Clinical outcome and tolerability of DS-8201 in patients with advanced HER2-positive breast cancer: a retrospective study

OBJECTIVE: There are limited data about DS-8201 (trastuzumab deruxtecan) in Chinese patients with advanced human epidermal growth factor receptor 2 (HER2)-positive breast cancer previously treated with trastuzumab emtansine (T-DM1). This study aimed to evaluate the efficacy and safety of DS-8201 compared to the treatment of physician's choice (TPC) in this population. METHODS: In this retrospective cohort study, 185 eligible patients treated between December 2022 and March 2025 were assigned to either the DS-8201 group (n=83) or the TPC group (n=102), which received regimens such as capecitabine combined with anti-HER2 therapy. Progression-free survival (PFS), overall survival (OS), objective response rate (ORR), duration of response (DoR), disease control rate (DCR), quality of life (QoL), and safety were assessed. RESULTS: The DS-8201 group demonstrated significantly superior 12- and 24-month PFS (62.65% vs. 42.16%; 50.60% vs. 23.53%) and OS (90.36% vs. 60.78%; 75.90% vs. 54.90%) compared to the TPC group (all P