O10.05 * FINAL ANALYSIS OF THE BELOB TRIAL (A RANDOMIZED PHASE II STUDY ON BEVACIZUMAB VERSUS BEVACIZUMAB PLUS LOMUSTINE VERSUS LOMUSTINE SINGLE AGENT IN RECURRENT GLIOBLASTOMA) AND FIRST RADIOLOGY REVIEW RESULTS

Abstract

INTRODUCTION: Bevacizumab (BEV) is widely used in recurrent glioblastoma, alone or in combination with other agents. There is however no controlled trial to support this use. MATERIAL AND METHODS: In a Dutch multicenter randomized phase II study patients were assigned to BEV 10 mg/kg day 1, 15 and 29 iv, BEV 10 mg/kg day 1, 15 and 29 iv in combination with 110 mg/m2 lomustine orally on day 1, or lomustine 110 mg/m2 orally on day 1, in a 6- weekly schedule . Eligible were patients with histologically proven glioblastoma, first recurrence after chemo-irradiation with temozolomide, having concluded radiotherapy more than 3 months ago, with adequate bone marrow, renal and hepatic function, and WHO performance status (PS) 0-2. Primary endpoint was 9 months overall survival (OS). RESULTS: Between December 2009 and November 2011, 148 eligible patients were enrolled . Median age was 57 years (range, 24-77) and median WHO PS was 1. After a preplanned safety review after the first 8 patients the lomustine dose in the combination arm was reduced to 90 mg/m2, 44 patients were treated at this dose level. 130 patients were evaluable for response. Nine month OS [95% confidence interval] was 43% [29, 57] in the lomustine arm, 38% [25, 51] in the BEV arm, and 59% [43, 72] in the BEV/lomustine 90 arm. Objective response rate (complete or partial response) by local investigator was 5% in the lomustine arm, 38% in the BEV arm and 34% in the BEV/lomustine 90 arm. CONCLUSION: The combination bevacizumab/lomustine warrants further investigation, and is currently investigated in the randomized controlled phase III EORTC trial 26101. At the meeting the analysis based on IDH and MGMT status and the first results on the radiology review, pattern of progression and clinical impact of isolated T2/FLAIR progression will be presented.