Randomized phase III trial in extensive-disease small cell lung cancer comparing first-line etoposide to topotecan in combination with platinum.

7519 Background: Randomized trials in extensive disease (ED) small cell lung cancer (SCLC) comparing the camptothecins to standard etoposide based chemotherapy have reached conflicting results. Here we report the results of an interim analysis of a phase III trial randomly allocating patients (pts) with ED SCLC to etoposide or topotecan in combination with platinum. Methods: Previously untreated pts with ED SCLC were randomized to six cycles of T (topotecan 2.0 mg/m2 IV, day 1-3; cisplatin 50 mg/m2 IV, day 3) or E (etoposide 120 mg/m2, day 1-3; carboplatin IV AUC = 5, day 1) every 3 weeks. Primary end-point was overall survival (OS) and secondary end-points were response, progression-free survival (PFS), and safety. A sample size of 380 pts was estimated to detect an increase in 2-year survival from 7.5 to 15 % (α=0.05, β=0.20.) ClinicalTrials.gov NCT 00812266. Results: The trial was prematurely stopped due to poor accrual according to a pre-planned interim analysis after the accrual of 281 pts reducing p...