Trovato Maria
Department of Clinical and Experimental Medicine, Policlinico Universitario, Consolare Valeria 1, 98125 Messina, Italy.
Diagnostics (Basel). 2022 Mar 9;12(3):662. doi: 10.3390/diagnostics12030662.
Biomarkers (BMs) are medical signs which can be precisely measured and reproduced. Mainly, BMs provide information on the likely disease which can occur in an individual. On the other hand, BMs also signal disease recurrence in patients receiving therapy. The U.S. Food and Drug Administration coupled with the National Institutes of Health and the European Medicines Agency have proposed two distinct procedures to validate BMs. These agencies have elaborated two glossaries to describe the role of BMs. The aim of this study was to investigate medical taxonomies adopted by different governmental agencies for BM validation. Additional goals were to analyze efficiencies of the validated and candidate BMs for thyroid cancers (TCs). Currently, thyroglobulin is validated for monitoring TCs. Sorafenib-tosylate, Doxorubicin-hydrochloride, Vandetanib, Cabozantinib-s-malate, Dabrafenib-mesylate, Trametinib-dimethyl-sulfoxide, Lenvatinib-mesylate, Pralsetinib and Selpercatinib are validated for TC treatment. Among candidate BMs for TC diagnosis, there are molecular combinations including BRAF, RAS, RET/PTC and PAX8-PPARγ mutations. Noteworthy are BRAF and RET/PTC alterations already validated as targets of Dabrafenib-mesylate, Pralsetinib and Selpercatinib. Finally, cellular expressions of c-met in nodal TC metastases have diagnostic imaging applications. On the basis of this analysis, BM taxonomies should have common standards internationally recognized. BMs show different efficiencies depending on their diagnostic or therapeutic use.
生物标志物(BMs)是能够被精确测量并重现的医学指标。主要而言,生物标志物提供有关个体可能发生疾病的信息。另一方面,生物标志物也能提示接受治疗患者的疾病复发情况。美国食品药品监督管理局联合美国国立卫生研究院以及欧洲药品管理局已经提出了两种不同的程序来验证生物标志物。这些机构已经制定了两个术语表来描述生物标志物的作用。本研究的目的是调查不同政府机构采用的用于生物标志物验证的医学分类法。其他目标是分析经验证的和候选的甲状腺癌(TCs)生物标志物的有效性。目前,甲状腺球蛋白已被验证可用于监测甲状腺癌。甲苯磺酸索拉非尼、盐酸多柔比星、凡德他尼、苹果酸卡博替尼、甲磺酸达拉非尼、曲美替尼、甲磺酸仑伐替尼、普拉替尼和塞尔帕替尼已被验证可用于甲状腺癌治疗。在用于甲状腺癌诊断的候选生物标志物中,有包括BRAF、RAS、RET/PTC和PAX8-PPARγ突变在内的分子组合。值得注意的是,BRAF和RET/PTC改变已被验证为甲磺酸达拉非尼、普拉替尼和塞尔帕替尼的靶点。最后,c-met在甲状腺癌淋巴结转移中的细胞表达具有诊断成像应用。基于这一分析,生物标志物分类法应具有国际认可的共同标准。生物标志物根据其诊断或治疗用途显示出不同的有效性。