Association of topotecan with improved performance status (PS) in relapsed small cell lung cancer (SCLC) patients with poor PS at baseline

Abstract

7208 Background: Topotecan is approved for the treatment of patients with relapsed SCLC and is the only single agent proven in randomized clinical trials to provide symptom palliation in these patients. Previous data have demonstrated that topotecan provides improvement even in patients with poor PS (PS=2). In this analysis, we investigated whether treatment with topotecan is associated with an improvement in PS assessed by the frequency of conversion from PS 2 to PS 0/1. Methods: A retrospective analysis of data from 5 clinical trials (N = 479) investigating topotecan in relapsed SCLC patients was performed. A total of 98 patients with PS 2 at baseline were included. All patients received topotecan 1.5 mg/m2/day on days 1 through 5 of a 21-day course. Results: Sixty-six patients had disease sensitive to first-line chemotherapy, and 32 patients were chemoresistant. A total of 341 courses of therapy were administered in patients with PS 2 (median, 2; range, 1 to 14 courses). Of the 98 PS 2 patients, 32 (33%) experienced PS improvement to PS 0/1 during topotecan treatment. Approximately two thirds of these patients converted to PS 0/1 after the first course of topotecan, and the improvement in PS persisted for at least 2 courses in 24 of the 32 patients. Overall antitumor response to topotecan was 46% in patients who experienced PS conversion compared with 8% in patients who had no improvement. Similarly, median overall survival in patients with PS improvement was 37 weeks (95% CI = 30, 45 weeks), compared with 12 weeks (95% CI = 9, 16 weeks) in patients with no improvement. Conclusions: A significant proportion of patients with poor PS at baseline experience PS improvement after treatment with topotecan. This may also be associated with a survival benefit. Improvement in PS seems to be an early surrogate for benefit from topotecan. Based on this analysis, a substantial proportion of patients with relapsed SCLC and PS 2 experience an improvement in PS and should not be denied treatment with topotecan. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration GlaxoSmithKline GlaxoSmithKline GlaxoSmithKline Bristol-Myers Squibb Oncology; GlaxoSmithKline GlaxoSmithKline