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贝伐单抗在卵巢癌患者中的安全性分析。

Safety Analysis of Bevacizumab in Ovarian Cancer Patients.

作者信息

Wang Yingwen, Lin Hao, Ou Yuche, Fu Hungchun, Tsai Chingchou, Chien Chanchao Chang, Wu Chenhsuan

机构信息

Department of Obstetrics and Gynecology, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City 833, Taiwan.

Department of Obstetrics and Gynecology, Chia-Yi Chang Gung Memorial Hospital, Chiayi County 613, Taiwan.

出版信息

J Clin Med. 2023 Mar 6;12(5):2065. doi: 10.3390/jcm12052065.

Abstract

Bevacizumab (BEV) is beneficial for ovarian cancer patients, but the real world's patient settings differ from those in clinical trials. This study tries to illustrate adverse events in the Taiwanese population. Patients with epithelial ovarian cancer treated with BEV at Kaohsiung Chang Gung Memorial Hospital between 2009 and 2019 were retrospectively reviewed. The receiver operating characteristic curve was adopted to identify the cutoff dose and the presence of BEV-related toxicities. A total of 79 patients receiving BEV in neoadjuvant, frontline, or salvage settings were enrolled. The median follow-up time was 36.2 months. Twenty patients (25.3%) had "De novo" hypertension or the worsening of a preexisting one. Twelve patients (15.2%) had "De novo" proteinuria. Five patients (6.3%) had thromboembolic events/hemorrhage. Four patients (5.1%) had gastrointestinal perforation (GIP), and one patient (1.3%) had wound-healing complications. Patients with BEV-related GIP had at least two risk factors for developing GIP, most of which were conservatively managed. This study revealed a compatible but distinct safety profile from those reported in clinical trials. The presence of BEV-related changes in blood pressure showed a dose-dependent trend. Most of the BEV-related toxicities were managed individually. Patients with potential risks for developing BEV-related GIP should use BEV with caution.

摘要

贝伐单抗(BEV)对卵巢癌患者有益,但现实世界中的患者情况与临床试验中的不同。本研究试图阐明台湾人群中的不良事件。对2009年至2019年期间在高雄长庚纪念医院接受BEV治疗的上皮性卵巢癌患者进行回顾性研究。采用受试者操作特征曲线来确定截止剂量以及BEV相关毒性的存在情况。共有79例在新辅助、一线或挽救治疗中接受BEV的患者入组。中位随访时间为36.2个月。20例患者(25.3%)出现“新发”高血压或原有高血压病情恶化。12例患者(15.2%)出现“新发”蛋白尿。5例患者(6.3%)发生血栓栓塞事件/出血。4例患者(5.1%)发生胃肠道穿孔(GIP),1例患者(1.3%)出现伤口愈合并发症。发生BEV相关GIP的患者至少有两个发生GIP的危险因素,大多数采用保守治疗。本研究揭示了与临床试验报告中相符但又不同的安全性概况。BEV相关的血压变化呈剂量依赖性趋势。大多数BEV相关毒性采取个体化处理。有发生BEV相关GIP潜在风险的患者应谨慎使用BEV。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7d5d/10003828/94df51578a29/jcm-12-02065-g001.jpg

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