He Miao, Liu Xiaohui, Zhang Yan, Shao Zhenyu, Sun Tiantian, Hu Yu
Department of Medical Oncology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.
Department of Medical Oncology, Qilu Hospital (Qingdao), Cheeloo College of Medicine, Shandong University, Qingdao, China.
Front Oncol. 2025 Aug 18;15:1582498. doi: 10.3389/fonc.2025.1582498. eCollection 2025.
In mainland China, trastuzumab deruxtecan was first authorized in February 2023 as a monotherapy for the treatment of patients with HER-2-positive adult breast cancer who were either unresectable or had metastasized after receiving one or more anti-HER-2 treatments. In July 2023, trastuzumab deruxtecan was approved for the treatment of patients with metastatic disease who had undergone at least one previous systemic therapy, as well as those with unresectable or metastatic adult breast cancer who had low expression of HER-2 and who had experienced a relapse within six months of finishing adjuvant chemotherapy.
The study included seven participants with HER-2 low expression breast cancer and eighteen participants with HER-2-positive advanced breast cancer from six study centers in Shandong Province, China. Efficacy and safety data on trastuzumab deruxtecan were also gathered. The study involved intravenous injection of trastuzumab deruxtecan at a dosage of 5.4 mg/kg every three weeks until the disease progressed or the drug's toxicity became unmanageable, whichever came first.
During a 8-month follow-up period, the disease control rate for patients with HER-positive breast cancer was 88.89% (16/18). The disease control rate for patients with HER-2 low-expressing breast cancer was 85.71% (6/7). The most common adverse reactions were gastrointestinal reactions, such as nausea, which occurred in 64.00% (16/25), and interstitial lung disease, which had a probability of occurring in 4.00% (1/25). In this real-world study, trastuzumab deruxtecan showed favorable efficacy and safety in both HER-2-positive breast cancer and HER-2 low-expressing breast cancer.
在中国内地,曲妥珠单抗德鲁昔单抗于2023年2月首次获批作为单药疗法,用于治疗接受过一种或多种抗HER-2治疗后不可切除或发生转移的HER-2阳性成年乳腺癌患者。2023年7月,曲妥珠单抗德鲁昔单抗被批准用于治疗既往至少接受过一种全身治疗的转移性疾病患者,以及HER-2低表达且在辅助化疗结束后6个月内复发的不可切除或转移性成年乳腺癌患者。
该研究纳入了来自中国山东省6个研究中心的7例HER-2低表达乳腺癌患者和18例HER-2阳性晚期乳腺癌患者。还收集了曲妥珠单抗德鲁昔单抗的疗效和安全性数据。该研究采用静脉注射曲妥珠单抗德鲁昔单抗,剂量为5.4 mg/kg,每3周一次,直至疾病进展或药物毒性变得无法控制,以先出现者为准。
在8个月的随访期内,HER-2阳性乳腺癌患者的疾病控制率为88.89%(16/18)。HER-2低表达乳腺癌患者的疾病控制率为85.%;71%(6/7)。最常见的不良反应是胃肠道反应,如恶心,发生率为64.00%(16/25),间质性肺病的发生率为4.00%(1/25)。在这项真实世界研究中,曲妥珠单抗德鲁昔单抗在HER-2阳性乳腺癌和HER-2低表达乳腺癌中均显示出良好的疗效和安全性。