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Dalpiciclib combined with endocrine therapy for patients with HR+/HER2- metastatic breast cancer: a multicenter
Xuelian Chen1, Lin Lin2, Guangning He3
1Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen, Guangdong, China.
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.
Insights
Dalpiciclib combined with endocrine therapy shows favorable efficacy and safety in real-world metastatic breast cancer patients. This combination demonstrated promising outcomes, even in patients with brain metastases or prior CDK4/6 inhibitor exposure.
Area of Science:
- Oncology
- Clinical Pharmacology
Background:
- Dalpiciclib is a new cyclin-dependent kinase 4/6 (CDK4/6) inhibitor approved in China for metastatic breast cancer (MBC).
- Real-world data on dalpiciclib's efficacy and safety in MBC patients are limited.
Purpose of the Study:
- To evaluate the real-world outcomes of dalpiciclib plus endocrine therapy (ET) in a diverse population of hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) MBC patients.
- To assess the efficacy, including real-world progression-free survival (rwPFS) and objective response rate (ORR), and safety profile of this combination therapy.
Main Methods:
- Retrospective analysis of 160 HR+/HER2- MBC patients treated with dalpiciclib plus ET from January 2022 to March 2025 across four South China centers.
- Collected demographic and clinical data, analyzing rwPFS, ORR, and safety profiles.
Main Results:
- The median follow-up was 17.6 months. Overall median rwPFS was 20.6 months with an ORR of 17.5%.
- First-line treatment showed a median rwPFS of 26.7 months versus 13.8 months for second- or later-line treatment.
- Patients with brain metastases (n=13) had a median rwPFS of 14.8 months, and those previously treated with CDK4/6 inhibitors (n=33) had a median rwPFS of 7.2 months.
- De novo metastatic disease was an independent factor for increased progression risk (HR 0.47, p=0.025). Hematologic toxicity was the most common adverse event.
Conclusions:
- Dalpiciclib plus ET demonstrates favorable clinical activity in a real-world HR+/HER2- MBC cohort.
- The regimen shows promising efficacy in patients with brain metastases and those with prior exposure to CDK4/6 inhibitors.
