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
Pancreas. 2018 May/Jun;47(5):631-636. doi: 10.1097/MPA.0000000000001049.
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.
The study included 399 patients with unresectable or recurrent pancreatic cancer, from 27 institutions in Japan, treated with FOLFIRINOX and surveyed until December 2015.
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.
When carefully managed, FOLFIRINOX is acceptably safe and efficacious in Japanese patients with unresectable pancreatic cancer.
FOLFIRINOX（奥沙利铂、伊立替康、5-氟尿嘧啶和亚叶酸钙）是全球范围内不可切除胰腺癌的标准治疗方案；然而，日本患者的临床数据有限。因此，开展了关于FOLFIRINOX治疗胰腺癌患者的观察性研究。
该研究纳入了来自日本27家机构的399例不可切除或复发性胰腺癌患者，这些患者接受了FOLFIRINOX治疗，并随访至2015年12月。
中位年龄为63岁；大多数患者东部肿瘤协作组体能状态评分为1分或更低。270例患者（68%）初始剂量降低。主要的3/4级毒性反应为中性粒细胞减少（64%）、厌食（14%）和发热性中性粒细胞减少（13%）。5例患者发生致命不良事件，其中4例不符合日本之前一项FOLFIRINOX II期研究的主要纳入标准。中位总生存期和无进展生存期分别为10.8个月和4.5个月。客观缓解率为21%，疾病控制率为61%。初治的转移性、局部晚期和复发性疾病患者的中位总生存期分别为11.1个月、18.5个月和4.9个月。
在谨慎管理的情况下，FOLFIRINOX对于日本不可切除胰腺癌患者而言安全性和有效性良好。
