CancerTumor marker
A B S T R A C TBiomarkers have many potential applications in oncology, including risk assessment, screening, differential diagnosis, determination of prognosis, prediction of response to treatment, and monitoring of progression of disease. Because of the critical role that biomarkers play at all stages of disease, it is important that they undergo rigorous evaluation, including analytical validation, clinical validation, and assessment of clinical utility, prior to incorporation into routine clinical care. In this review we address key steps in the development of biomarkers, including ways to avoid introducing bias and guidelines to follow when reporting results of biomarker studies.ª 2012 Federation of European Biochemical Societies.Published by Elsevier B.V. All rights reserved.With the tremendous increase in knowledge about the biology of cancer and the rapid changes in molecular technology that have occurred in the past decade, studies of biomarkers in cancer are published almost daily. Because of this overabundance of information, it is necessary for clinicians and scientists to have a thorough understanding of biomarkers and biomarker development so they can critically review the literature, in order to determine whether and in what setting a biomarker can and should be used for patient care, or whether additional evaluation is required before it can be incorporated into routine medical practice.
What is a biomarker?According to the National Cancer Institute, a biomarker is "a biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease,"(NCI) such as cancer. Biomarkers typically differentiate an affected patient from a person without the disease. The alterations can be due to a number of factors, including germline or somatic mutations, transcriptional changes, and posttranslational modifications. There is tremendous variety of biomarkers, which can include proteins (e.g., an enzyme or receptor), nucleic acids (e.g., a microRNA or other non-coding RNA), antibodies, and peptides, among other categories. A biomarker can also be a collection of alterations, such as gene expression, proteomic, and metabolomic signatures. BiomarkersAbbreviations: ASCO, American Society of Clinical Oncology; EGFR, epidermal growth factor receptor; FISH, fluorescence in situ hybridization; IHC, immunohistochemistry; LOE, Level of Evidence; NCCN, National Comprehensive Cancer Network; NCI, National Cancer Institute; PSA, prostate specific antigen; TMUGS, Tumor Marker Utility Grading Scale.