PRODIGE 24/CCTG PA6: adjuvant modified FOLFIRINOX versus gemcitabine after resection of pancreatic cancer
Six months of the four-drug combination modified FOLFIRINOX after surgery for pancreatic cancer kept the disease away for almost twice as long as gemcitabine alone and added about a year and a half to median survival. It is the reason fit patients are now offered FOLFIRINOX after a pancreatic operation.
Overview
Randomised phase 3 trial in 493 patients in France and Canada who had undergone a complete (R0 or R1) resection of pancreatic ductal adenocarcinoma, had a CA19-9 below 180 U/mL and were fit enough for combination chemotherapy. Patients received six months of modified FOLFIRINOX (oxaliplatin, irinotecan, leucovorin and infusional fluorouracil without the bolus) or gemcitabine.
At a median follow-up of 33.6 months, median disease-free survival was 21.6 months with modified FOLFIRINOX against 12.8 months with gemcitabine (hazard ratio 0.58), and median overall survival 54.4 against 35.0 months (hazard ratio 0.64). Grade 3 or 4 adverse events were more frequent with modified FOLFIRINOX (about 76 against 53 percent). Five-year results published in 2022 confirmed the survival benefit.
- Median disease-free survival 21.6 versus 12.8 months, hazard ratio 0.58.
- Median overall survival 54.4 versus 35.0 months, hazard ratio 0.64.
- Grade 3 or 4 adverse events in about 76 percent with modified FOLFIRINOX and 53 percent with gemcitabine.
Modified FOLFIRINOX is the adjuvant standard for patients who recover well from a pancreatic resection and can tolerate combination chemotherapy; gemcitabine-based regimens remain for those who cannot.
- Patients were selected for fitness and a low postoperative CA19-9, so the result does not transfer directly to frailer patients.
- Adjuvant chemotherapy must start within 12 weeks of surgery, and many patients never recover enough to receive it, which is one argument for neoadjuvant treatment.
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