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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)