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Pill okayed for advanced cases of breast cancer

Published Sep. 13, 2005

Women suffering advanced breast cancer gained a new medicine Thursday that might help slow the deadly disease.

Hoffman-La Roche's Xeloda is not a cure or useful in all cases, the Food and Drug Administration cautioned as it approved the pills. But early studies suggest it helps tumors shrink significantly in some advanced breast cancer patients who have exhausted other options.

The FDA considered Xeloda promising enough to approve it under a special program that lets certain drugs for deadly diseases be sold before doctors have final proof of their efficacy. And it appears easier to take than typical chemotherapy.

"This is the beauty of this drug: I have my hair, I'm not nauseous, I'm not wearing a pump," said Cathy Adelson, 53, of Houston, who joined a clinical trial of Xeloda in October 1996 after failing every conventional treatment _ and almost immediately improved.

Adelson had been taking a powerful prescription painkiller for severe cancer pain, but said she didn't need even an aspirin after six weeks of Xeloda. The breast cancer that had spread to her bones is still there but doesn't appear to be growing, and two cancerous lesions on her liver disappeared five months into therapy.

An estimated 44,000 women will die this year of advanced breast cancer that has spread to other parts of the body.

Once that happens, the gold-standard treatment is Taxol taken with a class of potent chemotherapy drugs called anthracyclines. These drugs can cause powerful side effects, not just the hair loss and nausea usually associated with chemotherapy but even deadly heart toxicity.

When these drugs fail _ or when women's bodies simply cannot tolerate taking anthracyclines _ doctors are at a loss as to what to offer next.

Xeloda will reach pharmacies in May; a price has not been set.

In a study of 135 patients with advanced breast cancer, tumors shrank by at least half in 18.5 percent of the women, the FDA said. More important, in 43 patients who failed both Taxol and anthracyclines, Xeloda helped shrink tumors in 25 percent.

Although the shrinkage numbers sound small, they were significant for such an aggressive disease, and most women's cancer did stabilize, said Dr. Linda Vahdat of Columbia-Presbyterian Medical Center, who participated in the trial.