofageo
Studi preclinici su modelli in vitro e in vivo hanno dimostrato l’attività radiosensibilzzante degli inibitori EGFR
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Neoadjuvant chemoradiotherapy with FOLFOX-4 and Cetuximab in locally advanced esophageal cancer:
preliminary data from B152 trial.
F. De Vita, C. Pinto, M. Orditura, V. Chiarion Sileni, E. Martinelli, R. Innocente, L. Vecchione, S. Pini, G. Catalano,
F. Ciardiello. Medical Oncology, 2° University of Naples; Medical Oncology, S. Orsola of Bologna; Medical Oncology
of Padova; Radiation Oncology, CRO Aviano
ASCO, (poster accepted for June 2008 )
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Schema di trattamento giorni 1 2 15 16 29 30 43 44 57
Oxap 85/mq
AF 200/mq
5FU 400/mq
5FU 600/mq
Cetux 400/mq 250/mq
RT 50.4 Gy/28
giorni 1 2 15 16 29 30 43 44 57
Oxap 85/mq
AF 200/mq
5FU 400/mq
5FU 600/mq
Cetux 400/mq 250/mq
RT 50.4 Gy/28
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Schema di trattamento
RT 50.4 Gy/28
Cetux 250/mq
57 63 70 77 84 91
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Swisher, Cancer, 2002
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Wieder, JCO, 22:900, 2004
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Luthra, J Clin Oncol, 2006
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Problematiche e conclusioni nella gestione dei pazienti con EC
• Multidisciplinarietà
• Valore dell’ esperienza specifica
• Comorbidità
• Ricerca di regimi più efficaci e/o meno tossici
• Ruolo della chirurgia
• Problematiche di stadiazione e ristadiazione
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L’esofago e la sua organizzazione per sedi anatomo-topografiche TT
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NEOPLASIE ESOFAGEE I TRATTAMENTI CON INTENTO RADICALE
(forme potenzialmente resecabili):
Metodologia seguita
Gradi di Raccomandazione
Livelli di Evidenza Requisito
A Ia Metanalisi di trials
random controllati
Ib Almeno un trial random
controllato
B IIa Almeno un trial ben definito controllato no random
IIb Almeno uno studio “quasi” sperimentale ben definito
III Studi ben definiti non sperimentali descrittivi: es. studi comparativi; di correlazione; studi “case-control”
C IV Opinioni di esperti e/o esperienze cliniche di autorità riconosciute/”rispettate”
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TT
NEOPLASIE ESOFAGEELa quantificazione ed i profili di Tossicità delle terapie combinate
LA TOSSICITA’ TARDIVA
Stenosi da restringimento:- Incidenza: 60%- Spesso richiede interventi terapeutici quali dilatazioni esofagee o posizionamento di stents
Lee H. IJROBP 2003
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NEOPLASIE ESOFAGEE: peculiarità oncologiche
• Elevata aggressività locale (extraparietalità T)
• Elevata incidenza alla metastatizzazione linfonodale
• Il ruolo del Performance Status: strategia terapeutica; prognosi
• Il “particolare” ruolo della CHIRURGIAPatti MG ’97; Tanisada K. ’98; Perez CA ‘04 Akiyama H. ’81;
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TT
NEOPLASIE ESOFAGEELa quantificazione ed i profili di Tossicità delle terapie combinate
Prevalenti Tossicità acute loco-regionali: - EMATOLOGICHE: LEUCOPENIA; TROMBOCITOPENIA
- GASTROINTESTINALE: esofagite; disfagia - CUTANEE: eritema - DISTRESS RESPIRATORI - GENERALI: fatigue; calo ponderale
RT-CT pre-op & esclusiva vs RT+/-CT post-op: - MINORE TOSSICITA’ - MAGGIORE COMPLIANCE
LA TOSSICITA’ ACUTA
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NEOPLASIE ESOFAGEE
I TRATTAMENTI CON INTENTO RADICALE(forme potenzialmente resecabili)
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NEOPLASIE ESOFAGEE: PROPOSTA LINEE GUIDA AIROGruppo G.I.
Obiettivo di questo documento è fornire linee guidaObiettivo di questo documento è fornire linee guidaminimali nell’approccio radioterapico minimali nell’approccio radioterapico
alle Neoplasie Esofagee anche al fine di favorire alle Neoplasie Esofagee anche al fine di favorire le ottimali integrazioni terapeutiche le ottimali integrazioni terapeutiche
con chemioterapia e chirurgiacon chemioterapia e chirurgia
INDICEINDICE NOTE INTRODUTTIVE INDAGINI CLINICO-STRUMENTALI NECESSARIE PER LA RADIOTERAPIA OPZIONI TERAPEUTICHE ED INDICAZIONI ALLA RADIOTERAPIA NOTE DI TECNICA RADIOTERAPICA MONITORAGGIO DEI RISULTATI E DEGLI EFFETTI COLLATERALI ORIENTAMENTI DI RICERCA BIBLIOGRAFIA
STATO DI AVANZAMENTO 06/’06: Revisione finale del documento
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EBRT NEOPLASIE ESOFAGEE
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NEOPLASIE ESOFAGEE
La quantificazione ed i profili di Tossicità delle terapie combinate
TT
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Response rates in adenocarcinoma vs
squamous cell carcinoma of the esophagus
Trials No. of patients Response rates (%)
AC SCC AC SCC
Paclitaxel (single agent) 32 18 34 28
5-FU+IFN (two trials)* 24 31 29 26
CDDP+MG+VBL 18 11 33 64
CDDP+5-FU+IFN 15 11 33 73
CDDP+5-FU+Pac 30 30 47 50
CDDP+Pac 27 10 37 60
CDDP+CPT-11 11 6 55 50
CDDP+VP-16 27 65 48 48
All trials 184 182 39 46
*Preoperative trial
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Problematiche nella gestione dei pazienti con EC
• Multidisciplinarietà
• Valore dell’ esperienza specifica
• Comorbidità
• Ricerca di regimi più efficaci e/o meno tossici
• Ruolo della chirurgia
• Problematiche di stadiazione e ristadiazione
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INT 0116 Adjuvant Gastric Trial
• 603 pts trattati, 556 eligibili• Stadio IB- IV (non-M1)• 20% Giunzione esofago-gastrica• 69% T3/4• 85% N+• Follow-up mediano: 4 aa
La Radioterapia post-operatoria
NEOPLASIE ESOFAGEE I TRATTAMENTI CON INTENTO RADICALE
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INT 0116 Adjuvant Gastric Trial
3aa Ripresa Grado IVSVV Locale Tossicità
Chirurgia 30%** 29% 32%
RT/CT post 40% 19% 41%
La Radioterapia post-operatoria
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La Radioterapia post-operatoria
NEOPLASIE ESOFAGEE I TRATTAMENTI CON INTENTO RADICALE
2 Trial Random CHIR vs CHIR + RT+/-CT post-op:nessun beneficio per il trattamento adiuvante;
maggiore Tossicità !!
Teniere P. ’91; Fok M. ‘93
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NEOPLASIE ESOFAGEE I TRATTAMENTI CON INTENTO RADICALE
La Radioterapia post-operatoria
Summary:
NO BENEFIT per RT post-op
Maggiore Tossicità
Lesioni esofago distale (difficoltà chirurgia radicale) J.S. Macdonald ’01; T.W. Rice ‘03
Margini +; R1-R2; LFN +
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MDACC Esophageal Database
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Chemioterapia neoadiuvante: studi selezionati
No. pazienti
Trattamento Resezioni RO
(%)
RCp
(%)
Sopravvivenza
Mediana 3 anni Autore
(%)
100 CDDP+FU+VLB+RT
vs chirurgia
90
90
28
-
1,46 anni
1,48 anni
30
16
Urba et al
(1995,1997)
113 CDDP+FU+RT
chirurgia
non riportato
non riportato
25
0
16 mesi
11 mesi
32
6
Walsh et al
(1996)
282 CDDP+RT
vs chirurgia
81
69
26
-
19 mesi
19 mesi
34
36
Bosset et al
(1997)
CDDP: cisplatino; FU: fluorouracile; VLB: vinblastina; RCp: remissioni patologiche complete; RT: radioterapia.
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CHEMIO pre-op - INT 133
NEOPLASIE ESOFAGEE I TRATTAMENTI CON INTENTO RADICALE
(forme potenzialmente resecabili-forme non resecabili): II-III TNM
Le terapie neoadiuvanti
Resezioni R0 62% 59%Margini + 14% 30%Mortalità Post-op 7% 6%RL (R0 only) 32% 31%SVV mediana 15 mesi 15 mesiSVV 5 aa 20% 20%
Pre-op CT Chirurgia
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Stahl, ASCO, 2007
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NEOPLASIE ESOFAGEE - STADIAZIONE
UICC-TNM 2002
Palliazione
IntentoCurativo
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