Efficacy and Safety of Niraparib as First-Line Maintenance Treatment for Patients with Advanced Ovarian Cancer: Real-World Data from a Multicenter Study in China.

IF 4.4 3区医学 Q2 ONCOLOGY

Targeted Oncology Pub Date : 2023-11-01 Epub Date: 2023-10-17 DOI:10.1007/s11523-023-00999-x

Minmin Zhao, Shanhu Qiu, Xin Wu, Pengcheng Miao, Zhi Jiang, Tao Zhu, Xizhong Xu, Yanling Zhu, Bei Zhang, Donglan Yuan, Yang Zhang, Wei Sun, Aiqin He, Min Zhao, Wenjie Hou, Yingli Zhang, Zhuyan Shao, Meiqun Jia, Mei Li, Jun Chen, Jingcheng Xu, Bingwei Chen, Ying Zhou, Yang Shen

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引用次数: 0

Abstract

Background: Poly (ADP-ribose) polymerase (PARP) inhibitors are a new maintenance therapy option for patients with ovarian cancer (OC).

Objective: To evaluate the efficacy and influencing factors of the novel PARP inhibitor niraparib for maintenance treatment of Chinese patients with advanced OC.

Patients and methods: In this retrospective multicenter real-world study patients with advanced OC from 15 hospitals throughout China were enrolled. The primary endpoint was progression-free survival (PFS) and the secondary endpoints included the time to treatment discontinuation and safety. Least Absolute Shrinkage and Selection Operator (LASSO) regression was used to identify possible risk factors for PFS, after which a prediction model was established to evaluate the likelihood of achieving an 18-month PFS. The relationship between the dose of niraparib and PFS was also evaluated.

Results: The PFS rates of 199 patients at 6, 12, 18, 24, and 30 months were 87.4%, 75.9%, 63.6%, 56.1%, and 51.8%, respectively. LASSO regression model revealed that only age < 65 years (P = 0.011), BRCA mutations (P < 0.001), and R0 status after cytoreductive surgery (P = 0.01) were significant factors associated with prolonged PFS times. Based on the LASSO logistic regression analysis, a clinical prediction formula was developed: - 2.412 + 1.396Age_≥65yr + 2.374BRCA_wt + 1.387R₁ + 0.793Interval_≥12w + 0.178BMI_>24kg/m2 which yielded a cut-off value of 0.091, an area under the curve (AUC) of 0.839 (0.763-0.916), a sensitivity of 94.3%, and an accuracy of 78.5%. A nomogram was then built to visualize the results. The major treatment-emergent adverse events of ≥ grade 3 included a platelet count decrease (19.1%), white blood cell count decrease (15.1%), neutrophil count decrease (13.1%), and anemia (18.6%). The 18-month PFS rates in patients treated with 200 mg niraparib were somewhat higher than in patients treated with 100 mg after 3-months of therapy.

Conclusions: For Chinese OC patients, niraparib, particularly at a 200 mg individual starting dose, was an effective therapy with easily manageable safety.

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Niraparib作为晚期癌症患者一线维持治疗的有效性和安全性：来自中国多中心研究的真实世界数据。

背景：聚（ADP-核糖）聚合酶（PARP）抑制剂是癌症（OC）患者的一种新的维持治疗选择。目的：评价新型PARP抑制剂niraparib维持治疗中国晚期OC的疗效及影响因素。患者和方法：在这项回顾性多中心真实世界研究中，来自中国15家医院的晚期OC患者被纳入研究。主要终点是无进展生存期（PFS），次要终点包括停药时间和安全性。使用最小绝对收缩和选择算子（LASSO）回归来确定PFS的可能风险因素，之后建立预测模型来评估实现18个月PFS的可能性。还评估了尼拉帕利剂量与PFS之间的关系。结果：199例患者在6个月、12个月、18个月、24个月和30个月时的PFS发生率分别为87.4%、75.9%、63.6%、56.1%和51.8%。LASSO回归模型显示只有年龄≥65岁 + 2.374BRCAwt + 1.387R1 + 0.793间隔≥12w + 0.178BMI>24kg/m2，其截止值为0.091，曲线下面积（AUC）为0.839（0.763-0.916），灵敏度为94.3%，准确度为78.5%。然后建立列线图以可视化结果。主要治疗突发不良事件≥ 3级包括血小板计数下降（19.1%）、白细胞计数下降（15.1%）、中性粒细胞计数下降下降（13.1%）和贫血（18.6%）。服用200mg尼拉帕林的患者在治疗3个月后的18个月PFS率略高于服用100mg的患者。结论：对于中国OC患者，尼拉帕利是一种有效的治疗方法，特别是200 mg个体起始剂量，安全性易于控制。

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.