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Verzenios ® ▼ (abemaciclib)
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What was the incidence and management of venous thromboembolic events with Verzenios® (abemaciclib) in early breast cancer?
Venous thromboembolic events were reported in 2.5% of patients in the abemaciclib arm, compared to 0.6% in the ET alone arm of monarchE, and was managed with dose reductions, dose holds and anticoagulation therapy.
How was venous thromboembolic events (VTEs) defined and risk assessed in monarchE?
For the purposes of adverse event reporting in monarchE, all reported terms included in the broad clinical category of VTE were summarized under the composite term venous thromboembolic events (VTEs), with the most frequently reported individual terms being deep vein thrombosis and pulmonary embolism.1
In monarchE, patients with a prior history of VTE were excluded from enrollment in the trial. The baseline Khorana risk score was well balanced across arms. Known risk factors (eg, increased age and body mass index [BMI]) were also analyzed in patients experiencing VTE.1
The Khorana score, summarized in The Khorana Scoring System, was utilized to determine the baseline risk of a VTE for patients enrolled in monarchE.2
Patient Characteristics |
Score |
|
1 point |
|
2 points |
|
1 point |
|
1 point |
|
1 point |
|
1 point |
Total combined points |
Patients are divided into low risk (0 points), intermediate risk (1-2 points), and high risk (≥3 points) based on the scoring system.3