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Capecitabine In Combination With Docetaxel Offers Superior Survival.(Statistical Data Included)
2001 OCT 11 - (NewsRx.com & NewsRx.net) --
The U.S. Food and Drug Administration (FDA) has approved the oral cancer drug, Xeloda (capecitabine), in combination with Taxotere (docetaxel), given by infusion, for the treatment of metastatic breast cancer.
The approval pertains to patients whose anthracycline treatment has failed. The combination of Xeloda and Taxotere is the first and only chemotherapy combination to significantly extend survival in these patients compared to Taxotere alone.
The median survival was extended by three months over Taxotere alone (median survival 14.5 months vs. 11.5 months). Previous to this combination, Taxotere monotherapy (100 mg/m(2) dose on day one of each 21-day cycle) has been the only regimen to show improved survival over a standard regimen of mitomycin and vinblastine combination.
The recent findings indicate that patients treated with the combination Xeloda+Taxotere had a superior survival with a 22.5% reduced risk of death (hazard ratio=0.775, p=0.013) compared to those treated with Taxotere alone. In addition to demonstrating a significant survival advantage, the combination of Xeloda+Taxotere also demonstrated a statistically significant superior tumor response of 32% compared to Taxotere monotherapy of 22% (p=0.009) in this large Phase III study of 511 patients. In addition, time to disease progression is significantly longer for patients treated with Xeloda+Taxotere: median 6.1 months vs. 4.2 months with Taxotere alone (p=0.001, Hazard Ratio=0.643).
"Xeloda combined with Taxotere is an important treatment improvement for women with metastatic breast cancer," said Joyce O'Shaughnessy, MD, codirector of breast cancer research at Baylor-Sammons Cancer Center and U.S. Oncology. "The clinical data showed significant improvements in survival, tumor response and time to disease progression for the combination compared to Taxotere alone in patients after failure of anthracycline treatment. This represents a major advance in the management of women with metastatic breast cancer as improvements in survival are the bottom line."
"Physicians use a combination of anti-cancer drugs, radiation and surgery to fight breast cancer and extend life," said Carolyn Aldige, president of the Cancer Research Foundation of America. "Xeloda+Taxotere is a critical addition to the arsenal of cancer treatments a physician now has to treat metastatic breast cancer."
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