Phase II study of weekly amrubicin for refractory or relapsed non-small cell lung cancer

Background: Amrubicin is usually administered on days 1-3 every 3 weeks by intravenous infusion. However, it causes severe hematological toxicity, especially febrile neutropenia. It was reported that weekly administration confers higher dose intensity, less severe adverse events, and anti-tumor activity that is as effective as that of treatment with a conventional schedule. Patients and Methods: Weekly amrubicin was administered at a dose of 60 mg/m² on days 1 and 8 every 3 weeks. The primary endpoint was overall response rate. Results: A total of 33 patients were enrolled. The overall response rate was 6.1% (95% confidence interval(CI)=0.7-20.2%) and the disease control rate after 2 months was 51.5%. The median progression-free survival was 2.93 months. Febrile neutropenia was observed in only two patients. Conclusion: The primary endpoint was not met in this study. However, weekly amrubicin achieved a high disease control rate and good tolerability.