caa a22 4500 397562284 CHVBK 20180308164819.0 cr unu---uuuuu 161202e19961016xx s 000 0 eng 10.1093/jnci/88.20.1456 doi (NATIONALLICENCE)oxford-10.1093/jnci/88.20.1456 Tumor Marker Utility Grading System: a Framework to Evaluate Clinical Utility of Tumor Markers [Elektronische Daten] [Daniel F. Hayes, Robert C. Bast, Christopher E. Desch, Herbert Fritsche, Nancy E. Kemeny, J. Milburn Jessup, Gershon Y. Locker, John S. Macdonald, Robert G. Mennel, Larry Norton, Peter Ravdin, Sheila Taube, Rodger J. Winn] 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. We propose a Tumor Marker Utility Grading System (TMUGS) to evaluate the clinical utility of tumor markers and to establish and investigational agenda for evaluation of new tumor markers. A Tumor Marker Utility Grading Worksheet has been designed. The initial portion of this worksheet is used to clarify the precise characteristics of the marker in question. These characteristics include the marker designation, the molecule and/or substance and the relevant alteration from normalcy, the assay format and reagents, the specimen type, and the neoplastic disease for which the marker is being evaluated. To determine the clinical utility of each marker, one of several potential uses must be designated, including risk assessment, screening, differential diagnosis, prognosis, and monitoring clinical course. For each of these uses, associations between marker assay results and expected biologic process and end points must be determined. However, knowledge of tumor marker data should contribute to a decision in practice that results in a more favorable clinical outcome for the patient, including increased overall survival, increased disease-free survival, improvement in quality of life, or reduction in cost of care. Semiquantitative utility scales have been developed for each end point. The only markers recommended for use in routine clinical practice are those that are assigned utility scores of "++” or "+++” on a 6-point scale (ranging from 0 to +++) in the categories relative to more favorable clinical outcomes. Each utility score assignment should be supported by documentation of the level of evidence used to evaluate the marker. TMUGS will establish a standardized analytic technique to evaluate clinical utility of known and future tumor markers. It should result in improved patient outcomes and more cost-efficient investigation and application of tumor markers. © Oxford University Press SPECIAL ARTICLE nationallicence Hayes Daniel F. Breast Evaluation Center, Dana-Farber Cancer Institute Boston, MA aut Bast Robert C. The University of Texas M. D. Anderson Cancer Center Houston aut Desch Christopher E. Massey Cancer Center, Medical College of Virginia Richmond aut Fritsche Herbert The University of Texas M. D. Anderson Cancer Center Houston aut Kemeny Nancy E. Memorial Sloan-Kettering Cancer Center New York, NY aut Jessup J. Milburn New England Deaconess Hospital Boston aut Locker Gershon Y. Evanston Hospital IL aut Macdonald John S. Temple University Cancer Center Philadelphia, PA aut Mennel Robert G. Texas Oncology Dallas aut Norton Larry Memorial Sloan-Kettering Cancer Center New York, NY aut Ravdin Peter University of Texas Health Science Center San Antonio aut Taube Sheila Cancer Diagnosis Branch, Division of Cancer Biology, Diagnosis, and Centers, National Cancer Institute Bethesda, MD aut Winn Rodger J. The University of Texas M. D. Anderson Cancer Center Houston aut JNCI: Journal of the National Cancer Institute Oxford University Press 88/20(1996-10-16), 1456-1466 0027-8874 88:20<1456 1996 88 jnci https://doi.org/10.1093/jnci/88.20.1456 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1093/jnci/88.20.1456 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Hayes Daniel F. Breast Evaluation Center, Dana-Farber Cancer Institute Boston, MA aut NATIONALLICENCE 700 1- Bast Robert C. The University of Texas M. D. Anderson Cancer Center Houston aut NATIONALLICENCE 700 1- Desch Christopher E. Massey Cancer Center, Medical College of Virginia Richmond aut NATIONALLICENCE 700 1- Fritsche Herbert The University of Texas M. D. Anderson Cancer Center Houston aut NATIONALLICENCE 700 1- Kemeny Nancy E. Memorial Sloan-Kettering Cancer Center New York, NY aut NATIONALLICENCE 700 1- Jessup J. Milburn New England Deaconess Hospital Boston aut NATIONALLICENCE 700 1- Locker Gershon Y. Evanston Hospital IL aut NATIONALLICENCE 700 1- Macdonald John S. Temple University Cancer Center Philadelphia, PA aut NATIONALLICENCE 700 1- Mennel Robert G. Texas Oncology Dallas aut NATIONALLICENCE 700 1- Norton Larry Memorial Sloan-Kettering Cancer Center New York, NY aut NATIONALLICENCE 700 1- Ravdin Peter University of Texas Health Science Center San Antonio aut NATIONALLICENCE 700 1- Taube Sheila Cancer Diagnosis Branch, Division of Cancer Biology, Diagnosis, and Centers, National Cancer Institute Bethesda, MD aut NATIONALLICENCE 700 1- Winn Rodger J. The University of Texas M. D. Anderson Cancer Center Houston aut NATIONALLICENCE 773 0- JNCI: Journal of the National Cancer Institute Oxford University Press 88/20(1996-10-16), 1456-1466 0027-8874 88:20<1456 1996 88 jnci Metadata rights reserved CC BY-NC-4.0 http://creativecommons.org/licenses/by-nc/4.0 nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-oxford