QLIF-07. HEALTH-RELATED QUALITY OF LIFE (HRQoL) IN PATIENTS WITH PROGRESSIVE GLIOBLASTOMA TREATED WITH COMBINED BEVACIZUMAB AND LOMUSTINE VERSUS LOMUSTINE ONLY (RANDOMIZED PHASE III EORTC STUDY 26101)

Abstract

Background: Progression‐free survival, but not overall survival, was prolonged in the experimental treatment arm with bevacizumab and lomustine (BEV/LOM) compared to the lomustine only control (LOM) arm of randomized EORTC 26101. Secondary outcomes, such as Health‐Related Quality of Life (HRQoL), are important to determine a possible net clinical benefit of BEV in progressive glioblastoma. Objective: To evaluate treatment effects on HRQoL in recurrent glioblastoma patients treated in randomized phase III EORTC 26101. Methods: Recurrent glioblastoma patients were randomized, after standard radio‐chemotherapy, to either BEV/LOM, or LOM (2:1 randomization). HRQoL was assessed using the EORTC core questionnaire (QLQC30) and brain module (QLQ‐BN20). Assessments were performed at baseline, and every 12 weeks during treatment until progression of disease. Preselected scales for analysis were Global Health Status (GHS), Physical Functioning (PF), Social Functioning (SF), Motor Dysfunction (MD) and Communication Deficit (CD). Primary endpoint was HRQoL during the last assessment following baseline until week 36. In addition, mean changes from baseline to week 12, 24, and 36 were calculated as well as Time to HRQoL Deterioration (TTD) and HRQoL Deterioration Free Survival (DFS). Results: 402/437 patients (92%) had a HRQoL assessment at baseline. Compliance dropped to 66% at week 36, limiting further analysis, with no differences between treatment arms until week 36 with compliance in favor of BEV/LOM arm (71.2% versus 50%). At the last assessment, no differences were observed for preselected scales, apart from SF at last assessment being clinically relevant lower in the BEV/LOM arm (mean 66 versus 81, p=0.001). Of note, baseline score for SF was 66 in the BEV/LOM arm and 71 in the LOM arm, showing stable SF for patients in BEV/LOM arm and improved SF for patients in the LOM arm during follow‐up. Mean change in HRQoL from baseline was not different between arms at week 12 and 24, but GHS and SF were clinically relevant lower in the BEV/LOM arm at week 36 (mean change ‐5.6 versus +4.6 for GHS and ‐1.1 versus +9.3 for SF, in the BEV/LOM [n=35] and LOM arm [n=9] respectively), likely driven by low patient numbers in the LOM arm. TTD, not including progression as an event, was not different between treatment arms (median 13 weeks versus 13.1 weeks in the BEV/LOM and LOM arm, respectively; p=0.648), in contrast to DFS, with a significantly longer DFS in the BEV/LOM arm (median12.4 weeks versus 6.7 weeks in the BEV/LOM and LOM arm, respectively; p<0.001), reflecting the difference in time to progression between arms. Conclusion: Addition of bevacizumab to lomustine did not negatively affect HRQoL during the progression‐free period.