A phase III trial of topotecan and whole brain radiation (WBRT) therapy for patients with CNS metastases due to lung cancer

2049 Background: Brain metastases represent an important cause of morbidity in patients (pts) with lung cancer and are associated with a mean survival of less than 6 months. Thus studies to improve outcome are urgently needed. Methods: Based on promising data raised in a phase I/II trial, in which WBRT was combined with topotecan (ASCO #444, 2003), we initiated an open, randomized, prospective, multicentric phase III trial, comparing WBRT (20 x 2 Gy; arm A) alone with WBRT + topotecan (0.4 mg/m2/d x 20; arm B). 320 pts with CNS-metastases due to SCLC or NSCLC were projected. Primary endpoint was overall survival (OS), secondary endpoints were local response and progression-free survival (PFS). However, since until the cut off date of study completion (i.e. a study duration of 34 months) only a total of 96 (A: 49, B: 47) pts have been recruited, an interim analysis was performed at that time point. Results: The demographic data (o age 59 (34–75), 64% male, 66% NSCLC, mainly (64%) ECOG 0–1, extracerebral me...