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PRODIGE 4 is the 2011 French trial that changed pancreatic cancer treatment for the first time in fourteen years: the four-drug FOLFIRINOX combination kept fit patients alive a median 11.1 months against 6.8 with gemcitabine, at the price of more side effects, and it remains the reference first-line regimen for people well enough to have it.
PRODIGE 4/ACCORD 11 randomised 342 patients with metastatic pancreatic adenocarcinoma and ECOG 0 or 1 to FOLFIRINOX (oxaliplatin 85 mg/m2, irinotecan 180 mg/m2, leucovorin 400 mg/m2, fluorouracil 400 mg/m2 bolus then 2,400 mg/m2 over 46 hours, every two weeks) or gemcitabine 1,000 mg/m2 weekly for seven of eight weeks then three of four. Median overall survival was 11.1 against 6.8 months (hazard ratio for death 0.57, 95 percent confidence interval 0.45 to 0.73; p below 0.001), median progression-free survival 6.4 against 3.3 months (hazard ratio 0.47) and objective response 31.6 against 9.4 percent. Febrile neutropenia occurred in 5.4 percent on FOLFIRINOX, and at six months 31 percent of FOLFIRINOX patients had a definitive deterioration in quality of life against 66 percent on gemcitabine (hazard ratio 0.47). The trial restricted entry to fit patients under 76 with normal bilirubin, which is why guidelines pair it with gemcitabine plus nab-paclitaxel for everyone else; NICE NG85 recommends FOLFIRINOX for performance status 0 to 1 (recommendation 1.9.4, an off-label use in England). The modified regimen without the bolus became the adjuvant standard in PRODIGE 24, and NAPOLI 3 later showed the liposomal-irinotecan variant NALIRIFOX beats gemcitabine plus nab-paclitaxel.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
342 enrolled.
Shares Quality of life, Leucovorin (folinic acid), FOLFIRINOX / mFOLFIRINOX, Fluorouracil (5-FU).
Shares Leucovorin (folinic acid), Oxaliplatin, Platinum agents, Gemcitabine.
Shares NAPOLI 3, Leucovorin (folinic acid), Fluorouracil (5-FU), Topoisomerase-I inhibitors (and ADC payloads).
Shares Irinotecan (and liposomal irinotecan), Leucovorin (folinic acid), Oxaliplatin, Fluorouracil (5-FU).
Shares Leucovorin (folinic acid), Oxaliplatin, Fluorouracil (5-FU), Platinum agents.
Shares FOLFIRINOX / mFOLFIRINOX, Topoisomerase-I inhibitors (and ADC payloads), Platinum agents, Gemcitabine.
Shares Irinotecan (and liposomal irinotecan), Leucovorin (folinic acid), Fluorouracil (5-FU), Topoisomerase-I inhibitors (and ADC payloads).
Shares FOLFIRINOX / mFOLFIRINOX, Topoisomerase-I inhibitors (and ADC payloads), Platinum agents, Metastatic pancreatic ductal adenocarcinoma.