Originally created 09/17/99

FDA approves new breast cancer drug



WASHINGTON -- Breast cancer patients whose tumors have spread to the lymph nodes won a new drug today that promises to improve their chances of survival over one common chemotherapy.

The Food and Drug Administration today approved Ellence, known chemically as epirubicin, for treatment of node-positive, early-stage breast cancer.

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, vs. 53 percent of women who had received CMF.

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

In addition to experiencing somewhat more nausea, vomiting and hair loss, the Ellence-treated women had a higher rate of serious infections -- 8 percent vs. just 1 percent in CMF-treated women, Bramwell said. The infections were serious enough for hospitalization, she said.

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

Pharmacia & Upjohn did not compare Ellence to the other common breast-cancer treatment, AC. Some studies suggest AC and CMF are equally effective, but AC requires three months of chemotherapy instead of six and may cause fewer side effects than CMF.

Still, the FDA calls the improvement over CMF significant, and said Ellence offers patients an important alternative.

For patients and doctors, all this means is more choice in picking the chemotherapy 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.