A phase II trial of single-agent amrubicin (AMR) in patients with extensive disease small cell lung cancer (ED-SCLC) that is refractory or progressive within 90 days of completion of first-line platinum-based chemotherapy

Abstract

8041 Background: Pts with SCLC who progress while on first-line chemotherapy or relapse within 3 months are less likely to respond to additional chemotherapy treatment. Refractory patients have an expected response rate to subsequent therapy of 10%. Recent data suggest that single-agent amrubicin (AMR), a synthetic anthracycline analogue and potent DNA topoisomerase II inhibitor, may result in improved response rates and survival in refractory SCLC patients when compared to standard treatment. Methods: This is a phase 2, open-label, multicenter trial of single-agent AMR for the treatment of patients with ED-SCLC (≥18 years, ECOG performance status ≤2) refractory to prior platinum-based first-line therapy (best response to 1st-line chemotherapy is progression or response/stable disease with subsequent progression within 90 days of completion of 1st-line chemotherapy). Pts were to receive AMR 40 mg/m2 daily x 3 days IV every 21 days. Treatment was to be continued until disease progression, unacceptable toxi...