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Global quantitative assessment of the colorectal polyp burden in familial adenomatous polyposis by using a web-based tool.

ABSTRACT: Accurate measures of the total polyp burden in familial adenomatous polyposis (FAP) are lacking. Current assessment tools include polyp quantitation in limited-field photographs and qualitative total colorectal polyp burden by video.To develop global quantitative tools of the FAP colorectal adenoma burden.A single-arm, phase II trial.Twenty-seven patients with FAP.Treatment with celecoxib for 6 months, with before-treatment and after-treatment videos posted to an intranet with an interactive site for scoring.Global adenoma counts and sizes (grouped into categories: <2 mm, 2-4 mm, and >4 mm) were scored from videos by using a novel Web-based tool. Baseline and end-of-study adenoma burden results were summarized by using 5 models. Correlations between pairs of reviewers were analyzed for each model.Interobserver agreement was high for all 5 measures of polyp burden. Measures that used both polyp count and polyp size had better interobserver agreement than measures based only on polyp count. The measure in which polyp counts were weighted according to diameter, calculated as (1) × (no. of polyps <2 mm) + (3) × (no. of polyps 2-4 mm) + (5) × (no. of polyps >4 mm) had the highest interobserver agreement (Pearson r = 0.978 for two gastroenterologists, 0.786 and 0.846 for the surgeon vs each gastroenterologist). Treatment reduced the polyp burden by these measurements in 70% to 89% of patients (P < .001).Phase II study.This novel, Web-based polyp scoring method provides a convenient and reproducible way to quantify the global colorectal adenoma burden in FAP patients and a framework for developing a clinical staging system for FAP.

SUBMITTER: Lynch PM

PROVIDER: S-EPMC3574220 | biostudies-literature | 2013 Mar

REPOSITORIES: biostudies-literature

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Global quantitative assessment of the colorectal polyp burden in familial adenomatous polyposis by using a web-based tool.

Lynch Patrick M PM Morris Jeffrey S JS Ross William A WA Rodriguez-Bigas Miguel A MA Posadas Juan J Khalaf Rossa R Weber Diane M DM Sepeda Valerie O VO Levin Bernard B Shureiqi Imad I

Gastrointestinal endoscopy 20130118 3

<h4>Background</h4>Accurate measures of the total polyp burden in familial adenomatous polyposis (FAP) are lacking. Current assessment tools include polyp quantitation in limited-field photographs and qualitative total colorectal polyp burden by video.<h4>Objective</h4>To develop global quantitative tools of the FAP colorectal adenoma burden.<h4>Design</h4>A single-arm, phase II trial.<h4>Patients</h4>Twenty-seven patients with FAP.<h4>Intervention</h4>Treatment with celecoxib for 6 months, with ...[more]

PMID: 23332604

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Project description:ImportancePatients with familial adenomatous polyposis (FAP) are at markedly increased risk for duodenal adenomas and cancer. Combination sulindac and erlotinib was previously shown to reduce duodenal polyp burden but was associated with a relatively high adverse event (AE) rate.ObjectiveTo evaluate if a once weekly dosing schedule for erlotinib intervention improves the AE profile, while still providing efficacy with respect to reduced polyp burden, in participants with FAP.Design, setting and participantsSingle-arm trial, enrolling 46 participants with FAP, conducted from October 2017 to September 2019 in eight academic cancer centres.ExposuresParticipants self-administered 350 mg of erlotinib by mouth, one time per week for 6 months.Main outcomes and measuresDuodenal polyp burden (sum of polyp diameters) was assessed in the proximal duodenum by esophagogastroduodenoscopy performed at baseline and 6 months, with mean per cent change defined as the primary efficacy outcome of interest. Rate of grade 2-3 AEs was evaluated as a co-primary outcome. Secondary outcomes included changes in total duodenal polyp count, along with changes in lower gastrointestinal (GI) polyp burden and count (for participants examined by optional lower endoscopy).ResultsForty-six participants (mean age, 44.1 years (range, 18-68); women, 22 (48%)) were enrolled; 42 participants completed 6 months of intervention and were included in the per-protocol analysis. Duodenal polyp burden was significantly reduced after 6 months of weekly erlotinib intervention, with a mean per cent change of -29.6% (95% CI, -39.6% to -19.7%; p<0.0001). Similar results were observed in subgroup analyses defined by participants with advanced duodenal polyposis (Spigelman 3) at baseline (mean, -27%; 95% CI, -38.7% to -15.2%; p<0.0001). Post-intervention Spigelman stage was downstaged in 12% of the participants. Lower GI polyp number was also decreased after 6 months of intervention (median, -30.8%; IQR, -47.4% to 0.0%; p=0.0256). Grade 2 or 3 AEs were reported in 71.7% of subjects, with only two experiencing grade 3 toxicity at least possibly related to intervention.ConclusionIn this single-arm, multi-centre trial of participants with FAP, erlotinib one time per week resulted in markedly lower duodenal polyp burden, and modestly reduced lower GI polyp burden, after 6 months of intervention. While AEs were still reported by nearly three-quarters of all participants, these events were generally lower grade and well-tolerated. These findings support further investigation of erlotinib as an effective, acceptable cancer preventive agent for FAP-associated GI polyposis.Trial registration numberNCT02961374.

Dataset Information

Global quantitative assessment of the colorectal polyp burden in familial adenomatous polyposis by using a web-based tool.

Publications

Global quantitative assessment of the colorectal polyp burden in familial adenomatous polyposis by using a web-based tool.

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