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      The implementation of CDK 4/6 inhibitors and its impact on treatment choices in HR+/HER2− advanced breast cancer patients: A study of the Dutch SONABRE Registry

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          Abstract

          In August 2017, cyclin‐dependent kinase 4/6 (CDK4/6) inhibitors combined with endocrine therapy have been reimbursed in the Netherlands for patients with hormone receptor positive (HR+), HER2 negative (HER2−) advanced breast cancer (ABC). This study evaluates the implementation of CDK4/6 inhibitors and changes in treatment choices in the Netherlands. All patients diagnosed with HR+/HER2− ABC in 2009 to 2018 in seven hospitals were selected from the Southeast Netherlands Advanced Breast cancer (SONABRE) registry. The 2‐year cumulative use of CDK4/6 inhibitors since reimbursement date (August 2017) was assessed using competing‐risk methodology in two cohorts. The first cohort included patients with ABC diagnosis between August 2017 and December 2018. The second cohort included patients with ABC diagnosis between 2009 and August 2017, and still alive on August 1, 2017. In addition, treatment choices in the first three lines of therapy in calendar years 2009 to 2018 were evaluated for the total study population. Among patients diagnosed since August 2017 (n = 214), 50% (95% confidence interval [CI] = 43‐57) received CDK4/6 inhibitors within 2 years beyond diagnosis. Of eligible patients diagnosed before August 2017 (n = 417), 31% (95% CI = 27‐36) received CDK4/6 inhibitors within 2 years following reimbursement. Another 20% of both cohorts are still CDK4/6 inhibitor naïve and on first‐line therapy. The use of chemotherapy decreased in first two lines of therapy between 2009 and 2018 (first‐line: 29%‐13%; second‐line: 26%‐19%). The implementation rate of CDK4/6 inhibitors since reimbursement is currently 50% within 2 years beyond diagnosis and is expected to increase further. The implementation of targeted therapy decreased the use of chemotherapy as first‐line therapy.

          Abstract

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          In the Netherlands, inhibitors of cyclin‐dependent kinase 4/6 (CDK 4/6) are eligible for reimbursement by health insurers. The present report describes implementation patterns of CDK4/6 inhibitors for the treatment of advanced breast cancer since 2017, based on data and observations collected from seven hospitals across the Southeast Netherlands. Analyses show that about half of patients with HR+/HER2‐ metastatic breast cancer are treated with CDK4/6 inhibitors. Following the implementation of these therapies, use of first‐line chemotherapy decreased significantly. Reduced chemotherapy use may have beneficial effects on quality of life for patients, adding value to overall gains in survival.

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          Most cited references19

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          5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5) †

          Highlights • This ESO-ESMO ABC 5 Clinical Practice Guideline provides key recommendations for managing advanced breast cancer patients • It provides updates on the management of patients with all breast cancer subtypes, LABC, follow-up, palliative and supportive care • Updated diagnostic and treatment algorithms are also provided • All recommendations were compiled by a multidisciplinary group of international experts • Recommendations are based on available clinical evidence and the collective expert opinion of the authors
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            Overall Survival with Palbociclib and Fulvestrant in Advanced Breast Cancer

            The cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor palbociclib, in combination with fulvestrant therapy, prolongs progression-free survival among patients with hormone-receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. We report the results of a prespecified analysis of overall survival.
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              4th ESO–ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 4)†

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                Author and article information

                Contributors
                marissa.meegdes@mumc.nl
                vcg.tjan.heijnen@mumc.nl
                Journal
                Int J Cancer
                Int J Cancer
                10.1002/(ISSN)1097-0215
                IJC
                International Journal of Cancer
                John Wiley & Sons, Inc. (Hoboken, USA )
                0020-7136
                1097-0215
                14 September 2021
                01 January 2022
                : 150
                : 1 ( doiID: 10.1002/ijc.v150.1 )
                : 124-131
                Affiliations
                [ 1 ] Department of Internal Medicine, Division of Medical Oncology, GROW School for Oncology and Developmental Biology Maastricht University Medical Center Maastricht The Netherlands
                [ 2 ] Department of Internal Medicine Zuyderland Medical Center Sittard‐Geleen The Netherlands
                [ 3 ] Department of Medical Oncology Máxima Medical Center Eindhoven The Netherlands
                [ 4 ] Department of Internal Medicine Catharina Hospital Eindhoven The Netherlands
                [ 5 ] Department of Internal Medicine Laurentius Hospital Roermond The Netherlands
                [ 6 ] Department of Internal Medicine Elkerliek Hospital Helmond The Netherlands
                [ 7 ] Department of Internal Medicine St Anna Hospital Geldrop The Netherlands
                Author notes
                [*] [* ] Correspondence

                Vivianne C. G. Tjan‐Heijnen, Department of Internal Medicine, Division of Medical Oncology, GROW – School for Oncology and Developmental Biology, Maastricht University Medical Center (MUMC+), PO Box 5800, 6202 AZ Maastricht, The Netherlands.

                Email: vcg.tjan.heijnen@ 123456mumc.nl

                Author information
                https://orcid.org/0000-0002-7739-260X
                Article
                IJC33785
                10.1002/ijc.33785
                9290870
                34460112
                4cc94929-79b0-4c26-9a24-fd9b5156208a
                © 2021 The Authors. International Journal of Cancer published by John Wiley & Sons Ltd on behalf of UICC.

                This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.

                History
                : 20 July 2021
                : 19 April 2021
                : 27 July 2021
                Page count
                Figures: 4, Tables: 1, Pages: 8, Words: 4944
                Funding
                Funded by: Novartis BV , doi 10.13039/100004336;
                Funded by: Netherlands Organization for Health Research and Development (ZonMw) , doi 10.13039/501100001826;
                Award ID: 80‐82500‐98‐8003
                Funded by: Eli Lilly and Company , doi 10.13039/100004312;
                Funded by: Pfizer , doi 10.13039/100004319;
                Funded by: Roche , doi 10.13039/100004337;
                Categories
                Cancer Therapy and Prevention
                Cancer Therapy and Prevention
                Custom metadata
                2.0
                January 1, 2022
                Converter:WILEY_ML3GV2_TO_JATSPMC version:6.1.7 mode:remove_FC converted:18.07.2022

                Oncology & Radiotherapy
                breast cancer,cdk4/6 inhibitors,implementation,metastatic disease,real‐world

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