From the Guidelines
Clinical biomarker testing plays a crucial role in Colorectal Cancer (CRC) management, guiding targeted therapies and advancing personalized care.
Key Biomarkers
- EGFR signaling pathway mutations, such as KRAS and NRAS, have strong evidence as negative predictors of benefit to anti-EGFR therapies and should be used to guide the use of these agents 1.
- BRAF mutations are consistently associated with poor outcomes in patients with metastatic CRC, including those who relapse after adjuvant therapy 1.
- MMR status has predictive value in some settings, specifically in patients with advanced disease being considered for anti-PD-1/PD-L1 therapy 1.
Testing Approaches
- Targeted NGS cancer panels can effectively be used for molecular testing, allowing for the simultaneous analysis of multiple genes and amplicons with known mutational hotspots in cancer 1.
- Non-invasive biomarkers, such as blood-based tumor biomarkers, have potential for CRC screening, but larger scale studies are needed to support their clinical use 1.
Clinical Practice Guidelines
- The American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and American Society of Clinical Oncology have developed guidelines for molecular biomarker testing in CRC, which will be regularly updated to capture new advances in the field 1.
- The NCCN Guidelines Panel for Colon Cancer has evaluated various biomarker tests, including K-ras and B-raf mutation analyses, mismatch repair protein testing, and the Oncotype DX Colon Cancer Assay, but notes significant variability in the level of clinical evidence associated with these tests 1.
From the Research
Role of Clinical Biomarker Testing in Colorectal Cancer (CRC)
The role of clinical biomarker testing in Colorectal Cancer (CRC) is multifaceted, including:
- Early detection and diagnosis of CRC 2, 3, 4, 5, 6
- Prognostication and prediction of treatment response 2, 3, 4
- Identification of novel therapeutic targets and development of personalized treatment plans 2, 6
- Monitoring of minimal residual disease (MRD) and detection of recurrence 6
Types of Biomarkers
Various types of biomarkers are being investigated for CRC, including:
- Protein-based biomarkers 3
- DNA-based biomarkers 2, 5
- RNA-based biomarkers, such as long non-coding RNAs (lncRNAs) 2
- Epigenetic biomarkers, such as methylation of specific genes 5
Clinical Applications
Biomarkers have the potential to improve clinical management of CRC, including: