CDK4/6 inhibitor plus endocrine therapy for hormone receptor-positive, HER2-negative metastatic breast cancer: The new standard of care

Abstract

Patients presenting with hormone receptor-positive (HR⁺ ), human epidermal growth factor receptor 2-negative (HER2^- ) metastatic breast cancer (MBC) are usually treated with endocrine therapy (ET), except if there is a concern about endocrine resistance or a need to achieve rapid disease control due to visceral crisis. The combination of CDK4/6 inhibitor + ET has now replaced single-agent ET as the standard first-line treatment; and it can also be considered a standard option in the second-line setting. This review briefly summarizes recently reported efficacy findings from the key phase III clinical trials of CDK4/6 inhibitor + ET in patients with HR⁺ /HER2^- MBC, including evidence that adding a CDK4/6 inhibitor to ET improves overall survival and does so without reducing patients' quality of life. There is still much to learn regarding the use of CDK4/6 inhibitors and how they may be optimally integrated into clinical practice. In particular, there is a need for specific biomarkers that help predict the likelihood of response or resistance to CDK4/6 inhibitor therapy; and for data to guide treatment decisions when a patient's disease progresses on a CDK4/6 inhibitor.

Keywords: CDK4/6 inhibitor; HER2-negative; endocrine therapy; hormone receptor-positive; metastatic breast cancer; overall survival; progression-free survival; quality of life.