Journal Article

Treatment of initially unresectable local advanced pancreatic adenocarcinoma with FOLFIRINOX: A prospective study YCOG1403 (C-FLAP study)

Mori, Ryutaro, Homma, Yuki, Endo, Itaru, Takahashi, Tomoaki, Katsuta, Eriko, Miyake, Kentaro, Sawada, Yu, Okubo, Naoki, Ichikawa, Yasushi, Kobayashi, Noritoshi, Yabushita, Yasuhiro, Kubota, Kensuke, Matsuyama, Ryusei, Yamanaka, Shoji

2025

Overview

This study aimed to provide evidence regarding the treatment of patients with unresectable pancreatic cancer. We conducted a prospective single-arm phase II trial using the FOLFIRINOX regimen. After completing 4–8 cycles, patients underwent surgical resection when feasible. The primary endpoint was R0 resection rate. 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% and 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 of patients who underwent R0 resection or with R1 or unresectable disease was 47.8 months (95% confidence interval (CI), 22.5–73.1) or 14.5 months (95% CI, 11.8–17.2), respectively ( P  = 0.031). Well-selected patients with unresectable locally advanced pancreatic cancer treated with FOLFIRINOX achieved relatively high R0 resection rates and prolonged survival. Therefore, induction with FOLFIRINOX is feasible and well tolerated for locally advanced, initially unresectable pancreatic cancer and may be effective in facilitating R0 resection and prolonging survival.

• Publisher: Nature Publishing Group UK,Nature Publishing Group,Nature Portfolio
• Subject: 631/67 / 692/4020 / Adenocarcinoma / Adenocarcinoma - drug therapy / Adenocarcinoma - mortality / Adenocarcinoma - pathology / Adenocarcinoma - surgery / Adult / Aged / Antineoplastic Combined Chemotherapy Protocols - administration & dosage / Antineoplastic Combined Chemotherapy Protocols - adverse effects / Antineoplastic Combined Chemotherapy Protocols - therapeutic use / Cancer therapies / Chemotherapy / Clinical trials / Diarrhea / Female / Fluorouracil - administration & dosage / Fluorouracil - adverse effects / Fluorouracil - therapeutic use / FOLFIRINOX / Humanities and Social Sciences / Humans / Irinotecan - administration & dosage / Irinotecan - adverse effects / Irinotecan - therapeutic use / Leucovorin - administration & dosage / Leucovorin - adverse effects / Leucovorin - therapeutic use / Male / Metastasis / Middle Aged / multidisciplinary / Neutropenia / Oncology / Oxaliplatin - administration & dosage / Oxaliplatin - adverse effects / Oxaliplatin - therapeutic use / Pancreatic cancer / Pancreatic Neoplasms - drug therapy / Pancreatic Neoplasms - mortality / Pancreatic Neoplasms - pathology / Pancreatic Neoplasms - surgery / Prospective Studies / R0 resection / Science / Science (multidisciplinary) / Surgery / Survival / Tomography / Toxicity / Treatment Outcome / Tumors / Unresectable locally advanced pancreatic cancer / Veins & arteries