1. FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer.
- Author
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Conroy, T., Hammel, P., Hebbar, M., Abdelghani, M. Ben, Wei, A. C., Raoul, J.-L., Choné, L., Francois, E., Artru, P., Biagi, J. J., Lecomte, T., Assenat, E., Faroux, R., Ychou, M., Volet, J., Sauvanet, A., Breysacher, G., Di Fiore, F., Cripps, C., and Kavan, P.
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ANTINEOPLASTIC agents , *COMBINATION drug therapy , *COMBINED modality therapy , *COMPARATIVE studies , *FLUOROURACIL , *FOLINIC acid , *INTERSTITIAL lung diseases , *LONGITUDINAL method , *RESEARCH methodology , *MEDICAL cooperation , *PANCREATIC tumors , *ORGANOMETALLIC compounds , *PROGNOSIS , *RESEARCH , *EVALUATION research , *RANDOMIZED controlled trials , *PROPORTIONAL hazards models , *DEOXYCYTIDINE , *THERAPEUTICS - Abstract
Background: Among patients with metastatic pancreatic cancer, combination chemotherapy with fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) leads to longer overall survival than gemcitabine therapy. We compared the efficacy and safety of a modified FOLFIRINOX regimen with gemcitabine as adjuvant therapy in patients with resected pancreatic cancer.Methods: We randomly assigned 493 patients with resected pancreatic ductal adenocarcinoma to receive a modified FOLFIRINOX regimen (oxaliplatin [85 mg per square meter of body-surface area], irinotecan [180 mg per square meter, reduced to 150 mg per square meter after a protocol-specified safety analysis], leucovorin [400 mg per square meter], and fluorouracil [2400 mg per square meter] every 2 weeks) or gemcitabine (1000 mg per square meter on days 1, 8, and 15 every 4 weeks) for 24 weeks. The primary end point was disease-free survival. Secondary end points included overall survival and safety.Results: At a median follow-up of 33.6 months, the median disease-free survival was 21.6 months in the modified-FOLFIRINOX group and 12.8 months in the gemcitabine group (stratified hazard ratio for cancer-related event, second cancer, or death, 0.58; 95% confidence interval [CI], 0.46 to 0.73; P<0.001). The disease-free survival rate at 3 years was 39.7% in the modified-FOLFIRINOX group and 21.4% in the gemcitabine group. The median overall survival was 54.4 months in the modified-FOLFIRINOX group and 35.0 months in the gemcitabine group (stratified hazard ratio for death, 0.64; 95% CI, 0.48 to 0.86; P=0.003). The overall survival rate at 3 years was 63.4% in the modified-FOLFIRINOX group and 48.6% in the gemcitabine group. Adverse events of grade 3 or 4 occurred in 75.9% of the patients in the modified-FOLFIRINOX group and in 52.9% of those in the gemcitabine group. One patient in the gemcitabine group died from toxic effects (interstitial pneumonitis).Conclusions: Adjuvant therapy with a modified FOLFIRINOX regimen led to significantly longer survival than gemcitabine among patients with resected pancreatic cancer, at the expense of a higher incidence of toxic effects. (Funded by R&D Unicancer and others; ClinicalTrials.gov number, NCT01526135 ; EudraCT number, 2011-002026-52 .). [ABSTRACT FROM AUTHOR]- Published
- 2018
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