Abemaciclib: Treatment Adherence or Compliance

Detailed Information

Treatment adherence or compliance information for abemaciclib in the MONARCH 1, MONARCH 2, and MONARCH 3 trials was collected through pill counts at each visit, and the number of doses taken relative to the number expected to be taken was summarized for each cycle.¹ Compliance and dose intensity is summarized in Table 1.

Table 1. Abemaciclib Compliance and Dose Intensity^1-4

• Patient compliance was defined as taking ≥75% and ≤125% of the planned doses in a cycle.¹

• Compliance was calculated as the percentage of total dose taken relative to the total assigned dose (minus any dose adjustments and doses omitted for medical reasons).¹

• Dose intensity was defined as the actual cumulative amount of drug taken divided by the duration of treatment.¹

• Relative dose intensity was calculated as (actual amount of drug taken / amount of drug prescribed) x 100%.¹

Overall, discontinuation due to AEs was

• 8% in the MONARCH 1 trial

• 16% in the MONARCH 2 trial, and

• 25% in the MONARCH 3 trial.^2-4

References

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

2. Dickler MN, Tolaney SM, Rugo HS, et al. MONARCH 1, a phase II study of abemaciclib, a CDK4 and CDK6 inhibitor, as a single agent, in patients with refractory HR+/HER2- metastatic breast cancer. Clin Cancer Res. 2017;23(17):5218-5224. http://dx.doi.org/10.1158/1078-0432.CCR-17-0754. Published correction appears in Clin Cancer Res. 2018;24(21):5475. http://clincancerres.aacrjournals.org/content/24/21/5485.article-info

3. Sledge GW, Toi M, Neven P, et al. MONARCH 2: Abemaciclib in combination with fulvestrant in women with HR+/HER2- advanced breast cancer who had progressed while receiving endocrine therapy. J Clin Oncol. 2017;35(25):2875-2884. http://dx.doi.org/10.1200/JCO.2017.73.7585

4. Johnston S, Martin M, Di Leo A, et al. MONARCH 3 final PFS: a randomized study of abemaciclib as initial therapy for advanced breast cancer. NPJ Breast Cancer. 2019;5:5. http://dx.doi.org/10.1038/s41523-018-0097-z

Glossary

AE = adverse event