Two Landmark Studies of Taxotere(R) in Prostate Cancer Highlighted in American Society of Clinical Oncology Plenary Session
26 5월 2004 - 10:00PM
PR Newswire (US)
Two Landmark Studies of Taxotere(R) in Prostate Cancer Highlighted
in American Society of Clinical Oncology Plenary Session
BRIDGEWATER, N.J., May 26 /PRNewswire-FirstCall/ -- Aventis
announced today that two landmark Phase III studies of Taxotere(R)
(docetaxel) Injection Concentrate in men with androgen-independent
(hormone-refractory) metastatic prostate cancer have been selected
for presentation at the Plenary Session of the 2004 annual meeting
of the American Society of Clinical Oncology (ASCO) in New Orleans,
LA. The abstracts are two of only five selected for presentation
during the meeting's plenary session on Monday, June 7, in Hall F
of the Ernest N. Morial Convention Center. The plenary session is
considered the meeting's premier scientific session, as it features
prominent data selected by the ASCO Program Committee. Additional
data from a clinical trial about Taxotere(R) involving cancer of
the head and neck will also be presented at ASCO. Abstract #3,
Monday, June 7, 2:45 - 3:00 PM (CDT), Hall F Results from SWOG
9916, a randomized Phase III multi-center trial comparing
Taxotere(R) plus estramustine to mitoxantrone plus prednisone in
men with androgen-independent (hormone-refractory) metastatic
prostate cancer will be presented by Daniel P. Petrylak, MD,
Director, Genitourinary Oncology Program, Columbia Presbyterian
Medical Center. The study was conducted in cooperation with the
Southwest Oncology Group. Abstract #4, Monday, June 7, 3:00 - 3:15
PM (CDT), Hall F A second presentation given by Mario Eisenberger,
MD, Dale Hughes Professor of Oncology and Urology at the Johns
Hopkins Kimmel Cancer Center, will feature data from TAX 327, a
multicenter phase III trial comparing the combination of
Taxotere(R) and prednisone to the current standard treatment
regimen of mitoxantrone plus prednisone in patients with
androgen-independent (hormone-refractory) metastatic prostate
cancer. Abstract #5508, Tuesday, June 8, 11:45 - 12:00 PM (CDT),
Room O24 In addition, Jan Baptist Vermorken, MD, PhD, Department of
Oncology, University Hospital Antwerp Belgium, will present data
from TAX 323, a Phase III clinical trial comparing Taxotere(R) plus
cisplatin and infusional 5-fluorouracil to standard cisplatin and
infusional 5-fluorouracil in patients with nonresectable, locally
advanced, squamous cell carcinoma of the head and neck (LA-SCCHN).
About Prostate Cancer Prostate cancer ranks third worldwide in
cancer incidence and sixth in cancer mortality among men. In the
United States, more than 230,000 men will be diagnosed with
prostate cancer this year, and more than 29,900 will die of the
disease. Current therapy for advanced prostate cancer is hormonal
manipulation (i.e., blockage of androgen hormones like testosterone
that would otherwise stimulate the growth of prostate cancer
cells). However, the effects of this treatment typically last
between 24 and 36 months, at which time patients may become
refractory to hormonal therapy and be considered candidates for
chemotherapy, such as Taxotere(R). About Taxotere(R) 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 many
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 unresectable
locally advanced or metastatic NSCLC after failure of prior
platinum-based chemotherapy. On May 19, 2004, the U.S. Food and
Drug Administration granted approval of Taxotere(R) for use in
combination with prednisone as a treatment for men with
androgen-independent (hormone-refractory) metastatic prostate
cancer. Among patients receiving Taxotere(R) the most common severe
adverse events were low blood cell count, fatigue, diarrhea, and
mouth and throat irritation. The most common non-severe side
effects include hair loss, numbness, a tingling and/or burning
sensation, rash, nail changes, nausea, vomiting, and muscle pain.
Less common severe or potentially life threatening side effects
include fluid retention, infections, and allergic reactions.
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 2003, Aventis
generated sales of euro 16.79 billion (US $18.99), invested euro
2.86 billion (US $3.24) in research and development and employed
approximately 69,000 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, please visit: http://www.aventis-us.com/. 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 "Auto rite des marches financiers". DATASOURCE: Aventis
CONTACT: Lisa Kennedy, +1-908-243-6361, , or Marisol Peron
+1-908-243-7592, , both of Aventis U.S. Product Communications Web
site: http://www.aventisoncology.com/ http://www.aventis-us.com/
http://www.taxotere.com/
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