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. 2018 Sep 3;10:1758835918793326.
doi: 10.1177/1758835918793326. eCollection 2018.

Management of Adverse Events During Cyclin-Dependent Kinase 4/6 (CDK4/6) Inhibitor-Based Treatment in Breast Cancer

Free PMC article

Management of Adverse Events During Cyclin-Dependent Kinase 4/6 (CDK4/6) Inhibitor-Based Treatment in Breast Cancer

Marc Thill et al. Ther Adv Med Oncol. .
Free PMC article

Erratum in

  • Corrigendum.
    Ther Adv Med Oncol. 2018 Dec 3;10:1758835918810116. doi: 10.1177/1758835918810116. eCollection 2018. Ther Adv Med Oncol. 2018. PMID: 30574208 Free PMC article.


Cyclin-dependent kinase (CDK) 4/6 inhibitors have shown great results in numerous clinical trials and have improved the clinical outcome for patients with hormone-receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer significantly. To date, three CDK4/6 inhibitors are approved by the US Food and Drug Administration (FDA): palbociclib, ribociclib and abemaciclib; the first two compounds are aproved by the European Medicines Agency (EMA) as well. In combination with endocrine therapy, all of them led to significantly improved progression-free survival compared with endocrine therapy alone. The aim of this article is to give an overview of the efficacy data and to describe the CDK4/6 inhibitor-based treatment-associated adverse events, including hematological and nonhematological adverse events. In addition, it describes the corrrect approach to patient monitoring and adverse event mangement and summarizes the current recommendations for dose reductions and dose interruptions regarding the key adverse events, such as neutropenia, diarrhea, QTc prolongation and hepatobiliary toxicity. Accurate patient monitoring and management of the side effects is crucial, as several clinical trials in early breast cancer are in progress and may lead to an additional approval in the neo-/adjuvant setting.

Keywords: CDK4/6 inhibitor; abemaciclib; breast cancer; clinical management; palbociclib; ribociclib; toxicity.

Conflict of interest statement

Conflict of interest: Marc Thill has received speaker honoraria by Pfizer and Novartis, consultant honoraria by Pfizer, Novartis and Lilly, travel reimbursement by Pfizer, Novartis and Lilly. Marcus Schmidt has received speaker honoraria by Pfizer and Novartis, consultant honoraria by Pfizer and Novartis, and travel reimbursement by Pfizer and Novartis.

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