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
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.
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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 -