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Dr. Shahnaz Sultan: Pre-Endoscopy COVID-19 Testing Led to Disparities

The Colon Cancer Foundation had the opportunity to speak with Dr. Shahnaz Sultan, MD, MHSC, AGAF, about her research team’s findings that pandemic-related pre-procedure COVID-19 testing caused higher rates of endoscopy cancellations among patients from marginalized populations. A Professor of Medicine in the Division of Gastroenterology, Hepatology, and Nutrition and the Program Director for the Gastroenterology Fellowship Training Program at the University of Minnesota, Dr. Sultan’s research interests are focused on reducing colorectal cancer morbidity and mortality by improving adherence and quality of colonoscopy.

Q: What is the main takeaway you want people to understand from your research?

One of the most important things we want to emphasize is that colorectal cancer [CRC] is a very preventable cancer and there is a lot of high-quality evidence that shows that screening for CRC actually leads to a reduction in associated mortality. We really need to think about CRC screening along a continuum—whether you are doing stool-based testing or you’re getting a colonoscopy, it’s a multi-step process, and at every step, we need to be cognizant about reducing barriers and helping patients complete their CRC screening tests. Adding another step that patients have to complete prior to colonoscopy, such as pre-procedure SARS-CoV2 testing, in addition to completing their bowel prep, following dietary guidelines, finding transportation, and coming in to get a colonoscopy, really makes it that much more challenging. Pre-procedure testing serves as one more step and one more possible barrier in terms of getting people up-to-date with their screening. 

Q: As you were conducting your research, were there any findings that surprised you?

Our objective here was to understand the impact of pre-procedure COVID-19 testing—we wanted to see the magnitude of the impact and who was specifically affected by this additional requirement. When we looked at the canceled outpatient endoscopy procedures in our cohort from March 2021 to September 2021, we were surprised that the overall cancellation rate was so high in terms of getting people to complete their colonoscopy. Among the 574 cancellations, a little under 10% were due to pre-procedure COVID-19 testing requirements, and a good proportion of the remainder, about 51%, were patient-initiated cancellations. There were a lot of additional factors that were potentially holding people back from CRC screening. Additionally, we were surprised that pre-procedure testing was disproportionately affecting certain populations. Persons who self-identified as Black, American Indian, Alaskan Native, or Hispanic were more likely to have testing-related cancellations. 

Dr. Shahnaz Sultan

Q: Of the patients who canceled their colonoscopy, do we know if they went for an alternate form of testing for colorectal cancer, such as stool-based testing?

That’s an interesting question! We do not have that health data within our health system, but you bring up a good point. During the pandemic, a lot of other health systems were shifting gears from colonoscopy to stool-based testing and using programmatic efforts to directly reach out to patients to make sure they were getting some form of CRC screening. 

Q: Healthcare challenges, such as the COVID-19 pandemic, have demonstrated to significantly disrupt CRC screening procedures and participation, especially for medically underserved communities. What steps can be taken or what policies can be implemented in the future to support CRC screening participation and prevent significant disruptions to CRC screening?                                              

There is a lot of ongoing research to understand different barriers we can address or different interventions we can take to improve screening at the population level. We really need a multifaceted or multi-pronged approach to screening. We really need to think about interventions that not only focus on patients, but we also need to target providers, health systems, and community leaders, and think about national and federal policy decisions. I think there are a lot of opportunities to decrease barriers at different levels in terms of getting people to be more up-to-date with screening at a population level.

In terms of policy, one of the things that we have been able to fix recently is this loophole that existed in the past where if a test was done for screening purposes, but polyps were removed, then it was no longer counted as a screening test, and that incurred copayments and additional burdens on patients. I think that has been a real coup for us in the gastroenterology community and overall in terms of helping to support the care of our patients. Also, I think there are a lot of opportunities at the national level to support programmatic efforts to improve screening for populations that are underinsured or don’t have access to care, and I think we need to do more outreach and find ways to include health educators and patient navigators. We need to make sure we are educating patients about the importance of screening and helping address financial or logistical barriers that might serve as additional challenges for patients to overcome.

Continued on Page 2.

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ASCO: Studies Identify Associations and Disparities in Colorectal Cancer Care

There is little known about the connection between various factors (such as environmental quality index, unmet needs, cancer survivorship, etc.) and the outcomes of patients affected by colorectal cancer (CRC). Studying the trends and associations around the onset and progression of CRC is integral to educating people on risk reduction. Additionally, using a disparity lens can aid decision-making processes and allow providers to target high-risk populations who may be in need of greater assistance and care. 

Several such studies were presented at the 2022 annual meeting of the American Society of Clinical Oncology. For example, Suleyman Yasin Goksu and team studied the association of young-onset CRC with the national level Environmental Quality Index (EQI). Their greatest finding? YOCRC can be linked to lower environmental quality. Additionally, Megan E. Delisle and team identified the association between unmet needs (in the physical, emotional, and practical sense) and survivors’ utilization of emergency services in the first three years following treatment. They found that a greater amount of unmet needs could be linked to higher utilization of emergency services–which is an issue that can be resolved through preventative measures. Both these studies reach important conclusions regarding how we draw patterns from disease. 

Here are some other studies from ASCO that dived into disparities and early-age onset CRC (EAO-CRC) outcomes:

  1. Disparity of treatment-related adverse events and outcome in patients with early-onset metastatic colorectal cancer (mCRC). With the marked rise of early-onset metastatic CRC (mCRC), there is a gap in diagnosis and adverse events related to treatment. Patient outcomes have not been conclusively studied, so Lingbin Meng and team reviewed the potential age-related disparity and its causes. Using individual patient data from three clinical trials in Project Data Sphere, patients were categorized into three age groups and sorted by adverse events. Patients younger than 50 had shorter median overall survival, higher incidence of toxicity (abdominal pain, severe anemia, and nausea/vomiting), but lower incidence of severe diarrhea, neutropenia, and fatigue. This group had the earliest onset of these adverse events and was associated with worse overall survival. Some of these disparities may be explained by distinct genetic profiles, but overall, patients with early-onset mCRC had worse outcomes and endured greater overall treatment-related adverse events. This study provides a basis for developing a personalized treatment plan when selecting patients for chemotherapy, providing counseling, and monitoring adverse events.
  2. Modifiable and non-modifiable risk factors associated with early-onset colorectal cancer: Analysis of the National Health Interview Survey. Risk factors for EAO-CRC are largely understudied, while on the other hand, there is a rapid increase in incidence. Hyeun Ah Kang and Yahan Zhang of The University of Texas at Austin studied modifiable and non-modifiable risk factors associated with the rise. Their cross sectional study analyzed data from the 2004-2018 National Health Interview Survey (NHIS). Individuals between the ages of 18 and 49 with a history of CRC diagnosis at the time of the interview were compared with their non-cancer counterparts. Additionally, the researchers also compared their non–age-related characteristics to those with late-onset CRC, meaning after 50. One hundred and fifty six patients with EAO-CRC were identified. Results from the comparisons showed that greater odds of EAO-CRC were associated with older age, living in the Midwest, and history of alcohol consumption. Lower odds were associated with Hispanic or Asian race and a lifestyle of vigorous physical activity. This study points to both modifiable and non-modifiable characteristics of EAO-CRC risk. Further studies can help identify the associated risk in-depth.
  3. Racial disparities in receipt of guideline-concordant care for early-onset colorectal cancer in the U.S. Black patients diagnosed with EAO-CRC have worse survival than their white counterparts, even in lieu of early-stage disease. Leticia M. Nogueira and team studied these racial disparities, with specific focus on guidance-concordant cancer care.The study included newly diagnosed non-Hispanic black and white individuals  between the ages of 20 and 49. Demographics, comorbidities, and insurance coverage were added to multivariable models to predict their contribution in the disparities with quality measures. Out of the 84,728 colon and 62,483 rectal cancer patients, 20.8% and 14.5%, respectively, were black. They were less likely to receive guideline-concordant care than white patients, which was primarily driven by insurance coverage rather than demographics or comorbidities. Overall, black patients received worse and less timely care than their white peers. Health insurance, a modifiable factor, was identified as the largest contributor to this gap. This study suggests that access to care can significantly influence EAO-CRC outcomes.
  4. Racial parity in rectal cancer treatment and outcomes within an integrated healthcare system. Hyunjee V. Kwak and team also looked at the survival outcomes of patients in the context of their race. They conducted a retrospective study of patients at the Kaiser Permanente Northern California health system, who were treated between 2010-2019. The study included over 3,500 patients diagnosed with rectal adenocarcinoma. Using self-reported race information, various analyses evaluated differences in race, age, stage of diagnosis, treatment, and overall survival. There was a greater proportion of Black patients with localized disease, who also had the longest overall survival. Hispanic patients were more likely to be male, younger, and have a shorter overall survival. These results show a gap in survival outcomes for patients treated at a large integrated healthcare system, where access to care is roughly equal. This calls for an improvement in outreach and screening, as well as awareness in these communities.
  5. Trends and disparities in the treatment of older adults with colon cancer. Half of the patients diagnosed with colon cancer are aged above 70, yet there is a huge gap in treatment for this population. Most are undertreated, perhaps due to age-related biases. Philip Q. Ding and team looked at age-related disparities in the realm of CRC care. Their retrospective, population-based study of adults diagnosed with CRC between 2010 and 2018 in Alberta, Canada included more than 10,000 patients, 48% of whom were over 70 years old. Upon further examination, it was found that older age correlated with more comorbidities and less advanced disease. Despite this, there was no statistically significant correlation between age and treatment status. As compared to the younger group, the odds of receiving surgery and systemic therapy were three and five times lower (respectively) among older patients. These two interventions continue to improve the outcomes of colon cancer in old and young patients alike, but the rates of treatment were lower in older patients and with minimal change over time. This study highlights a disparity in CRC care within the geriatric population.

Identifying these trends and disparities is just one step towards improved CRC care. It empowers patients to identify their personal risk and also gives their provider another factor to consider for treatment and prognosis. Understanding these correlations may be the next step in eliminating the gap in care for many populations.

 

Juhi Patel is a Colorectal Cancer Prevention Intern at the Colon Cancer Foundation.

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Younger Patients at Greater Risk of Distant Stage Early-Onset Colorectal Adenocarcinoma

With an observed increase of distant-stage colorectal cancer (CRC) among young patients in recent years, researchers have been searching for the reasons behind rising numbers and ways to counteract them. Carcinoids, a subtype of slow-growing cancer, have been found to contribute to the steadily rising incidence rate of early-onset colorectal cancer, which is diagnosed before the age of 50. This has created a need to assess the shifts toward distant-stage adenocarcinoma and its impact on public health.

Why Are We Seeing This Increase?

A study recently published in Cancer Epidemiology, Biomarkers & Prevention sought to understand how the proportions of distant-stage disease changed over time. Several studies have identified a significant increase (49%) in the average annual percent change for distant stage colorectal cancer in the 20-34 years age group. However, many of these studies do not report histological subtypes of CRC. 

With carcinoids increasing in younger patients, it is important to look at adenocarcinoma (most common cancer of the colon and rectum) staging independently from carcinoids (neuroendocrine tumors). Therefore, these researchers focused specifically on adenocarcinomas. Yearly adenocarcinoma incidence rates from the 2000-2016 Surveillance Epidemiology And End Results (SEER) data were stratified by stage, age, subsite, and race for 103,975 patients. Changes in the three-year annual incidence rate were calculated with the percent contribution of each cancer stage. Lastly, the subgroup with the highest proportion of distant-stage disease was determined.

The greatest percent increases were seen in distant-stage cancer when comparing data from 2000-2002 with 2014-2016. Here are a few significant findings of the study:

  • Colon-only distant adenocarcinoma increased most in 30-39-year-olds (49%)
  • Rectal-only distant-stage adenocarcinoma increased most in 20-29-year-olds (133%)
  • Based on race:
    • Distant stage proportions increased most for both colon- and rectal-only subsites in 20-29-year-old non-Hispanic Blacks (14% and 46%, respectively) 
    • The second most-impacted group was 20-29-year-old Hispanics with a 13% increase in the proportion of those affected by rectal-only, distant stage adenocarcinoma.

From these findings, we can conclude that the greatest burden of disease was on younger patients, highest in the non-Hispanic Black and Hispanic subgroups (despite relatively low absolute case counts). The researchers also uncovered that there is a decrease in early-stage disease in these early-onset groups. As we now know, younger patients are presented with higher risks, but the absolute incidence rates in the youngest subgroups remain relatively low.

These findings are important because they set a new precedent for patients under 50 who may not be aware that preventive screening for those at average risk of CRC starts at 45 years. Studies moving forward should also note that not all adenocarcinomas are categorized as early-onset CRC. Although this study is limited in its observational nature, it raises important questions in analyzing staging results, promoting screening opportunities, and keeping the general public aware of their risks. This study also presents potential solutions, including optimizing earlier screening and the risk-stratification of younger patients by family history and symptoms.

 

Juhi Patel is  Colon Cancer Prevention Intern.

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Healthy Inside and Out: How Diet and Lifestyle Impact Colorectal Cancer

Diet and lifestyle play a large role in colorectal cancer (CRC) prevention and prognosis. Dietary factors such as consumption of meat, sugary drinks, and alcohol, and lifestyle factors such as western diet patterns, being overweight or obese, physical inactivity, and smoking can add to the risk of CRC.

Diet and the Risk of CRC

A systematic review of multiple research studies has shown that a diet high in red and processed meats and low in fiber is a prominent risk factor for CRC and can lead to DNA damage, gut epithelial damage, cell proliferation, and genotoxicity from the nitrates that are added as a preservative. A diet high in red meat and processed food can be damaging for CRC patients and survivors and can increase the risk of mortality. 

Including fiber, vegetables, and fruits in the diet is definitely healthy and can also prevent CRC. The Mediterranean diet—which includes fruits, vegetables, fish, and whole grains is a healthy preventive option to adopt in your food habits.

Research also points to a significant relationship between the consumption of processed meat and the development of early-age onset CRC (EAO-CRC), which developed among those younger than 50 years. A rapidly rising cancer across the globe, about 20% of EAO-CRC cases can be attributed to family history, and the remaining to other factors including diet and lifestyle.

  • Consumption of two or more sugary beverages per day doubles the risk of developing EAO-CRC in women 
  • An increase in consumption of sugary beverages in adolescence is associated with a 32% increased risk of developing EAO-CRC  
  • Consumption of sugary drinks is also known to increase the risk of mortality in CRC patients 
  • Alcohol consumption (greater than 14 drinks per week) also increases the risk of developing CRC.

Lifestyle Habits and the Risk of CRC

It is a well-known fact that a healthy lifestyle promotes health and well-being, while an unhealthy lifestyle can lead to health problems. Physical activity is important for overall health and studies point to physical inactivity and a sedentary lifestyle as major risk factors for CRC. Women who reported little to no physical activity after the age of 20 had a heightened risk of developing EAO-CRC.

Reduced physical activity can contribute to several different health problems, the most evident being obesity. Obesity modifies the gut microbiota leading to an increase in inflammation that damages the intestinal barrier. Obese and overweight individuals have a 42% higher risk of developing EAO-CRC than those at a healthy weight (an individual is considered to be a healthy weight if their BMI is between 18.5 and 24.9). There is also a correlation between obesity and the development of metabolic syndrome, which is a combination of multiple conditions that increase the risk of heart disease, stroke, and diabetes. Metabolic syndrome has been identified as a leading comorbidity in the development of EAO-CRC.

Smoking is also a significant risk factor in multiple cancers including CRC. Current smokers are at a higher risk of developing EAO-CRC, while past smokers may find their risk reduced. 

It is important to understand the significant role of diet and lifestyle in disease development. Maintaining a healthy diet, such as increasing fruit, vegetable, and fiber intake as well as decreasing one’s consumption of red meat, processed meat, and sugary beverages can prevent CRC. This, coupled with a healthy and active lifestyle can significantly reduce the risk of developing CRC. 

 

Abigail Parker is a Colon Cancer Prevention Intern with the Colon Cancer Foundation.

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Research on Early-Age Onset Colorectal Cancer Presented at ASCO

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. 

 

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ASCO: Technology, Socioeconomic Factors Can Influence Colorectal Cancer Outcomes

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. 

 

 

 

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Early-Age Onset Colorectal Cancer Summit, Day 3 Panel Discussion: A broad-spectrum approach to a young adult patient with colorectal cancer

Advancements in screening, diagnosis and treatment of colorectal cancer have come a long way in the past two decades, but the need to continue to spread awareness of the disease among young people and continued industry-wide collaboration and investment is necessary to offset the growth in incidence under the age of 50. Those were among the key topics of the 7th annual Early-Age Onset Colorectal Cancer Summit.

The three-day conference, which was held online in a virtual format because of ongoing Covid-19 precautions, concluded on Sunday, May 16. It was organized by the Colon Cancer Foundation, a New York-based 501(c)3 non-profit organization dedicated to reducing colorectal cancer incidence and death. (Presentations from all three days can be viewed online andCME and MOC credit will be available for 30 days.)

At the outset of the third day of the summit, a panel of distinguished experts addressed the case study of a 28-year-old colon cancer patient from a broad-spectrum approach, offering input on patient perspective, nurse navigation, genetics, medical oncology and new therapeutics, surgery, financial burden/toxicity, radiation oncology, psychological needs, pediatrics and palliative care.

The female patient in the opening panel discussion was described as presenting with a multi-year history of chronic constipation for which she took laxatives. Six months prior to visiting an emergency room, she started experiencing a change in symptoms with tenesmus, rectal pain, bowel urgency with intermittent rectal pressure deep in the pelvic region that worsened with prolonged standing.

At the ER, she had an abdominal/pelvic CT scan that showed presence of a moderate amount of stool in the ascending colon, a thick-walled appearance of the rectum about 6cm from the anal verge down to the anal canal/anorectal junction. Those abnormal symptoms prompted a colonoscopy that showed a non-circumferential mass in the distal rectum to the anal verge. A biopsy returned as invasive moderately differentiated adenocarcinoma.

The patient was described as healthy with a BMI of 22 and had no other medical history and was not taking any medications. The only colorectal family history she had was that her father had several polyps removed after the age of 50.

1. Spreading the message about early-age onset colorectal cancer to young people is crucial so symptoms aren’t overlooked or disregarded.

Often young people ignore or miscategorize their symptoms or are too busy to visit their doctor or aren’t concerned because of a lack of family history or because they lack general awareness about colorectal cancer. In some situations, the initial symptoms have disregarded after being attributed to hemorrhoids or other common benign conditions.

“About 70 to 80 percent of our patients that have colon or rectal cancer do not have a family history of the disease, even if someone in the family had a colonscopy and had polyps removed. I always think it’s important to get pathology of the polyps of family members and also to make sure the parents and siblings of the patients have had colonoscopies.”
— Zsofia Stadler, MD, Associate Professor, Clinical Director, Clinical Genetics Service, Memorial Sloan Kettering Cancer Center

“It typically takes about 270 days from the onset of symptoms to diagnosis in young patients because. Most of the time, their symptoms are dismissed as something benign like an upset GI tract that everyone has. As a result, they usually are not given the medical attention that they deserve.”
— Manju George, MVSc, PhD, Scientific Director, Paltown Development Foundation.

2. The top priority with younger colorectal cancer patients is curing the cancer, but there other quality-of-life issues are critical.

An ensuing pelvic MRI confirms a tumor that arises from the right lateral wall at the level of the levator. The distal edge of the tumor is at 2cm from the anal verge and the tumor abuts the internal sphincter. It is at clinic stage III (mrT3aN1b). In this kind of case with a distal tumor, sphincter preservation is very unlikely, and local recurrence is higher for distal tumors than for proximal tumors.

All three modalities of treatment would likely be considered for this patient: chemotherapy because she’s at risk of distant spread, radiation for local control and the distal location and an abdominal perineal resection surgery to maximize disease control. But quality of life priorities that must be considered include maintaining fertility and avoiding a permanent colostomy.

“This is a great case because it’s so illustrative of so many issues, but it’s also a terrible case because when you see cases like this you know the discussions are going to be very difficult and there is no perfect solution and compromises are going to need to be made.”

— Harvey Mamon, MD, PhD, Associate Professor, Radiation Oncology, Harvard Medical School, Director of GI Radiation Oncology, Brigham And Women’s Hospital, Chief, Division of Gastrointestinal Radiation Oncology

3. Fertility preservation options should be discussed as soon as possible after diagnosis.

When a patient has more time to consider egg harvesting or freezing sperm, they can consider it and accomplish it without significantly delaying the onset of their cancer treatments.

“We do want to see these patients as soon as possible, not only because it gives them more options and more time for options. When we talk to patients about fertility preservation, we want them to take a more bird’s-eye view instead of just whether or not they want to freeze their eggs or sperm. They also have to answer questions about whether they can carry a pregnancy after radiation treatment or do genetic testing in the case of a genetic mutation.”

— Terri L. Woodard, MD, Associate Professor Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center

4. Early psychological and social support is necessary for young colorectal cancer patients.

Early referral for a psycho/social assessment is especially important for adolescent and young adult colorectal patients who will have to transition to a permanent colostomy. Reducing the anxiety and depression related to the necessary changes in daily life, family, jobs, social interaction and more

“As clinical social workers and oncology social workers, the No. 1 goal is making sure we meet that patient where they are at and get a sense of who they are, who their support is, if they have any barriers to care based on their socioeconomic status and understanding workplace issues.”

— Krista Nelson, LCSW OSW-C BCD FAOS, President of the Association of Community Cancer Centers

“In my experience working with younger patients, it is such an enormous adjustment and really impacts their quality of life and body image and conversation with family and friends and dating and so many different layers of life. Providing support and psychotherapy around anticipating the adjustment and then making the adjustment to life with a colostomy is hugely important.”

— Hadley Maya, MSW, LCSW, Center for Young Onset Colorectal Cancer Clinical Social Worker, Memorial Sloan Kettering Cancer Center

For additional topics addressed in Session IV, view the full presentation online.

Other highlights of Day 3 included breakout sessions about “Understanding and Addressing Disparities in Early-Age Onset Colorectal Cancer” and “Integrating Music Therapy in Cancer” followed by the conference-concluding Session V, a panel discussion titled “How Did This Happen? Investigating the Causes of Early Onset Colorectal Cancers.”

Moderated by Stephen Gruber, M.D., that session addressed the future of early-age onset colorectal cancer that included discussions about mining electronic health record data and integration with large-scale genomic analyses, the international colorectal pooling project, how microbiome interactions contribute to the rise of early-age onset colorectal cancer and how diet, smoking and obesity, as well as maternal obesity and gestation growth.

Gruber stressed the need for continued collaboration and specific investment to help further the fight against the increasing trend of colorectal cancer in younger people.

“This is not a rare disease anymore but at each center there’s a relatively small number of cases,” Cynthia Sears, MD, Professor, Johns Hopkins University School of Medicine. “.  If I can dream, we would create a network, a center of communication and a way to contribute, maybe similar to the TCGA Data Portal – a big data set and some parallel sample collection that would allow, hopefully, the exposure questions to really be pursued. I do think it’s the epidemiology, exposures and sufficient population that we need and it’s hard to get it at one institution.”

In closing remarks, Cindy Borassi, president of the Colon Cancer Foundation, thanked the nearly 300 conference attendees and 50 medical professionals who participated in the seventh annual Early-Age Onset Colorectal Cancer Summit. Sponsors for the summit included Quest Diagnostics, Walgreens, Exact Sciences, Colon Cancer Coalition, Colon Cancer Prevention Project, Taiho Oncology, Daiichi-Sankyo, BRACCO Group, DuClaw Brewing Co. and Squatty Potty

“We invite you to join the discussion, collaborate with thousands of health professionals who are interested in solving the early-age onset colorectal cancer issue,” Borassi said. “I would encourage everyone to tell others to watch the videos on the platform, especially primary care physicians as we all know they are a bit part of the key to solving this issue.”

Day 2 Highlights

Day 2 included the Keynote Address of Stephen Gruber, MD, and Session II, a panel discussion called “The Dimensions of the EAO-CRC Problem: Do We Have Accurate, Regular, Up to Date Measurement of Key Metrics Describing the Early Age Onset Colorectal Cancer Public Health Crisis.” That session included an update about the rising early-onset CRC trends and racial disparities, the impact of COVID-19 on CRC screening and an under-19 incidence and mortality report. Session III was a panel discussion that explored “Risk Assessment/Family History Ascertainment” and included discussions about CRC screening guidelines, increased access to genetic testing and patient access to appropriate care.

Day 1 Highlights

On Day 1, Dr. Whitney Jones, MD, founder of the Colon Cancer Prevention Project, moderated an Session I, a panel discussion about “Improving Earliest Possible Diagnosis and Treatment through Timely Recognition of the Symptoms and Signs of Sporadic Young Adult CRC” with additional topics related to the echo chamber of cyclical discussions, incidence rates and mortality rates by 2040, primary care in improving early diagnosis and a colorectal cancer patient testimonial case study.

To watch any of the presentations, register for the Early Age Onset Colorectal Cancer Summit and access the recorded programs.

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USPSTF Draft Recommendation: Initiate CRC Screening at 45

The U.S. Preventive Services Task Force (USPSTF)—which is made up of an independent expert physician panel who recommend preventive care guidelines—has proposed initiating colorectal cancer (CRC) screening at 45 years for average-risk adults. This is a B grade recommendation. Screening for those between 50 and 75 years remains an A grade recommendation and screening for the 76 to 85 age group is a C grade recommendation.

An A grade recommendation means there is high certainty of a substantial net benefit, a B grade recommendation means that there is a high certainty of a moderate net benefit or a moderate certainty of a moderate net benefit, and a C grade recommendation means the service should be offered based on professional judgement and an individual patient’s situation because there is a moderate certainty of a small net benefit.

Task Force chair Alex Krist, MD, MPH, said, “Unfortunately, not enough people in the U.S. receive this effective preventive service that has been proven to save lives. We hope that this recommendation to screen people ages 45 to 75 for colorectal cancer will encourage more screening and reduce people’s risk of dying from this disease.” The Task Force has particularly recognized the disproportionately high number of CRC incidence and mortality among Black Americans and has urged physicians to offer this screening to their Black patients starting 45 years.

Both direct visualization (colonoscopy, CT colonography, flexible sigmoidoscopy, and flexible sigmoidoscopy with FIT) and stool-based tests (HSgFOBT, FIT, and sDNA-FIT) are included in the screening recommendation.

The draft recommendation is open for public comment till November 23.

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New Screening Strategies From the AGA

A recently published white paper by the American Gastroenterological Association (AGA) titled “Roadmap for the Future of Colorectal Cancer Screening in the United States” states that the development of structured organized screening programs is vital to achieving target colorectal cancer (CRC) screening rates and reductions in CRC morbidity and mortality. The paper includes information shared at the AGA’s Center for GI Innovation and Technology’s consensus conference in December 2018, which outlined the following priorities:

  • Identify barriers to screening uptake
  • Assess the efficacy of available screening diagnostic methods
  • Consider the potential integration of novel diagnostic approaches into screening and surveillance paradigms

 

The paper highlights the following strategies:

Modifications to CRC Screening to Improve Uptake and Outcomes

Although over 1,700 organizations across the 50 states signed onto the “80% by 2018” initiative announced by the National Colorectal Cancer Round Table (NCCRT) in 2014, one-quarter of eligible Americans are yet to undergo CRC screening. Organized screening offers an opportunity for screening improvements by the use of multiple strategies, such as defined target populations, timely access and follow-up, and systematic opportunities for shared decision-making between patients and clinicians. It can also improve efficiency by incorporating noninvasive testing such as annual mailed fecal immunochemical (FIT) tests and colonoscopy alternatives like stool testing. Multiple studies have shown that offering stool testing as an option, in addition to colonoscopy, increases screening uptake, however a diagnostic colonoscopy is still necessary to confirm positive noninvasive test results.

Racial, socioeconomic, and geographic health care disparities also limit screening efficacy. African American and Hispanic American communities and individuals in rural areas in particular face screening barriers, accounting for 42% of the disparity in CRC incidence and 19% of the disparity in CRC mortality between black and white individuals.

The following strategies were discussed to resolve these issues:

  • Incorporate adjunct noninvasive testing to improve screening rates
  • Minimize the ineffective practice of performing re-screening and surveillance colonoscopy sooner than recommended by guidelines
  • Reconsider surveillance strategies for individuals with a history of adenomatous polyps to prevent constraining colonoscopy resources

 

Continued Development of Noninvasive and Minimally Invasive screening Tests

The paper states than an ideal, noninvasive test would “identify lesions with high short-term potential to progress to CRC and should do so with high sensitivity and specificity in a convenient, low-risk, low-cost, and operator-independent manner” that is easy to complete and should achieve high uptake among individuals who are eligible for screening. While an ideal test is yet to be developed, the FIT test and a blood test currently face the least resistance from patients. The researchers propose the development of a noninvasive test that is capable of detecting advanced adenomas and advanced serrated lesions while also being minimally invasive and easy-to-use with a one-time sensitivity and specificity of a minimum of 90%.

 

Improved Personal Risk Assessment for Optimal Programmatic Screening

Current risk assessment guidelines focus on familial and personal colorectal neoplasia risk, but do not acknowledge additional factors such as sex, race, smoking, body mass index, and environmental factors. Family history can be challenging to obtain due to a lack of patient awareness and the health care provider’s limited ability to derive and record the information. The researchers have proposed using patient portals with integrated electronic health record to ensure updated and accurate family health history data and to allow health care providers the ability to accurately assess the patient’s risk by looking at the data in the portal, irrespective of their geographic location. Improved personal risk assessment would help health care professionals select the appropriate CRC screening test method. For example, individuals with a higher risk of advanced adenoma or CRC would be directed to a colonoscopy, while individuals with a lower risk would be directed to a less-invasive screening method.

 

Although initiatives like the 80% by 2018 proposed by the NCCRT are a good step towards increased screening rates, the development of organized screening programs is necessary to further these efforts even more. The desired goal of these screening efforts is testing that is available to at-risk individuals, noninvasive testing methods that are highly accurate and easy to use, increased screening uptake, and reduction in CRC incidence.

 

 

 

 

 

 

 

 

 

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Pembrolizumab Approved as First-Line for MSI-H/dMMR Metastatic CRC

At the virtual American Society of Clinical Oncology (ASCO) annual meeting in May/June 2020, promising results from the interim analysis of phase 3 data from the KEYNOTE-177 trial were presented during the plenary session. First-line treatment of a subset of patients with metastatic colorectal cancer (mCRC) with the immunotherapy drug pembrolizumab doubled the median progression-free survival (PFS) compared to patients treated with standard-of-care chemotherapy. This has now led to an FDA approval for the drug.

Trial Results

KEYNOTE-177 was designed as a global, multicenter, open-label, active-controlled, randomized trial that compared treatment of 307 previously untreated patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) mCRC. Mismatch repair is an inherent property of cells that allows them to correct DNA replication errors, and dMMR cell lack this process, resulting in mutations in the DNA. dMMR cells with alterations in short, repetitive DNA sequences are called MSI-H.  Patients were randomized to receive first-line pembrolizumab alone at 200 mg every 3 weeks for up to 2 years or investigator’s choice chemotherapy: FOLFOX (fluorouracil [5-FU], leucovorin, and oxaliplatin) or FOLFIRI (5-FU, leucovorin, and irinotecan) every 2 weeks, with or without bevacizumab or cetuximab.

This was a crossover trial, meaning patients on chemotherapy could cross over to receive pembrolizumab for up to 35 cycles if their disease had progressed. Primary end points were PFS and overall survival (OS); objective response rate (ORR) was the secondary endpoint.

Median PFS was 16.5 months in the pembrolizumab group and 8.2 months in the chemotherapy group. Pembrolizumab showed a 40% reduction in the risk of disease progression (P=0.0002); PFS rates were 55% vs 37% for pembrolizumab vs chemotherapy, respectively, at 12 months, and 48% vs 19%, respectively, at 24 months. ORR were 43.8% and 33.1%, respectively. While the median duration of response was 10.6 months for chemotherapy (2.8-37.5 months), it had not been reached with pembrolizumab (2.3-41.4 months). Complete responses were achieved in 11.1% and 3.9% patients receiving pembrolizumab vs chemotherapy, partial responses were achieved in 32.7% vs 29.2%, respectively.

Only 22% of patients in the pembrolizumab arm had treatment-related adverse events (TRAEs) compared to 66% in the chemotherapy arm. One TRAE death was reported in the chemotherapy arm.

The study is ongoing and OS data are expected to be presented at a later time.

FDA Approval

The above results have led to the FDA approval of pembrolizumab in previously untreated patients with MSI-H/dMMR mCRC. Importantly, this is the first immunotherapy to receive FDA-approval as first line of care in this patient population.

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