Therapeutic advances in medical oncology · 2026
Dalpiciclib combined with endocrine therapy for patients with HR+/HER2- metastatic breast cancer: a multicenter real-world study.
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Chen Xuelian, Lin Lin, He Guangning, Ren Guanghui, Huang Jiayi, Chen Liping, Lan Xiaofeng, Xie Xiaofeng, Song Lin, Bai Xue, Du Caiwen
Аннотация
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; n = 13) was 14.8 months (95% CI: 4.0-25.6), and the median rwPFS for patients treated by prior CDK4/6 inhibitors (n = 33) was 7.2 months. Stratified Cox regression analysis revealed that the presence of de novo metastatic disease was an independent factor for an increased risk of disease progression (hazard ratio 0.47, 95% CI: 0.25-0.91, p = 0.025). Hematologic toxicity was the most frequent adverse event associated with dalpiciclib treatment.
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.
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; n = 13) was 14.8 months (95% CI: 4.0-25.6), and the median rwPFS for patients treated by prior CDK4/6 inhibitors (n = 33) was 7.2 months. Stratified Cox regression analysis revealed that the presence of de novo metastatic disease was an independent factor for an increased risk of disease progression (hazard ratio 0.47, 95% CI: 0.25-0.91, p = 0.025). Hematologic toxicity was the most frequent adverse event associated with dalpiciclib treatment.
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.