NCCN Task Force Report: Evaluating the Clinical Utility of Tumor Markers in Oncology

被引:210
作者
Febbo, Phillip G.
Ladanyi, Marc
Aldape, Kenneth D.
De Marzo, Angelo M.
Hammond, M. Elizabeth
Hayes, Daniel F.
Iafrate, A. John
Kelley, R. Kate
Marcucci, Guido
Ogino, Shuji
Pao, William
Sgroi, Dennis C.
Birkeland, Marian L.
机构
来源
JOURNAL OF THE NATIONAL COMPREHENSIVE CANCER NETWORK | 2011年 / 9卷
关键词
NCCN; tumor marker; biomarker; analytic validity; clinical validity; clinical utility; predictive marker; prognostic marker; companion diagnostic marker; molecular marker; ACUTE MYELOID-LEUKEMIA; CELL LUNG-CANCER; ISLAND METHYLATOR PHENOTYPE; RANDOMIZED PHASE-III; K-RAS MUTATIONS; PATHOLOGISTS GUIDELINE RECOMMENDATIONS; MICRORNA-EXPRESSION SIGNATURES; CENTRALLY REVIEWED EXPRESSION; DEPENDENT PROBE AMPLIFICATION; REVISED BETHESDA GUIDELINES;
D O I
10.6004/jnccn.2011.0137
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
The molecular analysis of biomarkers in oncology is rapidly advancing, but the incorporation of new molecular tests into clinical practice will require a greater understanding of the genetic changes that drive malignancy, the assays used to measure the resulting phenotypes and genotypes, and the regulatory processes that new molecular biomarkers must face to be accepted for clinical use. To address these issues and provide an overview of current molecular testing in 6 major malignancies, including glioma, breast cancer, colon cancer, lung cancer, prostate cancer, and acute myelogenous leukemia, an NCCN Task Force was convened on the topic of evaluating the clinical utility of tumor markers in oncology. The output of this meeting, contained within this report, describes the ways biomarkers have been developed and used; defines common terminology, including prognostic, predictive, and companion diagnostic markers, and analytic validity, clinical validity, and clinical utility; and proposes the use of a combination level of evidence score to aid in the evaluation of novel biomarker tests as they arise. The current state of regulatory oversight and anticipated changes in the regulation of molecular testing are also addressed. (JNCCN 2011; 9[Suppl 5]:S1-S32)
引用
收藏
页码:S1 / S32
页数:32
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