Challenges and barriers for the adoption of personalized medicine in Europe: the case of Oncotype DX Breast Recurrence Score ® test.
| Autor: | Horgan D; European Alliance for Personalised Medicine, Brussels, Belgium.; Department of Molecular and Cellular Engineering, Jacob Institute of Biotechnology and Bioengineering, Faculty of Engineering and Technology, Sam Higginbottom University of Agriculture, Technology and Sciences, Prayagraj, India., Hofman P; Côte d'Azur University, FHU OncoAge, IHU RespirERA, Laboratory of Clinical and Experimental Pathology, Louis Pasteur Hospital, Nice, France., Giacomini P; Clinical Trial Center, Biostatistics and Bioinformatics, IRCCS-Regina Elena National Cancer Institute, Rome, Italy., Dube F; Astra Zeneca, Wilmington, DE, USA., Singh J; European Alliance for Personalised Medicine, Brussels, Belgium., Schneider D; N-Power Medicine, Redwood City, CA, USA., Hills T; Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany., Faikish J; Amgen Inc, 20 W Manilla Ave, Pittsburgh, PA, USA., Van Den Bulcke M; Belgian Cancer Centre, Sciensano, Brussels, Belgium., Malapelle U; Department of Public Health, University Federico II of Naples, Naples, Italy., Gajewski M; Exact Sciences, Baar, Switzerland., Subbiah V; Sarah Cannon Research Institute, Nashville, TN, USA. |
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| Jazyk: | angličtina |
| Zdroj: | Diagnosis (Berlin, Germany) [Diagnosis (Berl)] 2024 Dec 17. Date of Electronic Publication: 2024 Dec 17. |
| DOI: | 10.1515/dx-2024-0127 |
| Abstrakt: | Personalized medicine, aiming to tailor treatments based on individual patient characteristics, holds immense potential in oncology. However, its widespread adoption in Europe faces numerous challenges, as illustrated by the case study of the Oncotype DX Breast Recurrence Score ® assay, a genomic test for breast cancer. This manuscript delineates the multifaceted obstacles encountered during the introduction of the Oncotype DX ® test (Oncotype DX Breast Recurrence Score test) in Europe from 2004 to 2018. In June 2018, the TAILORx results were published in the New England Journal of Medicine Sparano JA, Gray RJ, Makower DF, Pritchard KI, Albain KS, Hayes DF, et al. Adjuvant chemotherapy guided by a 21-gene expression assay in breast cancer. N Engl J Med 2018;379:111-21, Sparano JA, Gray RJ, Ravdin PM, Makower DF, Pritchard KI, Albain KS, et al. Clinical and genomic risk to guide the use of adjuvant therapy for breast cancer. N Engl J Med 2019;380:2395-405, and reported that among 6,711 women with hormone-receptor-positive, HER2-negative, node-negative breast cancer and a midrange recurrence score of 11-25 on the Oncotype DX assay, endocrine therapy was not inferior to chemoendocrine therapy, which provides evidence that adjuvant chemotherapy was not beneficial in these patients. Through a comprehensive analysis of clinical evidence, commercial presence, reimbursement mechanisms, guideline recommendations, regulatory pathways, and local experiences, this study sheds light on the intricate dynamics influencing the adoption of personalized medicine technologies. This article examines the various obstacles encountered during the introduction of the Oncotype DX Breast Cancer Assay in Europe from 2004 to 2018. By analyzing clinical evidence, commercial presence, reimbursement mechanisms, guideline recommendations, regulatory pathways, and local experiences, this study reveals the complex factors that influence the adoption of personalized medicine technologies. By highlighting these challenges, this article offers valuable insights into strategies to facilitate the integration of innovative diagnostic tools into clinical practice across Europe, ultimately leading to improved treatment decision-making for cancer patients. (© 2024 Walter de Gruyter GmbH, Berlin/Boston.) |
| Databáze: | MEDLINE |
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