| Summary: | Yanmei Wu,1 Yu Zhang,2 Hao Pi,1 Yuan Sheng1 1Department of Breast and Thyroid Surgery, Changhai Hospital, Navy Medical University, Shanghai 200433, People’s Republic of China; 2Medical Affairs, Pfizer Biopharmaceutical Group, Shanghai 200041, People’s Republic of ChinaCorrespondence: Yuan ShengDepartment of Breast and Thyroid Surgery, Changhai Hospital, Navy Medical University, Shanghai 200433, People’s Republic of ChinaEmail sheng528yuan@126.comAbstract: The clinical use of selective cyclin-dependent kinase (CDK) 4/6 inhibitors has significantly improved the prognosis of patients with hormone receptor (HR)-positive human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer (ABC/mBC), which almost achieved the double progression-free survival (PFS) in combination with endocrine therapy (ET) compared with ET alone. To date, there are 3 CDK4/6 inhibitors (palbociclib, ribocilcib and abemaciclib) approved by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) to treat patients with HR+/HER2-ABC/mBC in the first and later lines. The aim of this review is to summarize the current clinical use and ongoing clinical trials of CDK4/6 inhibitors, the published overall survival data, and the potential biomarkers and resistance to CDK4/6 inhibitors.Keywords: CDK4/6 inhibitor, breast cancer, mechanism, clinical efficacy, resistance
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