Phase I study of amrubicin and cisplatin in previously untreated patients with advanced non-small-cell lung cancer

19119 Background: Amrubicin, a totally synthetic 9-aminoanthracycline, is one of the most active new agents for non- small-cell lung cancer (NSCLC). This is the first report of combination amrubicin with cisplatin in patients with advanced NSCLC. Methods: To determine the maximum-tolerated dose (MTD) and the recommended dose (RD) of amrubicin with a fixed dose of cisplatin, and to assess the toxicity and activity of this combination, we conducted a phase I trial in previously untreated patients with advanced NSCLC. In this study, patients with stage IIIB or IV NSCLC were eligible. Amrubicin, at a starting dose of 30 mg m-2 on days 1, 2, and 3, was combined with a fixed dose of cisplatin 80 mg m-2 on day 1. Chemotherapy was given in a 3-week cycle. Results: In this phase I study, 20 patients were enrolled. Dose-limiting toxicities (DLT) were neutropenia, febrile neutropenia, thrombocytopenia, and elevated creatinine levels. The MTD and RD were estimated to be 30 mg m-2. Overall response rate was 42.1% (95%...