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Randomized phase II trial evaluating two sequential treatments in first line of metastatic pancreatic cancer: Results of the PANOPTIMOX-PRODIGE 35 Trial

Journal of Clinical Oncology Jul 27, 2021

Dahan L, Williet N, Le Malicot K, et al. - For metastatic pancreatic cancer (mPC), chemotherapy with fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) represents the standard treatment in first line with a limiting oxaliplatin-related neurotoxicity, researchers undertook this randomized phase II trial to assess an oxaliplatin stop-and-go strategy and a sequential strategy. They randomized patients to receive either 6 months of FOLFIRINOX (arm A), 4 months of FOLFIRINOX followed by leucovorin plus fluorouracil maintenance treatment for controlled patients (arm B), or a sequential treatment alternating gemcitabine and fluorouracil, leucovorin, and irinotecan every 2 months (arm C). In these treatment arms, the 6-month progression-free survival was estimated to be 47.1%, 42.9%, and 34.1%, respectively, and the median overall survival was 10.1 months, 11.2 and 7.3 months, respectively. Overall, it appeared that leucovorin plus fluorouracil has feasibility as well as effectiveness as a maintenance treatment in patients with mPC controlled after 4 months of induction chemotherapy with FOLFIRINOX. The maintenance therapy arm exhibited higher severe neurotoxicity, possibly due to the higher cumulative dose of oxaliplatin.

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