Association of Pegylated Liposomal Doxorubicin with Improved Overall Survival Compared with Epirubicin in Early-Stage Breast Cancer: A Population Based Study from Taiwan

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Purpose: Anthracycline-based regimens are a cornerstone of adjuvant therapy for early-stage breast cancer but are limited by cumulative cardiotoxicity. This study compared the effectiveness and cardiotoxicity of pegylated liposomal doxorubicin (Lipo-Dox) and epirubicin in women with early-stage, HER2-negative breast cancer using nationwide real-world data from Taiwan. Patients and Methods: This population-based retrospective cohort study used Taiwan's National Health Insurance Research Database to identify adult women with stage I-III, HER2-negative breast cancer treated with adjuvant anthracycline-based chemotherapy between 2006 and 2018. Propensity score matching (1:1) was performed to balance baseline characteristics, resulting in 1050 matched patients with a median follow-up of 6.05 years. Overall survival (OS), disease-free survival (DFS), and cardiotoxicity were analyzed using Cox proportional hazards models and Kaplan-Meier methods. Results: Compared with epirubicin, Lipo-Dox was associated with significantly improved overall survival (adjusted hazard ratio 0.754, 95% CI 0.632-0.899; P < 0.001). Survival benefits were consistent across 3-year, 5-year, and full follow-up analyses and demonstrated a dose-dependent relationship. Kaplan-Meier curves confirmed superior overall survival in the Lipo-Dox group (log-rank P < 0.001). No significant differences were observed between the two groups in disease-free survival or clinically diagnosed cardiac events. Conclusion: In this nationwide propensity score-matched cohort, adjuvant Lipo-Dox was associated with sustained overall survival benefits without increased cardiotoxic risk compared with epirubicin. Lipo-Dox may represent a favorable anthracycline alternative, particularly for patients with cardiovascular comorbidities or elevated cardiotoxicity risk.

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