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. 2021 Mar 3;26(3):e522. doi: 10.1002/onco.13691

Management of Abemaciclib‐Associated Adverse Events in Patients with Hormone Receptor‐Positive, Human Epidermal Growth Factor Receptor 2‐Negative Advanced Breast Cancer: Safety Analysis of MONARCH 2 and MONARCH 3

Hope S Rugo, Jens Huober, José A García‐Sáenz, Norikazu Masuda, Joo Hyuk Sohn, Valerie AM Andre, Susana Barriga, Joanne Cox, Matthew Goetz
PMCID: PMC7930407  PMID: 33660385

The Oncologist 2020;26:e53–e65; first published on October 9, 2020; doi: 10.1002/onco.13531

Typographical errors occurred during composition that resulted in errors in the legends of Figures 1, 2, and 3. The corrected legends appear below. The online version of the article has been updated to reflect these changes.

Figure 1. Recommendation for management of adverse events. Specifically, recommendations for diarrhea (A), hematological toxicities (B), nonhematologic toxicities except diarrhea, increased ALT, and ILD/pneumonitis (C), increased ALT (D), and interstitial lung disease/pneumonitis (E) management. A dose reduction corresponds to a reduction of 50 mg of abemaciclib at a time. Discontinue abemaciclib for patients unable to tolerate 50 mg twice daily. For neutropenia evaluation, blood counts should be performed before starting abemaciclib treatment, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated. If blood cell growth factors are administered, abemaciclib treatment must be suspended for at least 48 hours after the last administration of cell growth factors and until toxicity resolves to grade ≤2. Reduce the abemaciclib dose, unless already performed, for the toxicity that led to the use of growth factor.

aGrade 2 toxicity that does not resolve with maximal supportive measures within 7 days to grade ≤1.

bFor grade 4 increased aminotransferases, discontinue abemaciclib.

Abbreviations: AE, adverse event; ALT, alanine aminotransferase; ILD, interstitial lung disease; ULN, upper limit of normal.

Figure 2. Percentage of patients with clinically significant diarrhea (grade ≥2, A) or neutropenia (grade ≥3, B), relative to exposure by cycle for MONARCH 2a and MONARCH 3b.

aAbemaciclib at 150 mg after amendment twice a day, plus fulvestrant.

bAbemaciclib at 150 mg twice a day plus nonsteroidal aromatase inhibitor.

Each light blue bar corresponds to the number of patients who received a cycle of treatment, representing total exposure by cycle. Each dark blue bar represents those with grade ≥2 diarrhea or grade ≥3 neutropenia. The number displayed above each dark blue bar is the percentage of patients with clinically significant diarrhea or neutropenia within each cycle. No grade ≥4 diarrhea was observed.

Figure 3. Time‐dependent covariate analysis of progression‐free survival among patients with reduced dose compared with those without.

Abbreviations: CI, confidence interval; HR, hazard ratio; NSAI, nonsteroidal aromatase inhibitor.


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