Costa Ricardo, Zaman Saif, Sharpe Susan, Helenowski Irene, Shaw Colleen, Han Hyo, Soliman Hatem, Czerniecki Brian
Department of Breast Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA,
Morsani College of Medicine, University of South Florida, Tampa, FL, USA.
Drug Des Devel Ther. 2019 Jan 14;13:309-316. doi: 10.2147/DDDT.S188925. eCollection 2019.
Human epidermal growth factor receptor 2 (HER2)-targeted vaccines are under development, but have so far demonstrated only modest clinical efficacy. Additionally, there has been a lack of adequate safety assessment in large-scale prospective clinical trials. Therefore, we performed a meta-analysis of available clinical trial data to summarize the toxicity profiles of these treatments. Literature search was conducted in February 2018. The trials analyzed had at least one study arm consisting of HER2 vaccine monotherapy. Heterogeneity across studies was analyzed using statistics. Data were analyzed using random-effects meta-analysis for absolute risk (AR). Eight trials and 248 patients were included. There was no evidence of heterogeneity between studies for grades 3/4 adverse events (AEs) or for death. The AR for treatment-related serious AEs was 5% with no treatment-related deaths. The AR of all-grade fatigue, injection site reaction, and fever/chills/rigors was 33%, 23%, and 31%, respectively. Asymptomatic drop in left ventricle ejection fraction was rare (8%). HER2 vaccines are well tolerated with increased AR of fatigue, injection site reactions, and fever/chills/rigors.
针对人表皮生长因子受体2（HER2）的疫苗正在研发中，但迄今为止仅显示出适度的临床疗效。此外，在大规模前瞻性临床试验中缺乏充分的安全性评估。因此，我们对现有临床试验数据进行了荟萃分析，以总结这些治疗方法的毒性特征。2018年2月进行了文献检索。所分析的试验至少有一个研究组由HER2疫苗单药治疗组成。使用统计学方法分析研究间的异质性。采用随机效应荟萃分析对绝对风险（AR）进行数据分析。纳入了8项试验和248例患者。在3/4级不良事件（AE）或死亡方面，研究间没有异质性证据。治疗相关严重AE的AR为5%，无治疗相关死亡。全级疲劳、注射部位反应和发热/寒战/发冷的AR分别为33%、23%和31%。左心室射血分数无症状下降罕见（8%）。HER2疫苗耐受性良好，但疲劳、注射部位反应和发热/寒战/发冷的AR有所增加。
