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曲妥珠单抗-德鲁替康:在不可切除或转移性 HER2 阳性乳腺癌中的应用评价。

Trastuzumab Deruxtecan: A Review in Unresectable or Metastatic HER2-Positive Breast Cancer.

机构信息

Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

出版信息

Target Oncol. 2023 May;18(3):463-470. doi: 10.1007/s11523-023-00971-9. Epub 2023 May 2.

Abstract

Trastuzumab deruxtecan (Enhertu) is a human epidermal growth factor receptor 2 (HER2)-targeted antibody-drug conjugate approved in several countries, including the USA and those of the EU, for adults with unresectable or metastatic HER2-positive breast cancer who have previously received at least one prior anti-HER2-based regimen. In a pivotal phase 3 trial in this setting, intravenous trastuzumab deruxtecan demonstrated prolonged progression-free survival compared with trastuzumab emtansine (previously the recommended second-line therapy in this indication). Trastuzumab deruxtecan had a generally manageable safety and tolerability profile. Common treatment-related adverse events included haematological and gastrointestinal disorders. Interstitial lung disease (ILD)/pneumonitis is associated with a regulatory warning and requires careful monitoring. In conclusion, trastuzumab deruxtecan is a valuable new treatment option for HER2-positive breast cancer, having been shown to be effective with a generally manageable safety and tolerability profile in adults with unresectable or metastatic disease who have received one or more prior anti-HER2-based regimens.

摘要

恩美曲妥珠单抗(Enhertu)是一种人表皮生长因子受体 2(HER2)靶向抗体-药物偶联物,已在包括美国和欧盟在内的多个国家获得批准,用于治疗先前接受过至少一种抗 HER2 为基础的方案治疗的不可切除或转移性 HER2 阳性乳腺癌成人患者。在这一适应证的一项关键性 3 期试验中,与曲妥珠单抗-美坦新偶联物(先前是该适应证的二线推荐治疗药物)相比,静脉注射恩美曲妥珠单抗显示出了延长的无进展生存期。恩美曲妥珠单抗具有总体可控的安全性和耐受性。常见的治疗相关不良事件包括血液学和胃肠道疾病。间质性肺病(ILD)/肺炎与监管警告相关,需要仔细监测。总之,恩美曲妥珠单抗是一种治疗 HER2 阳性乳腺癌的有价值的新选择,已显示在先前接受过一种或多种抗 HER2 为基础的方案治疗的不可切除或转移性疾病的成人中具有疗效,且安全性和耐受性总体可控。

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