旨在评估尼拉帕尼对接受过多次治疗的日本女性卵巢癌的长期疗效和安全性。这是对患有同源重组缺陷的日本女性进行的一项 2 期、多中心、开放标签、单组研究的后续分析铂敏感的复发性高级别浆液性上皮性卵巢癌、输卵管癌或原发性腹膜癌，已完成 3-4 线化疗且未接受过聚（ADP-核糖）聚合酶抑制剂治疗。参与者接受尼拉帕尼（起始剂量，300 mg）每天一次，连续 28 天为周期，直至客观疾病进展、出现不可接受的毒性或撤回同意。主要终点是确认的客观缓解率 (ORR)，使用实体瘤 1.1 版中的缓解评估标准进行评估。安全性评估包括治疗中出现的不良事件 (TEAE)。20 名患者参加了该研究，并纳入了疗效和安全性分析。总研究持续时间中位数为 759.5 天。中位剂量强度为 201.3 毫克/天。确认的 ORR 为 60.0%（90% 置信区间 [CI]=39.4-78.3）； 2名患者完全缓解，10名患者部分缓解。中位缓解持续时间为 9.9 个月（95% CI=3.9-26.9），疾病控制率为 90.0%（95% CI=68.3-98.8）。最常见的 TEAE 是贫血 (n=15)、恶心 (n=12) 和血小板计数减少 (n=11)。分别有 16 名 (80.0%)、15 名 (75.0%) 和 2 名患者 (10.0%) 报告了导致研究药物剂量减少、中断或终止的 TEAE。尼拉帕尼的长期疗效和安全性与先前在非日本患者的同等人群中的研究结果。未发现新的安全信号。ClinicalTrials.gov 标识符：NCT03759600。© 2024。亚洲妇科肿瘤学会、韩国妇科肿瘤学会和日本妇科肿瘤学会。

To evaluate the long-term efficacy and safety of niraparib in Japanese women with heavily pretreated ovarian cancer.This was the follow-up analysis of a phase 2, multicenter, open-label, single-arm study in Japanese women with homologous recombination-deficient, platinum-sensitive, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who had completed 3-4 lines of chemotherapy and were poly(ADP-ribose) polymerase inhibitor naïve. Participants received niraparib (starting dose, 300 mg) once daily in continuous 28-day cycles until objective disease progression, unacceptable toxicity, or consent withdrawal. The primary endpoint was confirmed objective response rate (ORR), as assessed using Response Evaluation Criteria in Solid Tumors version 1.1. Safety evaluations included treatment-emergent adverse events (TEAEs).20 patients were enrolled in the study and included in both efficacy and safety analyses. Median total study duration was 759.5 days. Median dose intensity was 201.3 mg/day. Confirmed ORR was 60.0% (90% confidence interval [CI]=39.4-78.3); 2 patients had complete response and 10 patients had partial response. Median duration of response was 9.9 months (95% CI=3.9-26.9) and the disease control rate was 90.0% (95% CI=68.3-98.8). The most common TEAEs were anemia (n=15), nausea (n=12), and decreased platelet count (n=11). TEAEs leading to study drug dose reduction, interruption, or discontinuation were reported in 16 (80.0%), 15 (75.0%), and 2 patients (10.0%), respectively.The long-term efficacy and safety profile of niraparib was consistent with previous findings in the equivalent population in non-Japanese patients. No new safety signals were identified.ClinicalTrials.gov Identifier: NCT03759600.© 2024. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology, and Japan Society of Gynecologic Oncology.