Phase III Randomized Trial of FOLFIRI Versus FOLFOX4 in the Treatment of Advanced Colorectal Cancer: A Multicenter Study of the Gruppo Oncologico Dell’Italia Meridionale

作者: Giuseppe Colucci , Vittorio Gebbia , Giancarlo Paoletti , Francesco Giuliani , Michele Caruso

DOI: 10.1200/JCO.2005.07.113

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摘要: Purpose We performed this phase III study to compare the irinotecan, leucovorin (LV), and fluorouracil (FU) regimen (FOLFIRI) versus oxaliplatin, LV, FU (FOLFOX4) in previously untreated patients with advanced colorectal cancer. Patients Methods A total of 360 chemotherapy-naive were randomly assigned receive, every 2 weeks, either arm (FOLFIRI: irinotecan 180 mg/m2 on day 1 LV 100 administered as a 2-hour infusion before 400 an intravenous bolus injection, 600 22-hour immediately after injection days [LV5FU2]) or B (FOLFOX4: oxaliplatin 85 LV5FU2 regimen). Results One hundred sixty-four 172 assessable B, respectively. Overall response rates (ORR) 31% (95% CI, 24.6% 38.3%) 34% 27.2% 41.5%; P = .60). In both arms median time progression (TTP; 7 v months, respectively), duration r...

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