Adjuvant Folfox Plus Nab-Paclitaxel (Folfox-A) For Pancreatic Cancer, Bruog 278: A Brown University Oncology Research Group Phase Ii Study.

e15733 Background: Adjuvant FOLFIRINOX increases survival in pancreatic cancer but is associated with significant toxicity. The Brown University Oncology Research Group (BrUOG) developed the FOLFOX-A regimen in a phase I study in advanced pancreatic cancer (Am J Clin Oncol, 2016). Phase II studies (BrUOG 292 and BrUOG 318) have shown substantial activity in patients with metastatic and locally advanced disease. Highly active regimens have the potential to improve survival in the adjuvant setting. The primary objective of BrUOG 295 was to determine the feasibility of administering 10 cycles of FOLFOX-A. Secondary objectives were toxicity and disease free survival. Methods: Patients received oxaliplatin, 85mg/m2 day 1, nab-paclitaxel, 150mg/m2 and leucovorin 400mg/m2 day 1 and fluorouracil 2400mg/m2 by continuous IV infusion over 46 hours. Myeloid growth factor support was optional. Cycles were repeated every 14 days for up to 10. Oxaliplatin was dose reduced to 68mg/m2 for grade 2 neurotoxicity. CTCAE version 4 toxicity scales were utilized. Results: The study reached its initial accrual goal of 25 patients. The median age was 60 (43-69). Twenty-one patients were node +. Twelve of the first 20 patients have received 10 cycles of FOLFOX-A and 17 of the first 20 patients received > 8 cycles. The most common grade >3 toxicities were neutropenia grade 3 (N = 3), grade 4 (N = 3) and fatigue grade 3 (n = 13). One patient had grade 3 neuropathy. Conclusions: Adjuvant FOLFOX-A is well tolerated with low incidences of grade 3 neuropathy and gastrointestinal toxicity. Toxicity, feasibility and disease free survival will be updated at the May 2019 BrUOG DSMB meeting. Clinical trial information: NCT02022033.