Interim analysis of perioperative modified FOLFIRINOX (mFOLFIRINOX) in resectable pancreatic cancer (PC).
2017
393Background: The mortality of patients (pts) with resectable PC is > 70% with surgery and adjuvant therapy. Based on the favorable results of our prospective phase II study of mFOLFIRINOX in locally advanced PC (Stein SM et al. Br J Cancer. 2016), we are conducting a single arm open-label phase II trial to evaluate the efficacy of peri-operative mFOLFIRINOX in resectable PC. Here we report our interim results. Methods: Pts with untreated resectable PC were treated with 6 cycles of mFOLFIRINOX every 2 weeks before and after surgical resection. Pre-op FDG-PET and CT scans were obtained at baseline and after 3 and 6 cycles, respectively. After study treatment pts were followed with serial CT scans and CA 19-9 levels. We performed our validated test for circulating tumor DNA (ctDNA) at baseline and multiple time points thereafter. Results: At our interim analysis, 19 pts are enrolled; 1 pt withdrew consent after 1 cycle and is not included. Baseline characteristics: median age 64; male 12; median CA-19 94 (...
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