The titular study published on March 30, 2021 was a comparative effectiveness study, a study that compares two or more health interventions to evaluate which poses the greatest benefit and harm, and was inspired by and relied on the International Duration Evaluation of Adjuvant (IDEA) trial. The IDEA trial was a pooled analysis of six randomized clinical trials that studied patients with stage III colon cancer and compared the effects of three months of adjuvant chemotherapy to the standard duration of six months. 

Adjuvant chemotherapy refers to the additional therapy given to cancer patients after their primary therapy; in this case, the primary therapy was surgery. Adjuvant chemotherapy is administered to maximize the benefits of the primary therapy and to decrease the risk of cancer recurrence.

In the IDEA trial, the adjuvant therapy was either adjuvant 5-flourouracil/leucovorin plus oxaliplatin (FOLFOX) or capecitabine plus oxaliplatin (CAPOX). Both FOLFOX and CAPOX are chemotherapy regimens used for advanced colorectal cancer, and, as stated, both contain oxaliplatin, a known neurotoxic agent. Therefore, the implications of reducing the duration of adjuvant therapy are immense, as it could potentially decrease the neuropathic effects of the drug, as well as reduce treatment cost and increase treatment adherence.

The IDEA trial in particular was chosen as a benchmark due to the many controversies that surrounded the study’s findings. The IDEA trial found that “a shortened duration of adjuvant chemotherapy was noninferior among patients with T1 to T3 and N1 stage disease and among patients prescribed CAPOX.” In this case, noninferior means that the experimental treatment, i.e. the shortened adjuvant chemotherapy, is not substantially worse than the control treatment, i.e. the standard six month duration of adjuvant chemotherapy. 

This was controversial, as a worldwide survey of 145 oncologists showed that 1 in 3 supported the six months duration of adjuvant chemotherapy. Additionally, there were concerns as to how these findings could be generalizable to a real-world population of cancer patients.

This current study aimed to remedy these controversies by conducting a target trial emulation, a method used by investigators to mimic a clinical trial using observational techniques. Though randomized clinical trials continue to provide the strongest evidence for comparing the effectiveness of two or more interventions, they can be slow, costly, and at times impossible to conduct due to ethical considerations. Therefore, target trial emulations, in which an ideal clinical trial is imitated using already-existing, real-world data, can prove useful.

This study utilized the data of patients who were diagnosed with stage III colon cancer between January 2004 and December 2015 in Alberta, Canada, and the eligibility criteria mimicked that of the IDEA trial. Overall, 485 patients were included in the trial emulation, with 230 being women and the median age being 59 years.

Both a target trial emulation and a naive observational analysis were conducted, a naive observational analysis being one that did not take into account any of the factors of the target trial emulation. More specifically, the naive observational analysis did not factor in allowable reasons for therapy cessation, values that change over time like treatment dosage, or immortal time bias. 

In this study, the findings of the target trial emulation and the naive observational analysis differed. The findings of the target trial emulation mirrored that of the original IDEA trial; a shortened duration of adjuvant therapy, specifically CAPOX, was found to be noninferior to the standard six month duration. However, the naive observational analysis found that a shortened duration of CAPOX therapy was associated with a decreased overall survival for patients. 

According to the authors, these disparate findings show “the importance of explicitly emulating a target trial when conducting comparative efficacy research using real-world data.”

 

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.

Updated phase III results from the BEACON study have found that encorafenib with cetuximab can lead to promising survival outcomes among patients with advanced colorectal cancer (CRC) who had received previous lines of treatment.

The third most common cancer and the third most common cause of cancer-related deaths in the U.S., CRC occurs when there is development of mutations in oncogenes, tumor suppressor genes, and genes that aid in DNA repair. Depending on the site of the mutation, CRC can be classified as familial, inherited, or sporadic. Chromosomal instability (CIN), microsatellite instability (MSI), and CpG island methylator phenotype (CIMP) are pathogenic mechanisms through which CRC can develop. These mutations, changes in the chromosomes, and translocations can affect various signaling pathways (Wnt, TP53, TGF-β, and MAPK/PI3K) and genes such as c-MYC, KRAS, BRAF, SMAD2, and SMAD4. Oftentimes, mutations in these genes can serve as important predictive markers in the context of patient outcomes.

In addition to CRC, mutations in BRAF have been found to be responsible for various other cancers such as melanoma, thyroid, small-cell lung, and hairy cell leukemia. BRAF encodes for  the B-RAF serine/threonine kinase protein, which is a part of the RAS/RAF/MEK/ERK pathway. Most of the mutations that take place in the BRAF gene lead to a V600E substitution, which often leads to a poor prognosis in patients. The BRAFV600E mutation initiates activation of the mitogen-activated protein kinase (MAPK) signaling pathway, which causes the tumor cells to rapidly divide. It has been estimated that approximately 10% of patients with metastatic CRC have a mutation in BRAF.

In the past, treating metastatic CRC with BRAFV600E mutations has led to low response rates, partly due to incomplete inhibition of the MAPK signaling. Recently, the combination of a BRAF (encorafenib) and EGFR (cetuximab) inhibitor has shown promising results compared to BRAF inhibitor monotherapy. The BEACON CRC study is a randomized, open-label, phase III trial that enrolled 665 patients and compared triple combination therapy; encorafenib (300 mg x1 a day) plus binimetinib (45 mg 2x a day) plus cetuximab (400 mg/m2 x1 a week) versus double combination therapy; encorafenib plus cetuximab versus cetuximab plus irinotecan or FOLFIRI. Of the total 665 patients, 224 received triple therapy, 220 received double therapy, and 221 received the control therapy.

The objective of the BEACON trial was to detect the overall survival in relation to the triple combination therapy/double combination therapy as compared to the control. It was determined that triple/double therapy led to a median overall survival of 9.3 months, while the control group showed an overall survival of 5.9 months. This indicates that both triple/double therapy improved the overall survival rate and can therefore be used as the new standard of care in patients with metastatic CRC with BRFV600E mutations.

 

 

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.”

 

Cancer has a massive impact globally, with an estimated 1.8 million cases per year in the U.S. The advances in screening, early diagnosis, and treatment modalities have greatly improved cancer-related morbidity and mortality. With approximately 16.9 million cancer survivors as of January 2019 in the U.S. alone, this number is only expected to grow. When diagnosed, many of these survivors were probably working, thus needing to adapt their lifestyle and work ability around their diagnosis and upcoming treatment. However, this aspect of cancer survival receives very little coverage in research and modern-day media.

The National Comprehensive Cancer Network’s (NCCN) 2021 Virtual Annual Conference highlighted many important aspects of cancer survivorship. Speaker, Anna J. Tevaarwerk, M.D., from the University of Wisconsin Carbone Cancer Centre, highlighted the importance of accommodating cancer survivors returning to work. Her talk, titled, ‘Helping Cancer Survivors Return to Work,’ discussed the impact of cancer and its treatment on a survivor’s work ethic, performance, and/or employment satisfaction and how employers can better assimilate survivors who choose to or need to work during or after their treatment.

 

The ‘Return to Work’ Issue

During her presentation, Dr. Tevaarwerk shared that around 46% of those diagnosed with cancer are in the 20-64 age group—the ‘working age group’ in the U.S. So, most are either in the workforce, in school, or not in the workforce. Additionally, the average retirement age in the U.S. is 64, but this is predicted to rise. This highlights how cancer survivors may have to undergo and recover from treatment while remaining within the working age group.

This also means, that the majority of patients or survivors will either want or need to continue working after their diagnosis. But evidence indicates that their successful return to work post-diagnosis is much more challenging than it should be. Some of these work limitations are physical and are likely to impair their ability to work:

  • Increased fatigue
  • Decreased stamina
  • Lack of productivity and the persistent side effects of the treatment itself Additionally, the numerous appointments and frequent sick leave associated with cancer treatments can interfere with daily tasks, resulting in unpredictable absences from work. Psychosocial, mental, and/or emotional issues may also emerge when a person is diagnosed with cancer, leading to:
    • Decreased confidence in being able to work
    • Reduced self-esteem
    • Increase anxiety about being shunned at work
    • Fear of being a burden on your colleagues or employer

While most survivors appear ‘normal’ on the outside, many of these psychological and psychosocial stressors associated with cancer treatment and self-confidence/body dysmorphia anxiety (e.g., hair loss associated with chemotherapy), can often make it very hard for survivors to return to work. Unfortunately, many are unable to stop working or reducing their work hours even during active treatment – especially with patients receiving palliative (treatment targeting the symptoms rather than the cancer itself) or non-curative (treatments that slow progression and tumour growth) treatments that are ongoing and need to remain in the workforce.

 

Consequences of Work Limitations

Explaining the impact of the above stressors on patients who need to work, Dr. Tevaarwerk said, “Cancer treatment creates demands on patient time that may impact employment and may require job accommodation such as increased personal calls or messages during work hours, perioding breaks for rest, reduced physical exertion, job restructuring and/or modification, provision or mobility assistance, improved building access and parking close to your work area, or modified office temperatures.

As a survivor with, undergoing, or recovering from cancer and its treatment it can be quite challenging to ask for these adjustments from your employer and can leave survivors feeling productively inadequate. Additionally, the impact of reducing work hours may lead to financial toxicity that culminates in treatment delays/lack of treatment adherence, treatment discontinuation, health insurance threat (becoming uninsured/paying for increased out-of-pocket expenses), lack of stable income, and psychosocial distress.

For many survivors, work also means a lot more than income—survivors may continue or want to return to work because, as Dr. Tevaarwerk says it creates a sense of normalcy, distraction, need for activity, and social contacts.” While there is no direct line between these concepts, it is important to highlight that work is important for a lot of reasons outside of income, and many survivors may find a sense of purpose that encourages them to continue to return to work.

 

Post-Diagnosis Work Outcomes

Cancer employment support varies widely in the U.S. depending on the system you are operating in, according to Dr. Tevaarwerk. Work-related productivity due to loss of health may change significantly, with lower levels of productivity happening after diagnosis and at the end of treatment, she said, with the main driver being absenteeism, which includes a loss of working days due to treatment. Additionally, patients receiving curative treatment have shown increased work ability, decreased work limitations, and a steady rise in hours worked when compared to their counterparts receiving palliative cancer therapy.

Dr. Tevaarwerk added that due to the stigma surrounding cancer, and the possibility of being laid off or misrepresented at work, patients find it extremely difficult to share their diagnosis and treatment plans with their employer. Thus, a majority of the time the type of treatment a cancer patient is receiving is unclear, meaning that employment facilities tend to be inadequately prepared to support a cancer patient either during (if they decide that they are in the position where they are able to comfortably continue working) or after their treatment. She added that the phrase ‘return to work’ is misleading as it “implies that a cancer survivor stops working and then re-starts only once at the exact same job,” when in reality a cancer survivor may never stop working, or may stop and start more than once, or may take up a very different level or job.

 

Overcoming Work Limitations and Barriers

To make returning to work successful, it is important for employers and their employees who are survivors to work together to create an accommodative environment that supports both their needs. A proactive discussion between both parties can help establish physical and emotion boundaries. Dr. Tevaarwerk highlighted several key things an employer can do to support the successful return of a cancer survivor to work:

  • A proactive discussion between the employer and employee to establish work-related boundaries (performance adjustments, work intensity etc.)
  • Increasing the availability of emotional support options within the workplace (physical work-place adjustments, increased work-from home hours, staggering schedules etc.)
  • Making shared decisions to mitigate work impact

Conclusion

Overall, the return to work of a survivor is complicated and influenced by numerous factors and the work ability and performance of a survivor or patient often depends on survivor characteristics, work conditions (flexibility/climate), and the interplay between complex employee-employer social systems. Being at work is considered both necessary and fulfilling, and is strongly associated with mental, emotional, physical, and therapeutic benefits for those suffering from chronic conditions like cancer. Therefore, understanding the ‘return-to-work’ dilemma that cancer survivors face and adjusting it to be more accommodative would open up a range of opportunities that could benefit both the employer and the survivor.

 

The American Cancer Society’s 2021 Cancer Facts and Figures includes staggering statistics about colorectal cancer (CRC) in the United States:

  • It is the third most common type of cancer diagnosed in men and women
  • It is the third leading cause of cancer-related deaths in men and women
  • CRC incidence rates are increasing in adults younger than 50
  • CRC mortality rates are increasing in adults younger than 55
  • Black people have the highest CRC incidence and mortality rates among all ethnic groups

These shocking figures are why Fight CRC, a patient advocacy group with a mission to “cure colorectal cancer,” is working with members of Congress to provide funding for CRC research.

Fight CRC calls for the allocation of $20 million for a CRC research program within the Department of Defense (DoD). Congressional champions of the group are leading a letter to the House Appropriations Committee in support of this effort. According to the letter, CRC is the only cancer among the top five cancer killers without its own program within the DoD’s Congressionally Directed Medical Research Program (CDMRP). 

Fight CRC wants to change that. They believe it is past time for CRC to be spotlighted, and they have “no plans of slowing down or stopping until they reach their goal: a cure.” At the Colon Cancer Foundation, we wholeheartedly stand by this mission and we will continue to work towards, in the words of founder Dr. Thomas K. Weber, “a world without colon cancer.”  

Imagine a world in which CRC is not one of the most common types of cancers. Imagine a world in which CRC does not cause deaths anymore. Now, imagine that you don’t have to imagine any of this: you can make this world a reality by clicking on Fight CRC’s action alert and urging your members of Congress to sign the letter to create a distinct program for CRC research. Share it with your friends, family, and colleagues so that together, we can all create a world without CRC.

 

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.

 

March 2021 brought 21 updated recommendations and guidelines from the American College of Gastroenterology (ACG) regarding colorectal cancer (CRC) screening.

While the American Cancer Society recommends CRC screening for those aged 45 and up, the ACG recommends regular CRC screening for those aged 50-75, which follows the current recommendations set by the U.S. Preventive Services Task Force and the Multi-Speciality Task Force. For those aged 76 and beyond, the ACG recommends that the decision to screen for CRC be dependent on the health status and lifestyle of each individual, as the risks of CRC screening can outweigh the benefits depending on the individual’s situation. 

The recommendation to start screening at age 50 is only for those at average risk for CRC. For those who have a family history of CRC or advanced polyps and are therefore at a two-fold increased CRC risk, the ACG recommends screening starting at the age of 40 or 10 years before the youngest affected relative—whichever comes first. 

The various CRC screening options include:

  • Stool-based tests like fecal immunochemical test (FIT) and multitarget stool DNA (mtsDNA)
  • Blood-based tests like Septin 9
  • Direct visualization like colonoscopy, flexible sigmoidoscopy, CT colonography, and colon capsule

The ACG recommends that colonoscopy and FIT should be the primary CRC screening methods. While advising against the Septin 9 blood test due to its low CRC detection sensitivity, the ACG does recommend the other screening methods outlined above for individuals who do not want to undergo a colonoscopy or FIT. It is important to note that all non-colonoscopy screening methods require a follow-up colonoscopy in the case of a positive result.  

In terms of chemopreventive methods, multiple long term studies have indicated that aspirin can reduce CRC incidence and mortality. However, these studies showed mixed results and did not break down the results by individual CRC screening history, so the ACG recommends against the usage of aspirin as a substitute for traditional CRC screening methods. 

Recommendations for Improving the Quality of Colonoscopy Screening 

Of all the screening methods, a direct visualization test like the colonoscopy is the most commonly performed procedure in the U.S. However, the colonoscopy does come with a main drawback: the results of the test are dependent upon the colonoscopist. The Adenoma Detection Rate (ADR), defined by “the fraction of persons aged 50+ who have one or more adenomas detected and removed,” is a good indicator of colonoscopy performance quality. Several studies have identified a link between colonoscopists with higher ADR rates and a reduction in CRC in their patients. Therefore, the ACG recommends remedial training for colonoscopists with an ADR of <25%.

The ACG further recommends that colonoscopists spend at least six minutes inspecting the mucosa before the scope is withdrawn from the anus, as a withdrawal time of six minutes or more increased the detection of neoplastic lesions and reduced the risk of post-colonoscopy CRC (PCCRC). An additional indicator of colonoscopy quality is the cecal intubation rate (CIR), which is defined as “the passage of the colonoscope tip into the cecal caput.” It is recommended that colonoscopists achieve a CIR of at least 95%, as studies have shown that a low CIR is associated with an increased risk of PCCRC.

Recommendations for Increasing Awareness About CRC Screening

As CRC remains the third leading cause of cancer in the U.S. among men and women, screening outreach is essential to increase participation in CRC screening. Studies have found that various screening outreach methods like brochures, invitations, reminders, patient navigation, patient reminders, clinical interventions, and clinical reminders were associated with increased CRC screening rates. Additionally, having primary care providers involved in screening outreach methods increased patient participation in CRC screenings. Therefore, the ACG recommends all the above to increase screening participation. 

To improve adherence to follow-up colonoscopies after positive non-colonoscopy results, the ACG recommends mail and phone reminders, patient navigation, and provider interventions.

The Colon Cancer Foundation implemented various campaigns this March to increase CRC screening participation in honor of National Colon Cancer Awareness Month. One of the most notable was the #GiveaCrapChallenge, where CCF partnered with Squatty Potty and DuClaw Brewing Company to screen 100 people for colon cancer. Participants traded a stool sample via a FIT kit for a limited edition, six-pack brew sample from DuClaw. These types of innovative screening outreach methods can increase participation in CRC screening, allowing for earlier detection of CRC.

Early detection can significantly reduce the incidence and mortality of CRC. Though there are currently no randomized clinical trials that compare the various CRC screening intervals in terms of the number of life-years gained, the Cancer Intervention and Surveillance Modeling Network, through various studies, recommends the following:

  • Annual FIT
  • Colonoscopy every 10 years
  • mtsDNA test every 3 years
  • Flexible sigmoidoscopy every 5-10 years
  • CT colonography every 5 years
  • Colon capsule every 5 years

 

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 49th 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.

 

Colorectal cancer (CRC) is the third most common cancer in terms of incidence and mortality in both males and females in the U.S. Screening remains the best method to detect the disease early and can reduce the incidence of advanced cancers. Depending on which guidance is followed, average-risk adults should start screening at 45 or 50 years, However, there is limited information on the ideal age to stop CRC screening. 

The US Preventive Services Task Forces (USPSTF) recommends CRC screening is beneficial only until age 75. In their study published in Clinical Gastroenterology and Hepatology, Cenin et al discuss the age at which men and women should stop screening based on their comorbidities and prior screening results. The authors used a CRC microstimulation model known as Microsimulation Screening Analysis (MISCAN)-colon, which works by answering questions in relation to an individual’s screening and age. The model assesses individuals based on an approach of benefit versus risk using a 76-year-old individual with an exemplary prior screening history as a measure by which all other cases are compared. But, the MISCAN model did not take into account an individual’s prior adherence to screening. 

Comparatively, Lansdorp-Vogelaar et al determined that colorectal cancer (CRC) screening with the fecal immunochemical testing (FIT) was reasonable up until 76 years of age, but only up to 66 years of age in individuals who had underlying comorbidities. Furthermore, Tian et al have emphasized the importance of the family history of CRC, primarily because it contributes towards CRC risk and when to stop screening. 

Based on the many studies conducted, it has been apparent that prior screening history holds far more importance than the number of underlying comorbidities in individuals. Additionally, the age to stop screening differs drastically between men and women. In women with similar comorbidities as men, screening tests were stopped 12-20 years prior depending on screening history, and as early as 24 years if a colonoscopy was done. 

Cenin et al’s study is based on FIT, which is not as relevant in countries where colonoscopy is used as a primary screening test. Individuals who opt for a colonoscopy have longer protection, as opposed to those who opt for FIT. CRC screening can stop at 74 years if the individual had a colonoscopy, irrespective of comorbidities. Therefore, in the U.S., the USPSTF recommends that screening should be stopped at 75 years of age because the primary screening test used is a colonoscopy. According to Pilonis et al, a negative colonoscopy has the ability to provide protection for up to 17.4 years, thereby reducing mortality by 81%. 

Cenin et al’s study also emphasizes the importance of attaining a full screening history and past medical history in order to determine what is the best age to stop CRC screening.