INTRODUCTION

Colorectal cancer ranks as the third most common cancer globally and is the second leading cause of cancer-related deaths in the US.1 More than half of these cases are associated with modifiable risk factors, such as smoking, obesity, high alcohol consumption, and physical inactivity. Over the past few decades, the death rate from colorectal cancer has been declining due to better health behaviors, increased screening rates, and improved therapies.2

With advancements in targeted therapies and updates to recommendations for biomarker and genomic testing, community providers are challenged to stay up to date on the latest scientific developments and ongoing research. This becomes increasingly difficult for providers who treat multiple cancer types, as they can lack confidence with biomarker testing, interpretation of results, and using this information to inform patient care.

ACCC QUALITY IMPROVEMENT INITIATIVE

The Association of Cancer Care Centers (ACCC) partnered with Pfizer Global Medical Grants on a quality improvement (QI) initiative to improve biomarker testing practices at centers that treat metastatic colorectal cancer

The project began with a survey of ACCC membership that examined patterns related to biomarker testing, barriers to testing in colorectal cancer, and the reasons for lack of adherence to current guidelines for biomarker testing in patients who are diagnosed with colorectal cancer. The survey, conducted in January 2021, queried 111 oncology practitioners around the US to assess the status of biomarker testing in patients with metastatic colorectal cancer and the challenges faced by cancer care teams. Results showed 70% of respondents reported that more than half of their patients undergo biomarker testing.3 However, while 66% of respondents reported that more than half of their patients with unresectable or metastatic colorectal cancer receive treatment based on biomarker test results, more than 40% reported that patients are treated with systemic medical therapy “frequently” or “almost always” before all biomarker test results are available.

Based on these results, ACCC sought oncology practices that were interested in integrating biomarker testing into their patient care plans and using the results of the genetic test to guide colorectal cancer management decisions. Letters of intent were requested from member centers and reviewed by a steering committee. From these submissions, 5 centers were awarded grant funding to support the implementation of their QI initiatives.

Piedmont Healthcare, Atlanta, GA

Piedmont Healthcare aimed to improve biomarker testing in patients with metastatic colorectal cancer. When a baseline sample of 100 patients revealed that most were not receiving biomarker testing in a systematic fashion, the QI team mapped out a new pathway for the pathology lab to perform reflex biomarker testing on biopsy samples that were suspected to be metastatic colorectal cancer.

The project successfully increased partial biomarker testing from 60% to 90.2% and complete testing from 34.7% to 70.6%.

Partial biomarker testing includes KRAS, NRAS, BRAF, and microsatellite instability/mismatch repair (MSI/MMR). Complete testing involves the above in addition to newer markers such as HER2, and NTRK. This initiative resulted in heightened clinician awareness of actionable biomarkers and streamlined the testing process in a scalable manner. Future projects may explore broader use of multigene next- generation sequencing (NGS) panels to further enhance testing completeness.

Blessing Hospital, Quincy, IL

Blessing Hospital focused on integrating biomarker testing into treatment planning for metastatic colorectal cancer. Through an interprofessional, multidisciplinary working group, the QI team delegated tasks to improve biomarker testing for all patients. With a collaborative effort, the project was able to achieve success in the following areas:

• Information Technology (IT): integrated electronic health record (EHR) pathways in an intuitive fashion, allowing for easier ordering of biomarker testing and more accessible tracking of test results.
• Financial Coordination: quantified the financial burden necessary to undertake routine biomarker testing and identified resources to minimize this barrier to quality care.
• Patient Education: aided the provider-patient discussion explaining how biomarker testing has the potential to impact the patient’s care.
• Provider Education: assisted the ordering physician with obtaining biomarker testing results in a timely manner and utilized test results during initial treatment planning.
• Surgical Standard Operating Procedures: ensured that sufficient tissue was collected during the surgical procedure to send for biomarker testing.

The initiative achieved a significant increase in biomarker testing from 35% to 100% of patients during the project and reduced the time from tissue procurement to test ordering from 34 days to 11.5 days. Next steps include addressing barriers to ensure sustainability and further improve outcomes.

Northwestern Medicine, Naperville, IL

Northwestern Medicine aimed to optimize treatment planning for patients with metastatic colorectal cancer by utilizing the 4R Oncology® Model (Right Information; Right Treatment; Right Patient; Right Time) to incorporate timely biomarker testing with results available prior to initiating therapy (see Figure 1). To achieve this, several datapoints were selected to measure baseline status and QI of this clinical pathway for patients receiving a new diagnosis and patients switching therapies:

• Date of pathological diagnosis
• Date of order for biomarker testing
• Date result reported for microsatellite status, expanded RAS, HER2, and BRAF (especially V600 mutation)
• Date of initiation of first-line therapy
• Date first-line therapy changed because of biomarker testing results
• Date of initiation of new-line therapy (ie, due to change in disease status).

While the project is largely complete, additional time is needed to collect more patient surveys to support dissemination activities. The revised project end date is March 31, 2025, with the goal of enhancing the project’s evaluation and sharing results through scientific forums.

Sanford Medical Center, Bismarck, ND

Sanford Medical Center developed a multidisciplinary approach for consistent and systematic biomarker testing in patients with metastatic colorectal cancer. The QI team was assembled using key personnel from the following departments: lab, pathology, genetics, compliance, billing, and clinical oncology. The team assessed available genomic testing vendors, prioritizing the ease of integration into the institutional EHR (namely, intuitive test ordering and reporting of results). Workflows were implemented at regular tumor board meetings that identified patients suitable for biomarker testing.

The project achieved 100% testing for all patients with metastatic colorectal cancer in 2022 and 2023 and reduced the average time from diagnosis to NGS test order from 62.2 days to 34.4 days.

Key performance indicators were selected to evaluate progress towards a systematic clinical workflow.

These metrics included:

• volume of tests processed,
• number of incomplete reports
• turnaround time for test results
• estimated out-of-pocket expense to the patient.

The application of molecular residual disease testing is also being explored, with multiple clinical research studies active onsite to investigate the utility of this new type of testing.

University of Maryland Kaufman Cancer Center, Bel Air, MD

The University of Maryland Kaufman Cancer Center aimed to standardize biomarker testing and integrate it into treatment plan-ning for patients with metastatic colorectal cancer. The QI team identified key objectives to advance towards this goal, including:

• Standardize communication between medical oncologists and the pathology department by developing an electronic communication pool in the EHR.
• Review and update pathology reports to include a molecular synopsis on the final path report for each patient. This allows the oncologist to easily locate biomarker results and use them to determine the optimal treatment plan, individualized for each patient.

The project increased the proportion of patients receiving all recommended biomarker tests from 0% to 80% and reduced the average time from diagnosis to test ordering from 11 days to 4 days.

Excluding an outlier of 34 days, the team reduced the average time from diagnosis to test order to 2 days. Future steps include further standardizing clinical workflows and improving communication between providers to enhance treatment planning and patient outcomes.

COMMON CHALLENGES

Several common challenges have emerged as institutions work to integrate biomarker testing into cancer care. These obstacles span technology, education, finances, and process consistency, all of which affect the successful implementation of testing. Some of the key challenges faced by various health care providers across the QI sites included:

IT Integration and Workflow Optimization. Both Blessing Hospital and Sanford Medical Center encountered significant hurdles when integrating biomarker testing into their EHR systems. These challenges affected the ability to streamline the processes for ordering, tracking, and delivering results. Sanford Medical Center also faced the added difficulty of needing to optimize their clinical workflows to improve the turnaround time for NGS testing.

Education and Awareness. Piedmont Healthcare and Blessing Hospital identified a gap in clinician education and awareness around the importance and application of biomarker testing. Blessing Hospital extended this concern to patient education, stressing the need for patients to understand how biomarker testing affects their care and treatment plans.

Financial Coordination. Blessing Hospital recognized financial coordination as a barrier, particularly regarding the challenge of mitigating the financial burden of patients undergoing biomarker testing.

Standardization and Consistency. Developing standardized processes and workflows for consistent biomarker testing was a priority for the University of Maryland Kaufman Cancer Center and Sanford Medical Center.

Data Collection and Evaluation. Northwestern Medicine faced difficulties while gathering sufficient patient survey data to support project evaluation and dissemination efforts. Adequate data collection is critical for evaluating the impact of biomarker testing initiatives and for sharing findings more broadly.

WORKING SOLUTIONS

Significant Achievements Across QI Sites

Each site achieved notable success in advancing biomarker testing initiatives. These accomplishments reflect progress in key areas, including testing rates, workflow efficiency, and provider education. Notable achievements across the sites included:

Increased Biomarker Testing Rates. Piedmont Healthcare, Blessing Hospital, and Sanford Medical Center all reported substantial improvements in their biomarker testing rates. Piedmont Healthcare raised partial biomarker testing from 60% to 90.2% and complete testing from 34.7% to 70.6%. Blessing Hospital achieved remarkable progress, reaching 100% biomarker testing for patients, up from just 35%. Similarly, Sanford Medical Center maintained a perfect 100% testing rate for all patients with metastatic colorectal cancer in both 2022 and 2023.

Reduced Time to Testing. Several institutions also reduced the time between tissue procurement or diagnosis and the ordering of biomarker tests. Blessing Hospital significantly shortened the interval from 34 days to 11.5 days, while the University of Maryland Kaufman Cancer Center reduced the average time from diagnosis to comprehensive biomarker test ordering from 11 days to just 4 days. These improvements reflect optimized workflows and more efficient care delivery.

Improved Clinical Workflows. Piedmont Healthcare and the University of Maryland Kaufman Cancer Center developed standardized workflows that streamlined biomarker testing processes. These enhanced workflows contributed to increased testing rates and reduced time to testing, improving overall clinical efficiency.

Enhanced Awareness and Education. Piedmont Healthcare successfully increased clinician awareness of actionable biomarkers, leading to more frequent discussions about the appropriate use of broad multigene NGS testing. This increase in awareness is a crucial step toward the wider adoption of advanced biomarker testing.

Sustainability and Future Planning. Both Blessing Hospital and Sanford Medical Center have ensured the sustainability of their biomarker testing initiatives. Through efforts such as IT integration, financial coordi-nation, and continuous workflow improvement, these institutions are well-positioned to maintain and expand on their successes.

CONCLUSION

Significant progress has been made towards reducing the death rate due to colorectal cancer, thanks to improved health behaviors, increased screening, and the development of new therapies. However, the rapid pace of innovation in targeted treatments and biomarker testing has introduced new challenges, particularly for community providers who must integrate these advancements into routine care. Continuous education and support for community providers are critical for successfully navigating these rapid advancements. Enhancing provider confidence and competence when applying genetic test results will be essential for integrating biomarker testing into everyday clinical practice. By doing so, providers can offer more personalized, effective care, ultimately improving the prognosis and quality of life for patients with colorectal cancer across the country. This ongoing commitment to education, quality improvement, and collaboration will be vital to ensuring that all patients, regardless of their location, have access to the latest and most effective cancer treatments.

ACKNOWLEDGMENTS

ACCC would like to thank the planning committee members for their participation in the process.

REFERENCES

1. World Health Organization. Colorectal cancer. Updated July 11, 2023. Accessed September 21, 2024. who.int/news-room/fact-sheets/detail/colorectal-cancer

2. American Cancer Society. Key statistics for colorectal cancer. Updated January 29, 2024. Accessed September 23, 2024. cancer.org/cancer/types/colon-rectal-cancer/about/key-statistics.html

3. Association of Community Cancer Centers. Assessing the status of biomarker testing in metastatic colorectal cancer and the challenges faced by community cancer care teams. February 2021. Accessed September 28, 2024. accc-cancer.org/docs/ projects/colorectal-cancer-biomarker/mcrc_survey-summary_ final-(1).pdf?sfvrsn=20c6687_0&