奥拉帕利在卵巢癌真实世界治疗中的不良反应

Adverse effects of olaparib in the treatment of ovarian cancer:a real-world study

目的分析奥拉帕利在真实世界中治疗卵巢癌的不良反应及最常见血液学不良反应——贫血的影响因素。方法回顾性分析2018年7月至2022年10月在我院妇科收治的146例卵巢癌患者使用奥拉帕利治疗期间的不良反应数据,尤其是贫血的发生情况,并对≥3级贫血的相关因素进行单因素及多因素分析。结果146例患者治疗期间不良反应总发生率为76.7%,≥3级不良反应发生率为37.0%,其中最常见的为贫血(31.5%)。开始治疗的前3个月、4~6个月及6个月后,≥3级贫血的发生率分别为60.5%、16.3%、23.2%,因贫血暂停用药的发生率在1年后仍为11.6%。多因素Logistic回归分析显示,年龄(χ^(2)=7.914,P=0.005,OR=1.066)、末次含铂化疗期间发生过≥3级贫血(χ^(2)=5.269,P=0.022,OR=3.563)是奥拉帕利维持治疗期间发生≥3级贫血的独立危险因素。结论贫血是奥拉帕利在卵巢癌真实世界治疗中最常见的血液学不良反应及最主要的≥3级不良反应,同时也是导致患者暂停用药的主要原因。奥拉帕利维持治疗期间,贫血的发生风险不限于3个月内,临床需持续关注。年龄及既往含铂化疗期间发生过≥3级贫血是奥拉帕利维持治疗期间重度贫血的高危因素,临床对高危人群应加强监测,避免重度不良事件的发生。

Objective To analyze the adverse reactions of olaparib in the treatment of ovarian cancer in the real-world,as well as the influencing factors of anemia,the most common hematological adverse reaction.Methods This study retrospective-ly analyzed the adverse reaction data,with a particular focus on the incidence of anemia,from a cohort of 146 ovarian can-cer patients who received olaparib treatment at our institution between July 2018 and October 2022.The factors associated with grade≥3 anemia were assessed through both univariate and multivariate analyses.Results During the treatment peri-od,the overall incidence rate of adverse effects was found to be 76.7%.Furthermore,the incidence rate of grade≥3 adverse reactions was 37.0%,with anemia(31.5%)being the most prevalent.Notably,the incidences of grade≥3 anemia were ob-served to be respectively 60.5%,16.3%,and 23.2%within the first 3 months,4~6 months,and 6 months after initiating treatment.Remarkably,the discontinuation of medication due to anemia persisted at a rate of 11.6%even after 1 year treatemnt.The results of the multivariate logistic regression analysis indicated that age(χ^(2)=7.914,P=0.005,OR=1.066)and grade≥3 anemia during prior platinum-containing chemotherapy(χ^(2)=5.269,P=0.022,OR=3.563)were identified as the in-dependent risk factors for grade≥3 anemia during the maintenance treatment of olaparib.Conclusion In the context of real-world ovarian cancer treatment with olaparib,anemia emerges as the predominant hematological adverse reaction,particularly of grade 3 and higher severity,and it significantly contributes to the treatment discontinuation.It is crucial to recognize that the risk of anemia during maintenance therapy extends beyond a three-month period and necessitates ongoing vigilance.Age and previous grade≥3 anemia during platinum-containing chemotherapy are identified as significant risk factors for the devel-opment of severe anemia during olaparib maintenance therapy.Consequently,it is imperative to enhance the monitoring of these high-risk groups in order to mitigate the occurrence of severe adverse events.