Phase III Trial of Infusional Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan (FOLFOXIRI) Compared With Infusional Fluorouracil, Leucovorin, and Irinotecan (FOLFIRI) As First-Line Treatment for Metastatic Colorectal Cancer: The Gruppo Oncologico Nord Ovest

作者: Alfredo Falcone , Sergio Ricci , Isa Brunetti , Elisabetta Pfanner , Giacomo Allegrini

DOI: 10.1200/JCO.2006.09.0928

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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

参考文章(29)
C Garufi, E Bria, B Vanni, A M R Zappalà, I Sperduti, E Terzoli, A phase II study of irinotecan plus chronomodulated oxaliplatin, 5-fluorouracil and folinic acid in advanced colorectal cancer patients. British Journal of Cancer. ,vol. 89, pp. 1870- 1875 ,(2003) , 10.1038/SJ.BJC.6601382
C. Pozzo, M. Basso, A. Cassano, M. Quirino, G. Schinzari, N. Trigila, M. Vellone, F. Giuliante, G. Nuzzo, C. Barone, Neoadjuvant treatment of unresectable liver disease with irinotecan and 5-fluorouracil plus folinic acid in colorectal cancer patients Annals of Oncology. ,vol. 15, pp. 933- 939 ,(2004) , 10.1093/ANNONC/MDH217
Emiliano Calvo, Javier Cortés, Javier Rodríguez, Óscar Fernández-Hidalgo, Joseba Rebollo, Salvador Martín-Algarra, Jesús García-Foncillas, Rafael Martínez-Monge, Jokin de Irala, Antonio Brugarolas, Irinotecan, oxaliplatin, and 5-fluorouracil/leucovorin combination chemotherapy in advanced colorectal carcinoma: a phase II study. Clinical Colorectal Cancer. ,vol. 2, pp. 104- 110 ,(2002) , 10.3816/CCC.2002.N.016
R. Adam, E. Avisar, A. Ariche, S. Giachetti, D. Azoulay, D. Castaing, F. Kunstlinger, F. Levi, F. Bismuth, Five-Year Survival Following Hepatic Resection After Neoadjuvant Therapy for Nonresectable Colorectal [Liver] Metastases Annals of Surgical Oncology. ,vol. 8, pp. 347- 353 ,(2001) , 10.1007/S10434-001-0347-3
Gianluca Masi, Samanta Cupini, Lorenzo Marcucci, Elisa Cerri, Fotios Loupakis, Giacomo Allegrini, Isa Maura Brunetti, Elisabetta Pfanner, Maurizio Viti, Orlando Goletti, Franco Filipponi, Alfredo Falcone, Treatment with 5-fluorouracil/folinic acid, oxaliplatin, and irinotecan enables surgical resection of metastases in patients with initially unresectable metastatic colorectal cancer. Annals of Surgical Oncology. ,vol. 13, pp. 58- 65 ,(2006) , 10.1245/ASO.2006.03.094
J Souglakos, N Androulakis, K Syrigos, A Polyzos, N Ziras, A Athanasiadis, S Kakolyris, S Tsousis, Ch Kouroussis, L Vamvakas, A Kalykaki, G Samonis, D Mavroudis, V Georgoulias, FOLFOXIRI (folinic acid, 5-fluorouracil, oxaliplatin and irinotecan) vs FOLFIRI (folinic acid, 5-fluorouracil and irinotecan) as first-line treatment in metastatic colorectal cancer (MCC): a multicentre randomised phase III trial from the Hellenic Oncology Research Group (HORG) British Journal of Cancer. ,vol. 94, pp. 798- 805 ,(2006) , 10.1038/SJ.BJC.6603011
G. Masi, G. Allegrini, S. Cupini, L. Marcucci, E. Cerri, I. Brunetti, E. Fontana, S. Ricci, M. Andreuccetti, A. Falcone, First-line treatment of metastatic colorectal cancer with irinotecan, oxaliplatin and 5-fluorouracil/leucovorin (FOLFOXIRI): results of a phase II study with a simplified biweekly schedule Annals of Oncology. ,vol. 15, pp. 1766- 1772 ,(2004) , 10.1093/ANNONC/MDH470
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, None, 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 Journal of Clinical Oncology. ,vol. 23, pp. 4866- 4875 ,(2005) , 10.1200/JCO.2005.07.113
G. Folprecht, A. Grothey, S. Alberts, H.-R. Raab, C.-H. Köhne, Neoadjuvant treatment of unresectable colorectal liver metastases: correlation between tumour response and resection rates Annals of Oncology. ,vol. 16, pp. 1311- 1319 ,(2005) , 10.1093/ANNONC/MDI246