Verzenios ® ▼ (abemaciclib)

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Verzenios® ▼ (abemaciclib): Alopecia in Early Breast Cancer

The majority of alopecia events with abemaciclib were grade 1, defined as <50% hair loss that is not obvious and does not require a wig or hair piece.

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Alopecia in monarchE

Incidence and Time to Onset of Alopecia

Alopecia events are summarized in Alopecia Events in monarchE.

Alopecia Events in monarchE1

 

Abemaciclib + ET
N=2791

ET Alone
N=2800

TEAE, n (%)

Any Grade

Grade 1

Grade 2

Any Grade

Grade 1

Grade 2

Alopecia

313 (11.2)

283 (10.1)

30 (1.1)

75 (2.7)

68 (2.4)

7 (0.3)

Abbreviations: ET = endocrine therapy; TEAE = treatment-emergent adverse event.

Median time to onset of alopecia was 219 days (range: 1-752) in the abemaciclib + endocrine therapy (ET) arm, compared to 277 days (range: 1-729) in the ET alone arm.1

Dose Modifications Due to Alopecia

In the abemaciclib + ET arm of monarchE, 4 patients (0.1%) had a dose reduction and 1 patient (<0.1%) had a dose omission due to alopecia. Additionally, 3 patients (0.1%) discontinued abemaciclib due to alopecia. There were no dose modifications or discontinuations in the ET alone arm due to alopecia.1

NCI CTCAE Grade Definition

In monarchE, toxicities were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03.2

The grade definition for alopecia is shown in NCI CTCAE Grade Definition.

NCI CTCAE Grade Definition3

Adverse Event

Grade 1

Grade 2

Grade 3

Grade 4

Alopecia

A disorder characterized by a decrease in density of hair compared to normal for a given individual at a given age and body location

Hair loss of <50% of normal for that individual that is not obvious from a distance but only on close inspection;

a different hair style may be required to cover the hair loss but it does not require a wig or hair piece to camouflage.

Hair loss of ≥50% normal for that individual that is readily apparent to others;

a wig or hair piece is necessary if the patient desires to completely camouflage the hair loss; associated with psychosocial impact.

NA

NA

Abbreviations: CTCAE = Common Terminology Criteria for Adverse Events Version 4.03; NA = not applicable; NCI = National Cancer Institute.

References

1Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2Johnston SRD, Harbeck N, Hegg R, et al; monarchE Committee Members and Investigators. Abemaciclib combined with endocrine therapy for the adjuvant treatment of HR+, HER2−, node-positive, high-risk, early breast cancer (monarchE). J Clin Oncol. 2020;38(34):3987-3998. https://doi.org/10.1200/JCO.20.02514

3US Department of Health and Human Services, National Institutes of Health, National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE). Version 4.03. May 28, 2009. Updated June 14, 2010. Accessed March 15, 2021. https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03/CTCAE_4.03_2010-06-14_QuickReference_8.5x11.pdf

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Date of Last Review: 08 September 2021


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