2018年6月1日
A phase II study of modified FOLFIRINOX for chemotherapy-naïve patients with metastatic pancreatic cancer
Cancer Chemotherapy and Pharmacology
- 巻
- 81
- 号
- 6
- 開始ページ
- 1017
- 終了ページ
- 1023
- 記述言語
- 英語
- 掲載種別
- 研究論文(学術雑誌)
- DOI
- 10.1007/s00280-018-3577-9
- 出版者・発行元
- Springer Verlag
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/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. 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.
- リンク情報
- ID情報
-
- DOI : 10.1007/s00280-018-3577-9
- ISSN : 1432-0843
- ISSN : 0344-5704
- SCOPUS ID : 85045113079
- Web of Science ID : WOS:000433507600007