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Annals of Oncology Advance Access published online on January 14, 2005
Annals of Oncology, doi:10.1093/annonc/mdi081
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© 2005 European Society for Medical Oncology
Received September 2, 2004
Revised October 14, 2004
Accepted October 22, 2004

Original article

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

Y. Ohe 1*, S. Negoro 2, K. Matsui 3, K. Nakagawa 4, T. Sugiura 5, Y. Takada 6, Y. Nishiwaki 7, S. Yokota 8, M. Kawahara 9, N. Saijo 7, M. Fukuoka 4, Y. Ariyoshi 10, and On behalf of the Amrubicin SCLC Study Group

1 Department of Internal Medicine, National Cancer Center Hospital, Tokyo, Japan
2 Department of Clinical Oncology, Osaka City General Hospital, Osaka, Japan
3 Department of Thoracic Malignancy, Osaka Prefectural Medical Center for Respiratory and Allergic Diseases, Habikino, Osaka, Japan
4 Department of Medical Oncology, Kinki University School of Medicine, Osakasayama, Osaka, Japan
5 Department of Internal Medicine, Aichi Cancer Center Hospital, Nagoya, Aichi, Japan
6 Department of Radiology, Hyogo Medical Center for Adults, Akashi, Hyogo, Japan
7 Division of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Chiba, Japan
8 Department of Internal Medicine, National Hospital Organization Toneyama National Hospital, Toyonaka, Osaka, Japan
9 Department of Internal Medicine, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai, Osaka, Japan
10 Aichi Prefectural Hospital, Okazaki, Aichi, Japan

* To whom correspondence should be addressed.
Y. Ohe, E-mail: yohe{at}ncc.go.jp


  Abstract

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.

Keywords: anthracycline; cisplatin; phase I-II; small-cell lung cancer.
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