Efficacy evaluation of novel targeted drugs in patients with human epidermal growth factor receptor 2-positive breast cancer: A meta-analysis based on multiple sets of clinical data.

ObjectiveTo evaluate the efficacy and safety of novel targeted drugs in patients with human epidermal growth factor receptor 2-positive breast cancer and their impact on clinical outcomes, including overall survival and progression-free survival.MethodsThis systematic review was registered with PROSPERO (CRD420261383276). A systematic search of PubMed, Embase, Cochrane Library, Web of Science, and ClinicalTrials.gov was conducted for randomized controlled trials and prospective cohort studies published between January 2000 and March 2024. Participants were adult females diagnosed with human epidermal growth factor receptor 2-positive breast cancer who were treated with novel agents (e.g. T-DXd, margetuximab, and tucatinib). Primary outcomes included overall survival, progression-free survival, objective response rate, and disease control rate. Statistical analyses were performed using RevMan 5.4 and Stata 16.0 with random-effects models.ResultsEight studies were included from 2567 identified records. Novel human epidermal growth factor receptor 2-targeted drugs significantly improved overall survival (hazard ratio = 0.73, 95% confidence interval: 0.68-0.79) and progression-free survival (hazard ratio = 0.65, 95% confidence interval: 0.60-0.71) compared with standard treatments. The objective response rate (50% vs. 35%) and disease control rate (80% vs. 60%) were also significantly higher in the novel drug group. Subgroup analyses revealed greater benefits among patients with hormone receptor-negative disease (progression-free survival, hazard ratio = 0.58, 95% confidence interval: 0.50-0.67) and those with brain metastases (progression-free survival, hazard ratio = 0.52, 95% confidence interval: 0.45-0.60). Furthermore, novel drugs were associated with lower incidences of cardiotoxicity (5% vs. 15%) and gastrointestinal reactions (10% vs. 25%).ConclusionsNovel targeted drugs demonstrate superior efficacy and a more favorable safety profile than traditional therapies in patients with human epidermal growth factor receptor 2-positive breast cancer. These findings provide a clinical basis for optimizing individualized treatment, particularly for high-risk subgroups.