FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer
Thierry Conroy, Françoise Desseigne, Marc Ychou, Olivier Bouché, Rosine Guimbaud, Yves Bécouarn, Antoine Adenis, Jean-Luc Raoul, Sophie Gourgou-Bourgade, Christelle de la Fouchardière, Jaafar Bennouna, Jean-Baptiste Bachet, Faiza Khemissa-Akouz, Denis Péré-Vergé, Catherine Delbaldo, Eric Assenat, Bruno Chauffert, Pierre Michel, Christine Montoto-Grillot, Michel Ducreux, Groupe Tumeurs Digestives of Unicancer, PRODIGE Intergroup, P Rougier, F Ghiringhelli, T N'guyen, J-L Jouve, G Piot, M Gasmi, P Texereau, C Borel, F Cvitkovic, M-P Galais, T Lecomte, J-P Lagasse, F Mornex, D Arsene, Y Rinaldi, G Deplanque, T Aparicio, V Palascak-Juif, G des Guetz, C Lecaille, C Lombard-Bohas, P-L Etienne, L Charneau, S Fratté, G Breysacher, A Azzedine, J-P Joly, L Poincloux, A-M Queuniet, J-F Blanc, O Dubroeucq, C Desauw, J-F Seitz, C Platini, Thierry Conroy, Françoise Desseigne, Marc Ychou, Olivier Bouché, Rosine Guimbaud, Yves Bécouarn, Antoine Adenis, Jean-Luc Raoul, Sophie Gourgou-Bourgade, Christelle de la Fouchardière, Jaafar Bennouna, Jean-Baptiste Bachet, Faiza Khemissa-Akouz, Denis Péré-Vergé, Catherine Delbaldo, Eric Assenat, Bruno Chauffert, Pierre Michel, Christine Montoto-Grillot, Michel Ducreux, Groupe Tumeurs Digestives of Unicancer, PRODIGE Intergroup, P Rougier, F Ghiringhelli, T N'guyen, J-L Jouve, G Piot, M Gasmi, P Texereau, C Borel, F Cvitkovic, M-P Galais, T Lecomte, J-P Lagasse, F Mornex, D Arsene, Y Rinaldi, G Deplanque, T Aparicio, V Palascak-Juif, G des Guetz, C Lecaille, C Lombard-Bohas, P-L Etienne, L Charneau, S Fratté, G Breysacher, A Azzedine, J-P Joly, L Poincloux, A-M Queuniet, J-F Blanc, O Dubroeucq, C Desauw, J-F Seitz, C Platini
Abstract
Background: Data are lacking on the efficacy and safety of a combination chemotherapy regimen consisting of oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) as compared with gemcitabine as first-line therapy in patients with metastatic pancreatic cancer.
Methods: We randomly assigned 342 patients with an Eastern Cooperative Oncology Group performance status score of 0 or 1 (on a scale of 0 to 5, with higher scores indicating a greater severity of illness) to receive FOLFIRINOX (oxaliplatin, 85 mg per square meter of body-surface area; irinotecan, 180 mg per square meter; leucovorin, 400 mg per square meter; and fluorouracil, 400 mg per square meter given as a bolus followed by 2400 mg per square meter given as a 46-hour continuous infusion, every 2 weeks) or gemcitabine at a dose of 1000 mg per square meter weekly for 7 of 8 weeks and then weekly for 3 of 4 weeks. Six months of chemotherapy were recommended in both groups in patients who had a response. The primary end point was overall survival.
Results: The median overall survival was 11.1 months in the FOLFIRINOX group as compared with 6.8 months in the gemcitabine group (hazard ratio for death, 0.57; 95% confidence interval [CI], 0.45 to 0.73; P<0.001). Median progression-free survival was 6.4 months in the FOLFIRINOX group and 3.3 months in the gemcitabine group (hazard ratio for disease progression, 0.47; 95% CI, 0.37 to 0.59; P<0.001). The objective response rate was 31.6% in the FOLFIRINOX group versus 9.4% in the gemcitabine group (P<0.001). More adverse events were noted in the FOLFIRINOX group; 5.4% of patients in this group had febrile neutropenia. At 6 months, 31% of the patients in the FOLFIRINOX group had a definitive degradation of the quality of life versus 66% in the gemcitabine group (hazard ratio, 0.47; 95% CI, 0.30 to 0.70; P<0.001).
Conclusions: As compared with gemcitabine, FOLFIRINOX was associated with a survival advantage and had increased toxicity. FOLFIRINOX is an option for the treatment of patients with metastatic pancreatic cancer and good performance status. (Funded by the French government and others; ClinicalTrials.gov number, NCT00112658.).
Source: PubMed