• Giuseppe Colucci, Vittorio Gebbia, Giancarlo Paoletti, Francesco Giuliani, Michele Caruso, Nicola Gebbia, Giacomo Cartenì, Biagio Agostara, Giuseppe Pezzella, Luigi Manzione, Nicola Borsellino, Andrea Misino, Sante Romito, Ernesto Durini, Stefano Cordio, Marisa Di Seri, Massimo Lopez, Evaristo Maiello, Severino Montemurro, Antonio Cramarossa, Vito Lorusso, Maurizio Di Bisceglie, Maurizio Chiarenza, Maria Rosaria Valerio, Teresa Guida, Vita Leonardi, Salvatore Pisconti, Gerardo Rosati, Francesco Carrozza, Giuseppe Nettis, Matteo Valdesi, Gianfranco Filippelli, Santo Fortunato, Sergio Mancarella, Cosimo Brunetti, and Gruppo Oncologico Dell'Italia Meridionale.
• Medical and Experimental Oncology Unit, Oncology Institute, Via Amendola 209, 70126 Bari, Italy. colucci@goim.it
• J. Clin. Oncol. 2005 Aug 1; 23 (22): 4866-75.

PurposeWe performed this phase III study to compare the irinotecan, leucovorin (LV), and fluorouracil (FU) regimen (FOLFIRI) versus the oxaliplatin, LV, and FU regimen (FOLFOX4) in previously untreated patients with advanced colorectal cancer.Patients And MethodsA total of 360 chemotherapy-naive patients were randomly assigned to receive, every 2 weeks, either arm A (FOLFIRI: irinotecan 180 mg/m(2) on day 1 with LV 100 mg/m(2) administered as a 2-hour infusion before FU 400 mg/m(2) administered as an intravenous bolus injection, and FU 600 mg/m(2) as a 22-hour infusion immediately after FU bolus injection on days 1 and 2 [LV5FU2]) or arm B (FOLFOX4: oxaliplatin 85 mg/m(2) on day 1 with LV5FU2 regimen).ResultsOne hundred sixty-four and 172 patients were assessable in arm A and B, respectively. Overall response rates (ORR) were 31% in arm A (95% CI, 24.6% to 38.3%) and 34% in arm B (95% CI, 27.2% to 41.5%; P = .60). In both arms A and B, median time to progression (TTP; 7 v 7 months, respectively), duration of response (9 v 10 months, respectively), and overall survival (OS; 14 v 15 months, respectively) were similar, without any statistically significant difference. Toxicity was mild in both groups: alopecia and gastrointestinal disturbances were the most common toxicities in arm A; thrombocytopenia and neurosensorial were the most common toxicities in arm B. Grade 3 to 4 toxicities were uncommon in both arms, and no statistical significant difference was observed.ConclusionThere is no difference in ORR, TTP, and OS for patients treated with the FOLFIRI or FOLFOX4 regimen. Both therapies seemed effective as first-line treatment in these patients. The difference between these two combination therapies is mainly in the toxicity profile.

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