Gleevec keeps stomach tumor at bay: study

WASHINGTON (Reuters) - Gleevec, a once-a-day pill that has helped boost the survival rate for some leukemia patients, lowers the risk that a rare stomach cancer will come back by 70 percent, U.S. researchers reported on Thursday.

The National Institutes of Health-funded team found that 97 per cent of patients with a stomach cancer called gastrointestinal stromal tumor of GIST who took Gleevec for one year remained cancer-free after surgery as compared to 83 percent of patients given a placebo.

The drug, made by Novartis under the generic name imatinib, was approved five years ago for patients with chronic myeloid leukemia.

It is also approved for GIST, but the government-funded study means it could work as a front-line treatment right after patients get the tumor surgically removed. The company said it would seek U.S. Food and Drug Administration approval for this.

"This is a major breakthrough that will change the way this type of cancer is treated," said Dr. Charles Blanke of Oregon Health and Sciences University, who led one of the teams that worked on the study.

"These results have major implications for patients with primary GIST," added Dr. Ronald DeMatteo of the Memorial Sloan-Kettering Cancer Center in New York.

"Conventional chemotherapy agents have been notoriously ineffective in GIST. This study for the first time demonstrated that targeted molecular therapy reduces the rate of recurrence after complete removal of a primary GIST."

Researchers tested more than 600 patients for the study, which lasted from 2002 until earlier this month. Patients who were given placebos will now be offered Gleevec, too.

"Gleevec was one of the first targeted therapies that showed remarkable efficacy in clinical trials," said Dr. John Niederhuber, head of the National Cancer Institute, which paid for the study.

"These current results emphasize the need to continue to investigate all possible uses of these cutting edge drugs and to make them available to as many patients as possible."

The American Cancer Society says it is not known how many new gastrointestinal stromal tumors are diagnosed each year but estimated that around 1,500 malignant cases occur in the United States. Novartis estimated that 5,000 to 6,000 U.S. cases, benign and malignant, occur each year.

"We will now work with the investigators on a submission to gain regulatory approval for Gleevec as adjuvant treatment for GIST," said Dr. Diane Young, head of global medical affairs at Novartis.