TY - JOUR
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
N1 - Funding Information:
Shizuoka Industrial Foundation Pharma Valley Center during the course of the study. A.T. has received honoraria from Yakult Honsha Co, Ltd, Daiichi Sankyo Co, Ltd, and Ono Pharmaceutical Co, Lt, for purposes unrelated to the submitted work. N.M. has received honoraria from Yakult Honsha Co, Ltd, during the execution of the study, as well as grants and honoraria from Taiho Pharmaceutical Co, Ltd; grants from Zeria Pharmaceutical Co, Ltd, Merck Serono, AstraZeneca, NanoCarrier Co, Ltd, Eisai, and MSD KK; and honoraria from Novartis, Pfizer Inc, and Kyowa-Hakko Kirin Co, Ltd, for purposes unrelated to the submitted work. H.U. has received honoraria from Yakult Honsha Co, Ltd, Taiho Pharmaceutical Co, Ltd, and Chugai Pharmaceutical Co for purposes unrelated to the submitted work. N.K. has received honoraria from Yakult Honsha Co, Ltd. N.O. has received grants from J-Pharma Co, Ltd, Sumitomo Dainippon Pharma Co, Ltd, Janssen Pharmaceutical, Daiichi Sankyo Co, Ltd, MSD KK, Yakult Honsha Co, Ltd, Takeda Pharmaceutical Co, Chugai Pharmaceutical Co, Ono Pharmaceutical Co, Ltd, Astellas Pharma, Zeria Pharmaceutical Co, Ltd, Novartis, Nanocarrier Co, Ltd, Shionogi, Onco Therapy Science Inc, Eli Lilly Japan KK, Bayer, Bristol-Myers Squibb, Kyowa Hakko Kirin Co, Eisai, and Mochida Pharmaceutical, Ltd; grants and honoraria from Taiho Pharmaceutical Co, Ltd, and Merck Serono; and nonfinancial support from Pfizer Inc for purposes unrelated to the submitted work. Y.Y. is employed by Daiichi Sankyo Co, Ltd. T.H. is employed by Yakult Honsha Co, Ltd. M.K. is employed by the Shizuoka Industrial Foundation Pharma Valley Center. N.B. has received an honorarium from Yakult Honsha Co, Ltd, Taiho Pharmaceutical Co, Ltd, and Eli Lilly Japan KK. A.F. has received honoraria from Yakult Honsha Co, Ltd, and Daiichi Sankyo Co, Ltd. for purposes unrelated to the submitted work.
Funding Information:
This trial was supported by Yakult Honsha Co, Ltd; Daiichi Sankyo Co, Ltd; and Shizuoka Industrial Foundation Pharma Valley Center.
Publisher Copyright:
© 2018 Lippincott Williams and Wilkins. All rights reserved.
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.
AB - 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.
KW - 5-fluorouracil
KW - FOLFIRINOX
KW - chemotherapy
KW - irinotecan
KW - oxaliplatin
KW - pancreatic cancer
UR - http://www.scopus.com/inward/record.url?scp=85054889172&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85054889172&partnerID=8YFLogxK
U2 - 10.1097/MPA.0000000000001049
DO - 10.1097/MPA.0000000000001049
M3 - Article
C2 - 29683973
AN - SCOPUS:85054889172
VL - 47
SP - 631
EP - 636
JO - Pancreas
JF - Pancreas
SN - 0885-3177
IS - 5
ER -
