Phase I–II study of amrubicin and cisplatin in previously untreated patients with extensive-stage small-cell lung cancer

  • Ohe, Y.
  • Negoro, S.
  • Matsui, K.
  • Nakagawa, K.
  • Sugiura, T.
  • Takada, Y.
  • Nishiwaki, Y.
  • Yokota, S.
  • Kawahara, M.
  • Saijo, N.
  • Fukuoka, M.
  • Ariyoshi, Y.

  • 1Department of Internal Medicine, National Cancer Center Hospital, Tokyo, Japan

    2Department of Clinical Oncology, Osaka City General Hospital, Osaka, Japan

    3Department of Thoracic Malignancy, Osaka Prefectural Medical Center for Respiratory and Allergic Diseases, Habikino, Osaka, Japan

    4Department of Medical Oncology, Kinki University School of Medicine, Osakasayama, Osaka, Japan

    5Department of Internal Medicine, Aichi Cancer Center Hospital, Nagoya, Aichi, Japan

    6Department of Radiology, Hyogo Medical Center for Adults, Akashi, Hyogo, Japan

    7Division of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Chiba, Japan

    8Department of Internal Medicine, National Hospital Organization Toneyama National Hospital, Toyonaka, Osaka, Japan

    9Department of Internal Medicine, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai, Osaka, Japan

    10Aichi Prefectural Hospital, Okazaki, Aichi, Japan

Received 2 September 2004; revised 14 October 2004; accepted 22 October 2004

*Correspondence to: Dr Y. Ohe, Department of Internal Medicine, National Cancer Center Hospital 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan. Tel: +81-3-3542-2511; Fax: +81-3-3542-7006; E-mail: [email protected]

Annals of Oncology 16(3):p 430-436, March 2005.

Background

Amrubicin, a totally synthetic 9-amino-anthracycline, demonstrated excellent single-agent activity for extensive-stage small-cell lung cancer (ED-SCLC). The aims of this trial were to determine the maximum-tolerated doses (MTD) of combination therapy with amrubicin and cisplatin, and to assess the efficacy and safety at their recommended doses (RD).

Patients and methods

Eligibility criteria were patients having histologically or cytologically proven measurable ED-SCLC, no previous systemic therapy, an Eastern Cooperative Oncology Group performance status of 0–2 and adequate organ function. Amrubicin was administered on days 1–3 and cisplatin on day 1, every 3 weeks.

Results

Four patients were enrolled at dose level 1 (amrubicin 40 mg/m2/day and cisplatin 60 mg/m2) and three patients at level 2 (amrubicin 45 mg/m2/day and cisplatin 60 mg/m2). Consequently, the MTD and RD were determined to be at level 2 and level 1, respectively. The response rate at the RD was 87.8% (36/41). The median survival time (MST) was 13.6 months and the 1-year survival rate was 56.1%. Grade 3/4 neutropenia and leukopenia occurred in 95.1% and 65.9% of patients, respectively.

Conclusions

The combination of amrubicin and cisplatin has demonstrated an impressive response rate and MST in patients with previously untreated ED-SCLC.

Copyright © 2005 The European Society for Medical Oncology