Portal de Periódicos da CAPES

plenary session

2009; Elsevier BV; Volume: 20; Linguagem: Inglês

10.1093/annonc/mdp436

1569-8041

Giuseppe Colucci, Roberto Labianca, Francesco Di Costanzo, Vittorio Gebbia, Giacomo Cartenì, B. Massidda, Luciano Frontini, Massimo Falconi, Paolo Pederzoli, Ciro Gallo, Massimo Di Maïo, Francesco Perrone, Michele Reni, Stefano Cereda, Giuseppe Aprile, Maria Chiara Tronconi, Carlo Milandri, Piercarlo Saletti, P. Passoni, Alessia Rognone, Clara Fugazza, Domenica Ceraulo, Gianpaolo Balzano, Valerio Di, Eugenio Villa,

Genetic factors in colorectal cancer

Background: Single-agent gemcitabine remains standard first-line treatment for patients with APC.The GIP-1 phase III trial compared the combination of gemcitabine and cisplatin vs. gemcitabine alone.Methods: Patients with locally advanced and/or metastatic pancreatic cancer, age 18-75, Karnofsky Performance Status (KPS) ‡50, were randomized to receive gemcitabine (arm A) or gemcitabine + cisplatin (arm B).In arm A, gemcitabine was administered at 1000 mg/m 2 weekly for 7 consecutive weeks, and, after a 14-day rest, on day 1, 8, 15 every 4 weeks.In Arm B, cisplatin 25 mg/m 2 weekly (with the exception of day 22) was added to gemcitabine.No maximum number of cycles was planned.Primary endpoint was overall survival (OS).To have 80% power of detecting a 0.74 Hazard Ratio (HR) of death (corresponding to increase in median OS from 4.8 to 6.5 months), with bilateral alpha=0.05,400 pts were planned and 355 deaths were required.Clinical benefit, objective response rate (ORR), progression-free survival (PFS), toxicity and quality of life were secondary endpoints.Results: From April 2002 to April 2007, 400 patients were enrolled (A:199, B; 201) in 46 Italian Institutions.Median age was 63 years (range 35-75), 59% males, 84% stage IV, 83% KPS ‡80.Median OS was 8.3 vs. 7.2 months in arm A and B, respectively (HR 1.10, 95%CI 0.89-1.35,p=0.38).Median PFS was 3.9 vs. 3.8 months in arm A and B, respectively (HR 0.97, 95%CI 0.80-1.19,p=0.80).ORR was 10.1% in arm A and 12.9% in B (p=0.37).Clinical benefit was experienced by 23.0% in arm A and 15.1% in arm B (p=0.057).Combination produced more anaemia (50% vs 39%, G3: 5% vs 1%), more neutropenia (44% vs 36%, G3&4: 25% vs 14%) and more thrombocytopenia (57% vs 29%, G3&4: 16% vs 5%).No relevant differences were seen in non-haematological toxicity.Conclusions: Weekly combination of gemcitabine and cisplatin as first-line treatment of APC failed to demonstrate any improvement compared to single-agent gemcitabine.