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


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Title: A phase II study of amrubicin and carboplatin for previously untreated patients with extensive-disease small cell lung cancer
Authors: Ikeda, Takaya / Fukuda, Minoru / Nakamura, Yoichi / Kinoshita, Akitoshi / Senju, Hiroaki / Nakano, Hirofumi / Kitazaki, Takeshi / Ogawara, Daiki / Taniguchi, Hirokazu / Motoshima, Kohei / Yamaguchi, Hiroyuki / Nakatomi, Katsumi / Shimada, Midori / Nagashima, Seiji / Tsukamoto, Kazuhiro / Kohno, Shigeru
Issue Date: Sep-2014
Publisher: Springer Verlag
Citation: Cancer Chemotherapy and Pharmacology, 74(3), pp.497-502; 2014
Abstract: 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-naïve ED-SCLC patients, performance status 0-1, age ≤75, 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 (41-75); stage IV = 34. Evaluation of responses was 6 complete response, 21 partial response, and 7 stable disease (response rate 79.4 %, 95 % CI 63.6-88.5 %). 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.
Keywords: Amrubicin / Carboplatin / Phase II study / Small cell lung cancer
URI: http://hdl.handle.net/10069/34902
ISSN: 03445704
DOI: 10.1007/s00280-014-2527-4
Rights: © 2014 Springer-Verlag. / The final publication is available at link.springer.com
Type: Journal Article
Text Version: author
Appears in Collections:Articles in academic journal

Citable URI : http://hdl.handle.net/10069/34902

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