Metastatic colorectal cancer (mCRC) is a complex, heterogeneous disease characterized by multiple gene alterations that can significantly impact a patient’s prognosis and treatment option profile. Biomarker testing has transformed the landscape of mCRC care and is critical to ensuring a patient receives appropriate, evidence-based care. Recent data suggests that implementing approved biomarker-driven therapy early in a patient’s treatment course is of significant benefit. Tumors that have high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR), are now eligible for immunotherapy in the first-line setting.1,3 BRAF V600E mutated mCRCs have a poorer prognosis overall, but may be eligible for targeted therapy. 2 MSI-H and BRAF mutated tumors do not respond well to traditional chemotherapy which further highlights the importance of biomarker testing early in a patient’s treatment course.3 Recent data has uncovered potential new treatment options targeting the HER2 amplification pathway in mCRC.
Given the current understanding of the role of biomarkers in mCRC, current practice guidelines recommend that all CRCs should be tested for KRAS/NRAS/BRAF mutations, HER2 (ERBB2) amplification and MSI-H or dMMR at diagnosis of metastatic disease. 5,6,7 Despite this recommendation, the execution of biomarker testing is wrought with challenges for all stakeholders including providers and patients. Testing is complex, cumbersome, and often inefficient, which leads to delays in appropriate patient care. Barriers exist throughout the biomarker testing continuum and include provider ordering, patient education, insurance coverage, tissue acquisition, data interpretation and treatment implications. These challenges are consistent in academic and community settings and lead to poor integration of evidence-based treatment, thus revealing an opportunity for improvement in a key component of delivering guideline-concordant care.
Potential strategies to optimize care delivery around biomarker directed therapy include increasing awareness of the need for biomarker testing and its impact on therapy, improving adherence to guidelines, and facilitating meaningful educational opportunities for oncology providers. Further approaches may include developing workflows to facilitate the testing process for providers as well as workflows to enhance collaboration between community and academic settings regarding biomarker testing guidelines and currently approved biomarker directed therapies. Strategies to improve patient understanding of biomarker-directed therapy are also needed. This RFP seeks to solicit projects that focus on optimizing biomarker-directed therapy according to established clinical practice guidelines in mCRC.