METHODS FOR TREATING FAMILIAL ADENOMATOUS POLYPOSIS
Provided are methods for preventing or delaying the need for surgical intervention in a patient having familial adenomatous polyposis (FAP) and an at least partially intact lower gastrointestinal tract. Also provided are methods for preventing or delaying the formation of neoplasia and/or cancer in a patient having FAP. The methods comprise administering an effective amount of a pharmaceutical therapy that comprises eflornithine and sulindac to a patient having FAP and an intact lower gastrointestinal tract.
1 - 20 . (canceled)
21 . A method of delaying or preventing the need for surgeries and high-risk polyp resection in the lower gastrointestinal tract of a human patient having familial adenomatous polyposis (FAP), the method comprising administering to the patient a pharmaceutical therapy comprising a combined effective amount of eflornithine and sulindac.
22 . The method of claim 21 , wherein the patient has an intact lower gastrointestinal tract.
23 . The method of claim 21 , wherein the patient has a retained rectum.
24 . The method of claim 21 , wherein the patient has an ileal pouch.
25 . The method of claim 21 , wherein the method delays or prevents the development of adenomas.
26 . The method of claim 25 , wherein the adenomas are high risk adenomas.
27 . The method of claim 21 , wherein the method delays polyposis progression.
28 . The method of claim 27 , wherein the method delays the need for endoscopic excision or surgical resection.
29 . The method of claim 21 , wherein the method prevents polyposis progression.
30 . The method of claim 29 , wherein the method prevents the need for endoscopic excision or surgical resection.
31 . The method of claim 21 , wherein the method delays the formation of colorectal cancer in the patient.
32 . The method of claim 21 , wherein the method prevents the formation of colorectal cancer in the patient.
33 . The method of claim 21 , wherein the combined effective amount of eflornithine and sulindac comprises 750 mg/day eflornithine and 150 mg/day sulindac.
34 . The method of claim 33 , wherein the eflornithine and sulindac are administered in two separate formulations.
35 . The method of claim 33 , wherein the eflornithine and sulindac are administered in a single formulation.
36 . The method of claim 35 , wherein the single formulation comprises about 375 mg of eflornithine hydrochloride monohydrate.
37 . The method of claim 35 , wherein the single formulation comprises about 288.6 mg of eflornithine in its anhydrous, free base form.
38 . The method of claim 35 , wherein the single formulation comprises about 75 mg of sulindac.
39 . The method of claim 35 , wherein the single formulation is in the form of a tablet.
40 . The method of claim 35 , wherein the patient is administered two units of the single formulation per day.