XlV NATIONAL CONGRESS MEDICAL ONCOLOGY
Plenary session
1* ITACA-S (INTERGROUPTRIALOF ADJUVANT
CHEMOTHERAPY IN ADENOCARCINOMA OF THE
STOMACH) TRIAL: COMPARISON OF A SEQUENTIAL
TREATMENT W1TH llUNOTECAN (CPT-n)
+ 5-FLUOROURACIL (5FU)/FOLINIC ACID (LV)
FOLLOWED BY DOCETAXEL AND CISPLATIN VERSUS
A 5-FUILV REGIMEN AS POSTOPERATIVE
TREATMENT FOR RADICALLY RESECTED GASTRIC
CANCER
Bajetta E.1, Floriani 1. 2, di Bartolomeo M.3, Labianca R.4, Falcone A.5, Di Costanzo F.6, ComeIla G.7, Amadori 0 8 , Martoni A.9, Tortora G.10, Nitti 0. 11 , Daniele B.12, Mini E.6, Rulli E.2, Cropalato Di Tullio M.2, 8antoro A.13, Casaretti R.7, Boni C.14, Pinotti G. 15, Bidoli P.16, Rosati G.17, Ravaioli A.1S, Cantore M.19 on behalf of ITACA-8 8tudy Group IIstituto di Oncologia del Policlinico di Monza, Monza ; 2Istituto
di Ricerche Farmacologiche "Mario Negri", Milano; 3Fondazio­
ne IRCCS Istituto Nazionale dei Tumori, Milano; 40spedali Riu­
niti, Bergamo; 5Azienda Ospedaliero-Universitaria Pisana, Pisa;
6Azienda Ospedaliero-Universitaria Careggi, Firenze; 7IRCCS
Studio Nazionale dei Tumori-Fondazione G. Pascale, Napoli;
8IRCCS-Istituto Scientifico Romagnolo per lo Studio e la Cura
dei Tumori-IRST, Meldola; 9Policlinico Sant'Orsola Malpighi,
Bologna; /OAzienda Ospedaliera Universitaria Integrata, Verona;
"Azienda Ospedaliera, Padova; 12Azienda Ospedaliera G. Rum­
mo, Benevento; 13Istituto Clinico Humallitas, Rozzano; 14Arcispe­
dale Santa Maria Nuova-IRCCS, Reggio Emilia; 15Azienda
Ospedaliera Ospedale di Circolo e Fondazione Macchi, Varese;
16Azienda Ospedaliera San Gerardo di Monza, Monza; 17Azienda
Ospedaliera San Carlo, Potenza; 180spedale Infermi, Rimini;
190spedale Civico, Carrara
PLENARY'<SESSION
SI
deaths (HR 1.00; 95% CI 0.83-1.20; P = 0.99). Toxieity was con­
sistent with literature. Given the data observed, both under the
originai hypothesis and the current D.·end, the probability to reach
statistieally signifieant results at the target events is <0.000 l.
ConcIusions. The results of this stùdy suggest that a postoper­
ative chemotherapy in gastric eancer with more intensive regi­
men does not result in a signifieant prolongation of both DFS and
OS when eompared to boluslinfusion FUILV regimen .
2* PARA.j\10UNT: FINALOVERALLSURVIVAL(OS) RESULTS OF THE PHASE ID STUDY OF MAINTENANCE PEMETREXED (PEM) PLUS BEST SUPPORTIVE CARE (BSC) VERSUS PLACEBO (PLB) PLUS BSC IMMEDIATELY FOLLOWING INDUCTION TREATMENT WITH PEM PLUS CISPLATIN (CIS) FOR ADVANCED NON-SQUAMOUS (NS) NON-SMALL CELL LUNG CANCER (NSCLC) Gridelli C.1, de Marinis F.2, Dediu M.3, Thomas M.4, Pujol J.L.5, Bidoli P.6, Molinier 0. 7, Laack E.s, Reck M.9, Chella A.10, Amoroso 0. 11 , Fasola G. 12, Bearz A.13, Boni C.14, Grossi F.15, Maione p'1, Ricciardi 8. 2 , Cortinovis 0. 6, Corral J.16, Melemed 8Y, John WY, Chouaki N.1S, Zimmermann A.18, Russo F.19, Paz-Ares L.16 ISG Moscati Hospital, Avellino; 2San Camillo-Forfanini Hospital,
Roma; 3Institute of Oncology, Bucharest, Romania; 4ThoraxKlinik,
University of Heidelberg, Germany; 5Montpellier Academic Hospi­
tal, Montpelliel~ France; 6San Gerardo Hospital, Monza; 7Le Mans
Regional Hospital, France; 8University Hospital, Hamburg Eppen­
dorf, Germany; 9Hospital Grosshansdorf, Germany; JOCisanelio
Hospital , Pisa; 1/ Lido di Camaiore Hospital, Viareggio; 12Santa
Maria della Misericordia Hospital, Udine; J3CRO, Aviano; 14Ar_
cispedale S. Maria Nuova, Reggio Emilia; 15IST, Genova; 16Virgen
del Rocio University Hospital, Seville, Spain; 17Eli Lilly and Com­
pany, Indianapolis, USA; 18Eli Lilly and Company, Suresnes, Hauts
de Seine, France; 19E1i Lilly and Company, ~esto Fiorentino, Italy
Background. Following radical resection of gastric or gastro­
esophageal junction (GEl) adenocarcinoma, a meta-analysis of
individuai data demonstrated better survival in patients treated
with fluoropyrimidine regimens compared to surgery alone. ITA­
CAoS trial is an Italian, no-profit, multicenter, randomized, open­
label, superiority phase III study aimed at evaluating whether a
more intensive postoperative chemotherapy has a better efficacy,
when replaces fluoropyrimidine.
Background. As previously reported, the PARAMOUNT trial
showed that pem continuation maintenanee therapy after pem­
cisplatin induction therapy significantly redueed the risk of dis­
ease progression over placebo (HR 0.62; 95% CI 0.49-0.79; P =
0.00007) in patients with advanced non-squamous NSCLC. Here
we present the fi~al OS data.
Methods. Patients radically resected for gastric or GEl adeno­
carcinoma, with <!:DI-Iymphadenectomy, node involvement
(pN+) or pNO with pT2b-3-4 withio 3-8 weeks after surgery were
eligible.
Treatment consisted in CPT-1I 180 mg/m 2 on dI, LV 100
Methods. In a double-blind, plaeebo-controlled study, 939 pts
were treated with induction therapy [four cyc1es of induction pem
(500 mglm2 ) and Cisplatin (75 mglm2 ) on day I of a 21-day cyc\e] ,
after whieh 539 pts who had not progressed and had an Eastem Co­
operative Oneology Group performance status (PS) of 01 1 were ran­
mg/m 2 dI-2, 5-FU 400 -600 rng/rn 2 dI-2, qI4; for " cycles,
dOrrllzed (2: 1; stratified for PS , induction response, rusease stage) to
maintenanee pem (500 mglm 2 , day 1 of a 21-day cyc1e) plus BSC
(FOLFIRI regimen) fo\1owed by docetaxel 75 mg/m 2 dI, cis- ','
platin 75 mg/m2 dI, q 21; for 3 cyc\es (arm A) vs LV 100 mglm2
dl-2, 5-FU 400-600 mglm 2 dl-2, q 14 for 9 cyc\es (arm B). The
primary hypothesis on disease-free survival (DFS) requires 636
events (first recurrence or death for any cause) to detect an haz­
ard ratio (HR) of 0.80, with 2-sided 5% significance level for the
log-rank test and a power of 80%.
Results. From February 2005 to August 2009, 1106 pts were
randomized and 1100 were inc\uded in the analysis (562 arm A,
538 arm B; 6 major violations) by 104 Italian centers. By Aprii
2012, with a median follow-up of 49 months (quartile range: 36­
62) we observed 562 events for DFS (HR 0.99; 95% CI 0.84­
1.17; P =0.91) accounting for 88% of the target number and 444
(n = 359) or plaeebo plus BSC (n = 180) unti! disease progression.
AlI pts reeeived vitamin B 12 , folie aeid, and dexamethasone. After
390 deaths, the final analysis of OS was done on randomized pac
tients and was based on a nominal alpha level ofO.0498.
Results. Patients characteristies were balanced between arms:
medjàn age = 61 years; 58% male; 32% PS O; 91 % stage N; 95%
Caueasian; 86% adenocarcinoma; and 45% complete/partial re­
sponse (CRlPR) to induction. Median number of cyc1es was 4 for
pem (range 1-44) and 4 for placebo (range 1-38), with 37% of ptsl
completing>6 cyc1es on pem vs 18% on placeb6. Among the 359 pts
randomized to continuation maintenance with pemetrexed, there was
a statistically significant increase in OS over the plaeebo arm (hazard