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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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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.

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Conflict of interest

None declared.

Author information

Authors and Affiliations

  1. Department of Medicine, Sasebo General Hospital, Nagasaki, Japan

    Takaya Ikeda & Hirokazu Taniguchi

  2. Clinical Oncology Center, Nagasaki University Hospital, 1-7-1 Sakamoto, Nagasaki, 852-8501, Japan

    Minoru Fukuda, Takeshi Kitazaki & Midori Shimada

  3. Second Department of Internal Medicine, Nagasaki University Hospital, Nagasaki, Japan

    Yoichi Nakamura, Daiki Ogawara, Kohei Motoshima, Katsumi Nakatomi, Seiji Nagashima & Shigeru Kohno

  4. Department of Medicine, Nagasaki Prefecture Shimabara Hospital, Shimabara, Japan

    Akitoshi Kinoshita

  5. Department of Medicine, National Hospital Organization Nagasaki Medical Center, Nagasaki, Japan

    Hiroaki Senju

  6. Department of Respiratory Medicine, National Ureshino Medical Center, Saga, Japan

    Hirofumi Nakano

  7. Department of Cellular Signaling, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan

    Hiroyuki Yamaguchi

  8. Department of Clinical Pharmacy, Nagasaki University School of Pharmaceutical Science, Nagasaki, Japan

    Kazuhiro Tsukamoto

Authors
  1. Takaya Ikeda
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  2. Minoru Fukuda
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Nagasaki Thoracic Oncology Group

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Correspondence to Minoru Fukuda.

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Ikeda, T., Fukuda, M., Nakamura, Y. et al. A phase II study of amrubicin and carboplatin for previously untreated patients with extensive-disease small cell lung cancer. Cancer Chemother Pharmacol 74, 497–502 (2014). https://doi.org/10.1007/s00280-014-2527-4

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  • DOI: https://doi.org/10.1007/s00280-014-2527-4

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