Comprehensive Genomic Profiling Approaches in Europe and the US: A Review of Guidelines and Recommendations for Solid Tumors

OBJECTIVES: Personalized cancer therapies are available in multiple indications, offering innovative, and potentially life-extending treatments compared with traditional chemotherapy. To receive these treatments, genetic testing is required, which can range from single gene tests to comprehensive genomic profiling (CGP). Despite these advancements in testing, not all patients receive access to CGP; barriers to testing vary by indication and geography. This research aims to explore CGP testing guidance and recommendations in the US and Europe.

METHODS: A rapid literature review was conducted to compare key clinical guidelines across the US, UK, France and Germany, and guidance from the FDA, NICE, HAS, and IQWIG, to highlight similarities and differences in their approaches to CGP use for solid tumors.

RESULTS: European guidelines were generally more conservative in their recommendations compared with the US. ESMO specified that NGS is useful for non-small cell lung cancer, prostate cancer, ovarian cancer and cholangiocarcinoma. Multigene panels were only recommended in other indications in cases where they would add an acceptable extra cost compared with small panels, and the use of off-label drugs based on the results was only recommended if a decision had been reached at a regional or national level. In comparison, an ASCO provisional clinical opinion stated that multigene testing could be of benefit to a patient, even in cases whereby there are no genotype-based approved treatments for the patient’s disease, and recommended that patients with any indication that had more than one approved targeted therapy should be tested.

CONCLUSIONS: Different approaches to CGP may affect patient access to personalized oncology treatments, although the extent of these differences is currently unknown. Large-scale, high-quality observational research is needed to better understand how patient access to CGP, and personalized cancer treatments, affects clinical outcomes in the real-world.