Ippei Matsumoto1, Keiko Kamei2, Katsuhiro Omae3, Shuhei Suzuki4, Hidehiko Matsuoka5, Nobumasa Mizuno6, Masato Ozaka7, Hideki Ueno8, Satoshi Kobayashi9, Kazuhiro Uesugi10, Marina Kobayashi11, Akiko Todaka12, Akira Fukutomi12. 1. Department of Surgery, Kindai University Faculty of Medicine, Osaka, Japan. Electronic address: ippeimm@gmail.com. 2. Department of Surgery, Kindai University Faculty of Medicine, Osaka, Japan. 3. Clinical Research Center, Shizuoka Cancer Center, Shizuoka, Japan. 4. Department of Clinical Oncology, Yamagata University Hospital, Yamagata, Japan. 5. University of Occupational and Environmental Health, Fukuoka, Japan. 6. Department of Gastroenterology, Aichi Cancer Center Hospital, Aichi, Japan. 7. Department of Gastroenterology, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan. 8. Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan. 9. Division of Hepatobiliary and Pancreatic Medical Oncology, Kanagawa Cancer Center, Kanagawa, Japan. 10. Department of Gastroenterology, National Hospital Organization Shikoku Cancer Center, Ehime, Japan. 11. Clinical Trial Promotion Section, Shizuoka Industrial Foundation Pharma Valley Center, Shizuoka, Japan. 12. Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
Abstract
BACKGROUND: FOLFIRINOX (oxaliplatin, irinotecan, 5-fluorouracil, leucovorin) treatment significantly improved overall survival in the recent phase III study and became a standard therapy for metastatic pancreatic cancer. However, treatment for locally advanced pancreatic cancer is still controversial. We conducted subset analyses from a nation-wide multicenter observational study in Japan to evaluate the tolerability and efficacy of FOLFIRINOX in patients with locally advanced pancreatic cancer and to investigate independent prognostic factors with pre-treatment variables. METHODS: The study included 66 patients with unresectable locally advanced pancreatic cancer from 27 institutions in Japan who received FOLFIRINOX as first-line treatment between December 20, 2013 and December 19, 2014 and surveyed until December 2015. RESULTS: The median age was 63 with the Eastern Cooperative Oncology Group performance status of 0 or 1. Major Grade 3 or 4 adverse events included neutropenia (64%), leukopenia (33%), febrile neutropenia (15%), and diarrhea (15%). Severe adverse event occurred in 14 patients (11%) without fatal event. The median overall survival and progression-free survival times were 18.5 and 7.6 months, respectively. The objective response rate 15.2% and the disease control rate was 81.9%. A high modified Glasgow prognostic score (mGPS, ≥1) (95%CI 1.96-12.5) and female (95%CI 0.20-0.97) were identified as independent poor prognostic factors. CONCLUSIONS: First-line FOLFIRINOX treatment for locally advanced pancreatic cancer seems to be effective with acceptable toxicities. A high mGPS may be associated with poor survival in patients with locally advanced pancreatic cancer who receive FOLFIRINOX. This study was registered at the UMIN Clinical Trials Registry (UMIN000014658).
BACKGROUND:FOLFIRINOX (oxaliplatin, irinotecan, 5-fluorouracil, leucovorin) treatment significantly improved overall survival in the recent phase III study and became a standard therapy for metastatic pancreatic cancer. However, treatment for locally advanced pancreatic cancer is still controversial. We conducted subset analyses from a nation-wide multicenter observational study in Japan to evaluate the tolerability and efficacy of FOLFIRINOX in patients with locally advanced pancreatic cancer and to investigate independent prognostic factors with pre-treatment variables. METHODS: The study included 66 patients with unresectable locally advanced pancreatic cancer from 27 institutions in Japan who received FOLFIRINOX as first-line treatment between December 20, 2013 and December 19, 2014 and surveyed until December 2015. RESULTS: The median age was 63 with the Eastern Cooperative Oncology Group performance status of 0 or 1. Major Grade 3 or 4 adverse events included neutropenia (64%), leukopenia (33%), febrile neutropenia (15%), and diarrhea (15%). Severe adverse event occurred in 14 patients (11%) without fatal event. The median overall survival and progression-free survival times were 18.5 and 7.6 months, respectively. The objective response rate 15.2% and the disease control rate was 81.9%. A high modified Glasgow prognostic score (mGPS, ≥1) (95%CI 1.96-12.5) and female (95%CI 0.20-0.97) were identified as independent poor prognostic factors. CONCLUSIONS: First-line FOLFIRINOX treatment for locally advanced pancreatic cancer seems to be effective with acceptable toxicities. A high mGPS may be associated with poor survival in patients with locally advanced pancreatic cancer who receive FOLFIRINOX. This study was registered at the UMIN Clinical Trials Registry (UMIN000014658).
Authors: Colin S Hill; Lauren M Rosati; Chen Hu; Wei Fu; Shuchi Sehgal; Amy Hacker-Prietz; Christopher L Wolfgang; Matthew J Weiss; Richard A Burkhart; Ralph H Hruban; Ana De Jesus-Acosta; Dung T Le; Lei Zheng; Daniel A Laheru; Jin He; Amol K Narang; Joseph M Herman Journal: Ann Surg Oncol Date: 2022-02-07 Impact factor: 5.344