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New Study Supports Early Use of Taxotere(R) in the Treatment of Operable Breast
Cancer
Improved Clinical and Pathological Response Rates Seen in Women Treated with
Taxotere(R) in Addition to Standard Regimen Prior to Surgery
BRIDGEWATER, N.J., Nov. 17 /PRNewswire-FirstCall/ -- Study results published
today in the Journal of Clinical Oncology (JCO) may provide support for the
early use of Taxotere(R) (docetaxel) Injection Concentrate in the treatment of
breast cancer. The study, conducted by the National Surgical Adjuvant Breast
and Bowel Project (NSABP), showed improved clinical and pathological complete
response rates in patients with operable breast cancer who were given
Taxotere(R) in addition to a standard anthracycline-based regimen prior to
surgery, compared with those patients who only received the pre-operative
(neoadjuvant) anthracycline-based regimen. A clinical complete response is
defined as the complete disappearance of all clinical signs of cancer and a
pathological complete response indicates that no invasive cancer is present in
the breast.
"While we've known for some time that neoadjuvant chemotherapy is beneficial for
patients with more advanced breast cancer, this study demonstrates that patients
with less advanced or operable breast cancer may also benefit from this
approach," said lead investigator Harry D. Bear, M.D., Ph.D., Professor and
Chairman, Division of Surgical Oncology, Virginia Commonwealth University's
Medical College of Virginia and the Massey Cancer Center. "The addition of
Taxotere(R) to the pre-operative regimen significantly improved response rates.
Research shows that improvement in response rates are predictive of longer
survival for patients, which is why we are so encouraged by these results."
In the large, Phase III study (NSABP Protocol B-27) patients were randomized to
receive either four cycles of doxorubicin and cyclophosphamide (AC) followed by
surgery (Group I) or four cycles of AC followed by four cycles of Taxotere(R),
followed by surgery (Group II) or four cycles of AC followed by surgery and then
four cycles of Taxotere(R) (Group III). Among the most compelling findings was
a 91 percent increase in pathologic complete response rate among patients in
Group II (AC followed by Taxotere(R)), compared with those patients given just
AC (26.1 percent vs. 13.7 percent).
In addition to the statistically significant increase in pathologic complete
response, patients in Group II (AC followed by T) also experienced a higher
clinical complete response rate than patients given AC alone (63.6 percent vs.
40.1 percent) and a higher overall response rate or tumor shrinkage (90.7
percent vs. 85.5 percent). There was also an improvement in nodal status among
patients given Taxotere(R) as part of the neoadjuvant regimen compared with
those given AC alone (58.2 percent pathologically node- negative vs. 50.8
percent).
In the study, 10.3 percent of patients experienced a grade 4 toxicity while
receiving AC, and 23.4 percent of patients experienced a grade 4 toxicity while
receiving Taxotere(R). The most common grade 4 event experienced by patients
during treatment with Taxotere(R) was febrile neutropenia (21.2 percent).
About Taxotere
Taxotere(R), a drug in the taxoid class of chemotherapeutic agents, inhibits
cancer cell division by essentially "freezing" the cell's internal skeleton,
which is comprised of microtubules.
Microtubules assemble and disassemble during a cell cycle. Taxotere(R) promotes
their assembly and blocks their disassembly, thereby preventing cancer cells
from dividing and resulting in cancer 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
warnings. 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.
DATASOURCE: Aventis
CONTACT: Corinne Hoff, Global Communications, +33-3-88-99-19-16,
, Lisa Kennedy, U.S. Communications, +1-908-243-6361,
, Marisol Peron, U.S. Communications,
+1-908-243-7592, , or Jason Ford, Global Product
Communications, +1-908-231-3850, , all of Aventis
Web site: http://www.aventisoncology.com/
http://www.aventis-us.com/
http://www.taxotere.com/