Niraparib Maintenance Therapy in Patients with Platinum-Sensitive Recurrent Ovarian Cancer: Real-World Experience at Hospitals in Spain.

IF 4 3区医学 Q2 ONCOLOGY Targeted Oncology Pub Date : 2025-03-01 Epub Date: 2025-01-24 DOI:10.1007/s11523-024-01121-5

Miguel Angel Rodríguez Sagrado, Javier Alvarez Criado, Ainhoa Elisa Arenaza Peña, Vicente Escudero-Vilaplana, Carlos Folguera Olias, Marta Herrero Fernandez, Concepción Martinez Nieto, Ana Rosa Rubio Salvador, Patricia Sanmartin Fenollera, Maria José Vazquez Castillo

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Abstract

Background: The reported benefit of poly (ADP-ribose) polymerase inhibitor (PARPi) maintenance in patients with newly diagnosed and platinum (Pt)-sensitive recurrent ovarian cancer (OC) included in randomized clinical trials needs to be corroborated in a less selected population.

Objective: The aim is to increase the evidence on niraparib in a real-world setting.

Methods: This is a retrospective observational study including women with platinum-sensitive relapsed high-grade serous OC who started niraparib maintenance between August 2019 (marketing data, Spain) and May 2022. Patients received ≥ 2 previous lines of therapy with complete or partial response to prior chemotherapy. Patient characteristics, niraparib dose, adequacy of dose individualization, effectiveness (progression-free survival [PFS] and overall survival), safety, and economic savings with an individualized starting dose (ISD) strategy were assessed.

Results: The study included 217 patients with a median of 8.9 months of niraparib duration: breast cancer gene (BRCA) wild-type OC, 70%; two prior treatment lines, 49%; Research on Adverse Drug Events and Reports (RADAR) criteria, 82% (receiving mainly 200 mg of niraparib, 79%). Median PFS was 10.8 months (95% confidence interval [CI], 8.4-14.8) without statistically significant differences based on starting dose strategy, contrary to what was observed on the basis of prior lines, response to prior chemotherapy, BRCA mutational status, and International Federation of Gynecology and Obstetrics (FIGO) stage at diagnosis. The last three variables also showed a statistically significant predictive prognostic value for effectiveness. Dose interruptions due to toxicity were required in 7% of patients, and dose adjustments in 56% were mainly due to hematologic toxicities. The actual dose of niraparib reveals economic savings versus the theoretical cost.

Conclusion: This large real-world analysis corroborates the tolerability and activity of niraparib maintenance for platinum-sensitive recurrent OC and economic savings.

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尼拉帕尼维持治疗对铂敏感的复发性卵巢癌患者：西班牙医院的真实世界经验

背景：在随机临床试验中报道的新诊断的铂（Pt）敏感复发性卵巢癌（OC）患者维持聚（adp -核糖）聚合酶抑制剂（PARPi）的益处需要在较少选择的人群中得到证实。目的：目的是在现实世界中增加关于尼拉帕尼的证据。方法：这是一项回顾性观察性研究，包括2019年8月至2022年5月期间开始尼拉帕尼维持治疗的铂敏感复发高级别严重OC女性。患者既往接受≥2条治疗线，对既往化疗完全或部分缓解。评估患者特征、尼拉帕尼剂量、剂量个体化的充分性、有效性（无进展生存期[PFS]和总生存期）、安全性和个体化起始剂量（ISD）策略的经济节约。结果：该研究纳入217例患者，尼拉帕尼持续时间中位数为8.9个月：乳腺癌基因（BRCA）野生型OC， 70%；两条既往治疗线，49%；药物不良事件和报告研究（RADAR）标准，82%（主要接受200 mg尼拉帕尼，79%）。中位PFS为10.8个月（95%可信区间[CI]， 8.4-14.8），不同起始剂量策略无统计学差异，这与基于既往治疗线、对既往化疗的反应、BRCA突变状态和国际妇产科学联合会（FIGO）诊断阶段的观察结果相反。最后三个变量也显示了统计上显著的有效性预测预后价值。7%的患者由于毒性需要中断剂量，56%的患者主要由于血液毒性需要调整剂量。尼拉帕尼的实际剂量显示了相对于理论成本的经济节约。结论：这一大型现实世界分析证实了尼拉帕尼维持对铂敏感的复发性OC的耐受性和活性，并节省了经济成本。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Targeted Oncology 医学-肿瘤学

CiteScore

8.40

自引率

3.70%

发文量

审稿时长

>12 weeks

期刊介绍： Targeted Oncology addresses physicians and scientists committed to oncology and cancer research by providing a programme of articles on molecularly targeted pharmacotherapy in oncology. The journal includes: Original Research Articles on all aspects of molecularly targeted agents for the treatment of cancer, including immune checkpoint inhibitors and related approaches. Comprehensive narrative Review Articles and shorter Leading Articles discussing relevant clinically established as well as emerging agents and pathways. Current Opinion articles that place interesting areas in perspective. Therapy in Practice articles that provide a guide to the optimum management of a condition and highlight practical, clinically relevant considerations and recommendations. Systematic Reviews that use explicit, systematic methods as outlined by the PRISMA statement. Adis Drug Reviews of the properties and place in therapy of both newer and established targeted drugs in oncology.