Long-term Chemoprevention with Sulindac in FAP patients: highly effective and capable of preventing pancolectomy in patients with an intact colon

Teresa Neuhann1, Katharina Haub1, Monika Morak1,2, Andreas Laner1, Gerhard Feder3, Wilhelm Hoechter4, Josef Weingart4, Berndt Birkner5, Wolfgang Schmitt6, Elke Holinski-Feder1,2

1MGZ – Medizinisch Genetisches Zentrum, Munich, Germany. 2Medizinische Klinik und Poliklinik IV, Campus Innenstadt, Klinikum der Universität München, Munich, Germany. 3Department of Gastroenterology, Kreisklinik Ebersberg, Ebersberg, Germany. 4Gastroenterology practice, 80637 Munich, Munich, Germany. 5Gastroenterology practice, 81675 Munich, Munich, Germany. 6Medical Department, Städtisches Klinikum München, Klinikum Neuperlach, Munich, Germany

Abstract

Objectives:

Several studies on effectiveness of non-steroidal anti-inflammatory drugs (NSAIDs) in patients with familial adenomatous polyposis (FAP) suggest a decrease in number and size of polyps. However, no data on long-term effectiveness and safety are available. This study has the longest follow-up on patients under sulindac chemoprevention in a large cohort of patients with FAP with and without prior colectomy, clearly showing the effectiveness and safety of this therapy.

Methods:

54 patients with adenomatous polyposis (pathogenic APC/MUTYH germline variants or classical clinical picture of FAP) taking sulindac > 2 years were evaluated; 39/54 patients had an intact colon. The total absolute observation period was almost 400 patient-years with a mean of more than 7 years / patient.

Results:

The majority of patients showed a fast (i.e. rapid decrease of polyp burden; 66.7%), and 14.8% a slow response on sulindac treatment, 16.7% had stable polyp burden allowing conservative treatment. Only one patient had slow progress of colonic polyp burden. There also was an effect on upper GI polyp burden with a stable course or improvement in 69% of patients. There were no serious side-effects. Detailed data on inclusion criteria, classification, and decrease in polyp burden will be given.

Conclusion:

Sulindac can be considered an effective and safe drug for long-term use in FAP patients, postponing or even preventing surgical procedures for the majority of patients, thereby maintaining higher quality of life in young adulthood. However, close surveillance and colonoscopy intervals remain necessary during the course of treatment.

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