Combination
of gemcitabine and paclitaxel may become new option for women with
unresectable locally recurrent or metastatic breast cancer
A
new treatment option for unresectable locally recurrent or metastatic
breast cancer may be in wider use soon: The manufacturers of Gemzar
R (gemcitabine HCl) are seeking an expanded indication for gemcitabine
in combination with paclitaxel as treatment for advanced disease.
The current submission to
European regulators is based on interim analysis of data obtained
from an ongoing Phase III trial of gemcitabine plus paclitaxel versus
paclitaxel alone in these two populations of women with breast cancer.
Breast cancer is diagnosed in more than 200,000 women within the
European Union annually, and it is the third most common malignancy
worldwide.
Pending final study results, trial investigators
anticipate presentation of full study findings at a major oncology
meeting in May 2003 and submission of gemcitabine for similar approval
in breast cancer treatment by the U.S. Food and Drug Administration.
"The data submitted for this expanded
indication show the efficacy of Gemzar (gemcitabine) as proven in
treating multiple tumors may again be demonstrated in breast cancer,"
said Jorge Otero, M.D., medical director within the manufacturer’s
organization for the Gemzar product.
Gemcitabine is a standard chemotherapeutic
option for pancreatic cancer and is entering wider use for non-small
cell lung cancer and bladder cancer. Gemcitabine is a nucleoside
analogue that interferes with DNA production, inhibiting cell division.
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