Cited by 7,810Pancreatic and Hepatic Oncology ResearchPancreatitis Pathology and TreatmentCancer Treatment and Pharmacology

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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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“Most chemotherapy [5-7], targeted therapy [8], and immunotherapy [9-11] are ineffective because most patients are already in the progressive stage with local invasion and distant metastases at the detection time [12,13].”
Background
Inhibition of HIF-1α by PX-478 enhances the anti-tumor effect of gemcitabine by inducing immunogenic cell death in pancreatic ductal adenocarcinoma
Zhao, T., Ren, H., Jia, L., Chen, J., Xin, W., Yan, F., Li, J., Wang, X., Gao, S., Qian, D., et al. (2015) · Oncotarget · doi:10.18632/oncotarget.2948 · Cited by 142
“…(fluorouracil, leucovorin, irinotecan, and oxaliplatin) significantly prolonged the overall survival of patients with metastatic pancreatic cancer, compared with gem along (11.1 vs 6.8 months), although the safety profile of FOLFIRINOX was not as favourable as that of single-agent Gem [40].”
ResultInfluential
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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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