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FOLFIRINOX versus Gemcitabine for Metastatic Pancreatic Cancer

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Conroy, Thierry, Desseigne, Françoise, Ychou, Marc, Bouché, Olivier, Guimbaud, Rosine, Bécouarn, Yves, Adenis, Antoine, Raoul, Jean-Luc, Gourgou-Bourgade, Sophie, de la Fouchardière, Christelle, Bennouna, Jaafar, Bachet, Jean-Baptiste, Khemissa-Akouz, Faiza, Péré-Vergé, Denis, Delbaldo, Catherine, Assenat, Eric, Chauffert, Bruno, Michel, Pierre, Montoto-Grillot, Christine, Ducreux, Michel·2011·New England Journal of Medicine

DOI 10.1056/nejmoa1011923

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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.).

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Authors: Conroy, T., Desseigne, F., Ychou, M., Bouché, O., Guimbaud, R., Bécouarn, Y., Adenis, A., Raoul, J.-L., Gourgou-Bourgade, S., de la Fouchardière, C., Bennouna, J., Bachet, J.-B., Khemissa-Akouz, F., Péré-Vergé, D., Delbaldo, C., Assenat, E., Chauffert, B., Michel, P., Montoto-Grillot, C., & Ducreux, M.
Affiliations: Centre Léon Bérard (FR)
Centre Hospitalier Universitaire de Reims (FR)
Institut Claudius Regaud (FR)
Institut Bergonié (FR)
Centre Oscar Lambret (FR)
Centre Eugène Marquis (FR)
Hôpital Ambroise-Paré (FR)
Centre Hospitalier de Perpignan (FR)
Hôpital de la Croix-Rousse (FR)
Centre Hospitalier Universitaire Henri-Mondor (FR)
Centre Georges François Leclerc (FR)
Université de Rouen Normandie (FR)
UniCancer Group (FR)
Institut Gustave Roussy (FR)
ORCID: Conroy, Thierry
Ychou, Marc
Bouché, Olivier
Guimbaud, Rosine
Adenis, Antoine
Raoul, Jean-Luc
Bennouna, Jaafar
Bachet, Jean-Baptiste
Khemissa-Akouz, Faiza
Michel, Pierre
Montoto-Grillot, Christine
Ducreux, Michel
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2011-05-12
Volume: 364
Issue: 19
Pages: 1817-1825
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa1011923
OpenAlex: W2151253787
Cited by: 7,810
References: 37
Citations by year: 2026: 425 · 2025: 521 · 2024: 560 · 2023: 604 · 2022: 622 · 2021: 785 · 2020: 692 · 2019: 563 · 2018: 577 · 2017: 558 · 2016: 454 · 2015: 473 · 2014: 388 · 2013: 282 · 2012: 222
FWCI: 150.63
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
HAL (submittedVersion)
Topics: Health Sciences › Medicine › Oncology › Pancreatic and Hepatic Oncology Research
Health Sciences › Medicine › Surgery › Pancreatitis Pathology and Treatment
Health Sciences › Medicine › Oncology › Cancer Treatment and Pharmacology
Keywords: FOLFIRINOX, gemcitabine, metastatic pancreatic cancer, first-line chemotherapy, oxaliplatin, irinotecan, 5-fluorouracil, leucovorin, overall survival, progression-free survival, objective response rate, febrile neutropenia, quality of life, adverse events, combination chemotherapy, randomized trial comparison
MeSH terms: Irinotecan, Oxaliplatin, Gemcitabine, Adenocarcinoma, Adult, Aged, Antimetabolites, Antineoplastic, Antineoplastic Combined Chemotherapy Protocols, Camptothecin, Leucovorin, Deoxycytidine, Female, Fluorouracil, Follow-Up Studies, Humans, Male, Middle Aged, Neoplasm Metastasis, Organoplatinum Compounds, Pancreatic Neoplasms, Quality of Life, Severity of Illness Index, Proportional Hazards Models, Survival Analysis

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FOLFIRINOX versus Gemcitabine for Metastatic Pancreatic Cancer

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