a Department of Woman and Child Health , Università Cattolica del Sacro Cuore at IRCCS- Policlinico Gemelli Foundation for Personalized Medicine Rome , Rome , Italy.
b Department of Clinical and Experimental Medicine , Gynecologic and Obstetrics Unit, University of Sassari , Sassari , Italy.
Expert Opin Drug Saf. 2018 Nov;17(11):1107-1113. doi: 10.1080/14740338.2018.1532500. Epub 2018 Oct 10.
The safety profile of bevacizumab (BV) remains a challenging issue, in particular its role in fragile OC patients. Areas covered: In this literature review, we have analyzed safety data from Phase III trials evaluating the combination of BV plus standard chemotherapy in advanced or recurrent OC patients. In particular, our review aimed at clarifying the impact of the drug on fragile patients, and the correlation between BV and postoperative complications after cytoreductive surgery. Expert opinion: The addition of BV to standard chemotherapy regimens may cause unexpected side effects such as hypertension or proteinuria in up to 10% of women receiving the drug. BV administration is not associated with increase postoperative complications after cytoreductive surgery. Artero-venous thromboembolism and gastrointestinal perforation/fistula occurring in around 3% of OC patients treated with BV represent life-threatening events always requiring drug suspension. A closer monitoring is required in selected groups of women including: women with inflammatory bowel disease, or uncontrolled hypertension. Age itself is not a major contraindication, but older women should be carefully evaluated prior to start the drug. Finally, BV maintenance therapy should not be prematurely stopped due to minor events, since drug suspension may reduce survival.
贝伐珠单抗(BV)的安全性仍是一个挑战,特别是在脆弱的 OC 患者中。
在这篇文献综述中,我们分析了评估 BV 联合标准化疗治疗晚期或复发性 OC 患者的 III 期试验的安全性数据。特别是,我们的综述旨在阐明药物对脆弱患者的影响,以及 BV 与细胞减灭术后术后并发症之间的相关性。
在接受该药物治疗的女性中,多达 10%的女性可能会出现意想不到的副作用,如高血压或蛋白尿。BV 给药与细胞减灭术后术后并发症的增加无关。接受 BV 治疗的 OC 患者中约有 3%发生的动静脉血栓栓塞和胃肠道穿孔/瘘是危及生命的事件,始终需要停药。需要对包括:炎症性肠病或未控制的高血压的特定女性群体进行更密切的监测。年龄本身不是主要禁忌症,但在开始用药前应仔细评估老年女性。最后,由于轻微事件不应过早停止 BV 维持治疗,因为药物停药可能会降低生存率。