| Added by | llasorsa |
|---|---|
| Group name | EquipeMY |
| Item Type | Journal Article |
| Title | Five-Year Outcomes of FOLFIRINOX vs Gemcitabine as Adjuvant Therapy for Pancreatic Cancer: A Randomized Clinical Trial |
| Creator | Conroy et al. |
| Author | Thierry Conroy |
| Author | Florence Castan |
| Author | Anthony Lopez |
| Author | Anthony Turpin |
| Author | Meher Ben Abdelghani |
| Author | Alice C. Wei |
| Author | Emmanuel Mitry |
| Author | James J. Biagi |
| Author | Ludovic Evesque |
| Author | Pascal Artru |
| Author | Thierry Lecomte |
| Author | Eric Assenat |
| Author | Lucile Bauguion |
| Author | Marc Ychou |
| Author | Olivier Bouché |
| Author | Laure Monard |
| Author | Aurélien Lambert |
| Author | Pascal Hammel |
| Abstract | 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/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 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? |
| Publication | JAMA oncology |
| Date | 2022-09-01 |
| Journal Abbr | JAMA Oncol |
| Language | eng |
| DOI | 10.1001/jamaoncol.2022.3829 |
| ISSN | 2374-2445 |
| Short Title | Five-Year Outcomes of FOLFIRINOX vs Gemcitabine as Adjuvant Therapy for Pancreatic Cancer |
| Library Catalog | PubMed |
| Extra | PMID: 36048453 PMCID: PMC9437831 |
| Tags | Antineoplastic Combined Chemotherapy Protocols, Canada, Carcinoma, Pancreatic Ductal, Chemotherapy, Adjuvant, Female, Fluorouracil, Humans, Leucovorin, Male, Neoplasm Recurrence, Local, Pancreatic Neoplasms |
| Date Added | 2022/09/29 - 14:54:18 |
| Date Modified | 2024/10/10 - 16:52:21 |
| Notes and Attachments | PubMed entry (Attachment) PubMed entry (Attachment) |
Institut de Recherche en Cancérologie de
