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 |
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| Main Authors: | , , , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
| Published: |
Berlin/Heidelberg
Springer Berlin Heidelberg
01.06.2018
Springer Nature B.V |
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| ISSN: | 0344-5704, 1432-0843, 1432-0843 |
| Online Access: | Get full text |
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| Abstract | 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. |
|---|---|
| AbstractList | BackgroundWe evaluated the efficacy and safety of a modified FOLFIRINOX regimen for chemotherapy-naïve patients with metastatic pancreatic cancer.MethodsPatients 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.ResultsSixty-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.ConclusionThis 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. 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. 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/m , irinotecan 150 mg/m , 5-FU infusion 2400 mg/m 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. We evaluated the efficacy and safety of a modified FOLFIRINOX regimen for chemotherapy-naïve patients with metastatic pancreatic cancer.BACKGROUNDWe 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.METHODSPatients 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.RESULTSSixty-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.CONCLUSIONThis 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. |
| Author | Ozaka, Masato Sato, Tosiya Ueno, Makoto Furuse, Junji Tsuji, Kunihiro Ishii, Hiroshi Ikeda, Masafumi Sata, Naohiro Miyashita, Kouichirou Uesugi, Kazuhiro Okusaka, Takuji Mizuno, Nobumasa |
| Author_xml | – sequence: 1 givenname: Masato orcidid: 0000-0002-5666-1970 surname: Ozaka fullname: Ozaka, Masato email: masato.ozaka@jfcr.or.jp organization: Department of Gastroenterology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research – sequence: 2 givenname: Hiroshi surname: Ishii fullname: Ishii, Hiroshi organization: National Hospital Organization Shikoku Cancer Center – sequence: 3 givenname: Tosiya surname: Sato fullname: Sato, Tosiya organization: Department of Biostatistics, Kyoto University School of Public Health – sequence: 4 givenname: Makoto surname: Ueno fullname: Ueno, Makoto organization: Division of Hepatobiliary and Pancreatic Oncology, Kanagawa Cancer Center – sequence: 5 givenname: Masafumi surname: Ikeda fullname: Ikeda, Masafumi organization: Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East – sequence: 6 givenname: Kazuhiro surname: Uesugi fullname: Uesugi, Kazuhiro organization: National Hospital Organization Shikoku Cancer Center – sequence: 7 givenname: Naohiro surname: Sata fullname: Sata, Naohiro organization: Department of Surgery, Jichi Medical University School of Medicine – sequence: 8 givenname: Kouichirou surname: Miyashita fullname: Miyashita, Kouichirou organization: Internal Medicine of Gastroenterology, Showa University Northern Yokohama Hospital – sequence: 9 givenname: Nobumasa surname: Mizuno fullname: Mizuno, Nobumasa organization: Department of Gastroenterology, Aichi Cancer Center Hospital – sequence: 10 givenname: Kunihiro surname: Tsuji fullname: Tsuji, Kunihiro organization: Department of Gastroenterology, Ishikawa Prefectural Central Hospital – sequence: 11 givenname: Takuji surname: Okusaka fullname: Okusaka, Takuji organization: Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital – sequence: 12 givenname: Junji surname: Furuse fullname: Furuse, Junji organization: Department of Medical Oncology, Kyorin University School of Medicine |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/29633005$$D View this record in MEDLINE/PubMed |
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| Copyright | Springer-Verlag GmbH Germany, part of Springer Nature 2018 Cancer Chemotherapy and Pharmacology is a copyright of Springer, (2018). All Rights Reserved. |
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| Snippet | Background
We evaluated the efficacy and safety of a modified FOLFIRINOX regimen for chemotherapy-naïve patients with metastatic pancreatic cancer.
Methods... We evaluated the efficacy and safety of a modified FOLFIRINOX regimen for chemotherapy-naïve patients with metastatic pancreatic cancer. Patients with... BackgroundWe evaluated the efficacy and safety of a modified FOLFIRINOX regimen for chemotherapy-naïve patients with metastatic pancreatic... We evaluated the efficacy and safety of a modified FOLFIRINOX regimen for chemotherapy-naïve patients with metastatic pancreatic cancer.BACKGROUNDWe evaluated... |
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| SubjectTerms | 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 |
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| Title | A phase II study of modified FOLFIRINOX for chemotherapy-naïve patients with metastatic pancreatic cancer |
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