Annals of Oncology Advance Access originally published online on January 14, 2005
Annals of Oncology 2005 16(3):430-436; doi:10.1093/annonc/mdi081
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© 2005 European Society for Medical Oncology
Phase I–II study of amrubicin and cisplatin in previously untreated patients with extensive-stage small-cell lung cancer
1 Department of Internal Medicine, National Cancer Center Hospital, Tokyo; 2 Department of Clinical Oncology, Osaka City General Hospital, Osaka; 3 Department of Thoracic Malignancy, Osaka Prefectural Medical Center for Respiratory and Allergic Diseases, Habikino, Osaka; 4 Department of Medical Oncology, Kinki University School of Medicine, Osakasayama, Osaka; 5 Department of Internal Medicine, Aichi Cancer Center Hospital, Nagoya, Aichi, 6 Department of Radiology, Hyogo Medical Center for Adults, Akashi, Hyogo; 7 Division of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Chiba; 8 Department of Internal Medicine, National Hospital Organization Toneyama National Hospital, Toyonaka, Osaka; 9 Department of Internal Medicine, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai, Osaka; 10 Aichi Prefectural Hospital, Okazaki, Aichi, Japan
* 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; Email: yohe{at}ncc.go.jp
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.
Key words: anthracycline, cisplatin, phase I–II, small-cell lung cancer
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