Phase II study of FOLFIRINOX for chemotherapy‐naïve Japanese patients with metastatic pancreatic cancer

Cancer Science

Takuji Okusaka⁶  Masafumi Ikeda⁷  Akira Fukutomi²  Tatsuya Ioka³  Junji Furuse⁴  Shinichi Ohkawa⁵  Hiroyuki Isayama¹ 

[1] Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan;Department of Gastrointestinal Oncology, Sunto-gun Cancer Center, Shizuoka, Japan;Department of Hepatobiliary and Pancreatic Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan;Department of Medical Oncology, Kyorin University School of Medicine, Mitaka, Japan;Department of Hepatobiliary and Pancreatic Oncology, Kanagawa Cancer Center, Yokohama, Japan;Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan;Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan

关键词: Chemotherapy;    FOLFIRINOX;    irinotecan;    oxaliplatin;    pancreatic cancer;   

DOI  :  10.1111/cas.12501

来源: Wiley

【 摘 要 】

Abstract

The FOLFIRINOX combination of chemotherapy drugs had not been fully evaluated for Japanese pancreatic cancer patients. Therefore, we carried out a phase II study to examine the efficacy and safety of FOLFIRINOX in chemotherapy-naïve Japanese patients with metastatic pancreatic cancer. FOLFIRINOX (i.v. infusion of 85 mg/m² oxaliplatin, 180 mg/m² irinotecan, and 200 mg/m² l-leucovorin, followed by a bolus of 400 mg/m² fluorouracil and a 46-h continuous infusion of 2400 mg/m² fluorouracil) was given every 2 weeks. The primary endpoint was the response rate. The 36 enrolled patients received a median of eight (range, 1–25) treatment cycles. The response rate was 38.9% (95% confidence interval [CI], 23.1–56.5); median overall survival, 10.7 months (95% CI, 6.9–13.2); and median progression-free survival, 5.6 months (95% CI, 3.0–7.8). Major grade 3 or 4 toxicities included neutropenia (77.8%), febrile neutropenia (22.2%), thrombocytopenia (11.1%), anemia (11.1%), anorexia (11.1%), diarrhea (8.3%), nausea (8.3%), elevated alanine aminotransferase levels (8.3%), and peripheral sensory neuropathy (5.6%). Febrile neutropenia occurred only during the first cycle. There were no treatment-related deaths. FOLFIRINOX can be a standard regimen showing favorable efficacy and acceptable toxicity profile in chemotherapy-naïve Japanese patients with metastatic pancreatic cancer.

【 授权许可】

CC BY-NC-ND   
© 2014 The Authors. Cancer Science published by Wiley Publishing Asia Pty Ltd on behalf of Japanese Cancer Association.

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