SAN ANTONIO, Dec. 4 /PRNewswire/ -- In a clinical trial, women treated with
Taxotere(R) (docetaxel) Injection Concentrate had a statistically significant
improvement in overall survival and time to disease progression compared to
those who were treated with Taxol(R)(paclitaxel) for locally advanced or
metastatic breast cancer after prior failure of chemotherapy. Importantly,
despite an increased incidence of certain toxicities, there was no difference in
quality of life scores between the treatment groups over time, according to a
study presented today at the 26th Annual San Antonio Breast Cancer Symposium.
Taxotere(R) and Taxol(R) are in a class of drugs known as taxanes that are used
extensively to treat women with metastatic breast cancer.
"Maintaining or improving the quality of life of patients is just one of
several goals that we set out to achieve when choosing a therapy for metastatic
breast cancer," said Stephen E. Jones, M.D., Medical Director of U.S. Oncology
Research, Director of Breast Cancer Research at the Baylor- Sammons Cancer
Center in Dallas, TX and an investigator of this study. "The significance of
this data is reflected in the fact that women who received Taxotere(R) not only
lived longer than those who received Taxol(R), but there was no statistically
significant difference in their quality of life scores over time with
Study Results and Protocol
This phase III, randomized study is the first to directly compare Taxotere(R)
and Taxol(R) in locally advanced or metastatic breast cancer after prior failure
of chemotherapy. The multi-center study accrued 449 women who were randomized
to receive either Taxotere(R) 100mg/m2 (1 hour infusion) or Taxol(R) 175 mg/m2
(3 hour infusion) every three weeks. Treatment with study medications was
continued until progression of disease, unmanageable toxicity or until the
patient decided to terminate treatment.
The primary endpoint of this study was the rate of overall response (tumor
shrinkage). The secondary endpoints included time to disease progression (time
without the cancer growing), overall survival and quality of life. In the
"intent to treat" population, the study found that women receiving Taxotere(R)
significantly improved their overall survival by 41 percent (median 15.4 months
vs. 12.7 months), p=0.03 over those treated with Taxol(R). In addition, women
receiving Taxotere(R) experienced a significant 62 percent improvement in time
to disease progression (median 5.7 months vs. 3.6 months), p<0.0001 as compared
to Taxol(R). Overall response rates were higher for Taxotere(R) (32.0 percent)
compared to Taxol(R) (25.0 percent, p=0.10).
Quality of life scores were similar between treatment arms over time despite
an increased incidence of grade 3/4 toxicities, including neutropenia (decrease
in white blood cells which help fight infection), fever, diarrhea and edema
(fluid retention) in women who received Taxotere(R). Quality of life was
assessed using the Functional Assessment of Cancer Therapy questionnaire which
is specific to breast cancer (modified FACT-B). The questionnaire is designed
to assess quality of life including the emotional, functional, physical and
social well being of patients. The women completed the questionnaire prior to
treatment, after cycle 4 and at the end of the treatment.
"Results of large, randomized phase III trials directly comparing one
treatment to another are essential to determine the best treatment options for
patients battling metastatic breast cancer," said Michael L. Meyers, Senior
Director, Oncology Medical Affairs, Aventis. "The results of this very
important trial add to the already large body of clinical evidence that shows
that Taxotere is the most active taxane in the treatment of metastatic breast
Breast cancer is the most common cancer among women other than skin cancer.
It is the second-leading cause of cancer death in women after lung cancer -- and
is the leading cause of cancer death among women ages 40 to 59. More than
1,000,000 new cases of breast cancer are reported worldwide annually and more
than 300,000 women die each year from the disease. The risk of a woman
developing breast cancer during her lifetime is approximately 11 percent (about
one in nine of all women), with about 3 to 4 percent dying of the disease.
Taxotere(R) (docetaxel) Injection Concentrate is an anticancer agent and a
taxane that inhibits cell division by preventing microtubule disassembly during
the cell cycle. Microtubules play an important structural role as the cell's
skeleton during cellular growth and replication. By inhibiting the structural
activity of the microtubules, and "freezing" the cell's internal skeleton,
Taxotere(R) treatment interferes with a vital component of cellular replication,
which can result in cell death.
Taxotere(R) is currently approved in the United States to treat patients with
locally advanced or metastatic breast cancer after failure of prior
chemotherapy, and patients with unresectable locally advanced or metastatic
non-small cell lung cancer (NSCLC) in combination with cisplatin, who had not
received prior chemotherapy. It also is approved for patients with locally
advanced or metastatic NSCLC after failure of prior platinum-based chemotherapy.
The most common severe side effects associated with Taxotere(R) include low
blood cell count, fatigue, fluid retention and mouth sores. The most common
non-severe side effects included hair loss, neurosensory, cutaneous, nail
changes, nausea and diarrhea. These side effects are generally reversible and
manageable. A premedication regimen with corticosteroids is recommended in
order to prevent or reduce hypersensitivity and fluid retention. Taxotere(R) is
not appropriate therapy for patients with significant liver impairment or a low
white blood cell count.
Patients 65 years of age or older may experience some side effects more
frequently. For more information about Taxotere(R), visit www.taxotere.com or
see full prescribing information including boxed WARNING. For more information
about ongoing clinical trials, please call 1-800-RxTrial or visit
Aventis is dedicated to treating and preventing disease by discovering and
developing innovative prescription drugs and human vaccines. In 2002, Aventis
generated sales of euro 17.6 billion (US $16.6 billion), invested euro 3.1
billion (US $3 billion) in research and development and employed approximately
71,000 people in its core business. Aventis corporate headquarters are in
Strasbourg, France. The company's prescription drugs business is conducted in
the U.S. by Aventis Pharmaceuticals Inc., which is headquartered in Bridgewater,
New Jersey. For more information about Aventis in the U.S., please visit:
Full prescribing information is available by visiting the Aventis
Pharmaceuticals U.S. Web site at http://www.aventis-us.com. Also available at
this U.S. Web site are copies of this release or any recent release.
Statements in this news release containing projections or estimates of
revenues, income, earnings per share, capital expenditures, capital structure,
or other financial items; plans and objectives relating to future operations,
products, or services; future economic performance; or assumptions underlying or
relating to any such statements, are forward-looking statements subject to risks
and uncertainties. Actual results could differ materially depending on factors
such as the timing and effects of regulatory actions, the results of clinical
trials, the company's relative success developing and gaining market acceptance
for new products, the outcome of significant litigation, and the effectiveness
of patent protection. Additional information regarding risks and uncertainties
is set forth in the current Annual Report on Form 20-F of Aventis on file with
the Securities and Exchange Commission and in the current Annual Report
-"Document de Reference"- on file with the "Commission des Operations de Bourse"
in France, recently renamed "Autorite des marches financiers."
/NOTE TO EDITORS: This press release has been previously distributed in
/CONTACT: Lisa Kennedy, +1-908-243-6361, Lisa.A.Kennedy@Aventis.com, or
Marisol Peron, +1-908-243-7592, Marisol.Peron@Aventis.com, both of Aventis US
/Web site: http://www.aventisoncology.com
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