Age, Age-Related Comorbidities and Survival in Palbociclib, Ribociclib and Abemaciclib Users With Advanced Breast Cancer: A Nation-Wide Retrospective Cohort Study.
Blair Rajamaki, Olli Tenhunen, Liisa Pylkkänen, Thuan Vo, Anne Paakinaho, Miia Turpeinen, Sirpa Hartikainen, Anna-Maija Tolppanen
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引用次数: 0
Abstract
Purpose: Prevalence of breast cancer (BC) increases with age, but the external validity of data obtained from pivotal trials of medicinal products remains a concern due to the underrepresentation of frail and older adults. Cyclin-dependent kinase inhibitors (CDKi), palbociclib, abemaciclib, and ribociclib are considered an essential part of the standard-of-care in the management of advanced/metastatic breast cancer. We investigated age, comorbidities, and survival in a nationwide real-world cohort of CDKi users.
Methods: Data from the Finnish Cancer Registry, reimbursed dispensed prescriptions, Electronic Prescription Database, Care Register for Health Care (CRHC), and Causes of Death Register were combined and analysed.
Results: Altogether 1921 women with BC initiated CDKi treatment in 2018-2022. The median age at initiation was 66.9 years, with 43.2% of the study cohort being < 65 years of age, 36.1% 65-74 years, 19.0% 75-84 years, and 1.7% 85 years or older. The prevalence of age or frailty-related comorbidities in individuals ≥ 65 years was low, highest for cardiovascular diseases, 32.3%, and diabetes, 16.9%. The median survival was 25.3 months, with longer median survival times in younger age groups (27.7 months in < 65 year-olds, 25.1 months in aged 65-74, 21.4 months in aged 75-84 years, and 15.4 months in 85 years or older).
Conclusions: Real-world CDKi users are older than women included in the pivotal trials, and the survival differences between age groups imply challenges in the generalisability of data from pivotal trials. The real-world CDKi user population is characterised by a low prevalence of major comorbidities.
期刊介绍：
The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data, methods and opinion in the discipline of pharmacoepidemiology. The Journal publishes peer-reviewed reports of original research, invited reviews and a variety of guest editorials and commentaries embracing scientific, medical, statistical, legal and economic aspects of pharmacoepidemiology and post-marketing surveillance of drug safety. Appropriate material in these categories may also be considered for publication as a Brief Report.
Particular areas of interest include:
design, analysis, results, and interpretation of studies looking at the benefit or safety of specific pharmaceuticals, biologics, or medical devices, including studies in pharmacovigilance, postmarketing surveillance, pharmacoeconomics, patient safety, molecular pharmacoepidemiology, or any other study within the broad field of pharmacoepidemiology;
comparative effectiveness research relating to pharmaceuticals, biologics, and medical devices. Comparative effectiveness research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition, as these methods are truly used in the real world;
methodologic contributions of relevance to pharmacoepidemiology, whether original contributions, reviews of existing methods, or tutorials for how to apply the methods of pharmacoepidemiology;
assessments of harm versus benefit in drug therapy;
patterns of drug utilization;
relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines;
evaluations of risk management plans and programmes relating to pharmaceuticals, biologics and medical devices.
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