Open AccessPhase II study of FOLFIRINOX for chemotherapy‐naïve Japanese patients with metastatic pancreatic cancer
Author(s) -
Okusaka Takuji,
Ikeda Masafumi,
Fukutomi Akira,
Ioka Tatsuya,
Furuse Junji,
Ohkawa Shinichi,
Isayama Hiroyuki,
Boku Narikazu
Publication year - 2014
Publication title -
cancer science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.035
H-Index - 141
eISSN - 1349-7006
pISSN - 1347-9032
DOI - 10.1111/cas.12501
Subject(s) - folfirinox , medicine , oxaliplatin , gastroenterology , neutropenia , irinotecan , chemotherapy , pancreatic cancer , regimen , febrile neutropenia , phases of clinical research , fluorouracil , nausea , clinical endpoint , surgery , cancer , colorectal cancer , clinical trial
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.