ACCC Recognizes Colorectal Cancer Awareness Month With RFP

Tremendous strides have been made in colorectal cancer prevention and treatment since 2000, when President Bill Clinton first designated March as Colorectal Cancer Awareness Month. In 2000, the treatment options for patients with metastatic colorectal cancer were limited to traditional chemotherapies. Today, biomarker testing has opened the door for more personalized treatments, including  immunotherapies that could not have been imagined twenty years ago.

These advancements have led to a tremendous improvement in patient outcomes. For the past decade, new cases of colorectal cancer (CRC) have fallen an average of 2.4 percent each year, and survivorship is on the rise. Sixty-four percent of all patients diagnosed with CRC live for five years or more, and the five-year survival rate for individuals diagnosed with Stage 1 CRC is 90 percent.

Even so, colorectal cancer is still the second-leading cause of cancer death in the U.S., in part due to the ongoing rise in the incidence of early onset, late-stage CRC. This occurs when CRC presents in individuals younger than age 50, before the recommended routine screening for colorectal cancer begins.

According to Al B. Benson III, MD, a professor of medicine and associate director of clinical investigations at the Robert H. Lurie Comprehensive Cancer Center at Northwestern University and a member of the ACCC planning committee, “If we look at the latest in precision oncology, the progress being made is breathtaking, and that includes drugs being developed to treat unresectable or metastatic CRC and biomarker testing of tissue to identify patients who have the potential to reap significant  benefits.”

However, says Dr. Benson, “There is still much work to be done in screening for early-onset CRC, developing comprehensive treatment plans for specific subtypes of metastatic disease, and continuing research to identify larger groups of people who could benefit from a combination of treatments, including immunotherapy.”

A significant proportion of that work falls to community cancer centers, says Dr. Benson, where 80 percent of cancer patients receive their treatment.

Testing Matters

The baseline test for all patients with colorectal cancer, regardless of stage, is what is known as MSI/MMR, or micro-satellite instability/mismatch repair. The result of this test determines whether a patient’s first line of treatment for metastatic CRC is traditional chemotherapy or immunotherapy. A positive MSI/MMR test result may indicate the presence of Lynch Syndrome, a rare, genetic predisposition for the disease that affects how a patient is monitored and whether family members are screened.

In addition to MSI/MMR, there is a growing field of molecular tests and concordant treatment regimens that clinicians must know how to navigate when caring for patients with metastatic CRC. For example, Dr. Benson explains that, “testing for RAS mutations is necessary because only people with the RAS wild-type gene are candidates for treatment with certain types of drugs known as epidermal growth factor receptor inhibitors or EGFRs.” Likewise, says Benson, “if a tumor is RAS wild-type, we need to test for HER2, for which there are other specific targeted therapies. There’s also now an FDA-approved regimen for BRAF-mutated tumors that represents yet another subtype of CRC patients. All of these tests are the minimum assessment we need to do because it directly affects patient treatment.”

ACCC Survey

In January 2021, ACCC conducted a survey of community oncologists to assess the status of biomarker integration in the treatment of patients with late-stage, unresectable colorectal cancer. The results of this original research highlight some of the challenges faced by care providers in the community, including the application of preferred treatment regimens linked to specific biomarkers.

The majority of respondents (74 percent) to ACCC’s survey reported regularly ordering biomarker testing for more than half of their patients with metastatic CRC. Fifty-six percent reported routinely ordering MSI/MMR testing, and 41 percent reported ordering multiplex panel tests, including KRAS, NRAS, and BRAF mutations.

Dr. Benson says these findings are encouraging. “It’s clear that clinicians are approaching testing in a variety of ways,” he notes. “But we are making inroads into patient selection for targeted treatment, and that’s an advancement. What we need is routine access to and utilization of universal pathways, standard protocols for everyone to follow.” Dr. Benson adds that he is currently working with the National Comprehensive Cancer Network to develop just that—national comprehensive treatment guidelines for colorectal cancer.

In addition to a varied approach to the types of biomarker tests ordered, the results of the ACCC survey revealed barriers to biomarker integration in CRC care, such as adequate tissue sampling, lab processing times, access to genetic consultants, and reimbursement issues.

Request for Proposals

To help address some of these challenges, ACCC has partnered with Pfizer Global Medical Grants and is inviting its members to submit proposals for quality improvement initiatives in the treatment of metastatic colorectal cancer. A total of $1.5 million is available to fund projects that aim to improve the integration of biomarker testing results into the treatment decision-making process. Proposals should address the enhancement of specific assessment and diagnostic processes, including:

• Quality-of-care assessments (such as the use of molecular tumor boards and tissue optimization practices)
• Standard workflows for biomarker testing
• Standard assessment of patients for clinical trial eligibility
• System-oriented barriers such as testing turnaround time and reimbursement
• Equity and access barriers to biomarker testing for underserved patient populations

As Dr. Benson explains, “Developing comprehensive, standard protocols for CRC care and making sure that physicians address all the component services with patients up front is an extension of patient advocacy. Our goal is for integrated biomarker testing and targeted therapy to become the standard of care for people with metastatic colorectal cancer.”

The opportunity to submit a proposal in response to the RFP is only available to ACCC member cancer programs and practices. Grant requests should describe concepts and ideas for design and implementation of systems or programs that will close clinical practice gaps related to biomarker testing in patients with mCRC through the establishment of education and support mechanisms for community providers.

The RFP process has two stages. Stage one is submission of a three-page letter of intent (LOI). If the LOI is selected, the applicant will be invited to submit a full proposal. Deadline for LOI submission is May 12, 2021.

For more information and to view the RFP, go to https://www.accc-cancer.org/projects/colorectal-cancer/overview.