Dose escalation and feasibility study of amrubicin combined with cisplatin in previously untreated patients with advanced non-small cell lung cancer.

Objectives: Cisplatin is a key drug used in the treatment of non-small cell lung cancer (NSCLC), and amrubicin is one of the new active agents for NSCLC. The objective of this study was to determine the recommended dose (RD) of amrubicin in combination with a fixed dose of cisplatin, and to assess the toxicity profile and feasibility of this regimen.

Methods: We conducted a dose escalation study of amrubicin and cisplatin in previously untreated patients with stage IIIB or IV NSCLC. Dose level 1 of amrubicin was 30 mg/m on days 1 to 3 and level 2 was 35 mg/m. Cisplatin was administered at a fixed dose of 80 mg/m on day 1. Chemotherapy was given in a 3-week cycle.

Results: Twenty patients were enrolled. Dose-limiting toxicities were neutropenia, febrile neutropenia, thrombocytopenia, and creatinine elevation. Level 1 (30 mg/m) was determined to be the RD, and 35 mg/m exceeded the RD. In 17 patients treated with the RD, the overall response rate was 41.2% (95% confidence interval, 17.7-64.7) and the median survival time was 16.4 months (95% confidence interval, 13.1-19.5).

Conclusions: This amrubicin and cisplatin regimen may be feasible and promising against advanced NSCLC. The efficacy and safety of this regimen should be confirmed in a phase II study.