Zhang Xizhou, Zhang Zetao, Lin Jianguang, Yi Jiarong, Zou Xuxiazi, Feng Jikun, Huang Guangsheng, Chen Bingfeng, Long Junxi, Wu Fengjia, Ye Feng, Wu Haoming
The Breast Center, Cancer Hospital of Shantou University Medical College, Guangdong Provincial Key Laboratory of Breast Cancer Diagnosis and Treatment, Shantou, 515031, China.
Department of Oncology, The Second Affiliated Hospital of Fujian Medical University, Quanzhou, 362000, China.
Oncol Res. 2025 Aug 28;33(9):2529-2547. doi: 10.32604/or.2025.065029. eCollection 2025.
Breast cancer remains a leading cause of morbidity and mortality among women worldwide, with significant geographic disparities in its impact. While human epidermal growth factor receptor 2 (HER2)-targeted therapies, such as trastuzumab, have improved outcomes for HER2-positive breast cancer, challenges like therapy resistance persist, highlighting the need for novel treatments. Recent developments in antibody-drug conjugates (ADCs), particularly disitamab vedotin (RC48), show promising efficacy in targeting both HER2-positive and HER2-low expression tumors, warranting further investigation through real-world studies to assess its broader clinical applicability.
This retrospective, multicenter observational study evaluated the real-world efficacy and safety of RC48 in patients with HER2-positive or HER2-low breast cancer across three medical centers in China. Patient demographic characteristics, treatment patterns, sequential use of ADCs, and treatment-related adverse events were recorded and analyzed.
The median progression-free survival (mPFS) for the overall population ( = 96) was 4.31 months, with HER2-positive patients demonstrating significantly longer mPFS (5.26 months) compared to HER2-low patients (3.45 months; = 0.044), while subgroup analyses revealed no significant differences in mPFS based on estrogen receptor (ER), progesterone receptor (PR), or hormone receptor (HR) status. Safety data indicated that adverse events were consistent with prior reports, with no new safety concerns identified during the study period.
This real-world study demonstrates the efficacy of RC48 in both HER2-positive and HER2-low breast cancer. Notably, combination therapy significantly improved outcomes in HER2-low patients.
乳腺癌仍然是全球女性发病和死亡的主要原因，其影响存在显著的地理差异。虽然针对人表皮生长因子受体2（HER2）的疗法，如曲妥珠单抗，改善了HER2阳性乳腺癌的治疗效果，但治疗耐药等挑战依然存在，这凸显了对新型治疗方法的需求。抗体药物偶联物（ADC）的最新进展，尤其是迪西他单抗维泊妥珠单抗（RC48），在靶向HER2阳性和HER2低表达肿瘤方面显示出有前景的疗效，需要通过真实世界研究进一步评估其更广泛的临床适用性。
这项回顾性、多中心观察性研究评估了RC48在中国三个医疗中心HER2阳性或HER2低表达乳腺癌患者中的真实世界疗效和安全性。记录并分析了患者的人口统计学特征、治疗模式、ADC的序贯使用情况以及治疗相关不良事件。
总体人群（n = 96）的中位无进展生存期（mPFS）为4.31个月，HER2阳性患者的mPFS（5.26个月）显著长于HER2低表达患者（3.45个月；P = 0.044），而亚组分析显示基于雌激素受体（ER）、孕激素受体（PR）或激素受体（HR）状态的mPFS无显著差异。安全性数据表明不良事件与先前报告一致，在研究期间未发现新的安全问题。
这项真实世界研究证明了RC48在HER2阳性和HER2低表达乳腺癌中的疗效。值得注意的是，联合治疗显著改善了HER2低表达患者的治疗效果。
