Virginia G Piper Cancer Care Network, University of Arizona, Creighton University, Phoenix, AZ, USA.
The Spanish Ovarian Cancer Research Group and Medical Oncology Department, Institut Català d'Oncologia, Badalona, Spain.
Gynecol Oncol. 2022 Sep;166(3):494-502. doi: 10.1016/j.ygyno.2022.06.028. Epub 2022 Jul 15.
Progression-free survival (PFS) is an important early efficacy endpoint in ovarian cancer (OC) and its relevance to patients should be assessed. PRIMA, a phase III trial, assessed niraparib in patients with OC; this post hoc analysis examined the relationship between disease progression in OC and health-related quality of life (HRQoL).
The PRIMA trial randomized patients with advanced OC responsive to first-line platinum-based chemotherapy to once daily maintenance oral niraparib or placebo. This post hoc analysis evaluated the impact of disease progression on HRQoL by comparing HRQoL at the last visit pre-progression to end of treatment (EoT), and after 4, 8, 12, and 24 weeks. Assessments included the Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI), the European Quality of Life Five Dimension Five Level questionnaire (EQ-5D-5L) and EQ Visual Analogue Scale (EQ-VAS), the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC-QLQ-C30), and the EORTC Quality of Life Questionnaire Ovarian Cancer module (EORTC-QLQ-OV28).
This post hoc analysis included 733 patients. Mean FOSI, EQ-5D-5L, and EQ-VAS scores deteriorated from last visit pre-progression to EoT and remained low up to 24-week follow-up. Least squares mean changes from last visit pre-progression to EoT were -2.1 (95% confidence interval -2.4, -1.7) for FOSI, -4.6 (-5.6, -3.5) for the EQ-5D-5L index, and -7.9 (-9.6, -6.3) for EQ-VAS.
Disease progression negatively impacted HRQoL in patients with OC. PFS is clinically relevant, and prolonging PFS may preserve HRQoL.
无进展生存期（PFS）是卵巢癌（OC）的一个重要早期疗效终点，应评估其与患者的相关性。PRIMA 是一项 III 期试验，评估了尼拉帕利在 OC 患者中的应用；这项事后分析检查了 OC 疾病进展与健康相关生活质量（HRQoL）之间的关系。
PRIMA 试验将对一线含铂化疗有反应的晚期 OC 患者随机分配至每日一次口服尼拉帕利维持治疗或安慰剂。这项事后分析通过比较疾病进展前的最后一次就诊时的 HRQoL 与治疗结束时（EoT），以及在 4、8、12 和 24 周后的 HRQoL，评估了疾病进展对 HRQoL 的影响。评估包括癌症治疗功能评估卵巢症状指数（FOSI）、欧洲五维健康量表（EQ-5D-5L）和 EQ 视觉模拟量表（EQ-VAS）、欧洲癌症研究与治疗组织（EORTC）生活质量问卷（EORTC-QLQ-C30）和 EORTC 卵巢癌模块（EORTC-QLQ-OV28）。
这项事后分析包括 733 名患者。FOSI、EQ-5D-5L 和 EQ-VAS 评分从疾病进展前的最后一次就诊到 EoT 逐渐恶化，并在 24 周随访时仍保持较低水平。从疾病进展前的最后一次就诊到 EoT 的最小二乘均值变化为 FOSI 为-2.1（95%置信区间-2.4，-1.7），EQ-5D-5L 指数为-4.6（-5.6，-3.5），EQ-VAS 为-7.9（-9.6，-6.3）。
疾病进展对 OC 患者的 HRQoL 产生了负面影响。PFS 具有临床相关性，延长 PFS 可能会保留 HRQoL。
