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FOLFIRINOX versus Gemcitabine for Metastatic Pancreatic Cancer
Open accessAbstract
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.”
From Artificial intelligence in pancreatic cancer (2022) · cites this paper as [5]
In the citing paper
“the ACCORD-11/PRODIGE-4 trial (a multicenter randomized control phase III trial) confirmed that FOLFIRINOX (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)”
From Inhibition of HIF-1α by PX-478 enhances the anti-tumor effect of gemcitabine by inducing immunogenic cell death in pancreatic ductal adenocarcinoma (2015) · cites this paper as [40]
In the citing paper
“two new combination regimens have emerged as the first-line therapy in patients with advanced PDAC. The first is a combination of 5-fluorouracil (5-FU), leucovorin, irinotecan and oxaliplatin, which carries the acronym FOLFIRINOX. The second is the combination of gemcitabine and an albumin nanoparticle conjugate of paclitaxel (nab-paclitaxel)8,9.”
From Pancreatic cancer: Advances and challenges (2023) · cites this paper as [8]
In the citing paper
“FOLFIRINOX versus | | First line advanced | OS (crossover | | | | 6.8 months 4.4 months 0.57 (0.45-0.73) | Delayed | 5 | [ 128]”
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“In the advanced/metastatic disease, the median OS of the patients treated with mFOLFIRINOX is 11.1 months (Conroy et al., 2011), while the patients treated with other systemic therapy regimens, such as gemcitabine + nab-paclitaxel have a median OS of 8.5 months according to the MPACT trial (Hoff et…”
Influential
Metadata
- 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
- 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
- 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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