Evaluation of the recommended dose and efficacy of amrubicin as second- and third-line chemotherapy for small cell lung cancer.

INTRODUCTION: This study was conducted to evaluate the recommended dose and activity of amrubicin (AMR) as second- or third-line chemotherapy for small-cell lung cancer (SCLC).

METHODS: Small-cell lung cancer patients with measurable disease who had previously been treated with at least one platinum-based chemotherapy regimen and had an Eastern Cooperative Oncology Group performance status of 0-2 were eligible. Two groups of patients were selected: (1) a group to be treated with second-line chemotherapy and (2) a group to be treated with third-line chemotherapy. AMR was administered to both groups as a 5-minute daily intravenous injection at a dose of 40 or 35 mg/m2 for three consecutive days every 3 weeks.

RESULTS: Between March 2003 and June 2006, 27 patients (second-line, 40 mg/m2: 13 patients; third-line, 40 mg/m2: seven patients; and 35 mg/m2: seven patients) were enrolled. Although the 40-mg/m2 dose of AMR was feasible (one of 13 patients developed febrile neutropenia and four of 13 patients had grade 4 neutropenia) and effective (six of 13 patients had a partial response) in the second-line group, it produced unacceptable toxicity in a third-line setting (three of seven patients with grade 3 nonhematologic toxicities [febrile neutropenia in two patients and fatigue in one patient] and four of seven patients with grade 4 neutropenia). The 35-mg/m2 dose of AMR had acceptable toxicity in the third-line group (one of seven patients with febrile neutropenia and one of seven had grade 4 neutropenia) and moderate efficacy (one of seven patients had a partial response and two of seven had stable disease).

CONCLUSIONS: AMR exhibits significant activity as second-line or third-line chemotherapy for small-cell lung cancer. The recommended dose is 40 mg/m2 in a second-line setting and 35 mg/m2 in a third-line setting.