Dose modifications of ribociclib and endocrine therapy for treatment of ER+ HER2- metastatic breast cancer.
| Autor: | Kristensen KB; Department of Oncology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8000, Aarhus N, Denmark. Krokri@rm.dk., Thomsen IMN; Department of Oncology, University Hospital Copenhagen, Copenhagen, Denmark., Berg T; Department of Oncology, University Hospital Copenhagen, Copenhagen, Denmark., Kodahl AR; Department of Oncology, Odense University Hospital, Odense, Denmark., Jensen AB; Department of Oncology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8000, Aarhus N, Denmark. |
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| Jazyk: | angličtina |
| Zdroj: | Breast cancer research and treatment [Breast Cancer Res Treat] 2021 Aug; Vol. 188 (3), pp. 799-809. Date of Electronic Publication: 2021 Apr 10. |
| DOI: | 10.1007/s10549-021-06215-6 |
| Abstrakt: | Purpose: Treatment for estrogen receptor positive (ER+), human epidermal receptor 2 negative (HER2-) metastatic breast cancer (MBC) has improved with the approval of CDK 4/6 inhibitors. Clinical trials with the CDK4/6 inhibitor ribociclib, suggest that 35% to 57.5% of the patients require a dose reduction during ribociclib treatment. Data on the possible consequences of dose reduction concerning efficacy is needed. Methods: A retrospective cohort study on patients with ER+ HER2- MBC from three Danish oncology departments. Data on tolerability and progression-free survival were collected from electronic health records. Results: One hundred and twenty-eight patients with ER+ HER2- MBC who initiated ribociclib treatment between 1st of January 2018 to 31st of March 2020 were included in our analysis. Of these patients, 48.4% required one or more dose reductions. Overall median PFS was 19.2 months (CI-95% 14.3-NR). Patients with one or more dose reductions did not have decreased median PFS (19.2 months, CI-95% 14.3-NR compared to 12.2 months, CI-95% 7.3-NR, p = 0.078). Frequency of adverse events were as previously reported, with grade III and IV neutropenia occurring in 45.3% and 7% of patients, respectively. Patients treated with fulvestrant versus an aromatase inhibitor and patients with lymph node involvement at baseline had lower odds of requiring a dose reduction (OR Conclusion: Our results indicate that dose reduction of ribociclib is safe and do not compromise the efficacy of the treatment. Furthermore, the study supports translation of results from the MONALEESA trials to patients treated in real-world clinical settings. (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.) |
| Databáze: | MEDLINE |
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