Topotecan—Single agent activity in a weekly intravenous (IV) schedule for first-line therapy in poor prognosis extensive stage small cell lung cancer (SCLC): A Minnie Pearl Cancer Research Network phase II trial

17000 Background: Topotecan IV weekly produces significantly less myelotoxicity than the standard 5-day IV schedule and appears as active in patients (pts) with relapsed ovarian cancer. Topotecan 5-day IV schedule is the standard for second-line therapy for pts with sensitive relapse SCLC. Methods: The primary endpoints were to determine the response rate and toxicity of weekly topotecan IV in pts with previously untreated extensive stage SCLC who were elderly, with poor performance status (PS), or severe coexistent medical illness. Topotecan 4mg/m2 IV over 30 minutes for 12 consecutive weeks was planned. Dose modifications were made based on toxicity. Pts were evaluated for response after 4 weeks; at least 3 weekly treatments were required to be eligible. Results: 39 pts were enrolled: 21 men, 18 women; age range 60–90 (median 71); PS 0 = 2, 1 = 18, 2 = 19). 31 pts were evaluable by WHO criteria for response. 4 pts had partial responses (13%, 95% CI 4%-30%); 20 pts (65%) had stable disease (4 had minor r...