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HERO ID
8643335
Reference Type
Journal Article
Title
Phase II study of FOLFIRINOX for chemotherapy-naive Japanese patients with metastatic pancreatic cancer
Author(s)
Okusaka, T; Ikeda, M; Fukutomi, A; Ioka, T; Furuse, J; Ohkawa, S; Isayama, H; Boku, N
Year
2014
Is Peer Reviewed?
Yes
Journal
Cancer Science
ISSN:
1347-9032
EISSN:
1349-7006
Volume
105
Issue
10
Page Numbers
1321-1326
Language
English
PMID
25117729
DOI
10.1111/cas.12501
Web of Science Id
WOS:000344245400012
URL
http://
://WOS:000344245400012
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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/m(2) oxaliplatin, 180 mg/m(2) irinotecan, and 200 mg/m(2) l-leucovorin, followed by a bolus of 400 mg/m(2) fluorouracil and a 46-h continuous infusion of 2400 mg/m(2) 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.
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