It is finally here! The U.S. Preventive Services Task Force (USPSTF)’s final recommendation has lowered the colorectal cancer (CRC) screening age for average-risk adults from 50 to 45 years. This long-awaited final recommendation came a little over six months after the draft recommendation was released in October last year.

This is a B grade recommendation, meaning that there is high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial. Screening for 50–75-year-old adults remains an A grade recommendation, meaning USPSTF believes there is high certainty of substantial net benefit with screening that age group. The recommendations have also been published in JAMA.

Lowering the screening age from 50 to 45 years is great news for the CRC community because it will significantly influence the earlier diagnosis of CRC among the younger age group. To bring this into perspective, a recent paper in JAMA Network Openprojected that by 2040, CRC will be the second most common cancer in the 20-49 age group and it will be the leading cause of cancer-related deaths in that age group.

Ana Acuna-Villaorduna, MD, Department of Medical Oncology at Montefiore Health System, believes that the lowering of screening age could halt the alarming rise in early-age onset CRC, particularly among racial and ethnic minority populations. “Considering US-based population projections that foresee a continuous increase in racial/ethnic minorities and have higher frequencies and worse clinical courses of colorectal cancer among young patients, it is necessary to adopt a screening strategy aimed to halt this alarming trend,” Dr. Acuna-Villaorduna wrote in an email.

She believes that general practitioners and family physicians will be strategic players in implementing the new measures by educating patients in the community, along with gastroenterologists and medical oncologists. However, uptake of these recommendations by the primary care clinical community may be slow, depending on the messaging strategies that are utilized.

“As usual, it will take a while to get the message out,” Zuri A. Murrell, MD, FASCRS, Chair, Cancer Committee, Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, told the Colon Cancer Foundation. “Having a media blitz will be helpful. Organizations like the American Cancer Society and the Colon Cancer Foundation will be the main people who will not only get the word out to providers, but to the community as well,” he added.

Dr. Acuna-Villaorduna thinks that the USPSTF recommendation will finally build a consensus across the various medical societies that have disparate CRC screening recommendations. She believes that some physicians may already have been screening average-risk adults at 45 years, so guideline uptake may be faster.

What Else Will Influence Uptake of the Guidance?

Another important question is whether our health care system has the capacity to onboard the 20-21 million adults in the 45-49 age group who are now eligible to get screened. While colonoscopy remains the gold standard, other screening options, including stool-based testing, could be used to conduct the initial screen. Whitney Jones, MD, Founder, Colon Cancer Prevention project, agrees. “While we cannot conduct colonoscopy in all the new population, we can definitely send them stool-based testing kits. That’s what health systems should focus on,” he said while speaking with the Colon Cancer Foundation.

The other issue is insurance coverage for CRC screening as a preventive care service for the 45-49 age group and making sure payers—both government and private—are aware of the updated guidelines and are integrating these within their policy.

Currently, most insurers will cover the cost of a preventive screening test for those 50 years or older, but the enrollee may have to share the cost of a diagnostic screening test if a polyp or tumor is found.

If historical trends are any indication, insurance coverage of colonoscopy will significantly influence increased screening in the younger age group. Evidence for this is stark in the Medicare population: colonoscopy rates jumped from 20% in 2000 to 61% in 2018 among those 50 and older after Medicare started covering colonoscopy screening for all beneficiaries in 2001.

Once the updated recommendations of CRC screening age are implemented, Dr. Murrell is hopeful that insurance companies will listen and hopefully start covering the cost of the simple preventive procedure. He also raised an important point about eliminating fear from the mind of the younger community. “I have coined a slogan that I always share with my patients: ‘You shouldn’t die from fear you shouldn’t die from embarrassment.’ This will be the first step in helping and encouraging people to get a colonoscopy,” he added.

Earlier this month, the U.S. Food and Drug Administration (FDA) authorized Medtronic and Cosmo Pharmaceuticals to start marketing its novel artificial intelligence (AI) device, the GI Genius, that improves the quality of colonoscopies by detecting precancerous polyps that clinicians may otherwise overlook if they are flat or are located in areas of the colon that are difficult to see with an endoscope.

According to a systematic review and meta-analysis of 43 international publications, 13 of which were conducted in the United States, many cases of colorectal cancer can be attributed to polyps and adenomas that are not detected during routine screenings. The study found that 26%  (95% CI: 23%-30%) of adenomas are missed during colonoscopies as well as 27% of serrated polyps (95% CI: 16%-40%). GI Genius is one of a few devices cleared by the FDA to aid in colonoscopies and is the first computer-aided detection (CADe) system that uses AI to recognize polyps. The tool was reviewed through the FDA’s De Novo premarket review pathway for low-to-moderate risk novel devices.

The GI Genius works by emitting a sound and displaying green markers that are superimposed over the endoscope video when it recognizes a potential lesion; it is compatible with many video endoscopy systems. GI Genius utilizes an algorithm to recognize polyps that was developed by reviewing over 13 million colonoscopy videos. Gastroenterologists labeled tissues as being either healthy or unhealthy to help “teach” the GI Genius how to distinguish the two. While the GI Genius can recognize unhealthy tissue, it does not characterize lesions and is not a substitute for lab sampling to diagnose the tissue in question.

The safety and effectiveness of the GI Genius were assessed through a large randomized controlled trial in Italy. Out of a subpopulation of 263 subjects who required screening or surveillance at least every three years, 136 patients had a colonoscopy with the assistance of the GI Genius, while 127 patients served as controls and underwent a standard colonoscopy. In the experimental group, adenomas or carcinomas were detected in 55.1% of patients, while they were only identified in 42% of patients in the control group. No adverse events related to the use of GI Genius were reported, although its use led to a small increase in the amount of healthy tissue that was biopsied.

Overall, GI Genius shows great promise as a way to enhance the quality and reliability of colonoscopies by aiding physicians who may otherwise miss polyps that are hard to see.

In February 2021, Brett Walker, M.D., became the 10th awardee of the Thomas K. Weber Colorectal Cancer Research Scholar Award, awarded by the Colon Cancer Foundation in partnership with the Society of Surgical Oncology.

The award was renamed in 2020 after Thomas K. Weber, M.D. (1954-2019), founder and former president of the Colon Cancer Foundation. Dr. Weber devoted his life to increasing colorectal cancer awareness, detection, and prevention, and his dedication to “a world without colon cancer” lies at the heart of the Colon Cancer Foundation. Thus, the award was renamed to keep his legacy alive while celebrating members of the community that display excellence in translational research pertaining to the molecular biology of colorectal cancer.

This year, Dr. Walker received the award for his abstract submission on circulating hybrid cells (CHCs) as a potential biomarker for treatment response in gastrointestinal cancers. CHCs are a type of hybrid cell created by the fusion of an immune cell and a tumor cell. Research pertaining to CHCs is novel as the primary focus of previous studies on cancer cell biomarkers has been on circulating tumor cells (CTCs), cells that bud off from a primary tumor and circulate in the bloodstream. 

Though CHCs also disseminate outward from a primary tumor and circulate in the peripheral blood, the difference between the two lies in their names. Whereas CTCs only express cytokeratin, a tumor protein, CHCs express both cytokeratin and CD45, an immune cell marker. It is postulated that CHCs have both immune and tumor cell markers in order to successfully evade the immune system to form new tumors. 

“CHCs have this opportunity to escape out of the primary tumor and migrate to different areas and potentially seed new metastatic tumors,” said Dr. Walker in an email correspondence with the Colon Cancer Foundation. 

According to Dr. Walker, CHCs have the potential to be a better evaluative marker of treatment response and disease progression compared to CTCs because there are more of them circulating in the bloodstream. 

Dr. Walker’s research itself indicates the effectiveness of CHCs as biomarkers. According to The ASCO’s Post description of his research, CHCs “successfully discriminated pathologic complete response from non–pathologic complete response in both rectal and esophageal cancers.”

Additionally, Dr. Walker mentioned that CHCs can provide information on the actual tumor itself. 

“By collecting CHCs, we can actually gain information on the tumor, specifically what proteins they express and their genetic makeup including mutations, which could potentially help guide targetable treatments for patients,” said Dr. Walker.  

Though more studies need to be conducted into CHCs, the implications of the research conducted by Dr. Walker’s laboratory are immense. If indeed CHC levels can be used as an effective biomarker, then patients with colorectal cancer can opt for non-invasive blood tests to track disease and treatment progression, as opposed to undergoing traditionally invasive imaging techniques and endoscopies. This in turn improves patients’ quality of life by avoiding intensive procedures that can cause stress and fear. 

Dr. Walker expressed excitement over CHCs as a biomarker and hopes that his research will inspire others in the field to conduct their own studies. 

“I think that there’s a huge opportunity here for us to really affect how we both detect and manage colon cancer. And so I really think this is an awesome opportunity to bring attention to hybrid cells and hopefully expand the number of researchers in this field.”

In 1999, the Prevent Cancer Foundation designated March as the National Colorectal Cancer Awareness Month. The foundation partnered with the American Digestive Health Foundation and the National Colorectal Cancer Roundtable to raise awareness and advocate for policy change for the third most common type of cancer in the United States. On November 19, 1999, an official declaration came through from the United States Senate and the House of Representatives. 

With approximately 100,000 new cases of colorectal cancer (CRC) every year, March is an important month to cast a spotlight on the value of preventative measures such as screening. The American Cancer Society estimates there will be 149,500 new cases of CRC and 52,980 deaths in 2021. In December 1995, the United States Preventive Services Task Force (USPSTF) recommended that adults with an average risk of CRC should be screened between the ages of 50-75 years. Due to increasing evidence over the last few decades, in December 2020 the USPSTF released draft recommendations saying screening should start at the age of 45 years.

The COVID-19 pandemic led to a drastic reduction in the number of colonoscopies in 2020: about a 90% drop compared to previous years. Approximately 1.7 million Americans missed their annual screening test in 2020, and 18,800 CRC diagnoses were either delayed or missed altogether. 

In recognition of the month of March, the Colon Cancer Foundation (CCF) had several activities planned, including the #GiveACrap Challenge. The Challenge encouraged individuals to sign up to receive a free Fecal Immunochemical Test (FIT), and the chance to receive a special limited-edition beer. People also had the option of making a donation to the foundation to receive the test kit and the beer. Other activities included the CCF Challenge which is a 45-mile walk-run and a concert celebrating the culmination of a week full of activities.

In his proclamation for National Colorectal Cancer Awareness Month, President Joseph Biden urged Americans to call attention to CRC risk factors and increase annual screening practices. He emphasized that March is the perfect opportunity to improve public understanding of CRC and to educate individuals about the age for proper screening. He reiterated that if caught early, CRC is highly treatable and curable. “Because of the Affordable Care Act, most health insurance plans must cover a set of preventive services with no out-of-pocket cost. This includes colorectal cancer screening in adults aged 50 and older,” President Biden said.

Fight Colorectal Cancer and the Colon Cancer Coalition urged business leaders and landmarks to go blue to spread CRC awareness. As of March 9, 2021, businesses, healthcare systems, and landmarks in 21 states had confirmed their status to “Go Blue” in honor of CRC Awareness Month. Moreover, the Colon Cancer Coalition hosted a ‘Get Your Rear in Gear’ event on March 21, 2021, in-person and virtually, as a 5K untimed run/walk-in Charlotte, North Carolina. 

Every year in March, various events take place all throughout the U.S. with the hope of spreading awareness and advocating for CRC. It is essential to spread the word about CRC and emphasize the importance of regular screening to prevent, manage, and treat CRC.

With activities in full swing across the U.S. during National Colorectal Awareness month in March, the Colon Cancer Foundation (CCF) spoke to Whitney Jones, MD, founder of the Colon Cancer Prevention Project (CCPP, Louisville, Kentucky), about the foundation’s history, their success with flipping colorectal cancer (CRC) screening rates in the state, and their vision for the future.

Back in 2003, Dr. Jones, a gastrointestinal specialist, was shocked when he encountered several individuals who should have been screened for CRC, presenting with advanced colon cancer in his clinic. Intrigued by this, he found out that Kentucky ranked 49^th for CRC screening rates and led the nation in incidence and mortality. It was then that he decided to make changes in the space and started the foundation the same year.

Partnerships to Help Move the Needle on Preventive Screening

While early years were focused on developing informational flyers and attending health fairs, by 2008 CCPP’s attention shifted to influencing policy changes, such as making sure CRC screening received preventive care coverage. They simultaneously developed a screening program for the state’s uninsured populations under the oversight of an advisory committee (healthcare providers, policy experts, and legislators) that continues to meet on a monthly basis even today.

In 2015, CCPP began promoting lead-time messaging and on-time screening, with a particular emphasis on high-risk and younger populations. “We called out, not the guidelines, but in fact our strategy for implementing our guidelines,” he said, which culminated in a paper on establishing a standard process for timely messaging for CRC screening for both average-risk and high-risk individuals, with an overall goal of changing mindsets. “If we have to reach disparate populations, we have to start earlier, message more frequently, and offer more choices,” Dr. Jones said.

CRC screening compliance is mainly driven by primary care providers (PCPs) and health care systems. “Gastroenterologists are the catchers, and the PCPs and health systems are the pitchers,” he said. “We can no longer trust opportunistic screening as in the past. We need to aim for a more systematic, longitudinal, benchmarked system for evidence-based and guideline-driven screening.”

This, he added, will require participation from payers, Medicaid, and the Department of Insurance to instill policies such as coverage for a colonoscopy following a positive FIT test, or genetic testing for those who meet criteria. Additionally, partnering with organizations that understand the local landscape—such as the Cancer Prevention Programs at a safety-net university-based hospital—provides vital on-the-grounds insight. Dr. Jones’ recommendation is for each state to create a statute for an advisory committee or a technical advisory committee that includes lawmakers and insurance companies, to help develop, clarify, and implement CRC policy.

To spread the success of their state-based screening programs, CCPP is partnering with FightCRC to replicate Kentucky’s success in other states—especially in the context of stakeholder engagement. “The key was really in engaging all of our partners that we have now and asking them, ‘What power can you bring from your organization to really advance something?’” He strongly believes that having a CRC-focused organization lead the charge can have a huge impact on moving the needle and getting things done for the community.

Family Health History for On-Time Screening

We all know that disparate platforms make it difficult for sharing information across electronic health records (EHRs). Add to that the time constraints faced by practitioners and gathering accurate information about a person’s family health history (FHH) could be really challenging. Dr. Jones’ vision rises a step above that—using an AI-based system that will gather FHH, critical to Hereditary Cancer Risk Assessment, prior to a patient’s appointment and integrate it within their EHR, compare it to existing guidelines, and provide the physician with a recommendation that can guide the conversation during the patient visit. “Logistics and informatics will play a significant role in improving our struggles with on-time screening,” Dr. Jones added.

45 IS The New 50: Now What?

While the debate over when to start screening average-risk adults is over (see USPSTF draft recommendation), onboarding 20-21 million people across the country in the 45-49 age group is going to be a challenge, especially during the COVID-19 pandemic. Catching-up will require a dramatic increase in the utilization of stool-based testing. “While we cannot conduct colonoscopy in all the new population, we can definitely send them stool-based testing kits. That’s what health systems should focus on,” Dr. Jones said.

In Kentucky, CCPP has been preparing hospitals, health systems, insurance companies, and large group payers since mid-2020 to adopt these guidelines as soon as they are finalized. The focus is on communicating with folks in their late 30s to inform them about symptoms, screening the high-risk population at age 40 or sooner with colonoscopy, identifying candidates for whom genetic testing is appropriate and for average risk individuals, and screening with either stool-based tests or colonoscopy in a shared decision-making model.

“Forty-five should be the finish line for starting risk-based CRC screening communication, not the starting point,” Dr. Jones said.