作者: Alfredo Falcone , Sergio Ricci , Isa Brunetti , Elisabetta Pfanner , Giacomo Allegrini
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摘要: Purpose The Gruppo Oncologico Nord Ovest (GONO) conducted a phase III study comparing fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI [irinotecan 165 mg/m 2 day 1, oxaliplatin 85 leucovorin 200 fluorouracil 3,200 48-hour continuous infusion starting on every weeks]) with infusional (FOLFIRI). Methods Selection criteria included unresectable metastatic colorectal cancer, age 18 to 75 years, no prior chemotherapy for advanced disease. primary end point was response rate (RR). Results A total of 244 patients were randomly assigned. An increase grade 3 peripheral neurotoxicity (0% v 19%; P .001), 4 neutropenia (28% 50%; .001) observed in the FOLFOXIRI arm. incidence febrile (3% 5%) diarrhea (12% 20%) not significantly different. Responses, as assessed by investigators, were, FOLFIRI FOLFOXIRI, respectively, complete, 6% 8%; partial, 35% 58%, (RR, 41% 66%; .0002). RR confirmed an external panel 34% versus 60% (P .0001). R0 secondary resection metastases greater arm (6% 15%; .033, among all patients; 12% 36%; .017 liver only). Progression-free survival (PFS) overall (OS) both improved (median PFS, 6.9 9.8 months; hazard ratio [HR], 0.63; .0006; median OS, 16.7 22.6 HR, 0.70; .032). Conclusion regimen improves RR, OS compared FOLFIRI, increased, but manageable, toxicity cancer favorable prognostic characteristics. Further studies combination targeted agents neoadjuvant setting are warranted. J Clin Oncol 25:1670-1676. © 2007 American Society Clinical Oncology