Evidence for the clinical use of tumour markers

Ann Clin Biochem 2004;41:370-377
© 2004 Association for Clinical Biochemistry


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Review Articles

Michael J Duffy

Department of Nuclear Medicine, St Vincent’s University Hospital, Elm Park, Dublin 4, Ireland and Department of Surgery, Conway Institute of Biomolecular and Biomedical Research, University College Dublin and Dublin Molecular Medicine Institute, Dublin, Ireland

Testing for tumour markers should only be performed if it resultsin a better patient outcome, increased quality of life or reducedoverall cost of care. Ideally, the clinical value of a tumourmarker should be validated in a large prospective study or ameta-analysis of small-scale retrospective/prospective studies(i.e. a level 1 evidence study) prior to routine use. Markersthat have been validated in such a level 1 evidence study includecarcinoembryonic antigen in the surveillance of patients withdiagnosed colorectal cancer, alphafetoprotein, human chorionicgonadotrophin and lactate dehydrogenase for evaluating prognosisin patients non-seminomatous germ cell tumours, CA 125 for monitoringtherapy in patients with ovarian cancer, oestrogen receptorsfor predicting response to hormone therapy in breast cancer,HER-2 for predicting response to trastuzumab in patients withadvanced breast cancer and urokinase plasminogen activator/plasminogenactivator inhibitor type 1 for determining prognosis in breastcancer. Although currently in widespread use, the value of prostate-specificantigen in screening for prostate cancer has yet to be validatedin a large prospective randomized trial.

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