studi randomizzati su t e n: iliade i iliade ii + lince astec · –controllo loco-regionale...
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Studi randomizzati su T e N:
ILIADE I ILIADE II + LINCE
ASTEC
Roldano FossatiTorino 26 febbraio 2010
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ILIADE I
Isterectomia radicale modificata-Piver II
vs isterectomia extrafasciale-Piver I
nel carcinoma dell’endometrio stadio clinico I
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ILIADE I
535 pazienti STADIO I535 pazienti STADIO I
RANDOMRANDOM
ISTERECTOMIA EXTRAFASCIALEISTERECTOMIA EXTRAFASCIALEPIVER IPIVER I
ISTERECTOMIA RADICALEISTERECTOMIA RADICALEPIVER IIPIVER II
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ILIADE I
PIVER I PIVER II
Età mediana 59 61
Stadio IA 13% 8%
Stadio IB 51% 51%
Stadio IC 16% 23%
Stadio II 8% 11%
Stadio III 12% 7%
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ILIADE I
PIVER I PIVER II
Infiltrazione Miometrio
Meno o uguale al 50% 73% 69%
Più del 50% 27% 31%
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ILIADE I
PIVER I PIVER II
No linfadenectomia 68% 70%
Linfoadenectomia Pelvica 23% 23%
Linfoadenectomia Aortica 9% 7%
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INTERVENTO .1
PIVER I PIVER II
Mediana tempo operatorio
No-linfadenectomia
130’
110’
150’
140’
Mediana perdita ematica (ml)
No-linfadenectomia
250
200
300
300
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INTERVENTO .2
PIVER I PIVER II
Pazienti trasfuse (n°)
No-linfadenectomia
18
9
23
16
Degenza (giorni) 5 5
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Complicazioni intra-operat.
PIVER I PIVER II
Total (n°) 5 4
vascolari 3 2
ureterali (risolte intr.) 0 2
perforazione ileo/vescica 2 0
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Terapie adiuvanti
PIVER I PIVER II
Nessuna 82% 83%
Radioterapia 10% 11%
Chemio-Radioterapia 6% 5%
Chemioterapia 3% 2%
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Recidive
PIVER I PIVER II
Totale 32 (12%) 29 (11%)
pelviche 11 10
distanti 19 16
distanti+pelviche 2 3
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Sede di recidiva
PIVER I PIVER II
Cuffia Vaginale 3 4
Pelvica - Centrale 4 2
Pelvica - Laterale 1 2
Uretrale 1 2
Linfonodi Pelvici 3 3
Linfonodi Aortici 4 2
Fegato 4 3
Polmone 8 10
Scheletro 1 1
Addome 8 5
SNC 2 1
Sedi multiple 6 4
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Analisi sopravvivenza
PIVER I PIVER II
3 yrs
Disease-Free Survival
5 yrs
89.4
87.7
91.3
89.7
3 yrs
Overall Survival
5 yrs
92.6
88.9
94.0
92.2
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Analisi multivariataDFS
HR (95% CI)
OS
HR (95% CI)
Stage IA-IIA (ref.)
Stage IIB-IIIC
1
2.42
(da 1.33 a 4.40)
1
3.39
(da 1.75 a 6.56)
PIVER I (ref.)
PIVER II
1
0.94
(da .56 a 1.56)
1
0.72
(da .41 a 1.26)
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• L’isterectomia Piver II ha determinato– Maggior perdita ematica intraoperatoria– Tempi operatori più lunghi
• L’isterectomia Piver II non ha migliorato il– Controllo loco-regionale– Disease free survival – Overall survival
Conclusioni
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ILIADE II - LINCE
Linfadenectomia pelvica versus non linfadenectomia
nel carcinoma dell’endometrio stadio clinico precoce
JNCI 2008
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Coinvolgimento ln pelvici
• Stadio I (tumore ben differenziato, infiltrazione miometriale superficiale): 3-5%
• Stadio I (tumore scarsamente differenziato, infiltrazione miometriale profonda): 20%
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537 paz. 537 paz. Stadio IStadio I
Randomizzazione intraRandomizzazione intra--operatoriaoperatoria
LINFOADENECTOMIALINFOADENECTOMIA NON LINFOADENECTOMIANON LINFOADENECTOMIA
M1 M2
G1 X
G2 X X
G3 X X
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ILIADE II - LINCELinf No linf
Età mediana 63 61
Stadio IA-C 191 195
Stadio IIA & B 22 21
Stadio IIIA & C 44 27
Grado 2 57% 59%
Grado 3 35% 31%
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N° mediano di LN asportati
Linf(25°-75°)
No Linf(25°-75°)
Pelvici* 26 (21-35) 0 (0-0)
Pelvici e Aortici* 30 (22-42) 0 (0-0)
*P< .001
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Pazienti con almeno un LN+
Linf No Linf
13.3% 3.2%
P< .001
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Complicazioni
Linf No linf
Totale* 81 34
Linfocisti - linfedema 35 4
Trombosi venosa profonda 2 2
Embolia polmonare 2 0
Fistola vescico-vaginale 2 0
*P< .001
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Terapie adiuvanti
Linf (%) No linf(%)
Nessuna 69 65
Radioterapia 17 25
Chemioterapia 9 6
Chemio-Radioterapia 6 4
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Sedi di recidiva
Linf No linf
Totale 34 33
polmone 8 8
intraperitoneo 8 7
vagina 7 6
linfonodi 4 4
scheletro 4 3
fegato 2 3
Dati mancanti 3 3
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0
20
40
60
80
100
0 6 12 18 24 30 36 42 48 54 60 monthsmonths
%%
χ2=0.17; P=0.68
events total
---- Lymphadenectomy 42 264
___ No lymphadenectomy 36 250
Disease Free Survival
81.7
81.0
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Overall Survival
0
20
40
60
80
100
0 6 12 18 24 30 36 42 48 54 60 monthsmonths
%%
χ2=0.45; P=0.50
events total
---- Lymphadenectomy 30 264
___ No lymphadenectomy 23 250
90.085.9
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Conclusioni• La linfoadenctomia pelvica non cambia la storia
naturale della malattia
• La linfoadenctomia determina un cambiamento di stadio nel 10% delle pazienti (a stadio FIGO IIIC)
• Lo stato linfonodale è ancora prognostico anche nel braccio linfoadenctomia
• La linfoadenectomia non migliora DFS e OS
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Linfoadenectomia pelvica versus non linfoadenectomia
nel carcinoma dell’endometrio stadio clinico precoce
ASTEC, Lancet 2008
ASTEC
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1408 pazienti 1408 pazienti Stadio IStadio I
RandomizzazioneRandomizzazione
LINFOADENECTOMIALINFOADENECTOMIA NON LINFOADENECTOMIANON LINFOADENECTOMIA
ASTEC
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ASTEC mediana di LN asportati
Linf(range)
No Linf(range)
Pelvici 12 (1-59)2 (1-27) ma su 35 pazienti
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ASTEC - intervento
Linf No linf
Mediana tempo operatorio 90’ 60’
Pazienti trasfuse 39 30
Degenza (giorni) 6 6
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ASTEC terapie adiuvanti
Linf (%) No linf (%)
Nessuna 67 67
Radioterapia 33 33
(solo brachiterapia) (8) (9)
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ASTEC, Lancet 2008
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ASTEC disease free survival
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ASTEC overall survival
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ASTEC, Lancet 2008
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ASTEC, Lancet 2008
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