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Treatment adherence or compliance information for abemaciclib in the MONARCH 2 (Verzenios in combination with fulvestrant), and MONARCH 3 (Verzenios in combination with aromatase inhibitors) 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. Compliance and dose intensity is summarized in Table 1. Abemaciclib Compliance and Dose Intensity
Table 1. Abemaciclib Compliance and Dose Intensity1-3
Patient compliance was defined as taking ≥75% and ≤125% of the planned doses in a cycle.3
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).3
Dose intensity was defined as the actual cumulative amount of drug taken divided by the duration of treatment.3
Relative dose intensity was calculated as (actual amount of drug taken / amount of drug prescribed) x 100%.3
Overall, discontinuation due to AEs was
1. Goetz MP, Toi M, Campone M, et al. MONARCH 3: Abemaciclib as initial therapy for advanced breast cancer. J Clin Oncol. 2017;35(32):3638-3646. https://doi.org/10.1200/jco.2017.75.6155.
2. 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.
AE = adverse event
▼ 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.
Datum fӧr senaste ӧversyn 2019 M06 05