Long-term treatment with sulindac in familial adenomatous polyposis: is there an actual efficacy in prevention of rectal cancer?

J Surg Oncol. 2000 May;74(1):15-20. doi: 10.1002/1096-9098(200005)74:1<15::aid-jso4>3.0.co;2-z.


Background and objectives: Ileorectal anastomosis (IRA) is still used in the treatment of familial adenomatous polyposis (FAP). Sulindac appears to induce regression of colorectal adenomas; however, its effects in long-term therapy and in preventing carcinoma remain unclear.

Methods: Fifteen FAP patients treated by IRA received sulindac (200 mg/day) for a mean period of 48.6 +/- 28.7 (range 12-124) months. Number, size, and type of rectal polyps were assessed by endoscopic and histological evaluation every 6 months.

Results: Significant regression of polyps was observed in all patients after 6 months (P < 0.02). However, after a mean of 48.6 +/- 28.7 months, both number and size of polyps increased again, showing no statistical difference with baseline values. Minute polyps appeared reddish, while the largest lesions were flat or slightly elevated. Endoscopic polypectomy was necessary in 9 patients and transanal surgical excision in 3. Two patients were submitted to restorative proctectomy because of a large polyp with severe dysplasia and a rectal cancer, respectively.

Conclusions: Sulindac appears to influence the morphological appearance of polyps in FAP patients, inducing apparent regression. However, at a dose of 200 mg, it does not influence the progression of polyps toward a malignant pattern.

MeSH terms

  • Adenomatous Polyposis Coli / drug therapy*
  • Adenomatous Polyposis Coli / pathology
  • Adenomatous Polyposis Coli / surgery
  • Adolescent
  • Adult
  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use*
  • Colorectal Neoplasms / pathology
  • Combined Modality Therapy
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Proctocolectomy, Restorative
  • Rectal Neoplasms / pathology
  • Rectal Neoplasms / prevention & control*
  • Sulindac / therapeutic use*


  • Anti-Inflammatory Agents, Non-Steroidal
  • Sulindac