Clinical utility of tumor markers

Abstract

As with all diagnostic tests, tumor markers are surrogate indicators that can be used clinically to increase or decrease the clinician’s suspicion that a future clinically important event will or will not happen, and/or that a specific treatment will reduce that risk. To determine the clinical utility of tumor markers, one of several potential uses must be designated, including risk assessment, screening, differential diagnosis, prognosis, and monitoring clinical course. Within these uses, only tumor markers for which the results effect a change that results in a more favorable clinical outcome (overall survival, disease free survival, quality of life, or decreased cost) are recommended for routine clinical use. Introduction of tumor markers into routine clinical practice has been poorly controlled, with few criteria or guidelines as to how such markers should be used. However, unlike the objective criteria established to evaluate new therapeutic agents, few guidelines have been established to determine if and/or when use of a tumor markers should become standard. Dr. Daniel Hayes of the University of Michigan, Ann Arbor, Michigan, United States and coworkers have proposed that it is appropriate to establish similar criteria for evaluation of tumor markers and to standardize the tumor marker information for clinical utility. The proposed an evidence-based system is called the Tumor Marker Utility Grading System or TMUGS. Acceptance of a tumor marker for clinical utility requires careful and thoughtful study design so that the results are meaningful in the clinical setting.

Kao svi dijagnostički testovi, tumorski markeri su surogat indikatori koji klinički mogu da se upotrebe za povećanje ili smanjenje sumnje lekara o tome da se neki važan događaj u budućnosti može da dogode ili ne dogode, kao i/ili da će se specifičnim tretmanom smanjiti rizik. Da bi se odredila klinička korisnost tumorskih markera neophodno je da rezultati njihovog određivanja precizno odgovaraju situaciji rizika, "skrininga", dijagnoze, prognoze, predviđanja i praćenja kliničkog toka. Za rutinsku kliničku praksu preporučuju se oni tumorski markeri koji mogu da pomognu pri donošenju pouzdanih kliničkih odluka koje će rezultirati u poboljšanju u jednom od četiri klinička ishoda: obuhvatno preživljavanje, preživljavanje bez bolesti, kvalitet života ili koštanje lečenja. Uvođenje tumorskih markera u rutinsku kliničku praksu je loše kontrolisano uz primenu nekoliko kriterijuma ili vodiča za njihovo korišćenje. Suprotno činjenici da postoje objektivni kriterijumi za evaluaciju terapeutskih agenasa, samo nekoliko vodiča za primenu tumorskih markera je postalo standard. Dr. Daniel Hayes sa "Ann Arbor" Univerziteta u Mičigenu, SAD i saradnici su preporučili uspostavljanje sličnih kriterijuma u evaluaciji tumorskih markera i standardizaciju njihove kliničke korisnosti. Preporučeni sistem zasnovan na dokazima je nazvan Tumor Marker Utility Grading System ili TMUGS. Prihvatanje tumorskih markera u kliničkoj praksi zahteva temeljan i smisleni dizajn studije tako da rezultati budu značajni u kliničkoj situaciji.