Document resource
Background and Importance Abemaciclib is a CDK4/6 inhibitor (CDKi) currently indicated for treatment of HER2 negative (HER2-) advanced luminal breast cancer (ALBC), besides adjuvant therapy.Aim and Objectives To evaluate abemaciclib’s effectiveness among several indicators: objective response rate (ORR), duration of response (DoR), progression-free survival (PFS) and overall survival (OS).Material and Methods Design: multicentric, observational, descriptive and retrospective study.Inclusion criteria: Cáceres and Badajoz patients who started abemaciclib during 1/7/17–31/3/24.Exclusion criteria: early–stage patients starting adjuvant treatment.Follow–up period: from 1/7/17 to 31/3/25.Data: age and date at abemaciclib beginning, progression date, death date, best response reached (complete response (CR), partial response (PR)), best response date, last observation date, abemaciclib ending date.Data collection and processing: electronic health record, FarmaTools, Excel and SPSS (Kaplan–Meier test).Results 64 patients met the inclusion criteria and finally 30 women resulted after exclusion criteria applied.Median age at beginning: 59 years (interquartile range IQR: 55.25–71.5).PFS: the mean was 29.8 months (95% CI: 21’86–37’7) and median was 31 months (95% CI not reached).OS: the mean was 33’8 months (95% CI:26’6–41’1) and median was not reached.ORR% (CR+PR) = 46’7% (95% CI:30’2–63’9).DoR = 32’4 months (95% CI: 22’3–42’4).Conclusion and Relevance Despite the limited sample size, the results suggest that abemaciclib’s effectiveness seems consistent with MONARCH-3 results:Median PFS in MONARCH–3: 28.2 months. Our own results are similar.Median OS in MONARCH–3: 66.81 months. Our own results do not reach the median.ORR in MONARCH–3: 49.7%. Our own results are similar.DoR in MONARCH–3: 27.4 months. Our own results seem to be higher.Conflict of Interest No conflict of interest