Background: Trastuzumab–deruxtecan (T-DXd), a new-generation antibody drug conjugate, has greatly improved the survival and clinical benefit rates of patients affected by advanced HER2-positive/HER2-low breast cancer according to the results of controlled clinical trials with a manageable safety profile. Data from randomized clinical trials can provide valuable information for the management of patients in everyday clinical practice, including those who would typically be excluded from such trials due to not meeting the inclusion criteria.Methods: In this narrative review, we describe and discuss real-world studies in the literature on the use of T-Dxd in HER2-positive and HER2-low MBC patients, providing a critical analysis of the specific settings of clinical interest.Results: Using a PubMed search, we identified nine real-world studies on T-DXd that are available in the literature. A total of 7146 patients have been included in these retrospective studies. A total of 5/9 studies also included HER2-low MBC patients. In the majority of cases, patients had high disease burden with lung and liver involvement. We then reviewed and discussed clinical areas of interest, including heavily pretreated patients, poor performance status, HER2-positive versus HER2-low disease, brain metastasis, elderly patients, lung toxicity, safety profile, and dose modifications.Conclusions: Our analysis confirms the activity of the drug described in real-world studies and shows a favorable safety profile, with manageable adverse effects.
背景：根据对照临床试验结果，新一代抗体药物偶联物曲妥珠单抗-德鲁替康（T-DXd）显著改善了晚期HER2阳性/HER2低表达乳腺癌患者的生存率和临床获益率，且安全性可控。随机临床试验数据可为日常临床实践中的患者管理提供宝贵信息，包括那些因不符合入组标准而通常被排除在此类试验之外的患者。 方法：本叙述性综述通过文献检索，描述并讨论了T-DXd在HER2阳性和HER2低表达转移性乳腺癌患者中应用的真实世界研究，并对临床关注的具体情境进行了批判性分析。 结果：通过PubMed检索，我们确定了文献中现有的九项关于T-DXd的真实世界研究。这些回顾性研究共纳入7146例患者，其中5/9的研究同时包含了HER2低表达转移性乳腺癌患者。在大多数病例中，患者疾病负荷较高，伴有肺部和肝脏受累。我们随后回顾并讨论了多个临床关注领域，包括重度预处理患者、体能状态较差者、HER2阳性与HER2低表达疾病、脑转移、老年患者、肺毒性、安全性特征及剂量调整。 结论：我们的分析证实了真实世界研究中该药物的活性，并显示出良好的安全性特征，其不良反应可控。
肿瘤(癌症)患者之家