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Verzenios ® (abemaciclib)
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What information is available regarding alopecia in patients treated with Verzenios® (abemaciclib) during monarchE?
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.
Alopecia in monarchE
monarchE is an open-label, randomized, phase 3 trial comparing adjuvant abemaciclib 150 mg twice daily plus endocrine therapy (ET) versus ET alone for a two-year duration, in 5,637 patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer (EBC) at high risk of recurrence. At the end of the study treatment, patients entered physician-directed ET follow up for a total of 5-10 years, as clinically indicated.1 The trial is active but not recruiting.2
A prespecified overall survival interim analysis (OS IA2) was recently conducted on the monarchE study data. At the data cutoff date (July 1, 2022), the median follow-up time for the overall population was 42 months and all treated patients were off abemaciclib treatment.3
Another prespecified overall survival interim analysis was recently conducted on the monarchE study data. At data cutoff on July 3, 2023, the median follow-up time was 54 months. The incidence of alopecia in monarchE at this analysis is presented in Incidence of Alopecia at OS IA3 Analysis of monarchE. There were no new safety concerns identified in the long-term follow-up with no cumulative or persistent symptoms observed following completion of treatment.4
Incidence and time to onset of alopecia
|
Abemaciclib + ET |
ET Alone |
||||
TEAE, n (%) |
Any Grade |
Grade 1 |
Grade 2 |
Any Grade |
Grade 1 |
Grade 2 |
Alopecia |
318 (11.4) |
288 (10.3) |
30 (1.1) |
79 (2.8) |
72 (2.6) |
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 + ET arm, compared to 277 days (range: 1-729) in the ET alone arm.5
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.5
NCI CTCAE Grade Definition
In monarchE, toxicities were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.1
The grade definition for alopecia is shown in NCI CTCAE Grade Definition.
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. |
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Abbreviations: CTCAE = Common Terminology Criteria for Adverse Events Version 4.03; NCI = National Cancer Institute.
References
1Johnston 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
2Endocrine therapy with or without abemaciclib (LY2835219) following surgery in participants with breast cancer (monarchE). ClinicalTrials.gov identifier: NCT03155997. Updated March 19, 2024. Accessed April 16, 2024. https://clinicaltrials.gov/study/NCT03155997
3Johnston SRD, Toi M, O'Shaughnessy J, et al; monarchE Committee Members. Abemaciclib plus endocrine therapy for hormone receptor-positive, HER2-negative, node-positive, high-risk early breast cancer (monarchE): results from a preplanned interim analysis of a randomised, open-label, phase 3 trial. Lancet Oncol. 2023;24(1):77-90. https://doi.org/10.1016/S1470-2045(22)00694-5
4Rastogi P, O'Shaughnessy J, Martin M, et al. Adjuvant abemaciclib plus endocrine therapy for hormone receptor-positive, human epidermal growth factor receptor 2-negative, high-risk early breast cancer: results from a preplanned monarchE overall survival interim analysis, including 5-year efficacy outcomes. J Clin Oncol. 2024;42(9):987-993. https://doi.org/10.1200/jco.23.01994
5Data on file, Eli Lilly and Company and/or one of its subsidiaries.
6US 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 January 4, 2024. https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03/CTCAE_4.03_2010-06-14_QuickReference_8.5x11.pdf
Date of Last Review: 15 April 2024