Taxotere(R) Study Shows Improved Survival And Reduced Relapse In Early-Stage Breast Cancer
December 05 2003 - 8:00PM
PR Newswire (US)
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
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