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.

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Management recommendations for Venous thromboembolic events (VTEs) in early breast cancer

Dose modification and management recommendations are summarized inDose Modification and Management - VTEs . 

Dose Modification and Management - VTEs1

CTCAE Grade

Abemaciclib Dose Modifications

Grade 1, 2, 3, or 4

Suspend dose and treat as clinically indicated. Abemaciclib may be resumed when the patient is clinically stable.

Abbreviations: CTCAE = Common Terminology Criteria for Adverse Events; VTEs = venous thromboembolic events.

Venous thromboembolic events in monarchE

The Khorana score, summarized in The Khorana Scoring System, was utilized to determine the baseline risk of a venous thromboembolic event (VTE) for patients enrolled in monarchE.2

The Khorana Scoring System3

Patient Characteristics

Score

  • site of cancer (high risk): lung, lymphoma, gynecologic, genitourinary (excluding prostate)

1 point

  • site of cancer (very high risk): stomach, pancreas

2 points

  • platelet count of 350×109/L or more

1 point

  • hemoglobin <10 g/dL and/or use of erythropoiesis-stimulating agents

1 point

  • leukocyte count >11×109/L

1 point

  • body mass index (BMI) >35 kg/m2

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