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Table 3 Definition of FAP-related disease progression by patient stratum

From: Efficacy and safety of eflornithine (CPP-1X)/sulindac combination therapy versus each as monotherapy in patients with familial adenomatous polyposis (FAP): design and rationale of a randomized, double-blind, Phase III trial

Patient stratum Disease progression
Pre-colectomy • ≥25 % increase in polyp burden (number, size) from baseline • Presence of large, sessile or ulcerated adenoma (not amenable to excision) • High-grade dysplasia • Large villous adenoma • In-situ or invasive cancer
Retained rectum/ileal pouch polyposis • ≥25 % increase in polyp burden (number, size) from baseline • Excisional intervention to remove any polyp ≥10 mm • High-grade dysplasia in any polyp • In-situ or invasive cancer on any biopsy
Duodenal polyposis • Increase in Spigelman Stage (2–4) from baseline • Need for excisional intervention • Development of cancer • Death (endoscopy/intervention related)