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已发表论文
曲妥珠单抗德鲁替康治疗 HER2 阳性和 HER2 低表达转移性乳腺癌的疗效：中国一项真实世界回顾性队列研究
Authors Yan Y, Jin Y, Lin M, Zeng C, Guo Q, Zhou T, Li DD, Zhang J
Received 11 June 2025
Accepted for publication 20 September 2025
Published 25 September 2025 Volume 2025:17 Pages 863—873
DOI https://doi.org/10.2147/BCTT.S545308
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Professor Harikrishna Nakshatri
Yuxin Yan,1,2 Yizi Jin,1,2 Mingxi Lin,1,2 Ceng Zeng,1,2 Qing Guo,1,2 Teng Zhou,1,2 Dou Dou Li,3 Jian Zhang1,4
1Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, People’s Republic of China; 2Department of Breast and Urinary Oncology, Fudan University Shanghai Cancer Center, Shanghai, People’s Republic of China; 3School of Clinical Medicine, Shanghai University of Medicine & Health Sciences, Shanghai, People’s Republic of China; 4Phase I Unit, Fudan University Shanghai Cancer Center, Shanghai, 200032, People’s Republic of China
Correspondence: Dou Dou Li, School of Clinical Medicine, Shanghai University of Medicine & Health Sciences, Shanghai, People’s Republic of China, Email 17111230019@fudan.edu.cn Jian Zhang, Phase I Unit, Fudan University Shanghai Cancer Center, No. 270, Dong’an Road, Shanghai, 200032, People’s Republic of China, Email jianz@fudan.edu.cn
Background: Limited real-world data are available on the effectiveness and safety of trastuzumab deruxtecan (T-DXd, DS8201a) in patients with HER2-positive and HER2-low metastatic breast cancer (MBC), particularly within the Chinese population.
Methods: Between 2022 and 2025, 98 patients with MBC treated with T-DXd were retrospectively enrolled at Fudan University Shanghai Cancer Center. Patients were categorized as HER2-positive and HER2-low cohort. Clinical outcomes including objective response rate (ORR), progression-free survival (PFS), disease control rate (DCR), and clinical benefit rate (CBR), were assessed and compared between cohorts. The primary endpoint of the study was PFS, which was estimated using the Kaplan–Meier method and compared using the Log rank test.
Results: Among the 98 patients, the median PFS was 15.0 months. The ORR, DCR, and CBR were 48.0%, 69.4%, and 41.8%, respectively. HER2-positive patients experienced longer PFS compared to HER2-low patients (not reached vs 9.0 months). Among HER2-low patients, liver metastases were associated with poorer outcomes. Patients with brain metastases achieved a median PFS of 15.5 months and a 1-year PFS rate of 65.3%. Grade ≥ 3 adverse events included neutropenia (20.4%), nausea (5.1%), anemia (4.1%), and interstitial lung disease in 6.1% of patients, leading to discontinuation in 2.0%.
Conclusion: In this real-world analysis, T-DXd demonstrated robust clinical activity in both HER2-positive and HER2-low MBC, consistent with the findings from the DESTINY-Breast clinical trials. Notably, we identified several clinically relevant prognostic factors, including HER2 status, metastatic site, treatment line, and prior therapies. These findings support the broader clinical application of T-DXd and offer insights into individualized treatment selection.
Keywords: T-DXd, prognosis, real-world, breast cancer, HER2
1Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, People’s Republic of China; 2Department of Breast and Urinary Oncology, Fudan University Shanghai Cancer Center, Shanghai, People’s Republic of China; 3School of Clinical Medicine, Shanghai University of Medicine & Health Sciences, Shanghai, People’s Republic of China; 4Phase I Unit, Fudan University Shanghai Cancer Center, Shanghai, 200032, People’s Republic of China
Correspondence: Dou Dou Li, School of Clinical Medicine, Shanghai University of Medicine & Health Sciences, Shanghai, People’s Republic of China, Email 17111230019@fudan.edu.cn Jian Zhang, Phase I Unit, Fudan University Shanghai Cancer Center, No. 270, Dong’an Road, Shanghai, 200032, People’s Republic of China, Email jianz@fudan.edu.cn
Background: Limited real-world data are available on the effectiveness and safety of trastuzumab deruxtecan (T-DXd, DS8201a) in patients with HER2-positive and HER2-low metastatic breast cancer (MBC), particularly within the Chinese population.
Methods: Between 2022 and 2025, 98 patients with MBC treated with T-DXd were retrospectively enrolled at Fudan University Shanghai Cancer Center. Patients were categorized as HER2-positive and HER2-low cohort. Clinical outcomes including objective response rate (ORR), progression-free survival (PFS), disease control rate (DCR), and clinical benefit rate (CBR), were assessed and compared between cohorts. The primary endpoint of the study was PFS, which was estimated using the Kaplan–Meier method and compared using the Log rank test.
Results: Among the 98 patients, the median PFS was 15.0 months. The ORR, DCR, and CBR were 48.0%, 69.4%, and 41.8%, respectively. HER2-positive patients experienced longer PFS compared to HER2-low patients (not reached vs 9.0 months). Among HER2-low patients, liver metastases were associated with poorer outcomes. Patients with brain metastases achieved a median PFS of 15.5 months and a 1-year PFS rate of 65.3%. Grade ≥ 3 adverse events included neutropenia (20.4%), nausea (5.1%), anemia (4.1%), and interstitial lung disease in 6.1% of patients, leading to discontinuation in 2.0%.
Conclusion: In this real-world analysis, T-DXd demonstrated robust clinical activity in both HER2-positive and HER2-low MBC, consistent with the findings from the DESTINY-Breast clinical trials. Notably, we identified several clinically relevant prognostic factors, including HER2 status, metastatic site, treatment line, and prior therapies. These findings support the broader clinical application of T-DXd and offer insights into individualized treatment selection.
Keywords: T-DXd, prognosis, real-world, breast cancer, HER2