Sanofi-Genzyme, Cambridge, MA, USA.
MCPHS University Worcester/Manchester, Worcester, MA, USA.
Ann Pharmacother. 2020 Oct;54(10):1010-1015. doi: 10.1177/1060028020912749. Epub 2020 Mar 16.
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).
A literature search via MEDLINE through PubMed from August 2013 to January 2020 was performed using the key terms , and .
Completed and ongoing trials were identified through a review of the website trial registry https://www.clinicaltrials.gov.
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.
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.
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.
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。
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”。
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。
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。
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。
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。