临床试验表明，与安慰剂相比，尼拉帕尼一线维持治疗 (1LM) 可以延长卵巢癌 (OC) 患者的生存期。然而，真实世界 1LM niraparib 单药治疗使用的数据有限，特别是在一线 (1L) 联合化疗加贝伐单抗后切换 1LM。这项真实世界研究旨在描述 OC 患者在 1L 联合化疗加贝伐珠单抗后接受 1LM niraparib 单药治疗的患者人口统计、临床特征和临床结果。这项回顾性观察研究使用的数据来自美国全国性的去识别化电子健康数据库记录导出的数据。在研究期间（2011年1月1日至2022年11月30日（含））诊断为OC的患者如果接受1L化疗加贝伐单抗治疗，然后在2017年1月1日（含）至2022年9月2日期间开始接受1LM尼拉帕尼单药治疗，则符合资格。从索引日期（尼拉帕尼 1LM 开始）开始，直至首次发生死亡、随访结束或研究结束。临床结果是治疗停止时间（TTD）和下次治疗时间（TTNT）。 Kaplan-Meier 曲线用于估计 TTD、TTNT 和 95% 置信区间 (CI)。在所选的 93 名患者中，指数的中位年龄为 67 岁（四分位数范围 [IQR] 60-72 岁）。大多数患者患有 BRCA 野生型/同源重组 (HR) 充分或 BRCA 野生型/HR 未知疾病 (75.3%)。总共有 18 名患者 (19.4%) 患有 HR 缺陷性疾病。五名 (5.4%) 患者的 BRCA 和 HR 缺陷状态检测结果未知。中位随访时间为 16.3 个月（IQR 8.7-25.4 个月），从 1L 治疗结束到 1LM 开始的中位时间为 35.0 天（IQR 25.0-53.9 天）。 TTD 中位数为 9.3 个月（95% CI 6.1-11.3 个月）。中位 TTNT 为 12.9 个月（95% CI 11.5-19.0 个月）。这项真实世界研究提供了有关 1LM niraparib 单药疗法的开关维持的见解，这可能是晚期 OC 患者的可行治疗选择。© 2024。作者）。

Clinical trials have demonstrated prolonged survival associated with niraparib first-line maintenance (1LM) therapy, compared with placebo, for patients with ovarian cancer (OC). However, data are limited on real-world 1LM niraparib monotherapy use, particularly as switch 1LM, following first-line (1L) combination chemotherapy plus bevacizumab. This real-world study aimed to describe patient demographics, clinical characteristics, and clinical outcomes of patients with OC receiving 1LM niraparib monotherapy following 1L combination chemotherapy plus bevacizumab.This retrospective observational study used data from a US-based nationwide database of deidentified, electronic health record-derived data. Patients diagnosed with OC during the study period (1 January 2011-30 November 2022, inclusive) were eligible if they received 1L chemotherapy plus bevacizumab treatment followed by 1LM niraparib monotherapy, initiated between 1 January 2017 (inclusive) and 2 September 2022. Patients were followed from index date (initiation of niraparib 1LM) until the first occurrence of death, end of follow-up, or end of study. Clinical outcomes were time to treatment discontinuation (TTD) and time to next treatment (TTNT). Kaplan-Meier curves were used to estimate TTD, TTNT, and 95% confidence intervals (CIs).Among 93 patients selected, median age at index was 67 years (interquartile range [IQR] 60-72 years). Most patients had BRCA wild-type/homologous recombination (HR)-proficient or BRCA wild-type/HR unknown disease (75.3%). In all, 18 (19.4%) patients had HR-deficient disease. Five (5.4%) patients had unknown test results for both BRCA and HR deficiency status. Median follow-up time was 16.3 months (IQR 8.7-25.4 months), and median time from end of 1L therapy to 1LM initiation was 35.0 days (IQR 25.0-53.9 days). Median TTD was 9.3 months (95% CI 6.1-11.3 months). Median TTNT was 12.9 months (95% CI 11.5-19.0 months).This real-world study provided insights into switch maintenance with 1LM niraparib monotherapy, which may be a viable treatment option for patients with advanced OC.© 2024. The Author(s).