Nationwide Multicenter Observational Study of FOLFIRINOX Chemotherapy in 399 Patients With Unresectable or Recurrent Pancreatic Cancer in Japan

Akiko Todaka, Nobumasa Mizuno, Masato Ozaka, Hideki Ueno, Satoshi Kobayashi, Kazuhiro Uesugi, Noritoshi Kobayashi, Hideyuki Hayashi, Kentaro Sudo, Naohiro Okano, Yosuke Horita, Keiko Kamei, Seigo Yukisawa, Shoji Nakamori, Yutaka Yachi, Toshiyuki Henmi, Marina Kobayashi, Narikazu Boku, Keita Mori, Akira Fukutomi

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

OBJECTIVES: FOLFIRINOX (oxaliplatin, irinotecan, 5-fluorouracil, and leucovorin) is the standard therapy worldwide for unresectable pancreatic cancer; however, clinical data for Japanese patients are limited. Therefore, the observational study of FOLFIRINOX for patients with pancreatic cancer was conducted.

METHODS: The study included 399 patients with unresectable or recurrent pancreatic cancer, from 27 institutions in Japan, treated with FOLFIRINOX and surveyed until December 2015.

RESULTS: The median age was 63 years; in most patients, the Eastern Cooperative Oncology Group performance status was 1 or lower. The initial dose was reduced in 270 patients (68%). The main grade 3/4 toxicities were neutropenia (64%), anorexia (14%), and febrile neutropenia (13%). Fatal adverse events occurred in 5 patients, 4 of whom did not satisfy the main inclusion criteria of a previous Japanese phase II FOLFIRINOX study. The median overall survival and progression-free survival times were 10.8, and 4.5 months, respectively. The objective response rate was 21%, and the disease control rate was 61%. The median overall survival times were 11.1, 18.5, and 4.9 months in chemotherapy-naïve patients with metastatic, locally advanced, and recurrent disease, respectively.

CONCLUSION: When carefully managed, FOLFIRINOX is acceptably safe and efficacious in Japanese patients with unresectable pancreatic cancer.

Original languageEnglish
Pages (from-to)631-636
Number of pages6
JournalPancreas
Volume47
Issue number5
DOIs
Publication statusPublished - 2018 May 1
Externally publishedYes

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Hepatology
  • Endocrinology

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    Todaka, A., Mizuno, N., Ozaka, M., Ueno, H., Kobayashi, S., Uesugi, K., Kobayashi, N., Hayashi, H., Sudo, K., Okano, N., Horita, Y., Kamei, K., Yukisawa, S., Nakamori, S., Yachi, Y., Henmi, T., Kobayashi, M., Boku, N., Mori, K., & Fukutomi, A. (2018). Nationwide Multicenter Observational Study of FOLFIRINOX Chemotherapy in 399 Patients With Unresectable or Recurrent Pancreatic Cancer in Japan. Pancreas, 47(5), 631-636. https://doi.org/10.1097/MPA.0000000000001049