ArticleTherapeutic advances in medical oncology2026
Dalpiciclib combined with endocrine therapy for patients with HR+/HER2- metastatic breast cancer: a multicenter real-world study.
Article in Therapeutic advances in medical oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Dalpiciclib is the latest cyclin-dependent kinase 4/6 (CDK4/6) inhibitor approved in China. Real-world data regarding the efficacy and safety of dalpiciclib for metastatic breast cancer (MBC) are still insufficient. Objectives: This study aims to investigate the real-world outcomes of dalpiciclib in a more heterogeneous population of patients with MBC. Design: We retrospectively collected data of hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) MBC patients who received dalpiciclib plus endocrine therapy (ET) between January 2022 to March 2025 from four clinical centers in South China. Methods: Demographic characteristics and clinical data were collected. Real-world progression-free survival (rwPFS), objective response rate (ORR), and safety profiles were analyzed. Results: In total, 160 patients were included. The median follow-up time was 17.6 months (95% confidence interval (CI): 15.0-20.2). The estimated overall median rwPFS was 20.6 months (95% CI: 12.4-28.8), and the ORR was 17.5% (28/160) for the entire cohort. Subgroup analysis showed that the median rwPFS was 26.7 months in patients receiving first-line dalpiciclib plus ET, compared with 13.8 months in those receiving second- or later-line treatment. The median rwPFS for patients with brain metastases (BMs; Conclusion: In this real-world cohort of HR+/HER2- MBC patients, dalpiciclib plus ET retains its favorable clinical activity. This regimen also showed promising activity in patients with BMs and those previously exposed to CDK4/6 inhibitors.
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