Promising Drug in Fight on Breast Cancer Is OKd

WASHINGTON —  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 drug. But early studies suggest that it helps shrink tumors significantly in some advanced breast cancer patients who have exhausted other options.

The FDA considered Xeloda promising enough to approve under a special program that lets certain drugs for deadly diseases sell before doctors have final proof of just how effective they are. 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 every conventional treatment failed. She improved almost immediately.

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 the Xeloda pills. 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 best treatment is Taxol taken together 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.

The other promising option is continual infusion of a drug called 5FU. Women wear a supply of the drug in a shoulder pack with a line that pumps it straight into a catheter near the neck 24 hours a day. About 20% of women are expected to respond.

Xeloda will reach pharmacies this month.