Five-Year Outcomes of FOLFIRINOX vs Gemcitabine as Adjuvant Therapy for Pancreatic Cancer
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Published:2022-11-01
Issue:11
Volume:8
Page:1571
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ISSN:2374-2437
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Container-title:JAMA Oncology
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language:en
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Short-container-title:JAMA Oncol
Author:
Conroy Thierry1, Castan Florence2, Lopez Anthony3, Turpin Anthony4, Ben Abdelghani Meher5, Wei Alice C.6, Mitry Emmanuel7, Biagi James J.8, Evesque Ludovic9, Artru Pascal10, Lecomte Thierry11, Assenat Eric12, Bauguion Lucile13, Ychou Marc14, Bouché Olivier15, Monard Laure16, Lambert Aurélien1, Hammel Pascal17, Francois Eric18, Ramee Jean-François18, Castanie Hélène18, Pracht Marc18, Ghiringhelli François18, Maillard Emmanuel18, Couffon Caroline18, Volet Julien18, Bourgeois Vincent18, Chauvenet Marion18, Blanc Jean-Frédéric18, Péré-Vergé Denis18, De La Fouchardiere Christelle18, Adenis Antoine18, El Hajbi Farid18, Bennouna Jaafar18, Texereau Patrick18, Faroux Roger18, Miglianico Laurent18, Platini Christian18, Legoux Jean-Louis18, Caroli-Bosc François-Xavier18, Bouhier-Leporrier Karine18, Gagnaire Alice18, Granger Victoire18, Lebrun-Ly Valérie18, Guimbaud Rosine18, Touchefeu Yann18, Gasmi Mohamed18, Di Fiore Frédéric18, Seitz Jean François18, Etienne Pierre-Luc18, Ligeza Poisson Catherine18, Rinaldi Yves18, Baba-Hamed Nabil18, Bachet Jean Baptiste18, Aparicio Thomas18, Chone Laurence18, Guillet Marielle18, Forestier Julien18, Terrebonne Eric18, Hebbar Mohamed18, Breysacher Gilles18, Andre Thierry18, Khemissa-Akouz Faiza18, Hautefeuille Vincent18, Guerin-Meyer Véronique18, Hartwig Johannes18, Becouarn Yves18, Malka David18, Louvet Christophe18, Raoul Jean-Luc18, Cany Laurent18, Juzina Beata18, Jouffroy Claire18, Gourgou Sophie18, Rassouli Mohammad18, Chalchal Haji18, Renouf Daniel18, Wong Ralph18, Lemay Frederic18, Aubin Francine18, Couture Felix18, Mc Whirter Elaine18, Welch Stephen18, Kavan Petr18, Findlay Brian18, Cripps Christine18, Cano Pablo18, Ahmed Shahid18, Harb Mohammed18, Pressnail Bryn18, Dowden Scott18, O'Callaghan Chris18,
Affiliation:
1. Medical Oncology department, Institut de cancérologie de Lorraine, Vandoeuvre-lès-Nancy, France and Université de Lorraine, APEMAC, équipe MICS, Nancy, France 2. Biometry Department, ICM Regional Cancer Institute of Montpellier, Montpellier, France and Montpellier University, Montpellier, France 3. Hepatogastroenterology department, University Hospital, Nancy, France 4. Medical Oncology Department, University hospital, Lille, France and University of Lille, Lille, France 5. Medical Oncology Department, ICANS, Strasbourg, France 6. Surgery department, Princess Margaret Hospital, Toronto, Ontario, Canada 7. Medical Oncology department, Institut Paoli-Calmettes, Marseille, France 8. Department of Oncology, Queen’s University, Canada 9. Medical oncology department, Centre Antoine-Lacassagne, Nice, France 10. Hepatogastroenterology department, Hôpital Jean-Mermoz, Lyon, France 11. Hepatogastroenterology department, Hôpital Trousseau, Tours, France and INSERM UMR 6239, Tours University, Tours, France 12. Medical oncology department, Centre Hospitalier Universitaire de Saint-Eloi, Montpellier, France 13. Hepatogastroenterology department, Centre Hospitalier Départemental Vendée, La Roche-sur-Yon, France 14. Oncology department, ICM Regional Cancer Institute of Montpellier, Montpellier, France and Montpellier University, Montpellier, France 15. Digestive oncology department, Centre Hospitalier Universitaire Robert Debré, Reims, France 16. R&D, Unicancer, Paris, France 17. Digestive and Medical Oncology department, Hôpital Paul Brousse and University Paris-Saclay, Villejuif, France 18. for the Canadian Cancer Trials Group and the Unicancer-GI–PRODIGE Group
Abstract
ImportanceEarly results at 3 years from the PRODIGE 24/Canadian Cancer Trials Group PA6 randomized clinical trial showed survival benefits with adjuvant treatment with modified FOLFIRINOX vs gemcitabine in patients with resected pancreatic ductal adenocarcinoma; mature data are now available.ObjectiveTo report 5-year outcomes and explore prognostic factors for overall survival.Design, Setting, and ParticipantsThis open-label, phase 3 randomized clinical trial was conducted at 77 hospitals in France and Canada and included patients aged 18 to 79 years with histologically confirmed pancreatic ductal adenocarcinoma who had undergone complete macroscopic (R0/R1) resection within 3 to 12 weeks before randomization. Patients were included from April 16, 2012, through October 3, 2016. The cutoff date for this analysis was June 28, 2021.InterventionsA total of 493 patients were randomized (1:1) to receive treatment with modified FOLFIRINOX (oxaliplatin, 85 mg/m2 of body surface area; irinotecan, 150-180 mg/m2; leucovorin, 400 mg/m2; and fluorouracil, 2400 mg/m2, every 2 weeks) or gemcitabine (1000 mg/m2, days 1, 8, and 15, every 4 weeks) as adjuvant therapy for 24 weeks.Main Outcomes and MeasuresPrimary end point was disease-free survival. Secondary end points included overall survival, metastasis-free survival, and cancer-specific survival. Prognostic factors for overall survival were determined.ResultsOf the 493 patients, 216 (43.8%) were women, and the mean (SD) age was 62.0 (8.9) years. At a median of 69.7 months’ follow-up, 367 disease-free survival events were observed. In patients receiving chemotherapy with modified FOLFIRINOX vs gemcitabine, median disease-free survival was 21.4 months (95% CI, 17.5-26.7) vs 12.8 months (95% CI, 11.6-15.2) (hazard ratio [HR], 0.66; 95% CI, 0.54-0.82; P < .001) and 5-year disease-free survival was 26.1% vs 19.0%; median overall survival was 53.5 months (95% CI, 43.5-58.4) vs 35.5 months (95% CI, 30.1-40.3) (HR, 0.68; 95% CI, 0.54-0.85; P = .001), and 5-year overall survival was 43.2% vs 31.4%; median metastasis-free survival was 29.4 months (95% CI, 21.4-40.1) vs 17.7 months (95% CI, 14.0-21.2) (HR, 0.64; 95% CI, 0.52-0.80; P < .001); and median cancer-specific survival was 54.7 months (95% CI, 45.8-68.4) vs 36.3 months (95% CI, 30.5–43.9) (HR, 0.65; 95% CI, 0.51-0.82; P < .001). Multivariable analysis identified modified FOLFIRINOX, age, tumor grade, tumor staging, and larger-volume center as significant favorable prognostic factors for overall survival. Shorter relapse delay was an adverse prognostic factor.Conclusions and RelevanceThe final 5-year results from the PRODIGE 24/Canadian Cancer Trials Group PA6 randomized clinical trial indicate that adjuvant treatment with modified FOLFIRINOX yields significantly longer survival than gemcitabine in patients with resected pancreatic ductal adenocarcinoma.Trial RegistrationEudraCT: 2011-002026-52; ClinicalTrials.gov Identifier: NCT01526135
Publisher
American Medical Association (AMA)
Subject
Oncology,Cancer Research
Cited by
82 articles.
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