Treatment of Initially Unresectable Local Advanced Pancreatic Adenocarcinoma with Folfirinox: A Prospective Study YCOG1403 (C-flap Study)

Background: A challenge in locally advanced, unresectable pancreatic cancer treatment is to achieve both survival benefits and a safe margin-negative resection. There is no robust evidence regarding the treatment of patients with unresectable pancreatic cancer. Methods: We conducted a prospective, single-arm, phase II trial in patients with unresectable pancreatic cancer using the FOLFIRINOX regimen. After completing 4–8 cycles, patients underwent surgical resection when feasible. The primary endpoint was the R0 resection rate. Results: Fifteen patients were enrolled in this study. A median of six courses of FOLFIRINOX chemotherapy was administered, and a partial response or R0 resection was achieved in 26.7% or 33% of the patients, respectively. Severe adverse events due to chemotherapy and major surgical complications were observed in 33.3% and 6.7% of patients, respectively. The median overall survival rate of patients who underwent R0 resection or with R1 or unresectable disease was 47.8 months (95% CI, 22.5–73.1) or 14.5 months (95% CI, 11.8–17.2), respectively (P=0.031). Conclusions: FOLFIRINOX treatment resulted in a relatively high rate of R0 resection and prolonged survival. Therefore, FOLFIRINOX is an effective, feasible, and well-tolerated treatment for locally advanced, initially unresectable pancreatic cancer and might be a suitable treatment to achieve survival benefits and R0 resection.