Pragmatic issues in biomarker evaluation for targeted therapies in cancer

被引：132

作者：

de Gramont, Armand ^{[1
]}

Watson, Sarah ^{[2
]}

Ellis, Lee M. ^{[3
,4
]}

Rodon, Jordi ^{[6
,7
]}

Tabernero, Josep ^{[6
,7
]}

de Gramont, Aimery ^{[8
]}

Hamilton, Stanley R. ^{[5
]}

机构：

[1] CHU Vaudois, Dept Oncol, Ctr Expt Therapeut, New Drug Evaluat Lab, CH-1011 Lausanne, Switzerland

[2] Inst Curie, INSERM, U830, Genet & Biol Paediat Tumours Grp, F-75231 Paris, France

[3] Univ Texas MD Anderson Canc Ctr, Dept Surg Oncol, Houston, TX USA

[4] Univ Texas MD Anderson Canc Ctr, Dept Mol & Cellular Oncol, Houston, TX USA

[5] Univ Texas MD Anderson Canc Ctr, Div Pathol & Lab Med, Houston, TX USA

[6] Univ Autonoma Barcelona, E-08193 Barcelona, Spain

[7] Vall dHebron Univ Hosp, Vall dHebron Inst Oncol VHIO, Med Oncol, Barcelona, Spain

[8] Inst Hosp Franco Britann, Dept Med Oncol, Levallois Perret, France

来源：

NATURE REVIEWS CLINICAL ONCOLOGY | 2015年 / 12卷 / 04期

关键词：

METASTATIC COLORECTAL-CANCER; PRIMARY BREAST-CANCER; CELL LUNG-CANCER; K-RAS MUTATIONS; FACTOR RECEPTOR 2; CETUXIMAB PLUS IRINOTECAN; RANDOMIZED PHASE-II; RESOLUTION MELTING ANALYSIS; CIRCULATING TUMOR-CELLS; IN-SITU HYBRIDIZATION;

D O I：

10.1038/nrclinonc.2014.202

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Predictive biomarkers are becoming increasingly important tools in drug development and clinical research. The importance of using both guidelines for specimen acquisition and analytical methods for biomarker measurements that are standardized has become recognized widely as an important issue, which must be addressed in order to provide high-quality, validated assays. Herein, we review the major challenges in biomarker validation processes, including pre-analytical (sample-related), analytical, and post-analytical (data-related) aspects of assay development. Recommendations for improving biomarker assay development and method validation are proposed to facilitate the use of predictive biomarkers in clinical trials and the practice of oncology.

引用

页码：197 / 212

页数：16

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