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首页> 外文期刊>Therapeutic advances in drug safety. >Risk of hepatotoxicity with trastuzumab emtansine in breast cancer patients: a systematic review and meta-analysis
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Risk of hepatotoxicity with trastuzumab emtansine in breast cancer patients: a systematic review and meta-analysis

机译:患有乳腺癌患者的曲妥珠单抗的肝毒性风险:系统审查和荟萃分析

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Background: Trastuzumab emtansine (T-DM1) is an anti-HER2 antibody-drug conjugate indicated for the treatment of HER2-positive breast cancer. One of the most severe adverse events reported with T-DM1 is hepatotoxicity. The objective of our meta-analysis is to investigate the risk of hepatic adverse events in patients with breast cancer receiving T-DM1 compared with controls. Methods: We conducted a systematic review and meta-analysis of randomized clinical trials (RCTs) comparing T-DM1 with a control treatment in patients with HER2-positive breast cancer. Phase II/III RCTs with available event number or event rate of hepatic toxicity with an assessable sample size were included. Relative risk (RR) and corresponding 95% confidence intervals (CI) for all grade and high-grade (grade 3/4) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) elevations were calculated. Results: Seven RCTs were deemed eligible and were included in the meta-analysis. The RR for all-grade AST and ALT elevations were 3.24 (95% CI 2.16–4.86; p Conclusions: Our meta-analysis demonstrates that T-DM1-based therapy is associated with an increased risk of AST and ALT elevations.
机译:背景:Trastuzumab Emtansine(T-DM1)是一种抗HER2抗体 - 药物缀合物,用于治疗HER2阳性乳腺癌。用T-DM1报道的最严重的不良事件之一是肝毒性。我们的荟萃分析的目的是探讨乳腺癌患者接受T-DM1患者肝不良事件的风险。方法:对随机临床试验(RCT)进行了系统的评价和荟萃分析,比较T-DM1与HER2阳性乳腺癌患者的对照治疗。包括可用事件编号的II / III次数或肝脏毒性事件率,具有可评估的样本量。计算所有等级和高级(3/4级)天冬氨酸氨基转移酶(AST)和丙氨酸氨基转移酶(ALT)升高的相对风险(RR)和相应的95%置信区间(CI)。结果:七个RCT被视为符合条件,并包含在Meta分析中。所有级AST和ALT升级的RR为3.24(95%CI 2.16-4.86; P结论:我们的META分析表明,基于T-DM1的疗法与AST和ALT升高的风险增加有关。

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