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Using The Appropriate Formula For Qt Measurement Can Save Lives, Taher Taher Al-Tweigeri Taher

Hematology/Oncology and Stem Cell Therapy

CDK 4/6 inhibitors, in combination with endocrine therapy, are the standard of care for patients with endocrine sensitive advanced breast cancer. This class of drug, however, is associated with QT prolongation, which serves as a surrogate marker for Torsades de Pointes (TdP), a cause of life-threatening ventricular arrhythmias and sudden cardiac death. The ICH E14 guidance document uses the Bazett formula for reporting of cardio-dynamic and safety ECG data in clinical trials. While there is substantial familiarity with the Bazett (QTcB) formula (QT/(RR) 1/2), the Fridericia (QTcF) formula (QT/(RR) 1/3 ) is preferred in the cancer population as it is …