Breast Cancer Drug Approved

Early-stage breast cancer patients can now use a new drug that promises to improve their chances of survival. Ellence, known chemically as epirubicin, was approved by the FDA to be used in chemotherapy treatment for patients whose tumors have spread to the lymph nodes.

Some 180,000 American women are diagnosed with breast cancer each year. About 75,000 of them need "adjuvant chemotherapy" after surgery for a tumor that has spread to the nearby lymph nodes under the arm, said Ellence manufacturer Pharmacia & Upjohn.

Typically, doctors choose between two types of chemotherapy. One is called AC, containing the drugs Adriamycin and cyclophosphamide. The other is called CMF, for cyclophosphamide, methotrexate and fluorouracil.

In a study of 716 patients, Pharmacia & Upjohn compared CMF with a combination of cyclophosphamide, fluorouracil and the new drug Ellence, a combination dubbed CEF. The women took either chemotherapy for six months.

Five years later, 62 percent of the women who received the new Ellence-containing chemotherapy had survived relapse-free, versus 53 percent of women who had received CMF.

There was a drawback: The Ellence-containing chemotherapy caused side effects such as nausea, vomitting and hair loss said Dr. Vivien Bramwell, a medical oncologist at the University of West Ontario, Canada, who helped study the drug.

Also, the drug poses a small risk of irreversible heart damage and later developing leukemia, a long-term consequence of certain chemotherapies.

For patients and doctors, this means more choice in picking the chemotherapy that's best for each individual case.

The more lymph nodes where cancer has spread, the more Bramwell encourages trying Ellence. For women with fewer cancerous lymph nodes, she lays out all the differences and lets them choose.

"Many feel the short-term toxicity is worthwhile even if it's a small absolute benefit," she said.

Ellence will be available in mid-October, and will cost about $12,000 for a six-month course, the company said.