A phase II study of modified FOLFIRINOX for chemotherapy-naïve patients with metastatic pancreatic cancer
We evaluated the efficacy and safety of a modified FOLFIRINOX regimen for chemotherapy-naïve patients with metastatic pancreatic cancer.
Patients with untreated metastatic pancreatic cancer (MPC) received modified FOLFIRINOX (intravenous oxaliplatin 85 mg/m2, irinotecan 150 mg/m2, 5-FU infusion 2400 mg/m2 over 46 h, no bolus 5-FU). The primary endpoints were overall survival and the incidence of grade 3 or higher neutropenia. No patients received prophylactic pegfilgrastim.
Sixty-nine pts. were enrolled from 39 institutions in Japan. The median overall survival was 11.2 months [95% confidence interval (CI) 9.0–]. The median progression-free survival was 5.5 months (95% CI 4.1–6.7). The response rate was 37.7% (95% CI 26.3–50.2), and the disease control rate was 78.3% (95% CI 66.7–87.3). The incidence of grade 3 or higher neutropenia was 47.8%. Serious adverse events occurred in six patients (8.7%). All AE proportions were less than those in the previous Japanese full-dose phase II study. One patient died due to interstitial pneumonia related to treatment.
This is the first prospective study of modified FOLFIRINOX in Asia. Modified FOLFIRINOX in this study has an improved safety profile with maintained efficacy in MPC without prophylactic pegfilgrastim.
KeywordsMetastatic Pancreatic cancer Chemotherapy FOLFIRINOX Modified FOLFIRINOX
We thank all the patients, their families, the investigators, co-medical staffs and all others who participated in the present study.
This research was supported by the Practical Research for Innovative Cancer Control from the Japan Agency for Medical Research and development, AMED, and in part by The National Cancer Center Research and Development Fund (26-A-4).
Compliance with ethical standards
Conflict of interest
Masato Ozaka received the honoraria from Taiho Pharmaceutical, Yakult, Bayer, Pfizer and Novartis. Hiroshi Ishii is a member of a Data and safety Monitoring Board of Ono, and received the honoraria from Eisai, Taiho, Chugai and Astellas. Makoto Ueno received honoraria from Abbott, Eli Lilly, Yakult and AstraZeneca and research funding from Eli Lilly, Kowa, Taiho, Yakult, Daiichi-Sankyo, Kyowa Hakko Kirin, Zeria, Merck Serono and AstraZeneca. Masafumi Ikeda received research funding from received research funding from GlaxoSmithKline, AstraZeneca, Yakult, Ono Pharmaceutical, and Eisai. Nobumasa Mizuno has received research grants from AstraZeneca, Eisai, Merck Serono, MSD, NanoCarrier, Taiho Pharmaceutical, and Zeria Pharmaceutical, and speakers bureau honoraria from Kyowa Hakko Kirin, Novartis, Pfizer, Taiho Pharmaceutical, and Yakult Honsha. Takuji Okusaka has had an editor role, research grant, and honoraria from Novartis; reports research grants and honoraria from Pfizer, Taiho, Bayer, Chugai, Eli Lilly and Company, Yakuruto Honsha, Ono Pharmaceutical, AstraZeneca, Merck Serono, Baxter, Nobelpharma Co.; and research grants from Nippon Boehringer Ingelheim, Dainippon Simitomo Pharma, Eisai Co., OncoTherapy Science Inc., Kyowa Hakko Kirin Co., Shizuoka Industry, Nano Carrier Co., Zeria Pharmaceutical Co. and Glaxo Smith Kline. Junji Furuse received has received honoraria from Taiho Pharmaceutical, Fujifilm, Eisai, Astellas, Yakult, Sumitomo Dainippon, Eli Lilly Japan, and Kyowa Hakko Kirin, and research funding from J-Pharma, Taiho Pharmaceutical, Ono Pharmaceutical, MSD, Janssen and Daiichi Sankyo. The other authors declare that they have no conflict of interest.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study.
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