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Chemotherapy Superior to New Drug for Early Breast Cancer
Date:5/13/2009

Standard treatment prolonged survival in older women, study finds ,,,,

WEDNESDAY, May 13 (HealthDay News) -- Older women with early-stage breast cancer do better after standard chemotherapy than they do with the oral drug capecitabine (Xeloda), a new study finds.

"After three years, 85 percent of people who received chemotherapy were doing well, and 68 percent of people who received capecitabine were doing well," said lead researcher Dr. Hyman Muss, a professor of medicine at the University of North Carolina at Chapel Hill.

"In this trial, we had hoped that it [capecitabine] would be as good as standard therapy, so we would have a pill treatment with less side effects, but it turned out it wasn't as good," Muss said.

The report is published in the May 14 issue of the New England Journal of Medicine.

Because it has fewer side effects, capecitabine has been approved by the U.S. Food and Drug Administration for use in patients with advanced breast and colon cancer. Used in this context, it improves quality of life and may extend life for several months, the researchers said.

For the study, Muss and colleagues randomly assigned 600 women aged 65 and older with early-stage breast cancer to standard treatment with a combination of chemotherapy drugs or capecitabine.

Women taking capecitabine were roughly twice as likely to have a relapse of their cancer or die, the researchers found. Three years after treatment, 85 percent of women who received standard chemotherapy were alive and cancer-free compared with 68 percent of the women who received capecitabine, the team found.

The greatest benefit of chemotherapy was among the minority of women with hormone receptor-negative breast cancer, Muss said.

However, in women whose cancer is hormone receptor-positive, "we showed that standard therapy and capecitabine were pretty similar," Muss said. "It would be reasonable for these women to select capecitabine over standard chemotherapy, but my bias would still be to pick the standard right now."

Other studies with women younger than 70 have also found standard chemotherapy provided better outcomes than a single drug, the researchers noted.

Dr. Nancy Davidson, director of the University of Pittsburgh Cancer Institute, thinks that the results of this study confirm the benefit of chemotherapy for treating women with early-stage breast cancer.

"This is a critical trial for two reasons," Davidson said. "It demonstrates that properly selected older women, who comprise the vast majority of patients with breast cancer, can benefit from state of the art chemotherapy just as younger women do. Thus, age alone should not be a reason to withhold chemotherapy," she said.

"It also demonstrates, yet again, that multi-agent chemotherapy gives better results than single agent chemotherapy for early breast cancer," Davidson said. "This trial does not say that capecitabine is an inactive drug -- rather its routine use should be limited to women with advanced breast cancer where it is used quite successfully as a way to minimize symptoms of disease. It is also very useful in other cancers like colon cancer."

Barbara A. Brenner, executive director of Breast Cancer Action, thinks most women like those in the study should opt for standard chemotherapy.

"The premise is always, if there is something new, let's do it, it will be better, and this actually shows that this is not the case," Brenner said.

Brenner doesn't think women should choose capecitabine even though its benefit is close to chemotherapy in some women. "Close, but not close enough," she said.

In selecting a breast cancer treatment, women should ask their doctor about their chance of relapse, Brenner stressed. "Make your best informed decision," she said.

More information

For more on breast cancer, visit the American Cancer Society.



SOURCES: Hyman Muss, M.D., professor, medicine, University of North Carolina at Chapel Hill; Barbara A. Brenner, J.D., executive director, Breast Cancer Action, San Francisco; Nancy Davidson, M.D., director, University of Pittsburgh Cancer Institute; May 14, 2009, New England Journal of Medicine


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