Evaluation of Tumor Markers: An Evidence-Based Guide for Determination of Clinical Utility

Oncology ◽  
2007 ◽  
pp. 106-111
Author(s):  
Daniel F. Hayes
1996 ◽  
Vol 11 (1) ◽  
pp. 40-45 ◽  
Author(s):  
X. Filella ◽  
A.M. Ballesta ◽  
M. Fox ◽  
H. Mitchell ◽  
R. Molina ◽  
...  

The aim of our study was to evaluate the clinical usefulness of the tumor markers CEA, CA 125 and PSA using the COBAS CORE system from Roche Diagnostic Systems. Our results demonstrate that determination of these markers on the COBAS CORE immunoassasy analyser provides the performance required for routine use in clinical practice. The results obtained in this clinical trial validate the correlation with disease extension, a characteristic that defines and determines the clinical utility of the tumor markers. We also conclude that learning to operate the COBAS CORE system is simple, as is management of the system through the user-friendly software.


2012 ◽  
Vol 30 (34) ◽  
pp. 4223-4232 ◽  
Author(s):  
Lisa M. McShane ◽  
Daniel F. Hayes

Clinical management decisions for patients with cancer are increasingly being guided by prognostic and predictive markers. Use of these markers should be based on a sufficiently comprehensive body of unbiased evidence to establish that benefits to patients outweigh harms and to justify expenditure of health care dollars. Careful assessments of the clinical utility of markers by using comparative effectiveness research methods are urgently needed to more rigorously summarize and evaluate the evidence, but multiple factors have made such assessments difficult. The literature on tumor markers is plagued by nonpublication bias, selective reporting, and incomplete reporting. Several measures to address these problems are discussed, including development of a tumor marker study registry, greater attention to assay analytic performance and specimen quality, use of more rigorous study designs and analysis plans to establish clinical utility, and adherence to higher standards for reporting tumor marker studies. More complete and transparent reporting by adhering to criteria such as BRISQ [Biospecimen Reporting for Improved Study Quality] criteria for reporting details about specimens and REMARK [Reporting Recommendations for Tumor Marker Prognostic Studies] criteria for reporting a multitude of aspects relating to study design, analysis, and results, is essential for reliable assessment of study quality, detection of potential biases, and proper interpretation of study findings. Adopting these measures will improve the quality of the body of evidence available for comparative effectiveness research and enhance the ability to establish the clinical utility of prognostic and predictive tumor markers.


2015 ◽  
Vol 29 (4) ◽  
pp. 441-445 ◽  
Author(s):  
Mary J. Sandage ◽  
Laura W. Plexico ◽  
Amy Schiwitz

2006 ◽  
Vol 21 (3) ◽  
pp. 141-148 ◽  
Author(s):  
B. Gronlund ◽  
E.V.S. Høgdall ◽  
I.J. Christensen ◽  
J.S. Johansen ◽  
B. Nørgaard-Pedersen ◽  
...  

Objective To examine if the determination of the levels of serological tumor markers at time of relapse had any predictive value for chemoresistance in the second-line treatment of ovarian cancer patients. Methods From a registry of consecutive single-institution patients with epithelial ovarian carcinoma pretreated with paclitaxel plus platinum, we selected 82 patients with (a) solid tumor recurrence, and (b) second-line chemotherapy consisting of topotecan (platinum-resistant disease) or paclitaxel plus carboplatin (platinum-sensitive disease). Stored serum samples were analyzed for the biochemical tumor markers tetranectin, YKL-40, CASA (cancer-associated serum antigen), and CA 125. The serum tumor marker levels at time of relapse were correlated with response status at landmark time after 4 cycles of second-line chemotherapy. Univariate and multivariate logistic regression analyses (chemoresistant vs non-chemoresistant disease) were performed. Results At landmark time, 26% of patients had progression according to the GCIG (Gynecologic Cancer Intergroup) progression criteria. In univariate logistic regression analysis, the tumor markers tetranectin (OR 0.4; 95% CI: 0.2–0.8; p=0.008), YKL-40 (OR 1.8; 95% CI: 1.0–3.3; p=0.045), and CASA (OR 1.8; 95% CI: 1.2–2.7; p=0.007) had predictive value for second-line chemoresistance, whereas serum CA 125 had no predictive value. In a multivariate logistic regression analysis, serum tetranectin and CASA both had independent predictive value for chemoresistance. The combined determination of tetranectin and CASA had a specificity of 90% with 33% sensitivity for the prediction of chemoresistance (area under the receiver operating characteristic curve = 0.78; 95% CI: 0.66–0.91; p=0.001). Conclusion Low serum levels of tetranectin, or high serum levels of CASA or YKL-40, are associated with increased risk of second-line chemoresistance in patients with ovarian cancer.


For many professional psychologists, assessment is viewed as a unique and defining feature of their expertise. Criteria for evaluating the scientific evidence supporting clinical instruments are presented in this chapter, including criteria for norms, reliability, validity, and clinical utility. These criteria are used by chapter authors in this volume in their condition-specific reviews of assessment instruments used for (a) diagnosis, (b) case conceptualization and treatment planning, and (c) treatment monitoring and treatment evaluation. Selecting and using scientifically sound instruments is a necessary starting point for evidence-based practice, but a remaining challenge is for professionals to integrate the resulting assessment data in a manner that is itself evidence-based.


Sign in / Sign up

Export Citation Format

Share Document