Phase III randomized trial of FOLFIRI versus FOLFOX4 in the treatment ofadvanced colorectal cancer: a multicenter study of the Gruppo OncologicoDell'Italia Meridionale

Vincenza Leonardi, Nicolo' Gebbia, Vittorio Gebbia, Nicola Gebbia, Nicola Borsellino, Vittorio Gebbia, Francesco Giuliani, Giuseppe Pezzella, Biagio Agostara, Giacomo Cartenì, Marisa Di Seri, Ernesto Durini, Stefano Cordio, Sante Romito, Evaristo Maiello, Giancarlo Paoletti, Giuseppe Colucci, Luigi Manzione, Michele Caruso, Massimo LopezAndrea Misino, Manuela Lopez

Risultato della ricerca: Articlepeer review

575 Citazioni (Scopus)

Abstract

We 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 METHODS:A 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).RESULTS:One 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.CONCLUSION:There 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.
Lingua originaleEnglish
pagine (da-a)4866-4875
Numero di pagine10
RivistaJournal of Clinical Oncology
Volume23
Stato di pubblicazionePublished - 2005

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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