Funding Information Yakult Honsha Co., Ltd.
Phase II study of FOLFIRINOX for chemotherapy-naïve Japanese patients with metastatic pancreatic cancer
Article first published online: 29 SEP 2014
© 2014 The Authors. Cancer Science published by Wiley Publishing Asia Pty Ltd on behalf of Japanese Cancer Association.
This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
Volume 105, Issue 10, pages 1321–1326, October 2014
How to Cite
Cancer Sci 105 (2014) 1321–1326
- Issue published online: 22 OCT 2014
- Article first published online: 29 SEP 2014
- Accepted manuscript online: 13 AUG 2014 02:10AM EST
- Manuscript Accepted: 5 AUG 2014
- Manuscript Revised: 24 JUL 2014
- Manuscript Received: 8 MAY 2014
- Yakult Honsha Co., Ltd.
- pancreatic cancer
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.