Eli Lilly and Company: Gemzar Combination Delays Disease Progression In First-Line Breast Cancer Study; Tumor Response Rate Also Significantly Improved.
Business Editors/Health/Medical Writers
CHICAGO--(BUSINESS WIRE)--June 1, 2003
Women with metastatic breast cancer experienced a significant delay in the progression of their disease when they received a combination of Gemzar(R) (gemcitabine HC1) and Taxol(R) (paclitaxel), compared to Taxol alone, according to an interim analysis of Phase III data unveiled today at the 39th annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Illinois.
The Gemzar/Taxol combination is one of the few combinations to surpass the single-agent efficacy of Taxol in delaying time to disease progression among patients with metastatic breast cancer, according to lead investigator Joyce O'Shaughnessy, M.D., U.S. Oncology, and co-director of breast cancer research at Baylor Sammons Breast Center in Dallas, Texas.
"Physicians always strive to provide effective treatment options for wives, mothers and daughters battling breast cancer," said O'Shaughnessy. "The advantage observed in this trial offered women receiving treatment an increased amount of time until the disease started to get worse."
The study involved 529 women who were previously treated with an anthracycline but had no prior chemotherapy in the metastatic setting. Taxol is commonly used in treating women with metastatic breast cancer under these circumstances.
One treatment arm, comprising 267 women, received repeated 21-day cycles of Taxol and Gemzar (175 mg/m2 of Taxol for three hours on day one followed by 1250 mg/m2 of Gemzar on the same day for 30 minutes and then Gemzar alone on day eight at the same dose). The remaining 262 women received Taxol only (175 mg/m2 for three hours on day one). Patients were treated until progressive disease was documented or an intolerable toxicity developed.
The global trial, which serves as the basis of Eli Lilly and Company's submissions for a metastatic breast cancer indication in Europe, yielded the following results:
-- Median time to disease progression, the primary interim
endpoint of the study, was 5.4 months for the Gemzar/Taxol arm
and 3.5 months for the Taxol arm, a finding that was
statistically significant (p= 0.0013). Time to disease
progression is a measure of time after cancer is treated until
the disease starts to get worse. More than 50 percent of women
