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Taxotere(R) Study Shows Improved Survival And Reduced Relapse In Early-Stage
Breast Cancer
Second Interim Analysis to Support U.S. and EU Registrational Submissions for
Adjuvant Breast Cancer
SAN ANTONIO, Dec. 5 /PRNewswire-FirstCall/ -- An updated analysis of an
important study shows the Aventis chemotherapy agent Taxotere(R) (docetaxel)
Injection Concentrate significantly improved the survival rate of women with
early-stage breast cancer and reduced their risk of a relapse compared with a
standard treatment.
The Breast Cancer International Research Group (BCIRG) 001/ TAX 316 study,
presented at the San Antonio Breast Cancer Symposium on December 5, showed women
with node-positive, early-stage breast cancer who received a Taxotere(R)-based
chemotherapy regimen after surgery experienced a 30 percent reduction in the
risk of death at a 55-month follow-up and a 28 percent reduction in the chance
of their cancer returning as compared to women treated with a commonly used,
standard (post-surgery) adjuvant regimen.
The first analysis of BCIRG001 presented at the American Society of Clinical
Oncology (ASCO) in May 2002 by Dr. Jean Marc Nabholtz, who designed the trial,
showed that the Taxotere(R) combination arm had strong activity in both women
with hormone-receptor positive or hormone-receptor negative tumors. The current
analysis shows Taxotere(R) to be the only taxane that demonstrates a
disease-free survival benefit for women, regardless of hormone-receptor status
of their tumors.
Aventis plans to use the phase III study data to support submissions for U.S.
and EU approval in early 2004 for the use of Taxotere(R) in treating early-stage
operable breast cancer with involved axillary lymph nodes. Taxotere(R) is
currently indicated as a therapy for treatment of locally advanced or metastatic
breast cancer after prior failure of chemotherapy.
"These mature data, which reflect nearly five years of follow-up, are exciting
as they demonstrate that adding Taxotere(R) to a standard anthracycline regimen
in the adjuvant setting can significantly reduce the risk of relapse for women
with early-stage breast cancer," said John Mackey, M.D., a member of the BCIRG
Scientific Committee and Chair of the Northern Alberta Breast Cancer Program at
the Cross Cancer Institute in Edmonton, Canada. "The results of this study
suggest that we may be able to cure more women with early-stage disease by
providing them a highly effective adjuvant chemotherapy regimen."
Study Results and Protocol
The study compared the combination of Taxotere(R), doxorubicin (Adriamycin(R))
and cyclophosphamide (Cytoxan(R)), (TAC), with the standard regimen of
5-fluorouracil, doxorubicin and cyclophosphamide, (FAC). The 55- month follow-up
results from this study were presented as a late-breaking oral presentation at
the San Antonio symposium.
The multi-center study, conducted by BCIRG, enrolled 1,491 pre- and post-
menopausal women with early-stage breast cancer from 112 sites in 20 countries
between June 1997 and June 1999. Women were randomized to receive either TAC or
FAC in the adjuvant (post-surgery) setting.
Among the findings of the study was a 28 percent improvement in the primary
endpoint of disease-free survival (p=0.0010) for patients treated with TAC as
compared to FAC. A similar benefit was observed regardless of nodal,
hormone-receptor and HER-2/neu status. The study also showed a 30 percent
reduction in the risk of death (p=0.0080) for women treated with the
Taxotere(R)-based regimen.
"The outcomes from this important trial demonstrate that Taxotere(R) extends the
lives of woman with node positive disease," said Dr. Frank Douglas, Executive
Vice President for Drug Innovation & Approval and a Member of the Management
Board of Aventis. "We are encouraged by these results in early-stage breast
cancer, and we will be using this data to support our submissions for regulatory
approval early next year for Taxotere(R) in this setting."
Adverse Events Manageable
Long-term follow-up of women on the study did not identify any new safety
concerns beyond those already presented at the time of the first interim
analysis.
Specifically, the TAC regimen was associated with a higher rate of febrile
neutropenia (low white blood cell count that can lead to infections) compared
with FAC (24.7 percent versus 2.5 percent). However, this increase in febrile
neutropenia did not lead to an increased incidence of severe infection, and
there were no toxic deaths from infection. Also, patients in the study were not
treated prophylactically with GCSF (granulocyte colony-stimulating factor), an
effective and widely used agent to prevent neutropenia in chemotherapy
patients.
The study compared an equal number of treatment cycles for both treatment groups
and more than 90 percent of patients in both treatment groups received all six
cycles of treatment.
Breast Cancer
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 three to four percent dying of the disease.
About Taxotere(R)
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
http://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 http://www.aventisoncology.com/.
About Aventis
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:
http://www.aventis-us.com/.
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".
DATASOURCE: Aventis US Product Communications
CONTACT: Lisa Kennedy, +1-908-243-6361, or ,
or Marisol Peron, +1-908-243-7592, or , both of
Aventis US Product Communications
Web site: http://www.aventis-us.com/
http://www.aventisoncology.com/
http://www.sabcs.org/
http://www.taxotere.com/