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

Takaya Ikeda, Minoru Fukuda, Yoichi Nakamura, Akitoshi Kinoshita, Hiroaki Senju, Hirofumi Nakano, Takeshi Kitazaki, Daiki Ogawara, Hirokazu Taniguchi, Kohei Motoshima, Hiroyuki Yamaguchi, Katsumi Nakatomi, Midori Shimada, Seiji Nagashima, Kazuhiro Tsukamoto, Shigeru Kohno
Cancer Chemotherapy and Pharmacology 2014, 74 (3): 497-502

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/m(2) 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.

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