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欧洲采用个性化医疗的挑战与障碍:以Oncotype DX乳腺癌复发评分检测为例

Challenges and barriers for the adoption of personalized medicine in Europe: the case of Oncotype DX Breast Recurrence Score test.

作者信息

Horgan Denis, Hofman Paul, Giacomini Patrizio, Dube France, Singh Jaya, Schneider Daniel, Hills Tanya, Faikish Jennifer, Van Den Bulcke Marc, Malapelle Umberto, Gajewski Maciej, Subbiah Vivek

机构信息

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.

出版信息

Diagnosis (Berl). 2024 Dec 17;12(2):175-181. doi: 10.1515/dx-2024-0127. eCollection 2025 May 1.

Abstract

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 DXtest (Oncotype DX Breast Recurrence Score test) in Europe from 2004 to 2018. In June 2018, the TAILORx results were published in the (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.

摘要

个性化医疗旨在根据患者个体特征量身定制治疗方案,在肿瘤学领域具有巨大潜力。然而,正如乳腺癌基因检测Oncotype DX复发评分检测的案例研究所示,其在欧洲的广泛应用面临诸多挑战。本手稿描述了2004年至2018年期间Oncotype DX检测(Oncotype DX乳腺癌复发评分检测)在欧洲引入过程中遇到的多方面障碍。2018年6月,TAILORx研究结果发表在《新英格兰医学杂志》上(Sparano JA, Gray RJ, Makower DF, Pritchard KI, Albain KS, Hayes DF等。乳腺癌21基因表达检测指导辅助化疗。《新英格兰医学杂志》2018;379:111 - 21,Sparano JA, Gray RJ, Ravdin PM, Makower DF, Pritchard KI, Albain KS等。临床和基因组风险指导乳腺癌辅助治疗的应用。《新英格兰医学杂志》2019;380:2395 - 405),报告显示,在6711名激素受体阳性、HER2阴性、淋巴结阴性乳腺癌且Oncotype DX检测复发评分为11 - 25的女性中,内分泌治疗并不劣于化疗内分泌治疗,这为这些患者辅助化疗无益提供了证据。通过对临床证据、商业存在、报销机制、指南建议、监管途径和当地经验的全面分析,本研究揭示了影响个性化医疗技术应用的复杂动态。本文探讨了2004年至2018年期间Oncotype DX乳腺癌检测在欧洲引入过程中遇到的各种障碍。通过分析临床证据、商业存在、报销机制、指南建议、监管途径和当地经验,本研究揭示了影响个性化医疗技术应用的复杂因素。通过强调这些挑战,本文为促进创新诊断工具在欧洲临床实践中的整合提供了有价值的见解,最终改善癌症患者的治疗决策。

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