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尼拉帕利治疗复发性上皮性卵巢癌、输卵管癌或原发性腹膜癌。

Niraparib for the Treatment of Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer.

机构信息

Sanofi-Genzyme, Cambridge, MA, USA.

MCPHS University Worcester/Manchester, Worcester, MA, USA.

出版信息

Ann Pharmacother. 2020 Oct;54(10):1010-1015. doi: 10.1177/1060028020912749. Epub 2020 Mar 16.

Abstract

OBJECTIVE

To review the efficacy and safety of niraparib for the treatment of recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancer (OC, FTC, and PPC).

DATA SOURCES

A literature search via MEDLINE through PubMed from August 2013 to January 2020 was performed using the key terms , and .

STUDY SELECTION AND DATA EXTRACTION

Completed and ongoing trials were identified through a review of the website trial registry https://www.clinicaltrials.gov.

DATA SYNTHESIS

In a phase III, double-blind clinical trial, progression-free survival improved in patients treated with niraparib compared with placebo as maintenance treatment for patients with platinum-sensitive, recurrent OC: 21 versus 5.5 months in the germline breast cancer susceptibility gene () cohort (hazard ratio [HR] = 0.27; 95% CI = 0.17 to 0.41; < 0.001) and 9.3 versus 3.9 months in the overall nongermline breast cancer susceptibility gene (non-) cohort (HR = 0.45; 95% CI = 0.34 to 0.61; < 0.001). Adverse events included thrombocytopenia and anemia.

RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE

Poly (ADP-ribose) polymerase (PARP) inhibitors have gained a place in the therapeutic management of OC, FTC, and PPC because of their ability to suppress growth of homologous recombination deficiency-positive tumors, including those with mutations. Niraparib inhibits the DNA repair mechanism vital to the survival of cancer cells, poly-ADP ribose polymerase.

CONCLUSIONS

PARP inhibitors can be used as a single agent for maintenance therapy for platinum-sensitive recurrent disease in patients with partial or complete response following 2 or more rounds of platinum-based therapy.

摘要

目的

回顾尼拉帕利治疗复发性上皮性卵巢癌、输卵管癌和原发性腹膜癌(OC、FTC 和 PPC)的疗效和安全性。

数据来源

通过 PubMed 中的 MEDLINE 从 2013 年 8 月至 2020 年 1 月进行了文献检索,使用的关键词为“niraparib”和“recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancer”。

研究选择和数据提取

通过审查网站临床试验注册处 https://www.clinicaltrials.gov,确定了已完成和正在进行的试验。

数据综合

在一项 III 期、双盲临床试验中,与安慰剂作为维持治疗相比,接受尼拉帕利治疗的患者无进展生存期得到改善,铂类敏感、复发性 OC 患者:胚系乳腺癌易感基因()队列中尼拉帕利组为 21 个月,安慰剂组为 5.5 个月(风险比[HR] = 0.27;95%CI = 0.17 至 0.41;<0.001),非胚系乳腺癌易感基因(非-)队列中尼拉帕利组为 9.3 个月,安慰剂组为 3.9 个月(HR = 0.45;95%CI = 0.34 至 0.61;<0.001)。不良反应包括血小板减少和贫血。

与患者护理和临床实践的相关性

多聚(ADP-核糖)聚合酶(PARP)抑制剂因其能够抑制同源重组缺陷阳性肿瘤(包括 突变肿瘤)的生长而在 OC、FTC 和 PPC 的治疗管理中占有一席之地。尼拉帕利抑制了对癌细胞存活至关重要的 DNA 修复机制,多聚 ADP 核糖聚合酶。

结论

PARP 抑制剂可作为铂类敏感复发性疾病的维持治疗单一药物,用于对 2 轮或以上铂类治疗有部分或完全反应的患者。

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