T-DM1 治疗曲妥珠单抗-帕妥珠单抗预处理的 HER2 阳性转移性乳腺癌患者的疗效：一项荟萃分析。
T-DM1 efficacy in trastuzumab-pertuzumab pre-treated HER2 positive metastatic breast cancer patients: a meta-analysis.
机构信息
Division of Medical Oncology, University Hospital of Modena, Via del Pozzo 71, 41122, Modena, Italy.
Department of Medical and Surgical Sciences for Children & Adults, University Hospital of Modena, Modena, Italy.
出版信息
BMC Cancer. 2022 Jun 7;22(1):623. doi: 10.1186/s12885-022-09556-7.
BACKGROUND
Current guidelines consider T-DM1 the standard 2 line therapy for HER2 positive metastatic breast cancer (MBC) patients following trastuzumab (T) + pertuzumab (P) and taxane 1 line treatment. Despite this, there are no prospective studies supporting this sequence.
METHODS
We performed a meta-analysis using real world data to determine the efficacy of T-DM1 after 1 line TP in HER2 positive MBC patients. We used a random-effect model to find differences in the rate of 1-year progression free survival (PFS) between TP pre-treated population and the EMILIA phase III pivotal trial.
RESULTS
Seven studies were eligible. The meta-analysis showed a combined 1-year PFS risk difference for T-DM1 efficacy after TP in 2 or more lines of -0.122, with lower and upper limits of -0.253 and 0.010, respectively (p = 0.07), with low heterogeneity among studies (I 0.01%, p = 0.836). Considering the four studies on T-DM1 in 2 line setting, 1-year PFS risk was -0.034 (95% CI -0.207 - 0,139; p = 0.701) (I 0.01%, p = 0.91).
CONCLUSION
Overall, the efficacy of T-DM1 after TP seems to be similar to that previously reported in the EMILIA trial. In the second line setting, data are not mature enough to confirm T-DM1 efficacy in TP pre-treated population.
背景
目前的指南认为，对于接受曲妥珠单抗（T）+帕妥珠单抗（P）和紫杉烷一线治疗后 HER2 阳性转移性乳腺癌（MBC）患者，T-DM1 是二线标准治疗。尽管如此，尚无支持这种治疗顺序的前瞻性研究。
方法
我们使用真实世界数据进行了一项荟萃分析，以确定在 HER2 阳性 MBC 患者中接受一线 TP 治疗后使用 T-DM1 的疗效。我们使用随机效应模型来比较 TP 预处理人群和 EMILIA 三期关键试验中 1 年无进展生存率（PFS）的差异。
结果
有 7 项研究符合纳入标准。荟萃分析显示，在二线或以上治疗线中，TP 预处理人群使用 T-DM1 的 1 年 PFS 风险差异为-0.122，下限和上限分别为-0.253 和 0.010（p=0.07），各研究之间的异质性较低（I 0.01%，p=0.836）。考虑到四项关于 T-DM1 在二线治疗中的研究，1 年 PFS 风险为-0.034（95%CI -0.207 至 0.139；p=0.701）（I 0.01%，p=0.91）。
结论
总体而言，TP 后使用 T-DM1 的疗效似乎与 EMILIA 试验中先前报道的相似。在二线治疗中，数据尚不成熟，无法确认 TP 预处理人群中 T-DM1 的疗效。
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