ACTIV1ZE研究：上皮性卵巢癌一线维持尼拉帕利治疗中血小板减少的真实世界监测与管理
该美国回顾性队列纳入543例接受一线维持尼拉帕利单药治疗的上皮性卵巢癌患者，约37%发生任何级别血小板减少、约22%发生≥3级血小板减少，多发生在治疗开始后1个月内，≥98.0%缓解，中位缓解时间约2周。多数患者首次血小板减少时接受剂量调整并继续治疗（约84%），但停药者多未先调整剂量。
要点
- 任何级别血小板减少约37%，≥3级约22%，多发生在尼拉帕利开始后1个月内。
- 血小板减少≥98.0%可缓解，中位缓解时间约2周。
- 首次血小板减少时多数患者接受剂量调整并继续治疗（约84%）。
核心结论
- 真实世界中上皮性卵巢癌一线维持尼拉帕利相关血小板减少多发生早、缓解快，经剂量调整后停药率低。
- 停药者多未先进行剂量调整，提示可通过优化管理支持治疗持续。
研究设计与样本
- 美国回顾性队列研究，纳入543例上皮性卵巢癌成人患者，开始一线维持尼拉帕利单药时血小板计数≥100,000/μL，时间为2020年4月1日至2023年6月3日。
主要发现
- 约37%患者发生任何级别血小板减少，约22%发生≥3级血小板减少。
- 血小板减少多发生在尼拉帕利开始后1个月内，≥98.0%的病例缓解，中位缓解时间约2周。
- 首次血小板减少时多数患者接受剂量调整，约84%继续治疗。
- 首次血小板减少期间停药的患者多数在停药前未接受剂量调整。
关键数值与推荐
- 起始尼拉帕利时血小板计数阈值≥100,000/μL。
- 任何级别血小板减少约37%，≥3级约22%。
- 血小板减少缓解率≥98.0%，中位缓解时间约2周。
- 首次血小板减少时约84%患者继续治疗。
临床怎么用
- 一线维持尼拉帕利治疗期间应密切监测血小板计数，尤其治疗开始后1个月内。
- 发生血小板减少时优先考虑剂量调整以支持继续治疗，而非直接停药。
以上解读依据论文摘要（全文未开放获取或许可不允许翻译转载）。
原文
OBJECTIVE: To describe the frequency of platelet count testing and decreased platelet counts (DPCs), time to onset and resolution of DPCs, and clinical management of DPCs among patients with epithelial ovarian cancer (EOC) who received first-line maintenance (1LM) niraparib monotherapy. METHODS: This retrospective US-based cohort study included adults with EOC who had a platelet count of ≥100,000/μL at 1LM niraparib monotherapy initiation (April 1, 2020-June 3, 2023). Platelet count testing patterns were described and patients grouped for any-grade DPC, grade ≥3 DPC, or no DPC. Timings of DPC onset and resolution were estimated and niraparib clinical management strategies (ie, dose modifications) and the frequency, timing of, and reasons for niraparib discontinuation were described. RESULTS: Among 543 eligible patients, most received frequent platelet count tests; for those who experienced DPCs (≈37% any-grade, ≈22% grade ≥3), onset was usually early (≤1 month after 1LM niraparib initiation), with ≥98.0% of cases resolving, with a median time to resolution of ≈2 weeks. Aligning with management guidelines, most patients received dose modifications during first DPC, and most continued treatment (≈84%). Most patients who discontinued treatment during first DPC did not receive dose modification prior to discontinuation. CONCLUSIONS: In this real-world setting of patients with EOC prescribed 1LM niraparib, DPCs usually occurred early, were quickly resolved for nearly all patients, and were generally managed with dose modifications, resulting in low discontinuation rates. However, dose modifications were absent in most patients who discontinued, highlighting an opportunity to improve clinical management strategies to support treatment continuation, thereby potentially optimizing patient benefit.
引用
- Musa FB, Boyle TAC, Lim JT, et al. Real-world monitoring and clinical management of decreased platelet counts in patients with epithelial ovarian cancer who received first-line maintenance niraparib in the ACTIV1ZE study. Gynecol Oncol. 2026. PMID: 42086009. doi:10.1016/j.ygyno.2026.04.012
供执业医师工作参考，不替代临床判断；数值与分级以指南原文为准。