Title :

Five-Year Outcomes of FOLFIRINOX vs Gemcitabine as Adjuvant Therapy for Pancreatic Cancer
A Randomized Clinical Trial

Author(s) :

Conroy, Thierry [Auteur]
Institut de Cancérologie de Lorraine - Alexis Vautrin [Nancy] [UNICANCER/ICL]
Adaptation, mesure et évaluation en santé. Approches interdisciplinaires [APEMAC]
Castan, Florence [Auteur]
Institut de Recherche en Cancérologie de Montpellier [IRCM - U1194 Inserm - UM]
Lopez, Anthony [Auteur]
Centre Hospitalier Régional Universitaire de Nancy [CHRU Nancy]
Turpin, Anthony [Auteur]
Centre Hospitalier Régional Universitaire [CHU Lille] [CHRU Lille]
Hétérogénéité, Plasticité et Résistance aux Thérapies des Cancers = Cancer Heterogeneity, Plasticity and Resistance to Therapies - UMR 9020 - U 1277 [CANTHER]
Ben Abdelghani, Meher [Auteur]
Centre Paul Strauss [CRLCC Paul Strauss]
Institut de Cancérologie de Strasbourg Europe [ICANS]
Wei, Alice [Auteur]
Princess Margaret Hospital
Mitry, Emmanuel [Auteur]
Institut Paoli-Calmettes [IPC]
Biagi, James [Auteur]
Queen's University [Kingston, Canada]
Evesque, Ludovic [Auteur]
Centre de Lutte contre le Cancer Antoine Lacassagne [Nice] [UNICANCER/CAL]
Artru, Pascal [Auteur]
Hôpital privé Jean Mermoz [Lyon]
Lecomte, Thierry [Auteur]
Niche, Nutrition, Cancer et métabolisme oxydatif [N2Cox]
Hôpital Trousseau
Assenat, Eric [Auteur]
Service Médico-Chirurgical des Maladies de l'Appareil Digestif et de Transplantation Hépatique
Institut de Génétique Moléculaire de Montpellier [IGMM]
Bauguion, Lucile [Auteur]
Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon [CHD Vendée]
Ychou, Marc [Auteur]
Département d'oncologie Médicale
Institut de Recherche en Cancérologie de Montpellier [IRCM - U1194 Inserm - UM]
Bouché, Olivier [Auteur]
Université de Reims Champagne-Ardenne [URCA]
Hôpital Robert Debré
Monard, Laure [Auteur]
UNICANCER
Lambert, Aurélien [Auteur]
Adaptation, mesure et évaluation en santé. Approches interdisciplinaires [APEMAC]
Institut de Cancérologie de Lorraine - Alexis Vautrin [Nancy] [UNICANCER/ICL]
Hammel, Pascal [Auteur]
Hôpital Paul Brousse
Université Paris-Saclay
Francois, Eric [Auteur]
Centre de Lutte contre le Cancer Antoine Lacassagne [Nice] [UNICANCER/CAL]
Ramee, Jean-François [Auteur]
Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon [CHD Vendée]
Castanie, Hélène [Auteur]
Pracht, Marc [Auteur]
Ghiringhelli, François [Auteur]
Maillard, Emmanuel [Auteur]
Couffon, Caroline [Auteur]
Volet, Julien [Auteur]
Bourgeois, Vincent [Auteur]
Chauvenet, Marion [Auteur]
Blanc, Jean-Frédéric [Auteur]
Péré-Vergé, Denis [Auteur]
de la Fouchardiere, Christelle [Auteur]
Adenis, Antoine [Auteur]
El Hajbi, Farid [Auteur]
Bennouna, Jaafar [Auteur]
Texereau, Patrick [Auteur]
Faroux, Roger [Auteur]
Miglianico, Laurent [Auteur]
Platini, Christian [Auteur]
Legoux, Jean-Louis [Auteur]
Caroli-Bosc, François-Xavier [Auteur]
Bouhier-Leporrier, Karine [Auteur]
Gagnaire, Alice [Auteur]
Granger, Victoire [Auteur]
Lebrun-Ly, Valérie [Auteur]
Guimbaud, Rosine [Auteur]
Touchefeu, Yann [Auteur]
Gasmi, Mohamed [Auteur]
Di Fiore, Frédéric [Auteur]
Seitz, Jean François [Auteur]
Etienne, Pierre-Luc [Auteur]
Ligeza Poisson, Catherine [Auteur]
Rinaldi, Yves [Auteur]
Baba-Hamed, Nabil [Auteur]
Bachet, Jean Baptiste [Auteur]
Aparicio, Thomas [Auteur]
Chone, Laurence [Auteur]
Guillet, Marielle [Auteur]
Forestier, Julien [Auteur]
Terrebonne, Eric [Auteur]
Hebbar, Mohamed [Auteur]
Breysacher, Gilles [Auteur]
Andre, Thierry [Auteur]
Khemissa-Akouz, Faiza [Auteur]
Hautefeuille, Vincent [Auteur]
Guerin-Meyer, Véronique [Auteur]
Hartwig, Johannes [Auteur]
Becouarn, Yves [Auteur]
Malka, David [Auteur]
Louvet, Christophe [Auteur]
Raoul, Jean-Luc [Auteur]
Cany, Laurent [Auteur]
Juzina, Beata [Auteur]
Jouffroy, Claire [Auteur]
Gourgou, Sophie [Auteur]
Rassouli, Mohammad [Auteur]
Chalchal, Haji [Auteur]
Renouf, Daniel [Auteur]
Wong, Ralph [Auteur]
Lemay, Frederic [Auteur]
Aubin, Francine [Auteur]
Couture, Felix [Auteur]
Mc Whirter, Elaine [Auteur]
Welch, Stephen [Auteur]
Kavan, Petr [Auteur]
Findlay, Brian [Auteur]
Cripps, Christine [Auteur]
Cano, Pablo [Auteur]
Ahmed, Shahid [Auteur]
Harb, Mohammed [Auteur]
Pressnail, Bryn [Auteur]
Dowden, Scott [Auteur]
O'Callaghan, Chris [Auteur]

Journal title :

JAMA oncology

Pages :

1571-1578

Publisher :

American Medical Association

Publication date :

2022-11-01

ISSN :

2374-2437

HAL domain(s) :

Sciences du Vivant [q-bio]/Cancer

English abstract : [en]

Importance Early 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 ...
Show more >Importance Early 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. Objective To report 5-year outcomes and explore prognostic factors for overall survival. Design, Setting, and Participants This 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. Interventions A total of 493 patients were randomized (1:1) to receive treatment with modified FOLFIRINOX (oxaliplatin, 85 mg/m 2 of body surface area; irinotecan, 150-180 mg/m 2 ; leucovorin, 400 mg/m 2 ; and fluorouracil, 2400 mg/m 2 , every 2 weeks) or gemcitabine (1000 mg/m 2 , days 1, 8, and 15, every 4 weeks) as adjuvant therapy for 24 weeks. Main Outcomes and Measures Primary 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. Results Of 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 Relevance The 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 Registration EudraCT: 2011-002026-52; ClinicalTrials.gov Identifier: NCT01526135Show less >

Language :

Anglais

Peer reviewed article :

Oui

Audience :

Internationale

Popular science :

Non

Collections :

• Cancer Heterogeneity, Plasticity and Resistance to Therapies (CANTHER) - UMR 9020 - UMR 1277

Source :

Harvested from HAL