Background Health-related quality of life (HRQoL) was a secondary end point in AGO-OVAR 16, which randomized 940 patients with EOC after first-line chemotherapy to maintenance pazopanib (PZ) or placebo (P). Additional post hoc analyses were carried out to investigate additional patient-centered end points. Patients and methods HRQoL was measured with EORTC-QLQ-C30, QLQ-OV28 and EQ-5D-3L. Pre-specified end points included mean differences in HRQoL between treatment arms. Exploratory analyses included quality-adjusted progression-free survival (QAPFS), impact of specific symptoms and progressive disease (PD) on HRQoL and time to second-line chemotherapy. The objective was to provide clinical perspective to the significant median PFS gain of 5.6 months with PZ. Results There were statistically significant differences between PZ and P in QLQ-C30 global health status [5.5 points; 95% confidence interval (CI), 0.7-10.4, P = 0.024] from baseline to 25 months, but not EQ-5D-3L (0.018 points; 95% CI - 0.033 to 0.069, P = 0.485). The impact of diarrhea was captured in QLQ-OV28 Abdominal/GI-Symptoms scale (8.1 points; 95% CI 3.6-12.5, P = 0.001). QAPFS was 386 days (95% CI 366-404 days) with PZ versus 359 days (95% CI 338-379 days) with placebo (P = 0.052). PD was associated with a decline in HRQoL (P < 0.0001). Median time to second-line chemotherapy was 19.7 months with PZ and 15.0 months with P [hazard ratio (HR) 0.72, 95% CI 0.69-0.86, P = 0.0001]. Conclusions There were small to no significant mean score differences in global HRQoL and EQ5D-3L between PZ and placebo, respectively, despite the increased toxicity of PZ. Exploratory end points including QAPFS, impact of specific symptoms on HRQoL during treatment and at PD help place the PFS gain with PZ in context and interpret the results. Additional patient-centered end points should be considered in trials of maintenance therapy in EOC beyond mean differences in HRQoL scores alone, to support the benefit to patients of prolongation of PFS. Clinical Trials Registration Number NCT00866697.

中文翻译：

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在AGO-OVAR 16试验中，一线化疗后随机分配给维持帕唑帕尼或安慰剂的晚期上皮性卵巢癌（EOC）患者的生活质量。在维持治疗的试验中，以患者为中心的终点测量很重要。

背景与健康相关的生活质量（HRQoL）是AGO-OVAR 16的次要终点，AGO-OVAR 16将一线化疗后的940例EOC患者随机分为维持帕唑帕尼（PZ）或安慰剂（P）。进行了额外的事后分​​析，以调查其他以患者为中心的终点。患者和方法HRQoL使用EORTC-QLQ-C30，QLQ-OV28和EQ-5D-3L进行测量。预先指定的终点包括治疗组之间HRQoL的平均差异。探索性分析包括质量调整的无进展生存期（QAPFS），特定症状和进行性疾病（PD）对HRQoL的影响以及进行二线化疗的时间。目的是为PZ显着增加5.6个月的中位PFS提供临床前景。结果QLQ-C30全球健康状况PZ和P之间存在统计学差异[5.5分；从基线到25个月的95％置信区间（CI）为0.7-10.4，P = 0.024]，但没有达到EQ-5D-3L（0.018点； 95％CI-0.033至0.069，P = 0.485）。以QLQ-OV28腹部/ GI症状量表（8.1分； 95％CI 3.6-12.5，P = 0.001）记录腹泻的影响。PZ的QAPFS为386天（95％CI 366-404天），安慰剂为359天（95％CI 338-379天）（P = 0.052）。PD与HRQoL下降相关（P <0.0001）。PZ患者接受二线化疗的中位时间为19.7个月，P患者为15.0个月[危险比（HR）0.72，95％CI 0.69-0.86，P = 0.0001]。结论PZ和安慰剂之间的总体HRQoL和EQ5D-3L的平均得分差异很小或没有显着差异，尽管PZ的毒性增加。探索性终点，包括QAPFS，治疗期间和PD时特定症状对HRQoL的影响，有助于将PFS获益与PZ结合起来并解释结果。在EOC维持治疗试验中，应考虑以患者为中心的其他终点指标，而不仅仅是HRQoL评分的均值差异，以支持延长PFS对患者的益处。临床试验注册号NCT00866697。支持延长PFS对患者的益处。临床试验注册号NCT00866697。支持延长PFS对患者的益处。临床试验注册号NCT00866697。