Clarity Pharma Research, LLC, 2375 E Main St., Spartanburg, SC 29307, USA.
TESARO: A GSK Company, 1000 Winter St North, Waltham, MA 02451, USA.
Future Oncol. 2019 Dec;15(36):4197-4206. doi: 10.2217/fon-2019-0471. Epub 2019 Nov 11.
To assess real-world occurrence of common clinical trial-reported adverse events (AE) among patients with recurrent ovarian cancer initiating niraparib 200 mg/day. This retrospective observational study used physician-extracted anonymized medical record data of eligible patients initiating niraparib 200 mg/day after platinum-based chemotherapy. Of 153 patients, 57 (37%) experienced ≥1 of the three most common all-grade AEs within 3 months after niraparib initiation: nausea (16%; grade 3/4: 2%), thrombocytopenia (14%; grade 3/4: 3%) and fatigue (24%; grade 3/4: 3%). In the ENGOT-OV16/NOVA trial, these respective AEs occurred in 74, 61 and 59% of patients. Incidence of common clinical trial-reported AEs was lower among patients initiating niraparib 200 mg/day in real-world practice versus patients initiating niraparib 300 mg/day in ENGOT-OV16/NOVA.
评估接受尼拉帕利 200mg/天治疗的复发性卵巢癌患者在真实世界中常见临床试验报告的不良事件（AE）的发生情况。本回顾性观察性研究使用了符合条件的患者在接受铂类化疗后开始接受尼拉帕利 200mg/天治疗的医生提取的匿名病历数据。在 153 名患者中，有 57 名（37%）在尼拉帕利起始后 3 个月内经历了≥1 种三种最常见的所有级别 AE：恶心（16%；3/4 级：2%）、血小板减少症（14%；3/4 级：3%）和疲劳（24%；3/4 级：3%）。在 ENGOT-OV16/NOVA 试验中，这些分别的 AE 在 74%、61%和 59%的患者中发生。在真实世界实践中，接受尼拉帕利 200mg/天治疗的患者与接受尼拉帕利 300mg/天治疗的患者相比，常见临床试验报告的 AE 发生率较低。
