Results from eribulin and capecitabine phase III comparison trial on metastatic breast cancer

Published on December 10, 2012 at 4:08 AM · No Comments

Results from a phase III clinical trial comparing a newer chemotherapy agent called eribulin mesylate with capecitabine, a standard drug used for chemotherapy today in women with previously treated metastatic breast cancer, showed that eribulin demonstrated a trend toward improved overall survival. This study was presented today by Peter A. Kaufman, M.D., during the 2012 CTRC-AACR San Antonio Breast Cancer Symposium.

"We didn't show a statistically significant superiority of eribulin over capecitabine, which was our goal," said Peter A. Kaufman, MD, associate professor of medicine at the Geisel School of Medicine at Dartmouth, and oncologist at Dartmouth-Hitchcock and Norris Cotton Cancer Center in Lebanon, N.H. "However, eribulin demonstrated a trend favoring an overall survival benefit, in comparison to capecitabine, which is a widely accepted and used standard therapy in this setting. Additionally, this is the first study demonstrating that eribulin is active earlier in the course of metastatic breast cancer," Kaufman said.

In 2010, the FDA approved eribulin for the treatment of patients with metastatic breast cancer who had previously received an anthracycline and a taxane and at least two cytotoxic chemotherapy treatment regimens for metastatic breast cancer. The FDA granted approval based on data showing a statistically significant improvement in overall survival compared with current treatments.

Kaufman and colleagues examined whether eribulin would be effective as an earlier-line treatment in women with metastatic breast cancer. They randomly assigned 1,102 patients to eribulin or capecitabine. Patients had all received prior anthracycline- and taxane-based therapy and received the study drug as the first, second or third line of therapy for metastatic disease.

The median overall survival for patients treated with eribulin was 15.9 months compared with 14.5 months for patients treated with capecitabine.

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