Standard chemo proves best for older women with early breast cancer

Standard chemotherapy is more effective than an oral drug, capecitabine, following surgery in older women with early breast cancer, according to a study co-led by Dana-Farber researchers.

In a clinical trial involving 633 patients, the investigators found that, two and a half years after beginning the trial, women who had received capecitabine were twice as likely to have a relapse or die as those who received standard chemotherapy.

"Although adjuvant therapy has improved survival rates among women with early-stage breast cancer, there is little data on whether these results apply to older women in particular," says the study's senior author Eric Winer, MD, director of the Breast Oncology Center. "Because standard chemotherapy agents are administered intravenously and patients often prefer oral agents, we wanted to compare the effectiveness of a proven oral drug with standard chemotherapy regimens in this group."

The study, one of the few to focus on follow-up, or adjuvant, chemotherapy in older women (over age 65) with breast cancer, was run by the Cancer and Leukemia Group B, a nationwide consortium of clinical research centers sponsored by the National Cancer Institute. The results are reported in the May 14 issue of the New England Journal of Medicine.

Capecitabine was chosen because its anti-tumor activity was similar to that of standard chemotherapy in small clinical trials involving women with metastatic breast cancer.

Patients enrolled in the study had small breast tumors that could be removed by surgery. Participants were randomly assigned to groups that received either standard chemotherapy (a combination of two or three intravenously administered drugs) or capecitabine following surgery.

At the two-and-a-half-year point, 20 percent of the patients who received capecitabine had relapsed, compared to 11 percent of those on standard chemotherapy. Twelve percent of the capecitabine patients had died, compared to 7 percent in the other group. At three years, 68 percent of those in the capecitabine group were alive without a cancer relapse, compared to 85 percent in the other group.

Dana-Farber co-authors of the study include Alice Kornblith, PhD, Ann Partridge, MD, MPH, and Harold Burstein, MD, PhD.

Dana-Farber Cancer Institute (www.dana-farber.org) is a principal teaching affiliate of the Harvard Medical School and is among the leading cancer research and care centers in the United States. It is a founding member of the Dana-Farber/Harvard Cancer Center (DF/HCC), designated a comprehensive cancer center by the National Cancer Institute.