A longitudinal study that evaluated colorectal cancer (CRC) screening habits of average-risk adults found an increase in screening rates between 2011 and 2019, although it did fall short of the 80% goal set by the National Colorectal Cancer Roundtable. Interestingly, the use of multitarget stool DNA test (mt-sDNA) increased between 2016 and 2019—once there was a reimbursement code for the test post–FDA approval. Fecal occult blood testing (FOBT) use, meanwhile, saw a decline during that same period.

The researchers used commercial and Medicare claims databases to draw information on CRC screening use between August 1, 2011, and August 31, 2019. The actual 18-year study period was split into the pre-mt-sDNA period (August 1, 2011-July 31, 2014) and the post-mt-sDNA period (August 1, 2016-July 31, 2019). Only those enrollees who were between 45-67 years old on August 1, 2011, and were at an average risk of developing CRC, were included in the study. This inclusion criteria made up nearly 98,000 individuals, with a  mean age of 50.8 years; 55.5% of them were women. About 62% of them were over 50 years old, and about 38% were aged between 45 and 49 years on August 1, 2011.

The analysis found a steady annual increase in up-to-date screening, from 50.4% in 2011-2012 to 69.7% in the final measurement year (2018-2019). While the 45-49 years old had low screening rates (25.8%) in the early years, the difference between age groups disappeared by the end of the study period (67.7%). The most interesting data were utilization patterns of the kinds of screening tests among those 50 and over:

  • FIT: 17.7% in 2011-2012 to 22.6% in 2016-2017
  • Colonoscopy: 64.6% in 2013-2014 to 60.3% in 2018-2019
  • FOBT: 17.4% in 2011-2012 to 6.6% in 2018-2019
  • mt-sDNA: 1.9% in 2016-2017 (when it was first available) to 14.2% in 2018-2019

Specifically in the 45-49 age group, colonoscopy use increased while use of FIT and FOBT decreased over the study period. However, use of mt-sDNA increased once the test was launched.

The authors attribute the successful increase in CRC screening utilization to multiple factors:

  • Various population-level interventions to increase CRC screening awareness and uptake
  • Changes in CRC screening guidelines, with the American Cancer Society recommending 45 years as the screening age for average-risk adults
  • The Affordable Care Act has provided increased insurance coverage, which increases access to CRC screening

The Colon Cancer Foundation, in partnership with 65 other organizations, has signed a memorandum urging New York Governor Kathy Hochul to sign S.4111/A4668 into law.

S.4111 Breslin/A.4668 Peoples-Stokes, which passed both the New York State Senate and the Assembly in April and May 2021, respectively, with bipartisan support, is a bill that prohibits mid-year formulary changes. (A formulary is a list of drugs that are covered by a prescription drug plan.) This in turn will prevent health plans from stopping coverage for a patient’s prescription drug in the middle of a coverage year, unless the switching is medically necessary—what is often referred to as non-medical switching.

Non-medical switching is described as changing a patient’s prescription medication to a clinically different non-generic alternative for non-clinical reasons, even if the patient is responding to his or her current drug. The reason for the switch is not based on a poor clinical response, treatment side effects, or non-adherence to treatment. The decision is often made by health plans to save costs.

A decision to replace a medication that a patient may be responding to may be particularly troublesome for patients with chronic disease or complex conditions. An online survey on non-medical switching among oncologists found:

  • 25% think it decreased medication effectiveness
  • 5% reported increased side effects
  • 5% indicated patients needed frequent or very frequent office visits
  • 5% said patients needed frequent or very frequent calls with pharmacies

The survey found that non-medical switching occurs across several specialties and that it can adversely affect patient care. Similar results were noted in a separate survey that sampled over a 1,000 physicians—physicians felt non-medical switching negatively impacted treatment efficacy, side effects, medication adherence, out-of-pocket costs, and medication errors.

Along with the adverse clinical impact of non-medical switching, there is the aspect of fairness. While consumers are bound by law to pay the premium, co-pays, deductibles, and honor the contract’s terms, insurance plans are not held to those same standards. Enrollees choose a certain plan based on their medical care and prescription needs. Being forced to switch in the middle of that contract is unfair on the patient.

We hope that Governor Hochul will support the bill and make it a law.

 

The Medicaid Performance Measures work group has voted to add the colorectal cancer (CRC) screening measure to the 2022 Adults Core Set. This will be taken into consideration when CMS finalizes the measures to be included in the core set. While this is not the end game, it is a good start for stakeholders to begin thinking about meeting CRC screening benchmarks within their Medicaid population.

According to 2018 data from the American Cancer Society, only 54% of age-eligible (50 years and above at that time) Medicaid-insured adults were current with their CRC screening as opposed to 65% of those covered by private health plans, 73% of those covered under Medicare or Medicare and Medicaid, and 80% of Medicare- and privately insured adults. Research has shown that low socioeconomic status and being covered by Medicaid increases the risk of poor CRC prognosis: those covered by Medicaid have a 50% higher likelihood of being diagnosed at late stage of the disease and dying from it.

The reason for this? CMS does not mandate reporting on Medicaid CRC screening rates. In contrast, Medicare CRC screening rates are a core reporting requirement for Medicare Advantage plans, which along with other HEDIS measures influence the reimbursement bonuses and other benefits for health plans. This then forces the health plan to pay attention to, and perform well on, the measures and results in better health outcomes for enrollees. The proof of this concept was evident from the BeneFIT program that monitored CRC screening rates among two Medicaid managed care plans: one in Oregon (which was required to report on the screening rates) and the other in Washington state (reporting was not mandated). While the Washington plan stopped mailing FIT kits to its Medicaid enrollees by the second year of the program, the Orgon plan expanded its program to add more Medicaid enrollees.

The hope is that once CMS integrates the measure in the 2022 Adult Core Set, CRC screening rates in the Medicaid population will improve and will translate into prevention, earlier detection, and potentially reduced mortality from CRC.

Did you know that the incidence and mortality rates of early-age onset colorectal cancer (EAO-CRC) have skyrocketed in recent years? Many of these patients may not have been screened yet for CRC, and may be misdiagnosed with another gastrointestinal condition. A lack of awareness of EAO-CRC combined with the potential for misdiagnosis and myriad other factors has contributed to patients under the age of 55 being 58% more likely to be diagnosed with advanced CRC than their older counterparts. While individuals with a known family health history of CRC may be more likely to get screened at a younger age, 70% of EAO-CRC cases occur in individuals with no known risk factors, who, therefore, may not have any knowledge of CRC symptoms and may not be inclined to consult a doctor if symptoms arise. 

The rapid rise in EAO-CRC cases makes it vital for primary care physicians to be acutely aware of CRC symptoms (e.g. rectal bleeding and abdominal pain), and not hesitate to refer patients to get screened even if they do not have a family history of the disease or are young. CRC is largely treatable if diagnosed at a localized stage, so it is imperative that patients are made aware of the symptoms and that physicians respond to their concerns appropriately. To learn more about what you can do to combat the rise of EAO-CRC, please take a look at the infographic below.

Final Clinical Alert Infographic Download

 

 

The growth of the telehealth market has highlighted a need for alternative remote outreach methods to reach individuals for preventive/wellness screens. Unlike some other screening tools, such as colonoscopy, fecal immunochemical test (FIT) can be conducted by the person at home and has become an attractive option during the COVID-19 pandemic. Previous studies regarding outreach and FIT testing focused on short-term metrics, such as a one-time intervention and limited follow-up. These studies also did not account for FIT compliance before the studies, which can be a strong predictor of one-time FIT compliance. 

In a recent multiyear, randomized study published in Clinical Gastroenterology and Hepatology, researchers looked at FIT outreach outcomes. The study included 10,771 patients from eight San Francisco Health Network clinics, aged 50-75 years, who were not up-to-date (UTD) with colorectal cancer (CRC) screening. Patients were first stratified by the clinic, gender, race/ethnicity, and FIT history and then randomly assigned to one group. The two groups were: outreach intervention and usual care. The outreach group received a mailed postcard and a phone call, followed by a FIT kit sent to the patient’s home. Patients who did not return the FIT kit after two weeks received two reminder calls. Usual care was left for the participating clinics to decide, including reminder calls, educational material, and coaching. 

Follow-ups for participants went up to 2.5 years unless the patient:

  • Was lost to follow-up 
  • Was 365 days out after an abnormal FIT result 
  • Had gotten a colonoscopy 
  • Had turned 76 
  • Had died 

At the end of the study, the cumulative proportion of patients with FIT completion in the outreach group was 73.2%, versus 55.1% in the usual care group. Patients who had previously done a FIT were more likely to complete FIT through mailed outreach. Outreach also increased FIT completion in patients who had not previously done one. However, the second cycle of mailed outreach did not increase completion in those who had not done so in the first cycle. Patients assigned to outreach were also more likely to be consistently adherent (2 of 2 FIT completed) versus intermittently (1 of 2) or non-adherent (0 of 2). The outreach group also had significantly more abnormal FIT results than the usual care group. As a result, more colonoscopies were also conducted in the outreach groups.

Overall, the study’s findings show that the outreach group had more benefits and compliance for FIT than the usual care group. Although there was no significant difference in CRC cases between the two groups, the outreach group did have more abnormal FIT results, leading to earlier detection and decreasing CRC risk over time. 

Limitations to the study included the use of safety-net populations, who are more likely to have changes in contact information, which could impact overall outreach. Stool-based option successes also require adherence to both FIT and colonoscopy follow-ups for abnormal results. However, the authors did not evaluate compliance with colonoscopy follow-ups in this study. While there was an overall increase in CRC screenings from FIT outreach, more research can be done on how other metrics impact the results. In the meantime, outreach and FIT are beneficial in the current telehealth era that we are in. 

 

Blue Note Therapeutics hosted a panel discussion in May 2021 with clinical experts and patient advisors from Memorial Sloan Kettering Cancer Center (MSKCC) to discuss cancer-related distress and how to navigate it in both a patient and caregiver role. 

Jimmie Holland, MD, a psychiatrist, pioneered the field of psycho-oncology to what it is today. She was very interested in the emotional aspects of cancer and wanted to address the humanistic elements of dealing with cancer. Each of the panelists continues to work towards what Dr. Holland initially set out to dohelp patients undergoing treatment at MSKCC face the stressors associated with the various stages of diagnosis, treatment, and survivorship. Both patient advisors have been through each role as a patient, caregiver, and survivor and highlighted how psycho-oncology has helped them cope with everything. 

Cancer-related distress, Haley Pessin, PhD said, “stems from having an illness and centers around that. But it can take a lot of different forms: It can be sadness and depression, it could be anxiety, worry, it could be anger, it could be feeling helpless and hopeless, feeling overwhelmed, not being able to navigate things.” He explained that while the statistics may vary depending on the study, about 35-80% of cancer patients experience distress, compared to 8-10% that may experience it in the general population. The clinicians use a distress thermometer that lists about 40 items to address concerns and problems appropriately and to understand the origin of stressors in the patients’ lives. 

When the panel was asked whether treatment for cancer-related distress could influence other areas of the disease like physical pain or the need for opioids, William S. Breitbart, MD said, “There are several areas in which psychosocial interventions can be used to ameliorate these nonsomatic components of cancer pain.” Another panelist, Wendy Lichententhal, PhD, spoke about how mental health providers can help alleviate stress and potentially improve medical outcomes. Psychological support can ease concerns and stressors and can help patients adhere to their medication and treatment regimens.

Even while receiving psycho-oncology treatment, it is very common for patients to yo-yo in their feelings of stress. For example, at the onset of diagnosis, patients might experience high stress levels, which might be lower post-treatment. This is very common not only for patients but also for caregivers. When encountering such a rollercoaster of emotions, patients might feel like a burden when wanting to ask for additional help from their medical team, but Allison J. Applebaum, PhD, says it is not a burden at all. Instead, it is as simple as saying, “I am having difficulty coping. Who, here or in the community, can provide support to me?” Not only are patients and caregivers encouraged to advocate for themselves, but also healthcare professionals should be doing the same. 

Highlighting the importance of mental health, Anne Marie, a patient advisor, said that it is of prime importance when coping with any serious health condition. Her recommendation is that when asked on a distress screener, patients should let the medical team know when they need help managing and handling issues beyond just their medical symptoms. There are many services and resources available to help patients and caregivers who may be struggling with their mental health. Learn more about them here: https://coloncancerfoundation.org/mental-health-cancer/.

 

At this year’s annual meeting of the American Society of Clinical Oncology, over 400 abstracts related to colorectal cancer (CRC) were presented. Here’s a glimpse into some of the early-age onset CRC research and how biological factors such as hyperlipidemia and the presence of circulating tumor cells may influence prognosis.

 

Early-Age Onset CRC:

  1. EAO-CRC, Infertility, and Sexual Dysfunction: The rates of early-age onset colorectal cancer (EAO-CRC), defined by the incidence of CRC in individuals under 50 years, have been increasing in the U.S. This pattern is even more concerning when considering the negative impact of CRC treatments on fertility and sexual function. Laura Diane Porter and team set out to explore the needs of EAO-CRC patients as they relate to fertility and sexual dysfunction by analyzing data from a questionnaire filled out by 884 EAO-CRC patients and survivors aged 20-50 years. Results from the questionnaire showed that 37% of women and 16% of men were left infertile after their treatments, but only 31% were referred to a reproductive endocrinologist. Additionally, more than 25% of respondents indicated they would have pursued alternate treatments had they known about the negative sexual effects of CRC treatment. These results indicate a need for providers to engage in transparent, supportive conversations with EAO-CRC patients about the impact of CRC treatment on fertility and sexual function

  2. Screening Guidelines for Patients with a Family History of CRC: As the rates of EAO-CRC increase, it is important to consider whether screening guidelines (SGs) accurately aim to detect and prevent it. Currently, there are established SGs on hereditary EAO-CRC, but screening for those with non-hereditary EAO-CRC who are at an increased CRC risk due to a family history of it remains poorly studied. Researcher Y. Nancy You and team aimed to define the proportion of individuals with non-hereditary EAO-CRC who also have a family history of CRC. Additionally, they set out to determine whether SGs could have helped prevent/detect EAO-CRC in this cohort. 329 EAO-CRC patients were analyzed for familial history of CRC, defined as having a first- or second-degree relative with CRC. Results showed that 27% of these individuals had a family history of CRC, and that half of the patients were screened for and diagnosed with EAO-CRC at an age earlier than the current SGs suggest for people with a family history of EAO-CRC. This indicates that refining current SGs for individuals with a family history of CRC can potentially aid in preventing/detecting EAO-CRC.

 

Biological Factors:

  1. Relationship Between CTCs and TILs in Patients with CRC: Circulating tumor cells (CTCs) are cells that have separated from a primary tumor to circulate in the bloodstream. The number of CTCs in the blood affects the risk and rate of metastasis, according to the abstract presented by Inna A. Novikova and team. The team wanted to investigate the association between CTCs and tumor infiltrating leukocytes (TILs), a type of immune cell that recognizes and kills cancer cells by moving from the blood into a tumor. The study included 299 patients with stage II-IV CRC. The number of CTCs in their blood was counted using a blood test, and their TILs were identified via histological processing of their tumor material. Results showed that in patients with moderate to strong lymphocytic infiltration, there was a notable absence of CTCs. Conversely, the presence of CTCs was most often seen in cases of weak lymphocytic infiltration. These results indicate that there is a relationship between CTC levels and the intensity of lymphocytic infiltration, which “can be used as a new prognostic approach.”

  2. Hyperlipidemia and CRC: Hyperlipidemia is a condition in which there are high levels of fat particles (lipids) in the blood. According to the abstract presented by Zahid Tarar and team, recent studies have shown that lipids play a role in tumor metastasis. Thus, the team set out to investigate the effect of hyperlipidemia in patients with a history of CRC, specifically in regard to mortality, hospital length of stay, and cost. Using the National Inpatient Sample Database for the year 2018, the team identified 34,792 patients with a history of CRC and hyperlipidemia. After conducting various analyses, the team found that patients with hyperlipidemia had lower odds of CRC-related mortality. Additionally, hyperlipidemia did not affect hospital length of stay or cost. The team postulated that statin therapy prescribed for patients with hyperlipidemia could have played a role in the lower odds of mortality seen for these patients. Thus, further research into hyperlipidemia’s effects on CRC should be conducted, and future studies should look specifically into the potential protective effects of statins in relation to CRC mortality. 

 

The American Society of Clinical Oncology held their annual meeting from June 4-8, 2021, where over 400 abstracts related to colorectal cancer (CRC) were presented. We at the Colon Cancer Foundation highlight some notable ones related to technological advancements, socioeconomic factors, and clinical care below. 

 

Technological Advancements:

  1. Using AI to Predict CRC progression: What if artificial intelligence (AI) could be used to predict disease progression and mortality in patients with metastatic CRC? That is the question Carlos Maria Galmarini presents in their abstract. By using patient datasets from two randomized phase III clinical trials, Galmarini and team created synthetic “fingerprints” (SFs) for each patient by integrating 44 various clinical features. These SFs were subsequently inputted into a deep learning framework (DLF) to categorize patients based on similarities. The SF/DLF system was able to categorize metastatic CRC into different subtypes based on clinical features that correlate with higher risk of disease progression and mortality, indicating that AI could prove beneficial to the cancer community. 

 

  1. Using miRNA and Machine Learning to Detect Cancer: Circulating microRNA (miRNA) have been associated with certain types of cancers, and their expression profiles are theorized to be cancer biomarkers. As such, Juntaro Matsuzaki and team investigated whether the combination of a novel diagnostic blood test and machine learning techniques could be used as a tool for the early detection of cancer. By processing the serum samples from individuals without cancer and comparing it to individuals with breast, colorectal, lung, stomach, and pancreatic cancer respectively, the team analyzed the entire miRNA expression profile of the samples using next generation sequencing. The expression profile was then used to train machine learning models. The diagnostic model showed an 88% accuracy for all five cancer types, indicating that circulating miRNAs can be useful biomarkers for the early detection of these cancers. 

 

Socioeconomic Factors:

  1. Intersection of Race & Rurality in CRC Surgical Treatment & Outcomes: It is widely known that racial disparities exist when it comes to CRC care, but the intersection of rurality and race on surgical treatments and outcomes among patients with nonmetastatic CRC has not been fully explored. To fill this knowledge gap, Niveditta Ramkumar and team studied 57, 710 Medicare patients who underwent surgery for non-metastatic CRC between 2016 and 2018. The patients were categorized by their race and area of residence, which was classified as metropolitan, micropolitan, and small/rural. Results showed that Hispanic patients and other minorities living in non-metropolitan areas had higher odds of facing 90-day surgical complications compared to individuals living in metropolitan areas. There was no such disparity found for white patients. Additionally, patients from minority groups had higher odds of 90-day mortality in rural areas compared to metropolitan areas, while white patients had lower odds. These results indicate the necessity to further explore the intersection of race and rurality when it comes to CRC treatment and outcomes so that specific guidelines can be enacted to protect patients belonging to vulnerable socioeconomic groups. 

 

  1. Impact of Socioeconomic Status on CRC Care: Socioeconomic factors are known to affect CRC care at all levels, but the research surrounding this topic is limited and conflicting. Therefore, Rajan Shah and team set out to explore how socioeconomic status (SES) affects CRC stage at presentation, receipt of diagnostic imaging and treatment, and overall survival. To meet this end, the team identified and analyzed data from 39,802 colon cancer and 13,164 rectal cancer patients in Canada using the Ontario Cancer Registry. In both cohorts, patients of lower SES were more likely to present at a higher stage, less likely to receive MRIs and other diagnostic tests and treatments, and had a less likely chance of overall survival. These results indicate the importance of focusing on CRC patients of lower SES to eradicate disparities in CRC care. 

 

Clinical Care:

  1. Access to Cancer Care for Medicaid Patients: According to the abstract presented by Victoria A. Marks, one in five Americans are insured with Medicaid. However, the large number of Medicaid patients does not necessarily indicate an increased access to care at Medicaid facilities. Thus, the team investigated the acceptance of Medicaid patients with new cancer diagnoses at various facilities across the U.S. They evaluated access to cancer care for a variety of cancer types (colorectal, breast, urologic, and skin) at hospitals accredited by the Commission on Cancer, and used data from the American Hospital Association and Centers for Medicare & Medicaid Services to study Medicaid access. Results showed that Medicaid acceptance was lowest in for-profit facilities and comprehensive cancer community centers. In hospitals that accepted Medicaid, only 68% of them accepted all four cancer types. These results suggest there are disparities that need to be addressed in regard to cancer care access for Medicaid patients, both between and within facilities. 

 

  1. Influence of Fellowship Training on CRC Post-Operative Outcomes: Christopher Thomas Aquina and team set out to investigate the relationship between fellowship training and surgical outcomes in CRC patients. Using two New York-based patient databases, the team identified patients who underwent stage I-III colorectal adenoma resection between 2004 and 2014. They analyzed the relationship between patient surgical outcomes and surgeon certification via the American Board of Colorectal Surgery. High volume colon surgeons (HVCS) were identified as those who performed more than 15 colon cancer resections annually, and high volume rectal surgeons (HVRS) were identified as those who performed more than 10 annual rectal resections. Results showed that patients with board-certified, HVC/HVR surgeons had better outcomes post-surgery and were associated with improved survival following resection. This suggests that individuals seeking CRC resections should go to board-certified, HVC/HVR surgeons for the best chance of recovery and survival.