Oncolytic virus TG6002 safety and activity after intrahepatic artery administration in patients with liverdominant metastatic colorectal cancer

The TG6002.03 trial is a dose-escalation phase 1 clinical trial of TG6002 infusion via the hepatic artery in patients with liver-dominant colorectal cancer metastases. TG6002 is an engineered Copenhagen strain oncolytic Vaccinia virus, deleted of thymidine kinase and ribonucleotide reductase to enhance tumor selective viral replication and expressing FCU1, an enzyme converting the non-cytotoxic prodrug 5-fluorocytosine (5-FC) into the chemotherapeutic compound 5-fluorouracil (5-FU). In this trial, patients with advanced unresectable liver-dominant metastatic colorectal cancer who had failed previous oxaliplatin and irinotecan-based chemotherapy were treated with up to 2 cycles of TG6002 infusion 6 weeks apart via the hepatic artery on day 1 combined with oral 5-FC on days 5 to 14 (where day 1 = TG6002 infusion). TG6002 infusion was performed over 30 minutes via selective catheterization of the hepatic artery proper. 5-FC oral dosing was 50mg/kg x4 daily. Blood was sampled for TG6002 pharmacokinetics and 5-FC and 5-FU measurements. Sampling of liver metastases was performed at screening and on day 4 or day 8 for virus detection and 5-FC and 5-FU quantification. In total, 15 patients (median age 61 years, range 37-78) were treated in 1 UK centre and 2 centres in France and received a dose of TG6002 of 1 x 106 (n=3), 1 x 107 (n=3), 1 x 108 (n=3), or 1 x 109 pfu (n=6). Fourteen of the 15 patients received a single cycle of treatment, including one patient who did not received 5-FC, and one patient received two cycles. TG6002 was transiently detected in plasma following administration, suggesting a strong tissue selectivity for viral replication. In the highest dose cohort, a virus rebound was observed on day 8, concordant with replication time of the virus. In serum samples, 5-FU was present on day 8 in all patients with a high variability ranging from 0.8 to 1072 ng/mL and was measurable over several days after initiation of therapy. Seven of the 9 patients evaluable showed the biodistribution of the virus in liver lesions by PCR testing on day 4 or day 8. Translational blood samples showed evidence for T-cell activation and immune checkpoint receptor-ligand expression. At 1 x 109 pfu, there was evidence for T-cell proliferation and activation against tumour-associated antigens by ELISpot and for immunogenic cell death. In terms of safety, a total of 34 TG6002-related adverse events were reported, of which 32 were grade 1-2 and 2 were grade 3. The maximum tolerated dose was not reached, and a single dose-limiting toxicity was observed consisting of a myocardial infarction in a context of recent Covid-19 infection in a 78-year-old patient. These results indicate that TG6002 infused via the hepatic artery in combination with oral 5-FC was well tolerated, effectively localized and replicated in the tumor tissues, expressed its therapeutic payload and showed anti-tumoral immunological activity.

Barriers to in-Person Focus Group Participation during the Third-Year of COVID-19 Pandemic: A Case Study of Colorectal Cancer (CRC) Screening in Underrepresented Groups

Objectives: In the process of conducting research to understand barriers to colorectal cancer (CRC) screening in underrepresented groups such as Blacks and Hispanics, it became evident that there were also barriers to recruitment in this population. This study assesses the challenges faced in recruitment of focus group participants regarding CRC screening practices among underrepresented groups. Since the COVID-19 pandemic, qualitative research participants have primarily been interviewed through online video or audio interactions. However, as restrictions on in-person interactions have been lifted, in-person focus groups are being increasingly considered. Method(s): The study investigators began recruitment through community health workers in August 2022, when COVID-19 vaccines were available for all adults (age>18 years). Eligible individuals were: age 45-75, Black or Hispanic, with Medicaid or no insurance, and no family history of CRC or diagnosis of certain colon-related diseases. We combined in-person and virtual recruitment strategies, including posting flyers in communities, advertising our study at health fairs, and on social media. Participants would receive a $50 gift card. Result(s): Fifty-five met the eligibility criteria among 144 respondents, and 45 subjects (29 women and 16 men) agreed to be contacted. An average of 2.5 attempts were made per eligible subject. Unfortunately, we were able to recruit only four women (3 Hispanic and one non-Hispanic black). Traveling to the research site was a barrier to participation. Many subjects (49%) requested virtual participation (online video or audio interactions);some declined because the topic was too sensitive (considered taboo), and eligible men were reluctant to participate in-person. Conclusion(s): The requirement of in-person participation affected our recruitment goals, suggesting that COVID-19 has shifted the preferences of research participants to virtual interaction. In response to the eligible participant preferences, the study protocol has been revised to re-contact patients and schedule virtual FG sessions.Copyright © 2023

THE IMPACT OF THE SARS-COV-2 PANDEMIC ON THE EPIDEMIOLOGICAL PICTURE AND CHARACTERISTICS OF COLORECTAL CANCER - A RETROSPECTIVE ANALYSIS OF THE DEPARTMENT OF ONCOLOGY AND RADIOTHERAPY, UH of SPLIT, FOR THE YEAR 2020 IN COMPARISON TO PRE PANDEMIC 2017

Introduction: Colorectal cancer is the third most common cause of cancer in the world, after lung and breast cancer, while in Croatia is the most common malignant disease. Among the EU members, Croatia ranks ninth in terms of the incidence of colon cancer and a high second place by mortality. Since 2007, Croatia has had a National Colon Cancer Early Detection Program, but the response rate is still very low - 36% (25-52% depending on county and year).2 Despite the prevention program, approximately 13% of patients in Croatia is initially diagnosed with metastatic disease.1 According to the results of the CONCORD 3 study3, Croatia is at the bottom of the five-year survival (48%) compared to some other western countries (up to 71%) in the world. Method(s): A retrospective analysis was conducted at the Clinic of Oncology and Radiotherapy, CHC Split. Patients with newly diagnosed colorectal adenocarcinoma enrolled in the clinic from January 1, 2020 to December 31, 2020 were processed. The data were analyzed using descriptive statistics methods, with the use of Microsoft Excel tools. Result(s): A retrospective analysis of the medical history identified 269 patients (compared to 387 in 2017) presented at the multidisciplinary team (MDT) of CHC Split who were diagnosed with colorectal adenocarcinoma in 2020. All patients were presented to the MDT before starting the treatment. The median age of patients was 66 years, and the youngest patient was 22 years old. Patients from other counties who did not undergo the entire treatment/monitoring in our institution were excluded from the analysis. 52 patients (19.3%) were diagnosed in the metastatic stage of the disease, in stage 0 4 patients (1.5%), in stage I 32 (12%), in stage II 91 (34%), and in stage III 88 (33%). In 2 patients, the stage couldn't be precisely determined. There is a significant decrease in the number (81 in 2017 and 52 in 2020) but no percentage wise (20.9% in 2017 and 19.3% in 2020) of patients diagnosed with de novo metastatic colorectal cancer compared to the previous analysis from 2017, when 81 of them were detected. Patients diagnosed with metastatic disease were mostly in good general condition: ECOG 0 status 21 patients (40.3%), ECOG 1 24 patients (46.2%), ECOG 2 7 patients (13.5%), while no patient was ECOG status 3 or 4. 32 (57.7%) patients had a left-sided tumor, while 20 (42.3%) patients had a right-sided tumor. Conclusion(s): The results of our retrospective analysis showed a significant decrease in the number of patients compared to previous years. The effect of the smaller number of newly diagnosed patients will be analyzed and the real consequences will be seen, however, the appearance of patients in the later stages of the disease is to be expected.

The relationship between inflammatory diet score and cancer-specific outcomes: Systematic review and meta-analysis

Cancer remains one of the most prevalent diseases in the United States and a leading cause of death. Large prospective studies have found significant correlations between dietary intake and cancer. Chronic inflammation promotes pro-cancer inflammatory environments and nutrition can influence inflammation, with the intake of certain food items increasing inflammatory biomarkers. The objective of this research was to explore the relationship between inflammatory diet score measured by the Dietary Inflammatory index and all-cause mortality, cancer-specific mortality, and cancer recurrence among cancer survivors. Web of Science, Medline, CINHAL, and PsycINFO databases were searched to collect potentially eligible sources that focus on dietary inflammation and cancer outcomes. All sources were uploaded to Covidence software and screened by two independent blinded reviewers. The quality of the sources was assessed using the Newcastle Ottawa scale and relevant data was extracted and transferred to the Comprehensive Meta Analysis software and a random effects model was used to perform meta-analysis. Of the 1444 studies imported into the Covidence software, 13 passed all the screening stages and were included in the final analysis. Eight studies reported on pre-diagnosis diet while five others reported on postdiagnosis diet. Five studies reported on colorectal cancer, four on breast cancer, two on ovarian cancer, one on endometrial cancer and one on prostate cancer. Meta-analysis of the studies found that being in the highest postdiagnosis DII score indicating pro-inflammatory diet significantly increased the risk of all-cause death among cancer survivors by 33.5% (HR = 1.335, 95% CI = 1.049, 1.698, n = 6). Analysis did not show a statistically significant association between DII score and cancer mortality or recurrence (HR = 1.097, 95% CI = 0.939, 1.281, n = 6). Analysis by cancer subtype found a significant correlation between postdiagnosis DII score and all-cause mortality among the breast cancer survivors (HR = 1.335, 95% CI = 1.041, 1.711, n = 3) though there were no significant associations between DII and the outcomes of interest from the other cancer types. The meta-analysis concludes that being in the highest postdiagnosis DII score group significantly increased the risk of all-cause death among cancer survivors. This suggests that risk of all-cause mortality could be reduced for cancer survivors by consuming more anti-inflammatory food components and reducing consumption of pro-inflammatory foods. These findings also warrant more research in this field to clarify the relationship between dietary inflammation as measured by the DII and cancer outcomes, particularly cancer-specific mortality.

The impact of COVID-19 on colorectal screening in Puerto Rico

INTRODUCTION: Puerto Rico has endured three major environmental and public health crises (Hurricane Irma, Hurricane Maria, the unprecedented seismic activity of January 2020) and the coronavirus disease 2019 (COVID-19) pandemic during the past 5 years. All these events might lead to an unquestionable deleterious impact in the prevention of cancer and across the cancer continuum, exacerbating cancer health disparities in the future. Cancer screening plays a critical role in early cancer detection. COVID-19 has significantly hampered screening programs in many countries' cancer screening infrastructure and services, affecting adherence. Cancer is the leading cause of morbidity and mortality in Puerto Rico. Limited information is available about the impact the current pandemic on colorectal cancer screening. In this study, we aim to describe the impact of the COVID-19 pandemic on colorectal cancer screening in 2020 and assess if this impact varied by health regions. METHOD(S): This study analyzed administrative data claims from the Public Health System of Puerto Rico which is managed by the Government of Puerto Rico through the Health Insurance Administration. The Current Procedural Terminology (CPT) codes included for this study were (81528, 82270, G0104, G0105, G0121, G0328, G0464). To assess changes in the numbers of colorectal cancer screening claims between the incurred year (2016 and 2020), Poisson regression was used. Initially, we fitted this model with only the incurred year as the predictor and offsetting the model with the annual average of total insured (univariate model). Based on this model, we estimate the magnitude of association between the number of claims and incurred year using the Prevalence Ratio (PR) of claims. Lastly, Poisson univariate regression model were used for each of the seven health regions (Ponce, Bayamon, Caguas, Mayaguez, Metro, Arecibo and Fajardo) to assess potential geographic disparities. RESULT(S): The numbers of colorectal cancer screening claims significantly decreased by 40% (PRcrude: 0.60, 95%CI: 0.59, 0.62) in 2020 when compared to 2016. However, when adjusting for claim incurred month, sex, health region and offsetting the model with the annual average of total insured, the numbers of colorectal cancer screening claims significantly decreased by 34%, (PRadj: 0.66, 95%CI: 0.64, 0.67). The numbers of colorectal cancer screening claims significantly decreased in all health regions in 2020 when compared to 2016 (p<0.05). However, the most impacted region was the Eastern region, Fajardo, with a 64% (PRFajardocrude: 0.36, 95%CI: 0.30, 0.42) significant decrease in numbers of colorectal cancer screening claims. CONCLUSION(S): COVID-19 had a profound negative effect on colorectal screening in Puerto Rico. Moreover, despite the beneficiaries of this governmental health plan sharing similar sociodemographic and socioeconomic background, regional differences were observed.

Community outreach and engagement to increase colorectal cancer screening in ethnic minority communities

PURPOSE: Colorectal cancer (CRC) is preventable with screening, yet remains the second leading cause of cancer deaths in the U.S. Nationally, CRC screening substantially declined during the COVID-19 pandemic and is underutilized by ethnic minorities and in safety-net systems. Therefore, City of Hope partnered with Federally Qualified Health Centers (FQHCs) and community and faithbased organizations to improve CRC screening among medically underserved communities. METHOD(S): Between October 2020 and October 2022, we implemented a multi-component intervention that included community outreach and education (a multi-ethnic multimedia campaign and community training adapted from the NCI Screen2Save (S2S) program) and clinic-based interventions (provider/staff training and patient education). Intervention reach and training participant surveys were assessed. Within our four FQHC sites, we also compared clinic-level CRC screening rates among age-eligible patients before (June 2021) and after implementation of the clinic-based intervention (June 2022). RESULT(S): Our reach assessment showed that our multi-ethnic multimedia campaign reached 35.4 million impressions, our S2S education training reached 300 diverse community members, and our provider/staff training reached 150 medical providers. Among the 100 providers surveyed, >80% felt confident they could get their patients to complete their CRC screening test and follow-up care. For the clinic-based intervention component, our baseline sample included 11,259 age-eligible patients across the four FQHC sites. Overall CRC screening rates increased from 45% to 52% before vs. after the intervention implementation period. The site with the highest CRC screening rate (>62%) maintained steady rates over the observation period, whereas three sites with lower baseline rates showed greater pre-post improvements (average 15 percentage-point increase). CONCLUSION(S): An overall increase in CRC screening rates was achieved across FQHCs, despite clinic staffing challenges during the COVID-19 pandemic. Intervention implementation is ongoing with attempts to document individual, clinic improvements by race/ethnicity.

Colorectal cancer knowledge and screening change in African Americans: Implementation phase results of the EPICS cluster randomized controlled trial

Introduction : African Americans are disproportionately affected by mortality risk for colorectal cancer (CRC). This study aimed to determine the most effective educational approach of four study arms that enhances the likelihood of pursuing subsequent CRC screening, and to identify the associated factors. Methods : Age-eligible adults (N = 2877) were recruited to participate in a cluster randomized control dissemination and intervention implementation trial entitled Educational Program to Increase Colorectal Cancer Screening (EPICS). The project began in May 2012 and ended in March 2017 (the implementation phase lasted for 36 months). Educational sessions were conducted through 16 community coalitions that were randomized into one of four conditions: website access (to facilitator training materials and toolkits) without technical assistance (WA-TA), website access with technical assistance (WA+TA);in-person training (provided by research staff and website access) without technical assistance (IP-TA);and in-person training with technical assistance (IP+TA). A follow-up to determine participant CRC screening was conducted three months later. Results : Compared to the WA+TA intervention group the two groups of IP+TA and IP-TA indicated significantly higher odds for obtaining CRC screening (OR (95% CI): 1.31 (1.04,1.64);p-value= 0.02 and 1.35 (1.07,1.71);p-value= 0.01, respectively). Though sociodemographic factors were not significantly associated with pursing subsequent CRC screening, the post intervention cancer knowledge increased significantly among the study participants. Conclusions : The importance of in-person interactions, local coalitions and community contexts may play a key role for successfully increasing CRC screening rates among African Americans as reflected through this study. The integration of telehealth and use of other virtual technologies to engage the public in research have increased since the COVID-19 pandemic and should be assessed to determine their impact on the degree to which in-person intervention are significantly more effective when compared to solely web assisted.

Changes in uptake of stool-based colorectal cancer screening during the Covid-19 pandemic.

PURPOSE: Colorectal cancer (CRC) screening is underutilized and endoscopic colon screening includes a number of barriers that were exacerbated by the Covid-19 pandemic. At-home stool-based screening (SBS) increased during the pandemic and potentially reached eligible adults hesitant to be screened by endoscopy. The purpose of this analysis was to examine the change in uptake of SBS during the pandemic among adults not screened within guidelines by endoscopy. METHODS: We used data from the 2019 and 2021 National Health Interview Surveys to estimate uptake of SBS among adults aged 50-75 years, without a previous diagnosis of CRC and without guideline-concordant endoscopic screening. We also examined provider recommendations for screening tests. To examine if changes in uptake differed during the pandemic by demographic and health characteristics, we combined survey years and ran logistic regression models with an interaction term for each factor and survey year. RESULTS: In our study population, SBS increased 74% overall from 2019 to 2021 (8.7% to 15.1%; p < 0.001), with the largest percent increase among those aged 50-52 years (3.5% to 9.9%; p < 0.001). Among those aged 50-52 years, the ratio of endoscopy to SBS changed from 83%/17% in 2019 to 55%/45% in 2021. Cologuard was the only screening test where recommendations by healthcare providers significantly increased from 2019 (10.6% to 16.1%; p = 0.002). CONCLUSIONS: Use and recommendations for SBS increased substantially during the pandemic. Increased awareness among patients could potentially improve future CRC screening rates if uptake of SBS occurs among those unable or unwilling to be screened by endoscopy.

Modeling the Tumor Microenvironment and Cancer Immunotherapy in Next-Generation Humanized Mice.

Cancer immunotherapy has brought significant clinical benefits to numerous patients with malignant disease. However, only a fraction of patients experiences complete and durable responses to currently available immunotherapies. This highlights the need for more effective immunotherapies, combination treatments and predictive biomarkers. The molecular properties of a tumor, intratumor heterogeneity and the tumor immune microenvironment decisively shape tumor evolution, metastasis and therapy resistance and are therefore key targets for precision cancer medicine. Humanized mice that support the engraftment of patient-derived tumors and recapitulate the human tumor immune microenvironment of patients represent a promising preclinical model to address fundamental questions in precision immuno-oncology and cancer immunotherapy. In this review, we provide an overview of next-generation humanized mouse models suitable for the establishment and study of patient-derived tumors. Furthermore, we discuss the opportunities and challenges of modeling the tumor immune microenvironment and testing a variety of immunotherapeutic approaches using human immune system mouse models.

Impacts of COVID-19 on Appropriate Use of Screening Colonoscopy in a Large Integrated Healthcare Delivery System.

BACKGROUND: Decreasing low-value colonoscopy is critical to optimizing access for high-need patients, particularly in resource-constrained environments such as those created by the COVID-19 pandemic. We hypothesized that rates of screening colonoscopy overuse would decline during COVID compared to pre-COVID due to enhanced procedural scrutiny and prioritization in the setting of constrained access. OBJECTIVE: To characterize impacts of COVID-19 on screening colonoscopy overuse DESIGN: Retrospective national cohort study using Veterans Health Administration administrative data PARTICIPANTS: Veterans undergoing screening colonoscopy in Q4 2019 (pre-COVID) and Q4 2020 (COVID) at 109 endoscopy facilities MAIN MEASURES: Rates of screening colonoscopy overuse KEY RESULTS: 18,376 screening colonoscopies were performed pre-COVID, 19% (3,641) of which met overuse criteria. While only 9,360 screening colonoscopies were performed in Q4 2020, 25% met overuse criteria. Overall change in median facility-level overuse during COVID compared to pre-COVID was 6% (95%CI 5%-7%), with significant variability across facilities (IQR: 2%-11%). Of colonoscopies meeting overuse criteria, the top reason for overuse in both periods was screening colonoscopy performed <9 years after previous screening procedure (55% pre-COVID, 49% during COVID). The largest shifts in overuse category were in screening procedures performed <9 years after prior screening colonoscopy (-6% decline COVID vs. pre-COVID) and screening procedures performed in patients below average-risk screening age (i.e., age <40 (5% increase COVID compared to pre-COVID), age 40-44 (4% increase COVID vs. pre-COVID)). Within facility performance was stable over time; 83/109 facilities changed their performance by <=1 quartile during COVID compared to pre-COVID. CONCLUSIONS: Despite pandemic-related resource constraints and enhanced procedural scrutiny and prioritization in the setting of COVID-related backlogs, screening colonoscopy overuse rates remained roughly stable during COVID compared to pre-COVID, with continued variability across facilities. These data highlight the need for systematic and concerted efforts to address overuse, even in the face of strong external motivating factors.

Examining Colorectal Cancer (CRC) Stage at Initial Diagnosis Before and During the COVID-19 Pandemic in the United States

Introduction: Colorectal Cancer (CRC) is on the rise, prompting the need for earlier screening in the United States (U.S.) population. The American Cancer Society now recommends screening for CRC in patients with average risk at the age of 45. Further complicating this picture, the COVID-19 pandemic has disrupted the routine screening process for CRC, which we hypothesize has impacted the stage at which CRC is detected. We sought to determine the extent to which the COVID-19 pandemic has affected colorectal cancer diagnosis trends at a large urban community hospital. Method(s): We performed a retrospective analysis of patients, comparing two time periods: pre-pandemic (1/1/2019-1/31/2020) and during COVID pandemic (2/1/2020-9/29/21). Data was extracted from the electronic medical record (EMR) to compile a database of patients diagnosed with CRC during these time periods. Patients included in this study had a new diagnosis of colorectal cancer and either followed with colorectal specialists at the hospital or had undergone tissue biopsy analysis by the Department of Pathology. The primary outcome was determining the stage at which CRC was detected and the modality utilized for CRC screening in that patient. Additional variables collected were as follows: age, pathological findings (grade, presence of tumor mutations, or microsatellite instability), gender, race, and insurance. Result(s): Data was collected from a total of 380 patients, which included 190 patients diagnosed with CRC within the timeframe defined as pre-pandemic and 190 diagnosed with CRC within the timeframe defined as during the pandemic. CRC diagnosis was analyzed in terms of TNM stage at time of diagnosis (Stages 0 through IV). Stage III and IV were grouped together and categorized as a late-stage diagnosis, whereas Stages 0, I, and II were grouped together and categorized as an early-stage diagnosis. Late-stage diagnosis was found in 34.7% (66/190) of patients in the pre-pandemic group. In comparison, late-stage diagnosis was found in 46.3% (88/190) of patients in the during pandemic group. Conclusion(s): Our results suggest that the COVID-19 pandemic did produce delays in care and work-up for CRC. We believe this is why CRC stage at the time of initial diagnosis was later for patients diagnosed during the pandemic than for patients diagnosed prior to the pandemic. In the future, we hope to evaluate if the impact of COVID-19 is reflected in tumor grade and genetic mutations at the time of diagnosis, and determine race and gender disparities.

Decline in Colorectal Cancer Screening Rates in Federally Qualified Health Centers in Los Angeles County From 2019 to 2020

Introduction: Federally Qualified Health Centers (FQHCs) are funded by the Health Resources and Services Administration (HRSA) to provide primary care services to low-income and underinsured individuals. Los Angeles County (LAC) is a large, diverse county with greater than 10.2 million residents and 8 distinct Service Planning Areas (SPAs) that represent specific geographic regions with variable resources. We aimed to describe colorectal cancer (CRC) screening rates (CRCSR) and the screening rate change (SRCs) in LAC overall and for each SPA between 2019 and 2020 to determine where resources are most needed for CRCSR recovery following the COVID-19 pandemic. Method(s): Our data source was the Uniform Data System (UDS), which includes quality data for the FQHCs funded by HRSA. We determined 2019 and 2020 CRCSR for LAC FQHCs overall and for each FQHC, including average-risk patients age 50-74. We then separated FQHCs into quartiles based on SRC and performed mixed-effects logistic regression to determine FQHC-level characteristics associated with the largest decline in CRCSR from 2019 to 2020 (i.e., predictors of category SRC Q1). Lastly, we determined SRC for each SPA in LAC. Result(s): In 2019, there were 58 FQHCs in LAC with 326,473 patients eligible for CRC screening. In 2020, there were 59 FQHCs with 350,405 eligible patients. The median 2020 CRCSR in LAC FQHCs was 37.3%, down from 48.0% in 2019 (2020 median SRC= -9.6%) (Table). In the regression model among all LAC FQHCs, those with higher proportions of patients preferring a non-English language had significantly higher odds of having the largest decline in CRCSR from 2019 to 2020 (SRC Q1) (aOR=3.25, 95% CI=1.22-8.65;data not shown). CRCSR decreased from 2019 to 2020 in all SPAs with SRC ranging from -17.0% (South Bay) to -1.4% (West LA) (Figure). Conclusion(s): In Los Angeles County FQHCs, CRC screening rates were higher than the national FQHC average in 2019 however declined considerably between 2019 and 2020. The decline in CRC screening rates was highest in FQHCs serving a higher proportion of patients with a preference for a non-English language and varied by county region. Our findings highlight the need for targeted measures, including language-appropriate resources, to improve CRC screening uptake in FQHCs that provide care to some of the most historically marginalized individuals.

Patient Navigator Pilot to Improve Completion of FIT Testing in Primary Care

Introduction: Colorectal cancer (CRC) screening is a critical preventative service and part of routine patient care. CRC is the second leading cause of cancer death in the US, and yet a third of the eligible population does not undergo routine screening. Endoscopy centers have been stretched thin by both COVID-19 and the recent drop in screening initiation age to 45. Fecal immunochemical testing (FIT), a sensitive and specific CRC screening modality, may be used to reach and risk-stratify more patients to increase the yield for detecting advanced neoplasia and cancer, reducing pressure on colonoscopy centers. Unfortunately, FIT is often suboptimal as patients inconsistently complete and return the test for analysis. Method(s): We performed a retrospective analysis of 5211 individuals at a single internal medicine clinic who had FIT ordered as part of USPSTF recommended care from 01/2017 through 12/2021. Starting in 01/2021 we instituted a dedicated patient navigator to support patients in completing FIT. Chi-square, Fisher exact test, and Student's t-tests were performed for descriptive analyses. Multivariable logistic regression was used to compare FIT kit drop off rates pre- and post-intervention, with the model adjusted by age, gender, race, ethnicity, language, and insurance status. Analysis was performed in SAS version 9.4. (Table) Results: The post-intervention period included 1181 (22.7%) patients. The predominant reasons cited for failure to complete testing were forgot (25%), too busy (13%), and lost kit (11%). Our intervention improved drop off rates from 46.4% to 51.3% at 2 weeks (OR 1.19, 95%CI 1.01-1.41), 56.7% to 73.7% at 1 month (2.14 [1.78-2.58]), 64.7% to 89.7% at 3 months (4.73 [3.66-6.12]), and 78.9% to 98.2% at 1 year (14.39 [8.25-25.12]). Overall, our intervention improved FIT kit drop off rates by 53.4% (1.53 [1.30-1.81]). FIT was positive in 4.9% (p=0.0529). (Figure) Conclusion(s): FIT can increase CRC screening rates, particularly in resource-limited settings, and may decrease the burden on endoscopy centers nationwide by improving the efficiency of colonoscopy in the average risk screening population. The addition of a dedicated patient navigator is a simple intervention that, by providing culturally competent care and personalized attention, improves completion rates and return time, allowing FIT to be a reliable method of screening. The ability to increase screening rates and prioritize patients for diagnostic colonoscopies will ultimately lead to earlier detection and treatment of CRC.

Organization of medical care for patients with colorectal cancer during coronavirus-19 pandemic (review)

The COVID-19 pandemic, with it is rapid increase in new cases and deaths, has caused hospital overload around the world, creating an unprecedented challenge for health systems and requiring the rapid development of reliable and evidence-based guidelines. Moreover, this has led to urgent identification of non-COVID health priorities. The cancer service must be restructured. Diagnosis and treatment for colorectal cancer in the background of the COVID-19 pandemic requires a restrained approach based on the priority of patient care.Copyright © 2021, Association of Coloproctologists of Russia. All rights reserved.

Utilization of Patient-Centered Digital Tools to Improve Adherence Rates for Outpatient Screening Colonoscopies in a Metropolitan Hospital

Introduction: Colorectal cancer (CRC) is the second leading cause of cancer-related deaths in the United States. Screening through stool testing or colonoscopy is the standard of care for all ages 50 to 75 years, but national rates of procedures remain sub-optimal. Digital applications i.e., frequent automated text-based reminders and assess through personal healthcare apps on smartphones, can be effective tools to overcome barriers to screening colonoscopy adherence thus improving the outcomes. Method(s): We performed a retrospective study on a prospectively maintained database on CRC screening adherence rates from July 2019 to March 2022 in outpatient settings of a metropolitan hospital. Only screening colonoscopies (SC) scheduled during the study time period were included. Demographics and health-care resources utilization were reviewed. Primary comparison was between SC performance rates, prior to and after implementation of: a digital navigation program (DNP) developed by a private company that consisted of generating automated messages containing bowel-prep instructions, appointment reminders, driving instructions, short informative procedure videos;and EPIC EMR generated personal health app called MyChart. All participants were offered access to DNP through a digital platform and MyChart app set up on their smartphones. Result(s): Total of 3584 SC were scheduled during the study period. Overall age was 6069.6 years and majority were males at 55%;Hispanics were 49% with Not Hispanics at 24%. Pre-intervention period (n51057), 48% of SC performed and 52% cancelled;and in post-intervention period (n52527), 85% SC performed with 15% cancelled (p< .001) with a percent change of 74% increase in procedures. In postintervention group< DNP enrolled 930 patients of which 87% presented for procedure. Patients who did not present, received additional reminders. Bowel prep between groups showed no significant difference in quality (Table). Conclusion(s): Our study highlights a significant increase in performance rates of scheduled screening colonoscopies with a 74% increase after implementation of a DNP and MyChart app utilization. Usefulness of digital applications in improving screening colonoscopy adherence and reducing no show rates, has been well studied in literature with promising results, but implementation on a larger scale is lacking. Especially after COVID-19 pandemic, use of technology to increase adherence to CRC screening and surveillance seems more warranted.

Effective Messaging Strategies for Colorectal Cancer Screening: The Development of the 2022 NCCRT Messaging Guidebook for Black and African American People

Introduction: Colorectal cancer (CRC) is the second leading cause of cancer-related deaths in the United States (US) and disproportionately impacts Black individuals. The US Preventive Services Taskforce began recommending CRC screening for individuals aged 45-49 in 2021, however effective strategies to increase screening participation in Black individuals in this age group are unknown. Thus, the National Colorectal RoundTable (NCCRT) used a mixed methods approach to identify barriers and facilitators to CRC screening in Black individuals, with specific focus on those age 45-49. Results informed the development of the 2022 NCCRT Messaging Guidebook for Black & African American People. Method(s): We conducted a mixed-methods study in a large, nationally representative sample of unscreened Black individuals. We first conducted semi-structured qualitative interviews with Black individuals over age 45, recruited from the Schlesinger Group qualitative research platform. Findings informed content for a subsequent survey to understand barriers and facilitators, administered broadly via the Prodege online research platform. Messages to encourage screening participation were developed based on learnings from prior ACS and NCCRT work. Message were tested using MaxDiff analytic methods and reviewed by a multidisciplinary advisory committee for inclusion in the Guidebook. Result(s): There were 10 qualitative interview and 490 survey participants. The average age of participants was 52.7 (s.d.56.1) for interviews and 55.3 (s.d.57.3) for surveys. 40.0% were female and 38.2% lived in the Southeast US (Table). The most frequently reported barrier to screening was procrastination (40.0% in age 45-49;42.8% in age 50-65;34.2% in age .55). Procrastination was often attributed to financial concerns (20.8% in age 45-49) and COVID-19 (27.0% in age 50-54;21.8% in age .55) (Figure). Of those age 45-49, the majority preferred to receive screening information from a health care provider (57.5%), however only 31.7% reported that a provider had initiated a screening conversation. Several messages rated as highly effective in encouraging screening were included in the NCCRT Guidebook. Conclusion(s): We identified several age-specific barriers to CRC screening and developed unique messaging to motivate screening among unscreened Black individuals age 45 and over. Messages that tested positively are publicly available as a resource for organizations and institutions that aim to increase screening rates.

Barriers to Barrett's Esophagus Screening Within Veterans Affair Patient Population

Introduction: Barrett's esophagus (BE) is a metaplastic change in the distal esophagus in which squamous epithelium is replaced by columnar epithelium with goblet cells. Chronic gastroesophageal reflux disease (GERD) is strongly linked to the development of BE, which is a known precursor lesion to esophageal adenocarcinoma (EAC). There is no universal guideline for BE screening, however AJG suggest a single screening endoscopy in patients with chronic GERD symptoms and 3 or more addition risk factors, such as male sex, age > 50 years, white race, tobacco smoking, obesity and family history of BE or EAC. Within the Veteran's Affair (VA) hospital in Northport, New York, many veterans possess multiple risk factors for BE. Residents in VA primary care clinic are diligent in colorectal cancer screening, yet there is concern for limited offerings for BE screening. Our project aims to study the barriers to BE screening within a high-risk veteran population. Method(s): This is a survey-based study. A total of 36 internal medicine residents working in VA primary care clinic were asked to fill out a survey regarding their perspective towards BE screening. The results of the survey are compiled in Table. Result(s): 36 residents within the clinic completed the survey. As shown in Table, 35 out of 36 residents expressed that the primary care clinic does not screen for BE adequately. 30 residents expressed uncertainty regarding referral criteria for BE screening, 24 residents revealed having never referred patients for BE screening. When asked about barriers regarding BE screening, consensus polling showed that there is a lack of resident education surrounding indications for screening. Other common barriers include lack of transportation for veterans to appointments, the COVID 19 pandemic, and lack of health literacy within the veteran population. Conclusion(s): Although there is no established guideline for BE screening, per AJG there is recommendation for a one-time screening endoscopy in susceptible population. VA patients pose a high-risk population that appears to have low screening rates. Patients appear to be placed on long term PPIs without re-assessment and endoscopic screening despite possessing multiple risk factors for BE. Our survey shows that within our resident cohort there is concern for lack of awareness regarding screening criteria for BE. With the initiation of this project, we hope to increase awareness of BE screening within the resident group and improve health outcomes within veteran population. (Table Presented).

Appropriateness and Completion of Multitarget Stool DNA Testing in Primary and Subspecialty Care

Introduction: Colorectal cancer (CRC) is the third most prevalent cancer in the United States, with a 4% lifetime incidence. While more clinicians have begun ordering multitarget stool DNA (mt-sDNA) testing due to the COVID-19 pandemic, adherence to guidelines on mt-sDNA and rates of subsequent follow-up testing has not been well studied. We assessed the appropriateness of mt-sDNA orders and rate of high-quality colonoscopy completion following a positive result in a large academic medical center. Method(s): We identified patients ordered for mt-sDNA in primary care and gastroenterology clinics at our institution between April 2020 and July 2021. For each case, we reviewed the appropriateness of mtsDNA testing, documentation of shared decision making, result of testing, and subsequent follow-up. Appropriateness was defined in accordance to the most recent American College of Gastroenterology guidelines on mt-sDNA use for CRC screening. Result(s): Of the 797 patients in our study, 685 (86%) met all appropriateness criteria for mt-sDNA testing (Table). Shared decision making was documented in 488 (62%) cases, and the most common reason for ordering mt-SDNA was hesitancy for colonoscopy. 483 patients (61%) completed mt-sDNA testing, of which 74 cases (15%) were positive. Rates of positivity were higher in cases of inappropriate (28%) rather than appropriate (13.7%) orders (p = 0.01). Colonoscopy was ordered in 73 cases (99%) and completed by 59 patients (80%). Of the 56 patients who underwent colonoscopy at our institution, most had documentation of a high-quality colonoscopy, defined as adequate prep (84%), cecal intubation (93%), visualization of the appendiceal orifice and ileocecal valve (94%), and right colon retroflexion (83%). Sixteen patients (29%) were found with advanced adenomas and 19 (34%) had other adenomas or sessile polyps. Among the 409 patients with negative tests, a 3-year follow-up recommendation was documented for 369 patients (90%). Conclusion(s): Most clinicians at our institution identified appropriate patients for mt-sDNA testing and provided appropriate follow-up< and the majority of patients who underwent colonoscopy had documentation of a high-quality colonoscopy. In contrast, there were suboptimal rates of mt-sDNA completion and documentation of shared decision making. Further studies are needed to identify barriers to documentation of shared-decision making and to completion of high-quality colonoscopies in patients being screened with mt-sDNA.

Agreement of Skeletal Muscle Area and Muscle Quality Between Two Different Image Analysis Software Tools

Background: Both clinicians and researchers have a growing interest in assessment of muscle mass utilizing diagnostic abdominal computed tomography (CT) scans. Different imaging analysis software tools exist for the assessment of muscle mass;however, minimal information is available to describe the agreement between tools. The objective of this project was to determine the agreement, reliability, and strength of the relationship between skeletal muscle cross-sectional area (CSA) and muscle quality at the third lumbar region (L3) between two different image analysis software tools (3D Slicer vs SliceOmatic) using a convenient sample of individuals who have undergone diagnostic abdominal CT scan imaging. Method(s): A retrospective sample of individuals who had undergone a diagnostic abdominal CT scan was utilized. For both image analysis software tools, L3 skeletal muscle CSA was identified using a Hounsfield Unit (HU) range of -30 to +150 and muscle quality was defined as the mean HU. For each patient, L3 skeletal muscle CSA (cm2) and mean HU was calculated using 3D Slicer (version 5.0.3) and SliceOmatic (version 4.3, TomoVision, Quebec, Canada). Lin's correlation coefficient (LCC), intraclass correlation coefficient (ICC), and Spearman correlation coefficient (SCC) were used to examine the agreement, reliability, and strength of the relationship with both L3 skeletal muscle CSA and muscle quality using3D Slicer versus SliceOmatic. Bland Altman plots were created to depict the agreement of L3 CSA and muscle quality between the two tools. Result(s): A total of 504 patients were included;the sample included 128 healthy adults and 376 patients who had the following diagnoses: breast cancer (n = 175), colorectal cancer (n = 127), sepsis (n = 37) and COVID-19 (n = 37). The mean L3 skeletal muscle CSA measured using SliceOmatic was 140.6 +/- 36.0 cm2 and using 3D Slicer was 137.6 +/- 36.1 cm2. When examining the agreement, reliability, and strength of the relationship of L3 skeletal muscle CSA between SliceOmatic and 3D Slicer, LCC was 0.934 (p < 0.001), ICC was 0.968 (p < 0.001), and SCC was 0.930 (p < 0.001). The mean muscle quality measured using SliceOmatic was 35.1 +/- 10.8 HU and using 3D Slicer was 34.6 +/- 11.0 HU;LCC was 0.928 (p < 0.001), ICC was 0.964 (p < 0.001), and SCC was 0.957 (p < 0.001). Both the Bland Altman plots for L3 skeletal muscle CSA and muscle quality using SliceOmatic and 3D Slicer displayed overall strong agreement (Figures 1 and 2). However, 27 outliers were identified when visualizing the agreement L3 skeletal muscle CSA;further investigation of these outliers revealed that most of these measurements were conducted in critically ill patients (sepsis and COVID-19). Examining L3 skeletal muscle CSA between SliceOmatic and 3D Slicer among a subgroup of patients with sepsis and COVID revealed lower overall agreement (LCC: 0.679, p < 0.0001), reliability (ICC: 0.811, p < 0.001), and strength (SCC: 0.642, p < 0.001). Similar findings were observed with muscle quality between SliceOmatic and 3D Slicer among a subgroup of patients with sepsis and COVID (LCC: 0.585, p < 0.0001;ICC: 0.741, p < 0.001;SCC: 0.592, p < 0.001). Conclusion(s): Overall, both the SliceOmatic and 3D Slicer imaging analysis software tools had strong agreement, reliability, and strength when examining muscle mass and muscle quality. However, the agreement, reliability, and strength between muscle mass and muscle quality was lower between the two tools among critically ill patients compared to healthy controls and patients with cancer. Further research is needed to describe the etiology of this lower agreement in critically ill patients. (Table Presented).