Gemzar ®
Approved for Initial Treatment of Metastatic Breast Cancer
The Food and Drug Administration (FDA) recently approved
the chemotherapy agent Gemzar ® (gemcitabine), in combination
with paclitaxel, as first-line therapy for metastatic breast
cancer, offering patients with this disease a new and effective
treatment option.
Breast cancer is the most common cancer diagnosed in women
in the United States, claiming the lives of approximately
U.S. 40,000 women annually. Although treatment for patients
with early-stage breast cancer, or cancer that has not spread
from its site of origin results in high cure rates, some patients
ultimately experience a recurrence and spread of their cancer.
Metastatic breast cancer refers to cancer that has spread
from the breast to distant sites in the body, often invading
vital organs. Survival for patients with metastatic breast
cancer is poor, with the average survival time from diagnosis
of this advanced stage of cancer being 18 to 30 months. Patients
whose cancer has recurred following previous therapy and has
developed into metastatic breast cancer are often treated
with chemotherapy agent paclitaxel (Taxol ®).
The specific FDA indication for Gemzar ® is for use with
the chemotherapy agent paclitaxel in women who have stopped
responding to prior anthracycline-based chemotherapy for treatment
of earlier-stage breast cancer. The clinical trial from which
this indication was based included women with metastatic breast
cancer who were treated with either Gemzar ® plus paclitaxel,
or paclitaxel alone. These women had already been treated
for earlier-stage breast cancer with anthracycline-based regimens,
or other regimens if they were not able to tolerate anthracyclines.
The time to cancer progression was significantly greater in
the group of patients treated with Gemzar ® plus paclitaxel
(5.2 months), compared to paclitaxel alone (2.9 months). Overall
survival data will be presented at the upcoming meeting of
the American Society of Clinical Oncology in June 2004.
Patients who have been diagnosed with metastatic breast cancer
following a recurrence may wish to speak with their physician
regarding the risks and benefits of treatment with Gemzar ®.
Reference: Lilly Oncology. FDA Grants Approval for Lilly's
Gemzar in Combination with Taxol as First-Line Treatment for
Metastatic Breast Cancer. Available at: http://newsroom.lilly.com/news/Product/2004-05-19_gemzar_metastatic_breastcancer.html.
Accessed May 2004.
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