a University of California , Irvine Medical Center , Orange , CA , USA.
Expert Opin Drug Metab Toxicol. 2018 May;14(5):543-550. doi: 10.1080/17425255.2018.1461838. Epub 2018 May 16.
Ovarian cancer is a disease with a propensity to recur despite dramatic responses to initial treatment, which typically consists of a combination of cytoreductive surgery and platinum-based chemotherapy. A maintenance therapy, which may prevent or delay relapse while not negatively impacting quality of life, is critical to improving outcomes. Areas covered: This review discusses the pharmacologic properties, clinical efficacy, and safety profile of niraparib, a poly(ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Expert opinion: Following presentation of ENGOT-OV16/NOVA at the European Society for Medical Oncology (ESMO) 2016 Congress, niraparib became the first PARP inhibitor to receive full approval by the U.S. Food and Drug Administration (FDA) for the maintenance treatment of recurrent ovarian cancer, regardless of a patient's germline or somatic mutational status. This approval has had a sweeping impact on treatment strategies, moving the indication for a PARP inhibitor earlier in the treatment course and greatly expanding the population of patients who may benefit from this class of drugs. Active clinical trials suggest that new indications and novel treatment combinations are eagerly sought.
卵巢癌是一种疾病，尽管初始治疗（通常包括减瘤手术和铂类化疗的联合治疗）反应明显，但仍有复发倾向。维持治疗可以预防或延迟复发，同时又不会影响生活质量，对于改善预后至关重要。
本文讨论了尼拉帕利的药理学特性、临床疗效和安全性，尼拉帕利是一种聚（ADP-核糖）聚合酶（PARP）抑制剂，适用于对铂类化疗有完全或部分反应的复发性上皮性卵巢癌、输卵管或原发性腹膜癌患者的维持治疗。
在 2016 年欧洲肿瘤内科学会（ESMO）大会上公布了 ENGOT-OV16/NOVA 研究结果后，尼拉帕利成为首个获得美国食品和药物管理局（FDA）完全批准用于复发性卵巢癌维持治疗的 PARP 抑制剂，无论患者是否存在种系或体细胞突变状态。这一批准对治疗策略产生了深远的影响，将 PARP 抑制剂的适应证提前到治疗过程中更早的阶段，并大大扩大了可能从这类药物中获益的患者群体。正在进行的临床试验表明，人们迫切希望探索新的适应证和新的治疗组合。
