The Study: The French are bringing us another PRODIGE trial, and this one’s served at room temp. Two chemo regimens have changed the status quo for metastatic pancreatic cancer, but their uses in the adjuvant setting have been unclear. Until now. We’re talking, of course, about gemcitabine and FOLFIRINOX (folinic acid, 5-FU, irinotecan, and oxaliplatin). The phase 3 PRODIGE 24 trial randomized almost 500 patients from 77 centers to post-op gem x 6 cycles (24 weeks) or modified FOLFIRINOX x 12 cycles (also 24 weeks). Side note: The "modified" part makes it more tolerable. Patients were eligible with any margin status, but they couldn’t have an ECOG status >1. Each arm had a 12% grade 4 toxicity, which is no joke, but it wasn’t for nothing. The primary endpoint of overall survival was an impressive 34 (!) months among those receiving gem and an unbelievable 54 (!!!) months among those receiving modified FOLFIRINOX.
Bottom Line: Modified FOLFIRINOX is the new standard for adjuvant systemic therapy for any patient who has surgically parted with her pancreatic cancer while holding on to a good performance status. | Conroy, ASCO 2018