A phase II study of modified FOLFIRINOX for chemotherapy-naïve patients with metastatic pancreatic cancer

Background We evaluated the efficacy and safety of a modified FOLFIRINOX regimen for chemotherapy-naïve patients with metastatic pancreatic cancer. Methods Patients with untreated metastatic pancreatic cancer (MPC) received modified FOLFIRINOX (intravenous oxaliplatin 85 mg/m 2 , irinotecan 150 mg/m...

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Published in:Cancer chemotherapy and pharmacology Vol. 81; no. 6; pp. 1017 - 1023
Main Authors: Ozaka, Masato, Ishii, Hiroshi, Sato, Tosiya, Ueno, Makoto, Ikeda, Masafumi, Uesugi, Kazuhiro, Sata, Naohiro, Miyashita, Kouichirou, Mizuno, Nobumasa, Tsuji, Kunihiro, Okusaka, Takuji, Furuse, Junji
Format: Journal Article
Language:English
Published: Berlin/Heidelberg Springer Berlin Heidelberg 01.06.2018
Springer Nature B.V
Subjects:
Adult
Aged
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Cancer Research
Chemotherapy
Disease control
Disease-Free Survival
Drug Combinations
Female
Fluorouracil - adverse effects
Fluorouracil - therapeutic use
Humans
Intravenous administration
Irinotecan
Japan
Leucovorin - adverse effects
Leucovorin - therapeutic use
Male
Medicine
Medicine & Public Health
Metastases
Metastasis
Middle Aged
Neoplasm Metastasis
Neutropenia
Neutropenia - chemically induced
Neutropenia - epidemiology
Oncology
Organometallic Compounds - adverse effects
Organometallic Compounds - therapeutic use
Original Article
Oxaliplatin
Pancreatic cancer
Pancreatic Neoplasms - drug therapy
Pancreatic Neoplasms - pathology
Patients
Pharmacology/Toxicology
Survival
Survival Rate
Treatment Outcome
Japan
Modified FOLFIRINOX
Chemotherapy
FOLFIRINOX
Metastatic
Pancreatic cancer
ISSN:0344-5704, 1432-0843, 1432-0843
Online Access:Get full text
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Summary:Background We evaluated the efficacy and safety of a modified FOLFIRINOX regimen for chemotherapy-naïve patients with metastatic pancreatic cancer. Methods Patients with untreated metastatic pancreatic cancer (MPC) received modified FOLFIRINOX (intravenous oxaliplatin 85 mg/m 2 , irinotecan 150 mg/m 2 , 5-FU infusion 2400 mg/m 2 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. Results 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. Conclusion 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.
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ISSN:0344-5704
1432-0843
1432-0843
DOI:10.1007/s00280-018-3577-9