KEY TAKEAWAYS
- The three-phase III MONALEESA trials reviewed strategies for monitoring and managing QTcF prolongation and potential drug interactions associated with ribociclib in ABC.
- The study confirmed that ribociclib is an effective and manageable HR+/HER2− advanced breast cancer treatment.
- The ESC recommendations also suggested broader applicability for monitoring patients receiving any CDK4/6 inhibitor at high risk of QTc prolongation.
In this clinical practice perspective, an oncology team composed of a physician, nurse practitioner, and clinical pharmacist discussed strategies for monitoring and managing ribociclib’s adverse events (AEs).
Among the MONALEESA trials, only 1% of patients (pts) (14 out of 1054) experienced QTcF >500 ms, and 6% (59 out of 1054) had a >60-ms increase from baseline. While QTcF prolongation is rare, there are clear monitoring and management guidelines. ECG monitoring is recommended at specific points, including before treatment initiation, on cycle 1, day 14, cycle 2, day 1, and when clinically necessary, at the recommended starting dose of ribociclib. While the standard has been a 12-lead ECG, an FDA-cleared 6-lead mobile ECG device offers a more convenient and time-saving alternative. Additionally, patient medical history, electrolyte imbalances, and potential pharmacokinetic/pharmacodynamic interactions with concurrent medications, herbal supplements, and foods (e.g., strong CYP3A4 inhibitors/inducers) should be considered to optimize treatment outcomes.
Ribociclib is an effective treatment option for HR+/HER2− advanced breast cancer (ABC) with a manageable safety profile. Infrequent and reversible corrected QT interval (QTc) prolongation events have led to the development of monitoring and management strategies, including guidelines for concurrent medication use and new technologies that simplify traditional ECG monitoring. While guidelines emphasize QTc measured by Fridericia’s formula (QTcF) prolongation monitoring for ribociclib, recent recommendations from the European Society of Cardiology (ESC) (class 2A, level C evidence) suggested that these approaches may have broader applicability for monitoring pts taking any CDK4/6 inhibitor who are at high risk of QTc prolongation.
Source: https://ons.confex.com/ons/2023/meetingapp.cgi/Paper/13294
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT01958021
Deimler, R., Moore, H., Dent, S. P103 – Ribociclib Safety, Monitoring, and Management Strategies in Advanced Breast Cancer.
