Retrospective analysis of efficacy and safety of amrubicin in refractory and relapsed small-cell lung cancer.

BACKGROUND: Amrubicin, a totally synthetic 9-aminoanthracycline, was evaluated retrospectively for the treatment of refractory and relapsed small-cell lung cancer (SCLC).

METHODS: Retrospective analysis was performed in 32 patients. Amrubicin was infused over 5 min on days 1-3, with courses repeated at 3- or 4-week intervals. Amrubicin was given at a dose of 45 mg/m(2) per day, 40 mg/m(2) per day, 35 mg/m(2) per day, 30 mg/m(2) per day, or 25 mg/m(2) per day depending on medical conditions (patients' age and performance status [PS]), and the dose was modulated according to myelosuppression.

RESULTS: The median number of treatment cycles was 3 (range, 1-6). Seventeen patients (53.1%) had a partial response. Median progression-free survival time for all patients was 96 days, and median survival time was 166 days. Grade 3 or 4 hematologic toxicities comprised neutropenia (78.1%), anemia (65.6%), and thrombocytopenia (50.0%). Febrile neutropenia was observed in 8 patients (25.0%). Nonhematologic toxicities were mild. Treatment-related death was observed in 1 patient.

CONCLUSION: Treatment with amrubicin appeared effective in SCLC patients previously treated with chemotherapy, although it was not necessarily safe, because of myelosuppression. Further research is warranted to investigate amrubicin treatment for patients with SCLC.