| 薛 鸿,岳 鹏,刘晶晶.T-DM1治疗Her-2阳性晚期或转移性乳腺癌有效性及安全性的Meta分析[J].中国肿瘤,2018,27(9):726-732. |
| T-DM1治疗Her-2阳性晚期或转移性乳腺癌有效性及安全性的Meta分析 |
| Efficacy and Safety of Tratuzumab-Emtansine(T-DM1) in Treatment of Her-2-positive Advanced or Metastatic Breast Cancer：A Meta-analysis |
| 投稿时间：2018-04-12 |
| DOI：10.11735/j.issn.1004-0242.2018.09.A016 |
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| 中文关键词: 曲妥珠单抗共轭复合物 Her-2 乳腺癌 肿瘤转移 Meta分析 |
| 英文关键词:ado-tratuzumab emtansine（T-DM1） Her-2 breast cancer neoplasm metastasis Meta analysis |
| 基金项目:甘肃省青年科技基金计划（1606RJZA283，1606RJZA126）；甘肃省科技计划项目（17JR5RA196） |
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| 中文摘要: |
| 摘 要：［目的］ 系统评价T-DM1治疗Her-2阳性晚期或转移性乳腺癌的有效性和安全性。［方法］ 检索PubMed、Web of Science、EMBASE、the Cochrane Libarary、CNKI、万方数据库，搜集国内外公开发表的有关T-DM1治疗Her-2阳性晚期或转移性乳腺癌的随机对照研究（RCT），检索时限从建库到2017年12月。由2名评价员按纳入、排除标准独立进行文献筛选、提取资料，并评价纳入文献的偏倚风险，采用Stata12.0软件进行Meta分析。［结果］ 共纳入4项随机对照试验，共计2812例患者。Meta分析结果显示：与传统的治疗相比，T-DM1治疗Her-2阳性晚期或转移性乳腺癌，疗效方面，两组完全缓解率（RR=0.88，95%CI：0.57～1.36，P=0.574 ）和部分缓解率（RR=1.05，95%CI：0.85～1.29，P=0.667）差异均无统计学意义；安全性方面，两组总不良反应发生率无显著差异（RR=0.99，95%CI：0.98～1.01，P=0.319）；但T-DM1组3级及以上不良反应发生率低于对照组（RR=0.77，95%CI：0.65～0.92，P=0.004）。［结论］ 与传统治疗相比，T-DM1治疗晚期或转移性乳腺癌对完全缓解率、部分缓解率及总不良反应事件发生率无明显改善，但可减少3级以上不良反应发生率。 |
| 英文摘要: |
| Abstract：［Purpose］ To systematically evaluate the efficacy and the safety of tratuzumab-emtansine(T-DM1) in treatment of Her-2-positive advanced or metastatic breast cancer.［Methods］ Databases including PubMed，Web of Science，EMBASE，the Cochrane Libarary，CNKI，Wanfang database were searched from inception to December 2017 to collect randomized controlled trials(RCTs) about T-DM1 for Her-2-positive advanced or metastatic breast cancer. Two reviewers independently screened literature according to the inclusion and exclusion criteria，extracted data，and assessed the risk of bias of included studies. Stata 12.0 software was used for the Meta-analysis. ［Results］ A total of 4 eligible RCTs were finally included involving 2812 patients. Meta-analysis showed that T-DM1 had no advantages in complete response(RR=0.88，95%CI：0.57～1.36，P=0.574) and partial response(RR=1.05，95%CI：0.85～1.29，P=0.667）.In terms of safety，there was no statistical difference in the incidence of all-grade adverse events(RR=0.99，95%CI：0.98～1.01，P=0.319） between T-DM1 group and control group，whereas the incidence of adverse events grade≥3 was lower in T-DM1 group(RR=0.77，95%CI：0.65～0.92，P=0.004）. ［Conclusion］ Compared with traditional chemotherapy，T-DM1 may reduce the incidence of adverse events grade≥3，although there is evidence showing that it is more effective in treatment of Her-2-positive advanced or metastatic breast cancer. |
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