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Target Oncol. 2018 Aug;13(4):533-539. doi: 10.1007/s11523-018-0582-1.
Niraparib (Zejula), a poly (ADP-ribose) polymerase (PARP) inhibitor, is approved for the maintenance treatment of recurrent, epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients who are in complete or partial response to platinum-based chemotherapy. Approval was based on the results of the randomized, double-blind, placebo-controlled phase III NOVA trial. In NOVA, niraparib significantly prolonged progression-free survival (primary endpoint), chemotherapy-free interval and time to first subsequent therapy compared with placebo in patients with recurrent, platinum-sensitive, high grade serous ovarian, fallopian tube or primary peritoneal cancer. The beneficial effects of niraparib were consistent regardless of BRCA mutation or homologous recombination deficiency (HRD) status. Niraparib had a manageable tolerability profile, with the majority of grade 3 or 4 adverse events being haematologic abnormalities (e.g. thrombocytopenia, anaemia, neutropenia). Adverse events were generally well managed with dose interruption or modification of niraparib. Current evidence suggests that niraparib is an effective new option with a manageable tolerability profile for the maintenance treatment of recurrent, platinum-sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancer in adults, with or without BRCA1/2 mutation or HRD.
尼拉帕利（则乐），一种聚（ADP-核糖）聚合酶（PARP）抑制剂，获批用于对铂类化疗完全或部分缓解的复发性上皮性卵巢癌、输卵管癌或原发性腹膜癌患者的维持治疗。批准基于随机、双盲、安慰剂对照 III 期 NOVA 试验的结果。在 NOVA 试验中，与安慰剂相比，尼拉帕利显著延长了复发性铂类敏感、高级别浆液性卵巢癌、输卵管或原发性腹膜癌患者的无进展生存期（主要终点）、化疗无进展间期和首次后续治疗时间。无论 BRCA 突变或同源重组缺陷（HRD）状态如何，尼拉帕利的疗效均一致。尼拉帕利具有可管理的耐受性特征，大多数 3 级或 4 级不良事件为血液学异常（如血小板减少症、贫血、中性粒细胞减少症）。不良事件通常通过中断或调整尼拉帕利剂量来良好管理。目前的证据表明，尼拉帕利是一种有效的新选择，具有可管理的耐受性特征，可用于维持治疗成人复发性铂类敏感上皮性卵巢癌、输卵管癌或原发性腹膜癌，无论 BRCA1/2 突变或 HRD 状态如何。
