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曲妥珠单抗-美坦新偶联物(T-DM1)联合放射治疗的安全性:系统评价和荟萃分析。

Safety profile of trastuzumab-emtansine (T-DM1) with concurrent radiation therapy: A systematic review and meta-analysis.

机构信息

Department of Experimental and Clinical Biomedical Sciences "M. Serio", University of Florence, Florence, Italy; Radiation Oncology Unit, Oncology Department, Azienda Ospedaliero Universitaria Careggi, Florence, Italy.

Department of Experimental and Clinical Biomedical Sciences "M. Serio", University of Florence, Florence, Italy; Department of Radiation Oncology, Ewha Womans University College of Medicine, Seoul, Republic of Korea.

出版信息

Radiother Oncol. 2023 Sep;186:109805. doi: 10.1016/j.radonc.2023.109805. Epub 2023 Jul 10.

Abstract

BACKGROUND AND PURPOSE

In recent years, the treatment landscape for breast cancer has undergone significant advancements, with the introduction of several new anticancer agents. One such agent is trastuzumab emtansine (T-DM1), an antibody drug conjugate that has shown improved outcomes in both early and advanced breast cancer. However, there is currently a lack of comprehensive evidence regarding the safety profile of combining T-DM1 with radiation therapy (RT). In this study, we aim to provide a summary of the available data on the safety of combining RT with T-DM1 in both early and metastatic breast cancer settings.

MATERIALS AND METHODS

This systematic review and meta-analysis project is part of the consensus recommendations by the European Society for Radiotherapy and Oncology (ESTRO) Guidelines Committee on integrating RT with targeted treatments for breast cancer. A thorough literature search was conducted using the PUBMED/MedLine, Embase, and Cochrane databases to identify original studies focusing on the safety profile of combining T-DM1 with RT.

RESULTS

After applying eligibility criteria, nine articles were included in the meta-analysis. Pooled data from these studies revealed a high incidence of grade 3 + radionecrosis (17%), while the rates of grade 3 + radiation-related pneumonitis (<1%) and skin toxicity (1%) were found to be very low.

CONCLUSION

Although there is some concern regarding a slight increase in pneumonitis when combining T-DM1 with postoperative RT, the safety profile of this combination was deemed acceptable for locoregional treatment in non-metastatic breast cancer. However, caution is advised when irradiating intracranial sites concurrently with T-DM1. There is a pressing need for international consensus guidelines regarding the safety considerations of combining T-DM1 and RT for breast cancer.

摘要

背景与目的

近年来,乳腺癌的治疗领域取得了重大进展,引入了几种新的抗癌药物。其中一种药物是曲妥珠单抗-美坦新偶联物(T-DM1),这是一种抗体药物偶联物,在早期和晚期乳腺癌中均显示出改善的疗效。然而,目前关于 T-DM1 联合放射治疗(RT)的安全性概况缺乏全面的证据。在这项研究中,我们旨在总结 T-DM1 联合 RT 在早期和转移性乳腺癌治疗中的安全性相关的现有数据。

材料与方法

本系统评价和荟萃分析项目是欧洲放射肿瘤学会(ESTRO)指南委员会关于整合 RT 与乳腺癌靶向治疗的共识建议的一部分。我们使用 PUBMED/MedLine、Embase 和 Cochrane 数据库进行了全面的文献检索,以确定关注 T-DM1 联合 RT 的安全性概况的原始研究。

结果

在应用纳入标准后,共有 9 篇文章纳入荟萃分析。这些研究的汇总数据显示,3 级以上放射性坏死的发生率较高(17%),而 3 级以上放射性肺炎(<1%)和皮肤毒性(1%)的发生率非常低。

结论

虽然当 T-DM1 与术后 RT 联合使用时,放射性肺炎的发生率略有增加,但对于非转移性乳腺癌的局部区域治疗,这种联合治疗的安全性是可以接受的。然而,当同时用 T-DM1 照射颅内部位时需要谨慎。目前迫切需要制定关于 T-DM1 和 RT 联合治疗乳腺癌的安全性考虑的国际共识指南。

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