Risk-stratified FIT for urgent colonoscopy in Lynch syndrome: A clinical service throughout the COVID-19 pandemic

Background: Lynch syndrome (LS) is an inherited disorder characterized by pathogenic variants within mismatch repair genes resulting in an increased risk of colorectal cancer (CRC). In England, the fecal immunochemical test for Haemoglobin (FIT) is currently used in non-LS symptomatic and screening populations to guide subsequent colonoscopy. Herein, we report results from a national emergency clinical service implemented during the COVID-19 pandemic which used FIT to prioritize colonoscopy in LS patients while endoscopy services were limited. Methods: Regional genetic and endoscopy services across England were invited to participate. Patient eligibility was determined by 1) Diagnosis of Lynch Syndrome 2) Planned colonoscopic surveillance between 1 March 2020 and 31 March 2021. Requests for FIT testing from participating NHS Trusts were sent to the NHS Bowel Cancer Screening South of England Hub's Research Laboratory in Surrey. The Hub sent patients a FIT kit (OC-Sensor? (Eiken, Japan)), instructions for use, a questionnaire, and a pre-paid return envelope. Lab reports with feecal haemoglobin (f-Hb) results were returned electronically for clinical action. LS patients were risk-stratified for colonoscopy based upon the following f-Hb thresholds: (1) f-Hb ≥10mg of Haemoglobin (Hb)/g (mg/g) faeces: triaged for colonoscopy via an urgent two-week wait (2WW) pathway, (2) f-Hb ≤10mg/g: schedule patients for colonoscopy within 6-12 weeks, where local endoscopy service availability permits. Results: Fifteen centers across England participated in the clinical service from 9th June 2020 to 31st March 2021. An uptake rate of 64% was observed from this cohort (375/588 invites), though 21 cases were removed from analysis due to repeat FITs, insufficient sample, missing clinical data, or FIT completed after colonoscopy. Of the remaining 354 patients analyzed, 269 patients (76%) had a f-Hb of <6mg/g. 6% (n=23) of patients had a f-Hb that was at or between greater than the limit of detection of the assay (≥6mg/g) yet below 10mg/g.18% (n=62) had FIT results of ≥10mg/g and met criteria for urgent colonoscopy triage via the 2WW pathway. Of the 62 urgently triaged patients, 22 had detectable adenomas, 6 had advanced adenomas (AAs), and 4 were diagnosed with CRC (table). Conclusions: The utility of FIT during the pandemic has demonstrated clinical value for LS patients requiring CRC surveillance. Further longitudinal investigation on the efficacy of FIT in people with LS is warranted and will be examined as part of the multi-center prospective research study “FIT for Lynch Syndrome” (ISRCTN15740250) which is presently recruiting patients in the UK.

Drive By Flu-FIT: A novel way to mitigate the decrease in colorectal cancer screening during the COVID-19 pandemic

Background: During the height of the COVID-19 pandemic, screening colonoscopy rates decreased by 90%. The decreased screening rates will increase the burden of colorectal cancer (CRC) in communities. The pandemic has created a need for novel models for safely engaging and screening community members for CRC. Methods: We implemented NCI's Screen to Save CRC screening campaign using a socially-distanced, Drive By Flu-FIT protocol and report the results of the FIT component of the program. In partnership with the leadership of Enon Tabernacle Church, the largest Baptist church in the Philadelphia region, we invited community members at average risk for CRC and between the ages of 45-75 to register for one of three Drive by Flu-FIT events held between Oct-Nov, 2020. Interested participants also completed eligibility, registration, and demographic questionnaires administered electronically via REDCap. Upon completion of these questionnaires, participants watched a 8-minute CRC screening educational video and pre- and post- CRC knowledge and intentions questionnaires. Participants who attended one of the three events received a Flu vaccine and/or FIT test and instructions to return the completed FIT to a medical collection box at Enon Tabernacle Church. This research was approved by the University of Pennsylvania's Institutional Review Board. Results: Of the 335 participants that registered for the event, 80 (23.9%) did not show, 63 (18.8%) were ineligible and 192 attended the event and received a FIT (57.3%). Reasons for ineligibility were: age outside of the recommended age for screening (n=40);having had a recent colonoscopy (n=13);symptoms/signs of CRC including change in your bowel habits, rectal bleeding, abdominal pain, iron deficiency anemia, unexplained weight loss (n=10);a possible family history or possible Lynch syndrome (n=1). Patients with symptoms/signs and family history of CRC were referred to colonoscopy. The 192 participants that comprised this analytic had a mean (s.d.) age of 58.9 (9.5) years, 60.4% were female, 93.8% self-identified as Black, and 1.6% as Hispanic. The pre-and post-knowledge scores showed an increase after the video intervention (p=0.0006) as did the intention to screen scores (p=0.007). To date, of the 192 participants who received a FIT, 38 (19.7%) did not return the FIT, 141 (73.4%) had a negative FIT result and 13 (6.7%) had a positive FIT result and were referred to colonoscopy. The results of colonoscopy are pending. Conclusions This research shows that a socially-distanced Drive By Flu-FIT program is feasible, acceptable and effective in engaging the community in CRC education and screening during the COVID-19 pandemic. Novel programs such as this can help mitigate the significant decline in screening for CRC that has occurred as a result of the COVID-19 pandemic and, thus, can help reduce the burden of CRC in our diverse communities.

Hereditary colorectal cancer syndromes and the COVID-19 pandemic: results from a survey conducted in patients enrolled in a dedicated registry.

PURPOSE: The coronavirus 2019 (COVID-19) pandemic has had profound consequences also for non-infected patients. This study aimed to evaluate the impact of the pandemic on the quality of life of a population with hereditary gastrointestinal cancer predisposition syndromes and on the surveillance/oncological care program of patients enrolled in a dedicated registry. METHODS: The study was conducted by means of an online self-report survey during the first Italian national lockdown. The survey comprised four sections: demographics; perception/knowledge of COVID-19; impact of the COVID-19 pandemic on surveillance and cancer care; health status (SF-12 questionnaire). RESULTS: 211 complete questionnaires were considered. 25.12% of respondents reported being not at all frightened by COVID-19, 63.98% felt "not at all" or "a little" more fragile than the healthy general population, and 66.82% felt the coronavirus to be no more dangerous to them than the healthy general population. 88.15% of respondents felt protected knowing they were monitored by a team of dedicated professionals. CONCLUSION: Patients with hereditary gastrointestinal cancer predisposition syndromes reported experiencing less fear related to COVID-19 than the healthy general population. The study results suggest that being enrolled in a dedicated registry can reassure patients, especially during health crises.