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Published on: July 3, 2013
Clinical implementation of KRAS testing in metastatic colorectal carcinoma: the pathologist's perspective
1Department of Pathology and Laboratory Medicine, Albany Medical College, 47 New Scotland Ave., Albany, NY 12208, USA. rossj@mail.amc.edu
Context:
Mutation status of the KRAS gene identifies a distinct disease subtype of metastatic colorectal carcinoma that does not respond to antibody therapeutics targeting the epidermal growth factor receptor. This is currently the only validated marker in metastatic colorectal carcinoma with a clear implication in treatment selection. KRAS testing is widely accepted in clinical practice to guide metastatic colorectal carcinoma therapeutic decisions, and there are many commercially available platforms to perform the test.
Objective:
To evaluate the critical role of pathologists in the full implementation of KRAS testing by optimizing tumor tissue collection and fixation procedures and by choosing testing technologies and reliable Clinical Laboratory Improvement Amendments of 1988-certified laboratories to perform the tests.
Data Sources:
Prospective clinical trials, retrospective studies, and quality assessment and survey reports were identified in the following databases: PubMed, American Society of Clinical Oncology Proceedings (American Society of Clinical Oncology Annual Meeting and Gastrointestinal Cancer Symposium) and European Society for Medical Oncology Proceedings (Annals of Oncology European Society for Medical Oncology Congress and Annals of Oncology World Congress on Gastrointestinal Cancers).
Conclusions:
More bona fide standards are needed to address the variety of available test methods, which have different performance characteristics including speed, sensitivity to detect rare mutations, and technical requirements. Refined standards addressing timing of KRAS testing, laboratory performance and accuracy, quality assurance and control, proper tissue collection, and appropriate result reporting would also be greatly beneficial. Pathologists should be aware that the amount of information they need to manage will increase, because future trends and technological advances will enhance the predictive power of diagnostic tests or the scope of the biomarker panels tested routinely across tumor types.
Insights
KRAS testing is crucial for metastatic colorectal carcinoma treatment selection. Pathologists play a key role in optimizing KRAS testing through proper tissue handling and laboratory selection for accurate results.
Area of Science:
- Oncology
- Molecular Diagnostics
- Colorectal Cancer Research
Background:
- KRAS mutation status defines a colorectal cancer subtype unresponsive to EGFR-targeted therapies.
- KRAS testing is the sole validated biomarker for guiding treatment decisions in metastatic colorectal carcinoma.
- Numerous commercial platforms exist for KRAS testing in clinical practice.
Purpose of the Study:
- To assess the essential role of pathologists in fully implementing KRAS testing.
- To optimize tumor tissue collection and fixation for KRAS testing.
- To guide the selection of appropriate testing technologies and CLIA-certified laboratories.
Main Methods:
- Literature search across PubMed, ASCO, and ESMO databases.
- Inclusion of prospective clinical trials, retrospective studies, and quality assessment reports.
- Analysis of published data on KRAS testing methodologies and implementation.
Main Results:
- Variety of KRAS testing methods exist with differing performance characteristics (speed, sensitivity, technical needs).
- Need for standardized protocols for timing, laboratory performance, quality assurance, tissue collection, and result reporting.
- Pathologists must manage increasing data complexity due to evolving diagnostic technologies.
Conclusions:
- Development of bona fide standards is required for KRAS testing methods.
- Refined standards are beneficial for timing, laboratory accuracy, quality control, tissue handling, and reporting.
- Pathologists should anticipate increased information management with advancements in predictive diagnostic tests and biomarker panels.
