International Liver Cancer Association (ILCA) White Paper on Biomarker Development for Hepatocellular Carcinoma
Amit G. Singal et al.
Biomarkers are key components of the clinical management of patients with cancer, as they have contributed to major survival improvements in these patients.1 According to the National Cancer Institute, a biomarker is a biological molecule found in blood, other body fluids (eg, urine), or tissues that is a sign of a normal or abnormal process, or of a condition or disease. They allow classification of patients based on common features and facilitate risk stratification, early detection, diagnosis, and prediction of prognosis or treatment response. In hepatocellular carcinoma (HCC), there are few biomarkers incorporated in clinical practice despite a need to better stratify patients at different steps of clinical management. However, this has been an extensive area of research in recent years, with increasing efforts to identify biomarkers across the cancer care continuum from risk stratification to early detection to prognostication and treatment response (Table 1, Figure 1). One of the first systematic sets of recommendations dealing with biomarkers in cancer was introduced in 1996 by Hayes et al,2 known as the Tumor Marker Utility Grading System (TMGUS). These recommendations covered not only technical aspects of assay development, but also issues related to clinical utility and levels of evidence. TMGUS was later expanded by the Reporting recommendations for tumor marker prognostic studies (REMARK) guidelines,3 a more focused approach on recommendations for reporting prognostic biomarkers in oncology. There have also been specific initiatives to describe study design thoroughly for cancer biomarkers in specific clinical scenarios, such as the Early Detection Research Network (EDRN) publishing a framework for 5 phases of biomarker development and validation for cancer screening.
LEGGI TUTTO https://doi.org/10.1053/j.gastro.2021.01.233