Real-world efficacy and prognostic factors of CDK4/6 inhibitors in HR/HER2 metastatic breast cancer: a multicenter retrospective study from the Dongting Lake region of China.
[BACKGROUND] CDK4/6 inhibitors (CDK4/6i) combined with endocrine therapy (ET) have become the standard of care for hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR/HER2)
- p-value P<0.001
- p-value P=0.01
- HR 1.50
APA
Liu B, Wu T, et al. (2026). Real-world efficacy and prognostic factors of CDK4/6 inhibitors in HR/HER2 metastatic breast cancer: a multicenter retrospective study from the Dongting Lake region of China.. Translational breast cancer research : a journal focusing on translational research in breast cancer, 7, 2. https://doi.org/10.21037/tbcr-25-37
MLA
Liu B, et al.. "Real-world efficacy and prognostic factors of CDK4/6 inhibitors in HR/HER2 metastatic breast cancer: a multicenter retrospective study from the Dongting Lake region of China.." Translational breast cancer research : a journal focusing on translational research in breast cancer, vol. 7, 2026, pp. 2.
PMID
41675004
Abstract
[BACKGROUND] CDK4/6 inhibitors (CDK4/6i) combined with endocrine therapy (ET) have become the standard of care for hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR/HER2) metastatic breast cancer (MBC). However, real-world data from China's central regions remain limited. This study aimed to evaluate the real-world treatment patterns and efficacy of CDK4/6i in HR/HER2 MBC patients across the Dongting Lake region in China.
[METHODS] This multicenter retrospective study included 590 HR/HER2 MBC patients treated with CDK4/6i between 2016 and 2025 in five tertiary cancer centers in the Dongting Lake area of Hunan province, China. Patient demographics, treatment patterns, progression-free survival (PFS), and prognostic factors were analyzed.
[RESULTS] Among 616 initially screened patients, 590 met eligibility criteria. Of these, 63.39% received CDK4/6i as first-line treatment and 25.59% as second-line. The most commonly used CDK4/6i were abemaciclib (33.39%), dalpiciclib (28.98%), palbociclib (25.76%), and ribociclib (10.85%). Median PFS was significantly longer in the first-line group than in the second-line group (32.3 . 17.6 months, P<0.001). While the objective response rate (ORR) was numerically higher in the first-line setting (49.52% . 42.31%), only the disease control rate (DCR) showed statistical significance (97.14% . 91.03%). Multivariate Cox analysis identified several independent predictors of shorter PFS: stage IV disease (HR =1.50), Ki-67 ≥30% (HR =1.60), liver metastasis (HR =2.26), lung metastasis (HR =1.53), and use of CDK4/6i as second-line (HR =2.24), while disease-free interval ≥5 years was protective (HR =0.65, P=0.01).
[CONCLUSIONS] CDK4/6i demonstrates favorable real-world efficacy in HR/HER2 MBC patients in central China, particularly in the first-line setting. Several clinical factors may aid in treatment selection and risk stratification.
[METHODS] This multicenter retrospective study included 590 HR/HER2 MBC patients treated with CDK4/6i between 2016 and 2025 in five tertiary cancer centers in the Dongting Lake area of Hunan province, China. Patient demographics, treatment patterns, progression-free survival (PFS), and prognostic factors were analyzed.
[RESULTS] Among 616 initially screened patients, 590 met eligibility criteria. Of these, 63.39% received CDK4/6i as first-line treatment and 25.59% as second-line. The most commonly used CDK4/6i were abemaciclib (33.39%), dalpiciclib (28.98%), palbociclib (25.76%), and ribociclib (10.85%). Median PFS was significantly longer in the first-line group than in the second-line group (32.3 . 17.6 months, P<0.001). While the objective response rate (ORR) was numerically higher in the first-line setting (49.52% . 42.31%), only the disease control rate (DCR) showed statistical significance (97.14% . 91.03%). Multivariate Cox analysis identified several independent predictors of shorter PFS: stage IV disease (HR =1.50), Ki-67 ≥30% (HR =1.60), liver metastasis (HR =2.26), lung metastasis (HR =1.53), and use of CDK4/6i as second-line (HR =2.24), while disease-free interval ≥5 years was protective (HR =0.65, P=0.01).
[CONCLUSIONS] CDK4/6i demonstrates favorable real-world efficacy in HR/HER2 MBC patients in central China, particularly in the first-line setting. Several clinical factors may aid in treatment selection and risk stratification.
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