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4CPS-064 Effectiveness of ribociclib and abemaciclib as first line treatment for metastatic breast cancer in post-menopausal women
  1. MDP Briceño Casado1,
  2. MD Gil-Sierra2,
  3. CM Cuadros-Martinez3,
  4. B De La Calle-Riaguas4,
  5. R Gavira-Moreno3
  1. 1Hospital Universitario De Jerez De La Frontera, Hospital Pharmacy, Jerez De La Frontera Cádiz, Spain
  2. 2Hospital Universitario Puerto Real, Hospital Pharmacy, Puerto Real, Spain
  3. 3Hospital Universitario De Jerez De La Frontera, Hospital Pharmacy, Jerez De La Frontera, Spain
  4. 4Hospital Nuestra Señora Del Prado, Hospital Pharmacy, Talavera De La Reina, Spain


Background and Importance Ribociclib and abemaciclib are cyclin-dependent kinase 4/6 inhibitors (CDK4/6-i) used as treatment for patients with negative epidermal growth factor receptor 2 (HER2-) and positive hormone receptor (HR+) metastatic breast cancer (MBC). MONALEESA-2 and MONARCH-3 trials evaluated the efficacy of this drugs as first line treatment in post-menopausal women.

Aim and Objectives To assess effectiveness of ribociclib and abemaciclib in HER2- and HR+ MBC in clinical practice, comparing results with reference bibliography.

Material and Methods Descriptive retrospective study included post-menopausal women with HER2- and HR+ MBC receiving CDK4/6-i as first line of treatment between August-2017 and September-2022. Data were recorded from electronic clinical history and prescription program Prisma®: gender, age, ECOG, CDK4/6-i and combined endocrine therapy, dosage and treatment duration. Effectiveness was assessed by progression free survival (PFS), overall survival (OS) and PFS rate at 12 months, using Kaplan-Meyer statistical analysis with SPSS V.21.0. Results were compared with those described in pivotal clinical trials.

Results A total of 63 women were included. Mean age was 63 (range 50–84) years. At baseline, ECOG=0/1 was observed in 93.7% cases and ECOG=2/3 in 6.3%. Abemaciclib was used in 50.8% patients and 49.2% ribociclib. CDK4/6-i were combined with letrozole in 58.7% patients and fulvestrant in 41.3%. Dose reduction occurred in 48.4% patients with ribociclib and 34.4% with abemaciclib. For ribociclib, median treatment duration was 16 (2–54) months and 11 (2–32) months for abemaciclib. Estimated PFS median for ribociclib was 28.0 (95% Confidence Interval: 6.6–49.3) months and was not reached for abemaciclib. Ribociclib and abemaciclib estimated OS median were not reached at data cut-off. PFS rate at 12 months was 67.3% (95% CI: 58.8–75.8) for ribociclib, and 60.7% (95% CI: 51.4–70.0) for abemaciclib. For ribociclib, MONALEESA-2 trial presented a PFS median of 25.3 months, OS median of 63.9 months and 12-month PFS rate of 72.8%. For abemaciclib, MONARCH-3 showed a PFS median of 28.2 months, OS median was not reached and 12-month PFS rate was not described.

Conclusion and Relevance Real-life effectiveness results confirmed a substantial benefit of ribociclib and abemaciclib. These data appeared to be slightly superior than those described in the literature. Larger sample size and longer follow-up time are necessary to extract more conclusive information.

Conflict of Interest No conflict of interest

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