Cancer :: OHSU Cancer Institute, 1 of largest in GIST study and Gleevec

Gleevec, a pill developed in conjunction with Oregon Health & Science University is again showing excellent results in preventing cancer recurrence in GIST patients after complete removal of their tumors.

In a major news release from the National Institutes of Health today it was stated that: preliminary results from a large, randomized, placebo-controlled clinical trial for patients with primary gastrointestinal stromal tumor (GIST) showed that patients who received imatinib mesylate (Gleevec) after complete removal of their tumor were significantly less likely to have a recurrence of their cancer compared to those who did not receive Gleevec.

The clinical trial was sponsored by the National Cancer Institute, part of the National Institutes of Health, and conducted by a network of researchers led by the American College of Surgeons Oncology Group.

“This is a major breakthrough that will change the way this type of cancer is treated,” said Charles Blanke, M.D., F.A.C.P., leader of the Solid Tumors Program at the OHSU Cancer Institute and professor of medicine (hematology and medical oncology).

Researchers in the multi-site study found that approximately 97 percent of patients who received Gleevec one year after surgery were alive without a recurrence of their cancer, compared to approximately 83 percent who received one year of a placebo. That means that there is a 70 percent reduction in risk of occurrence. It was also found that Gleevec was well tolerated by most patients in the study. Mild side effects included nausea, diarrhea and swelling. More than 700 patients were enrolled in the study. Patients on placebo who had a recurrence of their cancer were given Gleevec.

The OHSU Cancer Institute, with Blanke as the principal investigator, was one of the largest study sites for this phase III double-blind trial with 28 GIST patients enrolled from January 2003 through February 2007. Gleevec works by blocking cellular communication to prevent tumor growth.

OHSU Cancer Institute’s Brian Druker, M.D., was the principal investigator of the trials for the initial development of Gleevec in collaboration with other research centers and the drug company Novartis. In addition to GIST, Gleevec is also being used as a potential therapy for certain types of blood and skin cancers. Novartis provided the drug for use in the study and also provided partial funding.

GIST affects about 5,000 to 10,000 Americans a year, striking any of the organs in the entire length of the gastrointestinal tract or its lining. These tumors are prone to spread to other organs and, once spread, they often are unresponsive to chemotherapy or radiation, and invariably used to be fatal. Another study, led by OHSU investigators, showed Gleevec benefits 90 percent of GIST patients with metastatic disease.

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