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Cancer Biomarkers in the era of precision oncology: Addressing the needs of patients and health systems
Seminars in Cancer Biology ( IF 14.5 ) Pub Date : 2021-08-10 , DOI: 10.1016/j.semcancer.2021.08.002
Nicola Normanno 1 , Kathi Apostolidis 2 , Francesco de Lorenzo 2 , Philip A Beer 3 , Raymond Henderson 4 , Richard Sullivan 5 , Andrew V Biankin 6 , Denis Horgan 7 , Mark Lawler 8
Affiliation  

Cancer Biomarkers are the key to unlocking the promise of precision oncology, selecting which patients will respond to a more personalised treatment while sparing non-responders the therapy-related toxicity. In this paper, we highlight the primacy of cancer biomarkers, but focus on their importance to patients and to health systems. We also highlight how cancer biomarkers represent value for money. We emphasise the need for cancer biomarkers infrastructure to be embedded into European health systems. We also highlight the need to deploy multiple biomarker testing to deliver the optimal benefit for patients and health systems and consider cancer biomarkers from the perspective of cost, value and regulation. Cancer biomarkers must also be situated in the context of the upcoming In Vitro Diagnostics Regulation, which may pose certain challenges (e.g. non-compliance of laboratory developed tests, leading to cancer biomarker shortages and increased costs) that need to be overcome. Cancer biomarkers must be embedded in the real world of oncology delivery and testing must be implemented across Europe, with the intended aim of narrowing, not widening the inequity gap for patients. Cancer patients must be placed firmly at the centre of a cancer biomarker informed precision oncology care agenda.



中文翻译:

精准肿瘤学时代的癌症生物标志物:满足患者和卫生系统的需求

癌症生物标志物是开启精准肿瘤学前景的关键,它可以选择哪些患者将对更个性化的治疗产生反应,同时避免无反应者与治疗相关的毒性。在本文中,我们强调癌症生物标志物的首要地位,但重点关注它们对患者和卫生系统的重要性。我们还强调了癌症生物标志物如何代表物有所值。我们强调需要将癌症生物标志物基础设施嵌入欧洲卫生系统。我们还强调需要部署多种生物标志物测试,以便为患者和卫生系统带来最佳效益,并从成本、价值和监管的角度考虑癌症生物标志物。癌症生物标志物也必须置于即将出台的体外诊断法规的背景下,这可能会带来某些挑战(例如 实验室开发的测试不合规,导致癌症生物标志物短缺和成本增加)需要克服。癌症生物标志物必须嵌入到肿瘤学交付的现实世界中,并且必须在整个欧洲实施测试,其预期目标是缩小而不是扩大患者的不平等差距。必须将癌症患者牢牢置于癌症生物标志物知情精准肿瘤护理议程的中心。

更新日期:2021-08-10
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