UH Seidman Team Innovates to Boost Targeted Therapy for Metastatic Colorectal Cancer

Power of IT will support greater communication and integration of effort

Innovations in Cancer | Fall 2023

A team from University Hospitals Seidman Cancer Center is launching an initiative supported by the National Comprehensive Cancer Network (NCCN) Oncology Research Program and the organization Fight Colorectal Cancer, with funding and research support from Pfizer, to boost rates of biomarker-directed therapy among patients with metastatic colorectal cancer.

Amit Mahipal, MD, MPH

Melissa Lumish, MD

Clinical need: More than half of these patients have an identifiable biomarker that can help guide treatment, including but not limited to RAS (50-60%), BRAF (10%), deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) (4%), and ERBB2 amplification/HER2+ (3%), raising the prospect of cancer therapy that is more effective and less toxic compared to standard of care chemotherapy. However, biomarker testing rates remain low among patients with metastatic colorectal cancer, and significant racial disparities in biomarker testing highlight the disproportionate effect on Black patients.

“Data supports a need for provider education regarding appropriate use and timing of biomarker testing, an improved workflow to incorporate reflex biomarker testing when appropriate and reduce time from molecular testing to results, improved patient awareness of the need for biomarker testing to empower individuals to participate in their care, increased patient diversity in biomarker testing, and increased access to biomarker-directed therapies including both FDA-approved drugs and clinical trials,” says Amit Mahipal, MD, MPH, GI oncologist at UH Seidman and one of the leaders of the new project. Dr. Mahipal also holds the Ruth and Donald Goodman Chair in GI Oncology.

“There a lot of new ways to individualize treatment for metastatic colon cancer based on markers within the cancer, either genetic markers or cell surface markers,” adds Melissa Lumish, MD, GI oncologist at UH Seidman, who is also leading the new project. “A lot of us have been involved in the trials that led to these therapies. But in some of the regional community sites where providers are taking care of colon cancer and breast cancer and other types of cancer, they may not know to perform this testing, and the patients in those regions may also not have as much health literacy to ask the question.”

IT innovation: Drs. Lumish and Mahipal are looking to the power of information technology to help solve this problem. They are developing and implementing the Biomarker-driven and Evidence-bAsed Therapy for metastatic ColoRectal Cancer (BEAT-CRC) platform across all UH Seidman Cancer Center sites in Northeast Ohio.

A BEAT-CRC Oncotracker EMR will support greater communication and integration of effort. It will inform the pathology department of newly diagnosed or newly metastatic cases of colorectal cancer, inform the treatment team about the real-time status of testing, sample adequacy and results availability, use a uniform system of reporting biomarker results to providers across the UH Seidman network and alert treating physician teams of the presence of actionable biomarkers.

“We have some great IT capabilities which make that happen,” Dr. Mahipal says. “The goal is a centralized, unified and multidisciplinary workflow, encompassing all academic and community-based sites in the UH Seidman network, from diagnosis to biomarker testing to guideline-based treatment and clinical trial participation.”

Results from reflex routine multigene tissue-based and blood-based sequencing panels (KRAS, NRAS, BRAF, ERBB2 amplification, NTRK fusion, microsatellite instability (MSI) status, mismatch repair (MMR) protein immunohistochemistry (IHC), and HER2 IHC (with or without HER2 fluorescence in situ hybridization (FISH) will populate the platform, allowing communication about molecular test results and organization of cases for discussion at a weekly molecular tumor board that involves providers from all sites in the network.

“This helps us implement reliable and timely biomarker assessment with for all patients with newly diagnosed metastatic colorectal cancer,” Dr. Lumish says.

Ultimately, Dr. Lumish and Dr. Mahipal hope this new effort will increase the number of patients with metastatic colorectal cancer who undergo FDA- or NCCN-guideline approved biomarker-directed therapy or participate in clinical trials. They’re also hoping to boost the diversity among patients who undergo biomarker testing through engagement of community providers. But they say the project could also have more general, downstream effects on patient care.

“When we recommend a therapy because it’s more effective, it also spares patients from ineffective therapies that are going to only cost toxicity, but actually are not going to work,” Dr. Lumish says. “It's about toxicity for the patients, about healthcare costs and about trying to improve progression-free survival and overall survival.”

Plus, they add, giving patients greater access to targeted therapies simply reflects the changing nature of modern cancer care.

“If you look at last decade almost, we can probably count on one hand how many new chemotherapy agents have been approved,” Dr. Mahipal says. “At the same time, probably over 50 targeted therapies have been approved. More individualized, precise patient selection is where the field is moving in oncology, and our project here at UH Seidman is part of that. If it’s a success, why not other cancers? The goal would be to expand to different areas slowly, build it up. But once we can show success and value, that's our goal.”

Contributing Expert:
Melissa Lumish, MD
Gastrointestinal Oncologist
UH Seidman Cancer Center
Assistant Professor of Medicine
Case Western Reserve University School of Medicine

Amit Mahipal, MD, MPH
Gastrointestinal Oncologist
UH Seidman Cancer Center
Ruth and Donald Goodman Chair in GI Oncology
Professor of Medicine
Case Western Reserve University School of Medicine