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


Chemotherapy: Open Access

Author(s): Ohe Y, Negoro S, Matsui K, Nakagawa K, Sugiura T,

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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/m(2)/day and cisplatin 60 mg/m(2)) and three patients at level 2 (amrubicin 45 mg/m(2)/day and cisplatin 60 mg/m(2)). 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. This article was published in Ann Oncol and referenced in Chemotherapy: Open Access

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