QOL-16HEALTH-RELATED QUALITY OF LIFE (HRQoL) IN A PHASE II TRIAL OF HYPOFRACTIONATED INTENSITY-MODULATED RADIATION THERAPY (HYPO-IMRT) WITH TEMOZOLOMIDE (TMZ) AND BEVACIZUMAB (BEV) FOR PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA MULTIFORME (GBM)

BACKGROUND: The initial results of this phase II clinical trial revealed a six-month progression-free survival of 90%, median PFS of 15.9 months and median overall survival of 16.3 months. We report here HRQoL that was assessed as a correlative study. METHODS: HRQoL was assessed using the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire core-30 (QLQ-C30) and the EORTC brain cancer module (QLQ-BN20). Questionnaires were administered at baseline, completion of RT, 1 month post-RT, and every 3 months thereafter. Changes from baseline were calculated for each specific scale. A ≥ 10 point change in any scale from the mean baseline score was deemed significant. RESULTS: A total of 30 patients were treated on trial. HRQoL data was available for 28 patients (11 women; median age: 57 years [range, 31-72]; median KPS 80%). Compliance with assessments at baseline, completion of RT, 1 month post-RT, 3, 6, 9, and 12 months was 100, 96, 100, 86, 84, 52, and 30% respectively. Compared to baseline scores, there was no significant change in global health status, physical functioning, role functioning, emotional functioning, cognitive functioning or social functioning. No significant change was noted in nausea, pain, dyspnea, appetite, constipation, diarrhea, future uncertainty, visual disorder, communication deficit, headache, seizure, drowsiness or bladder control scores. Significant improvement was noted in financial, insomnia and fatigue scales. Significant worsening was noted in motor dysfunction, itchy skin, hair loss and weakness of legs. CONCLUSIONS: Treatment with hypo-IMRT combined with TMZ and BEV did not negatively impact overall HRQoL.