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

6 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

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Pancreatic Neoplasms
Multicenter Studies
Observational Studies
Japan
Drug Therapy
oxaliplatin
irinotecan
Febrile Neutropenia
Survival
Leucovorin
Anorexia
Neutropenia
Fluorouracil
Disease-Free Survival

ASJC Scopus subject areas

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

Cite this

Nationwide Multicenter Observational Study of FOLFIRINOX Chemotherapy in 399 Patients With Unresectable or Recurrent Pancreatic Cancer in Japan. / Todaka, Akiko; Mizuno, Nobumasa; Ozaka, Masato; Ueno, Hideki; Kobayashi, Satoshi; Uesugi, Kazuhiro; Kobayashi, Noritoshi; Hayashi, Hideyuki; Sudo, Kentaro; Okano, Naohiro; Horita, Yosuke; Kamei, Keiko; Yukisawa, Seigo; Nakamori, Shoji; Yachi, Yutaka; Henmi, Toshiyuki; Kobayashi, Marina; Boku, Narikazu; Mori, Keita; Fukutomi, Akira.

In: Pancreas, Vol. 47, No. 5, 01.05.2018, p. 631-636.

Research output: Contribution to journalArticle

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, vol. 47, no. 5, pp. 631-636. https://doi.org/10.1097/MPA.0000000000001049
Todaka, Akiko ; Mizuno, Nobumasa ; Ozaka, Masato ; Ueno, Hideki ; Kobayashi, Satoshi ; Uesugi, Kazuhiro ; Kobayashi, Noritoshi ; Hayashi, Hideyuki ; Sudo, Kentaro ; Okano, Naohiro ; Horita, Yosuke ; Kamei, Keiko ; Yukisawa, Seigo ; Nakamori, Shoji ; Yachi, Yutaka ; Henmi, Toshiyuki ; Kobayashi, Marina ; Boku, Narikazu ; Mori, Keita ; Fukutomi, Akira. / Nationwide Multicenter Observational Study of FOLFIRINOX Chemotherapy in 399 Patients With Unresectable or Recurrent Pancreatic Cancer in Japan. In: Pancreas. 2018 ; Vol. 47, No. 5. pp. 631-636.
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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-na{\"i}ve 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.",
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T1 - Nationwide Multicenter Observational Study of FOLFIRINOX Chemotherapy in 399 Patients With Unresectable or Recurrent Pancreatic Cancer in Japan

AU - Todaka, Akiko

AU - Mizuno, Nobumasa

AU - Ozaka, Masato

AU - Ueno, Hideki

AU - Kobayashi, Satoshi

AU - Uesugi, Kazuhiro

AU - Kobayashi, Noritoshi

AU - Hayashi, Hideyuki

AU - Sudo, Kentaro

AU - Okano, Naohiro

AU - Horita, Yosuke

AU - Kamei, Keiko

AU - Yukisawa, Seigo

AU - Nakamori, Shoji

AU - Yachi, Yutaka

AU - Henmi, Toshiyuki

AU - Kobayashi, Marina

AU - Boku, Narikazu

AU - Mori, Keita

AU - Fukutomi, Akira

PY - 2018/5/1

Y1 - 2018/5/1

N2 - 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.

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