Field Kathryn M, King Madeleine T, Simes John, Espinoza David, Barnes Elizabeth H, Sawkins Kate, Rosenthal Mark A, Cher Lawrence, Hovey Elizabeth, Wheeler Helen, Nowak Anna K
Royal Melbourne Hospital, Parkville, VIC, 3050, Australia.
Department of Medicine, University of Melbourne, Parkville, VIC, 3050, Australia.
J Neurooncol. 2017 Jul;133(3):623-631. doi: 10.1007/s11060-017-2479-8. Epub 2017 May 22.
In recurrent glioblastoma, health-related quality of life (HRQL) is a crucial trial endpoint. We examined HRQL outcomes as a secondary endpoint for patients in the CABARET randomized phase 2 trial. 122 patients were randomly allocated to bevacizumab monotherapy or bevacizumab plus carboplatin. We calculated change scores from baseline for each HRQL measure on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and the Brain Cancer Module (QLQ-BN20), together with time to deterioration in HRQL, and the proportion of participants with clinically meaningful improvements in specific disease-related symptoms. At baseline, 117 of 122 randomized patients (96%) attempted questionnaires. Questionnaire participation rates were >90% for patients continuing on treatment, however at the end-of-treatment visit only 72 (64% of eligible participants) returned a form. There were no differences between arms in change scores over the treatment period. Time to ≥10 point deterioration in scores from baseline was also similar between arms. HRQL deterioration occurred largely before progression for the domains tested, but scores in HRQL domains specifically relevant to symptoms of recurrent glioblastoma also improved for about 50% of patients with symptoms at baseline. Neither detrimental nor beneficial effects on HRQL were seen with carboplatin added to bevacizumab, with a proportion of patients on both arms experiencing symptomatic benefit. Given the reduced questionnaire completion at end of treatment, time to HRQL deterioration is a feasible and robust clinical trial endpoint in this patient population. Clinical trials registration number: ACTRN12610000915055.
在复发性胶质母细胞瘤中，健康相关生活质量（HRQL）是一项关键的试验终点。我们将HRQL结果作为CABARET随机2期试验患者的次要终点进行了研究。122例患者被随机分配至贝伐单抗单药治疗组或贝伐单抗联合卡铂治疗组。我们计算了欧洲癌症研究与治疗组织生活质量问卷核心30项（EORTC QLQ-C30）和脑癌模块（QLQ-BN20）中各项HRQL指标相对于基线的变化分数，以及HRQL恶化时间，还有特定疾病相关症状出现具有临床意义改善的参与者比例。在基线时，122例随机分组患者中有117例（96%）尝试填写问卷。继续接受治疗的患者问卷参与率>90%，然而在治疗结束访视时，只有72例（符合条件参与者的64%）返回了表格。在治疗期间，两组的变化分数没有差异。两组从基线开始分数下降≥10分的时间也相似。在所测试的领域中，HRQL恶化主要发生在病情进展之前，但基线时有症状的患者中约50%在与复发性胶质母细胞瘤症状特别相关的HRQL领域分数也有所改善。在贝伐单抗中添加卡铂对HRQL既没有有害影响也没有有益影响，两组中都有一部分患者出现了症状改善。鉴于治疗结束时问卷完成率降低，HRQL恶化时间是该患者群体中一个可行且可靠的临床试验终点。临床试验注册号：ACTRN12610000915055。
