Verzenios ® (abemaciklib)

För fullständig produktresumé för Verzenios se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Verzenios® ▼ (abemaciclib): Behandlingsefterlevnad

Mediandosöverensstämmelsen för Verzenios (abemaciclib) var närmare 100%. Cirka 16% och 20% av patienterna avbröt hehandlingen på grund av en biverkning i MONARCH 2 respektive 3.

Detailed Information

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

 

MONARCH 2

MONARCH 3

Recommended abemaciclib dose

150 mg twice daily

150 mg twice daily

Median dose compliance

98%

98%

Relative dose intensity

80%

85%

Median dose intensity

273 mg/day

256 mg/day

  • 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

  • 16% in the MONARCH 2 trial, and

  • 20% in the MONARCH 3 trial.1,2

References

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.

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

Glossary

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


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