6/29/23, 1:45 AM PRODIGE 4 ACCORD 11 Pathway Feedback Search Clinical Topics Home Studies PRODIGE 4 ACCORD 11 PRODIGE 4 ACCORD 11 Disease Pancreatic cancer Trial question What is the effect of FOLFIRINOX (oxaliplatin, irinotecan, fluorouracil, and leucovorin) combination regimen as first-line therapy in patients with metastatic pancreatic cancer? Study design Multi-center Open label RCT Population Characteristics of study participants 38.0% female N = 342 62.0% male 342 patients (131 female, 211 male) Inclusion criteria: patients with metastatic pancreatic cancer and an ECOG performance status score of 0 or 1 (on a scale of 0 to 5, with higher scores indicating a greater severity of illness) Key exclusion criteria: age 76 years, endocrine or acinar pancreatic carcinoma, previous radiotherapy for measurable lesions, cerebral metastases, history of another major cancer, active infection, chronic diarrhea, clinically significant history of cardiac disease, and pregnancy or breast-feeding Interventions N=171 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 https://web.pathway.md/studies/recaSZ78Y0qAcklqP 1/2 6/29/23, 1:45 AM PRODIGE 4 ACCORD 11 Pathway meter given as a bolus followed by 2400 mg per square meter given as a 46-hour continuous infusion, every 2 weeks) N=171 gemcitabine (at a dose of 1,000 mg per square meter weekly for 7 of 8 weeks and then weekly for 3 of 4 weeks) Primary outcome Overall survival 11.1 months 11.1 8.3 months 6.8 5.5 months 2.8 months Significant increase 0.0 months FOLFIRINOX Gemcitabine Significant increase in overall survival (11.1 months vs. 6.8 months; HR 1.75, 95% CI 1.37 to 2.22) Secondary outcomes Significant increase in median progression-free survival (6.4 vs. 3.3; HR 2.13, 95% CI 1.69 to 2.7) Significant increase in objective response (31.6% vs. 9.4%; RR 3.36, 95% CI 1.37 to 5.35) Safety outcomes Significant differences in adverse events, including febrile neutropenia (5.4% vs. 1.2%, p = 0.03) and definitive degradation of quality of life (31% vs. 66%, p < 0.001; HR 0.47, 95% CI 0.30-0.70). Conclusion In patients with metastatic pancreatic cancer and an ECOG performance status score of 0 or 1 (on a scale of 0 to 5, with higher scores indicating a greater severity of illness), FOLFIRINOX was superior to gemcitabine with respect to overall survival. Reference Conroy T, Desseigne F, Ychou M et al. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. Open reference URL https://web.pathway.md/studies/recaSZ78Y0qAcklqP 2/2