摘要

Between April 1, 2015 and Nov 1, 2017, we screened 729 patients for eligibility and enrolled 463 patients, who were initiated on niraparib therapy. At the time of database lock (April 11, 2018), enrolment had closed and the study was ongoing, with 21 patients still on treatment. Patients had received a median of four (IQR 3–5) previous lines of therapy, and the median follow-up for overall survival was 12·2 months (IQR 3∙7–22∙1). 151 (33%) of 463 patients were resistant and 161 (35%) of 463 patients were refractory to the last administered platinum therapy. 13 (28%) of 47 patients in the primary efficacy population achieved an overall response according to RECIST (95% CI 15·6–42·6; one-sided p=0·00053). The most common drug-related grade 3 or worse treatment-emergent adverse events were anaemia (113 [24%] of 463 patients) and thrombocytopenia (95 [21%] of 463 patients). The most common treatment- emergent serious adverse events were small intestinal obstruction (34 [7%] of 463 patients), thrombocytopenia (34 [7%] of 463 patients), and vomiting (27 [6%] of 463 patients). One death due to gastric haemorrhage was considered treatment related.

译文

在2015年4月1日至2017年11月1日期间,我们筛选了729名患者的资格,并招募了463名患者,他们开始接受尼拉巴尼治疗。在数据库锁定时(2018年4月11日),注册已经结束,研究正在进行中,有21名患者仍在接受治疗。患者接受了中位数为4(IQR 3-5)的治疗,并且总生存期的中位随访时间为12·2个月(IQR 3∙7-22∙1)。 463名患者中有151名(33%)有耐药性,463名患者中有161名(35%)对最后一次铂类治疗无效。根据RECIST,主要疗效人群中47名患者中的13名(28%)达到总体反应(95%CI 15·6-42·6;单侧p = 0.00053)。最常见的与药物相关的3级或更严重的治疗后出现的不良事件是贫血(463名患者中有113名[24%])和血小板减少症(463名患者中有95名[21%])。最常见的治疗 - 紧急严重不良事件是小肠梗阻(463例患者中有34例[7%]),血小板减少症(463例患者中34例[7%])和呕吐(463例患者中有27例[6%])。因胃出血导致的一例死亡被认为与治疗有关。

Niraparib

肿瘤 卵巢癌 药物
概述  :  

尼拉帕尼是一种癌症治疗药物,可以干扰体内癌细胞的生长和扩散。该药物主要用于复发性上皮卵巢癌、输卵管癌、原发性腹膜癌(在腹部内侧排列并覆盖一些内部器官的膜)的治疗,以及对铂类化疗药物完全或部分响应的成人患者的维持治疗。该药物于2017年3月27日获得美国食品药品监督管理局(FDA)批准上市,商品名位Zejula。该药物的有效成分为甲苯磺酸尼拉帕尼一水物(niraparib tosylate monohydrate)。原理尼拉帕尼是一种化学合成药物,其中文化学名称为:(S)-2-(4-(哌啶-3

Niraparib

       【药物】尼拉帕尼/尼拉帕利

请扫描右侧二维码,免费查看词汇专业知识背景