Problems of variable biomarker evaluation in stratified medicine research--A case study of ERCC1 in non-small-cell lung cancer

Lung Cancer : Journal of the International Association for the Study of Lung Cancer
Kinga MalottkiLucinda Billingham

Abstract

Consistency of procedures for the evaluation of a predictive biomarker (including sample collection, processing, assay and scoring system) based on adequate evidence is necessary to implement research findings in clinical practice. As a case study we evaluated how a particular predictive biomarker, ERCC1, was assessed in research on platinum-based chemotherapy in non-small-cell lung cancer and what motivated the choice of procedure. A systematic review of studies completed since 2007 and ongoing was undertaken. Questionnaires on details of ERCC1 evaluation procedures and the rationale for their choice were sent to contacts of identified studies. Thirty-three studies of platinum-based chemotherapy in non-small-cell lung cancer using ERCC1 were identified. A reply to the questionnaire was received for 16 studies. Procedures for ERCC1 evaluation varied substantially and included reverse transcriptase quantitative polymerase chain reaction (nine studies), immunohistochemistry (five studies) and other methods (multiple methods-two studies, NER polymorphism-one study). In five studies ERCC1 use was planned, but not undertaken. In nine data was insufficient to identify the procedure. For each assay there was variation across studies i...Continue Reading

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Citations

Oct 30, 2016·Annals of Oncology : Official Journal of the European Society for Medical Oncology·K A Olaussen, S Postel-Vinay
Jun 8, 2017·Journal of Cellular Biochemistry·Yan ZhangKe-Xin Liu
Dec 12, 2017·Expert Opinion on Drug Metabolism & Toxicology·Gerhard Hamilton, Barbara Rath
Nov 29, 2016·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Siow Ming LeeAllan Hackshaw

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