QT STAR: concomitant QTc-prolonging medication use among patients with HR+/HER2- metastatic breast cancer receiving a CDK4/6 inhibitor in first line.

Background: The risk of drug-induced corrected QT interval (QTc) prolongation is an important consideration in clinical decision-making for patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (mBC). This retrospective analysis described concomitant QTc-prolonging medication use in patients with HR+/HER2- mBC who received first-line (1L) treatment with a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) plus an aromatase inhibitor (AI).

Methods: This retrospective claims analysis utilized the Optum Clinformatics Data Mart database to identify patients with HR+/HER2- mBC who initiated 1L CDK4/6i plus AI treatment between January 2017 and March 2022. Exposure to QTc-prolonging medications (overall and by Torsades de Pointes [TdP] risk, per www.crediblemeds.org ) was assessed at index (i.e., CDK4/6i treatment initiation) and during follow-up (i.e., duration of CDK4/6i treatment) in the overall cohort and cohorts stratified by patient age.

Results: A total of 1517 patients met the study criteria; 33.8%, 35.5%, and 30.8% were aged < 65, 65-74, and ≥ 75 years, respectively. Exposure to ≥ 1 QTc-prolonging medication or ≥ 1 medication with known TdP risk was observed in 53.3% and 15.4% of patients at index, respectively, and 78.6% and 57.1% of patients during follow-up, respectively. Patients were exposed to QTc-prolonging medications for 54.6% of total person-time during follow-up. Patients aged ≥ 65 years had higher exposure to medications with conditional TdP risk than those aged < 65 years, primarily driven by increased diuretic use.

Conclusions: QTc-prolonging medication use was common in patients with HR+/HER2- mBC receiving 1L CDK4/6i plus AI treatment, highlighting the importance of reviewing concomitant medications to inform CDK4/6i selection and patient monitoring while on treatment.