A phase II study of amrubicin and carboplatin for previously untreated patients with extensive-disease small cell lung cancer

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• 作者：Takaya Ikeda ; Minoru Fukuda ; Yoichi Nakamura…
• 关键词：Amrubicin ; Carboplatin ; Small cell lung cancer ; Phase II study
• 刊名：Cancer Chemotherapy and Pharmacology
• 出版年：2014
• 出版时间：September 2014
• 年：2014
• 卷：74
• 期：3
• 页码：497-502
• 全文大小：295 KB
• 参考文献：1. Vital Statistics of Japan (Ministry of Health, Labour & Walfare)
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• 作者单位：Takaya Ikeda (1)
  Minoru Fukuda (2)
  Yoichi Nakamura (3)
  Akitoshi Kinoshita (4)
  Hiroaki Senju (5)
  Hirofumi Nakano (6)
  Takeshi Kitazaki (2)
  Daiki Ogawara (3)
  Hirokazu Taniguchi (1)
  Kohei Motoshima (3)
  Hiroyuki Yamaguchi (7)
  Katsumi Nakatomi (3)
  Midori Shimada (2)
  Seiji Nagashima (3)
  Kazuhiro Tsukamoto (8)
  Shigeru Kohno (3)
  Nagasaki Thoracic Oncology Group
  
  1. Department of Medicine, Sasebo General Hospital, Nagasaki, Japan
  2. Clinical Oncology Center, Nagasaki University Hospital, 1-7-1 Sakamoto, Nagasaki, 852-8501, Japan
  3. Second Department of Internal Medicine, Nagasaki University Hospital, Nagasaki, Japan
  4. Department of Medicine, Nagasaki Prefecture Shimabara Hospital, Shimabara, Japan
  5. Department of Medicine, National Hospital Organization Nagasaki Medical Center, Nagasaki, Japan
  6. Department of Respiratory Medicine, National Ureshino Medical Center, Saga, Japan
  7. Department of Cellular Signaling, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
  8. Department of Clinical Pharmacy, Nagasaki University School of Pharmaceutical Science, Nagasaki, Japan
  
• ISSN：1432-0843

文摘

Background Amrubicin is active in the treatment of extensive-disease small cell lung cancer (ED-SCLC), and carboplatin is an analogue of cisplatin with less non-hematological toxicity. Purpose The purpose of this study was to determine the efficacy and toxicity of amrubicin and carboplatin combination chemotherapy for previously untreated patients with ED-SCLC. Patients and methods Eligibility criteria were chemotherapy-na?ve ED-SCLC patients, performance status 0-, age ?5, and adequate hematological, hepatic and renal function. Based on the phase I study, the patients received amrubicin 35?mg/m2 i.v. infusion on days 1, 2, and 3, and carboplatin AUC 5 i.v. infusion on day 1. Four cycles of chemotherapy were repeated every 3?weeks. Results Thirty-five patients were enrolled, and 34 patients were eligible and assessable for response, toxicity, and survival. Patients-characteristics were as follows: male/female?=?26/8; performance status 0/1?=?4/30; median age (range)?=?64 (41-5); stage IV?=?34. Evaluation of responses was 6 complete response, 21 partial response, and 7 stable disease (response rate 79.4?%, 95?% CI 63.6-8.5?%). Grade 3 and 4 leukopenia, neutropenia, and thrombocytopenia occurred in 59, 82, and 26?%, respectively. There were no treatment-related deaths or pneumonitis. Three patients experienced hypotension as an amrubicin infusion reaction. The median progression-free survival time was 6.5?months. The median overall survival time and 1-, 2-, and 3-year survival rates were 15.6?months, and 63, 28, and 7?%, respectively. Conclusions Amrubicin and carboplatin were effective and tolerable as chemotherapy for previously untreated patients with ED-SCLC. Further investigation of amrubicin and carboplatin is warranted.