Predictive and prognostic biomarkers with therapeutic targets in breast, colorectal, and non-small cell lung cancers: a systemic review of current development, evidence, and recommendation.

Appropriate evidence-based roles of prognostic and predictive biomarkers of known therapeutic targets in breast, colorectal, and non-small cell lung cancers in adults are reviewed, with summary of evidence for use and recommendation. Current development in biomarker studies is also discussed. Computerized literature searches of PubMed (National Library of Medicine), the Cochrane Collaboration Library, and commonly accepted US and international guidelines (American Society of Clinical Oncology, European Society for Medical Oncology, and National Comprehensive Cancer Network) were performed from 2001 to 2012. Literature published before 2001 was noted for historical interest but not evaluated. Literature review was focused on available systematic reviews and meta-analyses of published predictive (associated with treatment response and/or efficacy) and prognostic (associated with disease outcome) biomarkers of known therapeutic targets in colorectal, breast, and non-small cell lung cancers. In general, significant health outcomes (e.g. predicted response to therapy, overall survival, disease-free survival, quality of life, lesser toxicity, and cost-effectiveness) were used for making recommendations. Four breast cancer biomarkers were evaluated, two of which (2D6 genotyping, Oncotype Dx) were considered emerging with insufficient evidence. Seven colorectal cancer biomarkers were evaluated, five of which (EGFR gene expression, K-ras G13D gene mutation, B-raf V600E gene mutation, dihydropyrimidine dehydrogenase deficiency, and UGT1A1 genotyping) were considered emerging. Seven non-small cell lung cancer biomarkers were evaluated, five of which were emerging (EGFR gene expression, ERCC gene expression, RRM1 gene expression, K-ras gene mutation, and TS gene expression). Of all 18 biomarkers evaluated, the following showed evidence of clinical utility and were recommended for routine use in practice: ER/PR and HER2 for breast cancer; K-ras gene mutation (except G13D gene mutation) for colorectal cancer; mismatch repair deficiency or microsatellite instability for colorectal cancer; and EGFR and EML4-ALK gene mutations for non-small cell lung. Not all recommendations for these biomarkers were uniformly supported by all guidelines.