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Background <p>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).</p> Methods <p>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 <a href="http://www.crediblemeds.org">www.crediblemeds.org</a>) 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.</p> Results <p>A total of 1517 patients met the study criteria; 33.8%, 35.5%, and 30.8% were aged &lt; 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 &lt; 65 years, primarily driven by increased diuretic use.</p> Conclusions <p>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.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年7月4日

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  • Susan Dent,
  • Heather Moore,
  • Michael Fradley,
  • Chloe Grace Rose,
  • Stella Stergiopoulos,
  • Connie Chen,
  • Benjamin Li,
  • Avirup Guha

摘要

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.