Health-related quality of life in patients treated with temozolomide versus procarbazine for recurrent glioblastoma multiforme

Health-related quality of life in patients treated with temozolomide versus procarbazine for recurrent glioblastoma multiforme
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DOI:
10.1200/jco.2000.18.7.1481
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发表时间:
2000-04-01
影响因子:
45.3
通讯作者:
Prados, M
Prados, M
中科院分区:
医学1区
文献类型:
--
作者:
Osoba, D;Brada, M;Prados, M

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目的:确定替莫唑胺 (TMZ) 与丙卡巴肼 (PCB) 化疗治疗复发性多形性胶质母细胞瘤 (GBM) 是否与健康相关生活质量 (HRQOL) 的改善相关。患者和方法:在两项总共纳入 366 名患者的临床试验中,使用欧洲癌症研究和治疗组织生活质量问卷 C30 和脑癌模块 (BCM20) 在基线和治疗期间对 HRQOL 进行评估。 288 名患者提供了可用于分析的 HRQOL 数据;在一项 II 期研究中,有 109 名患者接受了 TMZ,而在一项随机 III 期研究中,89 名患者接受了 TMZ,90 名患者接受了 PCB。计算了所有组的七个预选 HRQOL 领域(角色和社会功能、总体生活质量 [QOL]、视觉障碍、运动功能障碍、沟通缺陷和嗜睡)评分相对于基线的变化。计算统计显着性、效应大小以及 HRQOL 评分改善(变化大于或等于 10 分)的患者比例。 结果:在疾病进展之前,发现接受 TMZ 治疗的患者与基线(治疗前)评分相比,大部分预选 HRQOL 领域评分都有所改善,而 6 个月时接受 TMZ 无进展的患者,所有预选 HRQOL 领域评分均有所改善。相反,接受 PCB 治疗的患者报告 HRQOL 恶化,这与疾病是否进展 6 个月无关,患者患有疾病!结论:与 PCB 治疗相比,TMZ 治疗与 HRQOL 评分改善相关,PCB 治疗患者报告的恶化可能是由于毒性,通过 TMZ 治疗延缓疾病进展有利于复发性 GEM 患者的 HRQOL 状态。 (C) 2000 年美国临床肿瘤学会。
Purpose: To determine whether chemotherapy with temozolomide (TMZ) versus procarbazine (PCB) for recurrent glioblastoma multiforme (GBM) was associated with improvement in health-related quality of life (HRQOL).Patients and Methods: HRQOL was assessed at baseline and during treatment using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 and a Brain Cancer Module (BCM20) in two clinical trials that enrolled a total of 366 patients. Two hundred eighty-eight patients provided HRQOL data that could be used for analysis; 109 patients received TMZ in a phase II study, whereas 89 patients received TMZ and 90 received PCB in a randomized phase III study, Changes from baseline in the scores of seven preselected HRQOL domains (role and social functioning, global quality of life [QOL], visual disorders, motor dysfunction, communication deficit, and drowsiness) were calculated for all groups. Statistical significance, effect sizes, and proportions of patients with improved HRQOL scores (changes of greater than or equal to 10 points) were calculated.Results: Before disease progression, patients treated with TMZ were found to have an improvement in most of the preselected HRQOL domain scores compared with their baseline (pretreatment) scores, Those who were progression-free on TMZ at 6 months had improvement in all the preselected HRQOL domains. Conversely, patients treated with PCB reported deterioration in HRQOL that was independent of whether or not the disease had progressed by 6 months, patients with disease! progression, regardless of treatment, experienced a sharp decline in all domains at the time of progression,Conclusion: Treatment with TMZ was associated with improvement in HRQOL scores compared with treatment with PCB, The deterioration reported by PCB-treated patients was likely because of toxicity, Delaying disease progression by treatment with TMZ is beneficial to the HRQOL status of patients with recurrent GEM. (C) 2000 by American Society of Clinical Oncology.