Investigators Report Taxotere(R) Offers Significant Survival Benefits for Head and Neck Cancer Patients

Investigators Report Taxotere(R) Offers Significant Survival
Benefits for Head and Neck Cancer Patients 


BRIDGEWATER, N.J., June 5  /PRNewswire-FirstCall/ -- Aventis (NYSE:AVE)
announced today the results of a phase III trial using Taxotere(R) (docetaxel)
Injection Concentrate when added to a standard therapy for nonresectable
locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN) were
presented at the annual meeting of the American Society of Clinical Oncology
(ASCO) in New Orleans, LA.  Investigators reported that the Taxotere(R)-based
regimen demonstrated superior overall survival rates, and patients also
benefited from significantly improved progression-free survival and cancer
response rates, as well as a lower rate of severe side effects compared to the
standard therapy.

The trial, conducted by the European Organization for Research and Treatment of
Cancer (EORTC) Head and Neck Cooperative Group, involved 358 patients and
demonstrated that patients receiving Taxotere(R) plus cisplatin and
5-fluorouracil (5-FU) had significant prolongation of progression-free
survival, the trial's primary endpoint, (12.7 months vs. 8.4 months, p=0.006)
compared to those who received the standard treatment of cisplatin and
5-fluorouracil (5-FU).  The Taxotere(R) combination also resulted in
significantly improved overall survival (18.6 months vs. 14.5 months, p=0.016)
and significantly increased overall response rates (67.8 percent vs. 53.6
percent, p=0.007), the trial's secondary endpoints.

"Head and neck cancer patients have very limited treatment options. The
addition of Taxotere(R) to this standard treatment regimen is very encouraging
and may change the paradigm by which we treat this disease," said Jan B.
Vermorken, MD, PhD, EORTC Principal Investigator, Professor of Oncology and
Head of the Department of Medical Oncology at the University Hospital of the
University of Antwerp in Belgium. "The trial findings provide new important
information for oral surgeons, medical oncologists and radiation oncologists."

Head and neck cancer is the seventh most frequently occurring cancer worldwide
with an incidence rate of 390,000 cases annually.  In the United States, it is
estimated that more than 38,000 cases will occur in 2004.

"We are encouraged by today's results that suggest a benefit with Taxotere(R)
for patients with advanced head and neck cancer, a difficult to treat disease,"
said Frank Douglas, MD, PhD, Executive Vice President of Drug Innovation and
Approval and a Member of the Board of Management at Aventis.

Study Results and Protocol

Patients in the multicenter trial were randomly assigned to receive one of two
treatments.  Of the 358 participants, 177 received an infusion of Taxotere(R)
plus cisplatin on day one and a five-day continuous infusion of 5-fluorouracil
(5-FU) and 181 patients received an infusion of a standard treatment consisting
of cisplatin on day one followed by a five-day continuous infusion of
5-fluorouracil (5-FU). Treatment cycles were to be repeated every three weeks
for a total of four cycles.  All patients received radiation therapy following
chemotherapy within four to seven weeks after completing the last cycle of
chemotherapy.  Radiation therapy was administered five days a week for up to
seven weeks.

In this trial, investigators reported that Taxotere(R) regimen was well
tolerated and had a generally predictable and manageable safety profile.
Patients receiving the cisplatin and 5-fluorouracil (5-FU) regimen showed
greater grade 3-4 nausea (7.3 percent vs. 0.6 percent), vomiting (5.0 percent
vs. 0.6 percent) stomatitis (11.2 percent vs. 4.6 percent) and more toxic
deaths (5.5 percent vs. 2.3 percent) when compared to the Taxotere(R) regimen.

These results are one of three large randomized phase III Taxotere(R) studies
highlighted at this premier oncology meeting from which investigators reported
survival advantages for cancer patients. Also two landmark phase III trials,
TAX 327 (abstract 4) and SWOG 9916   (abstract 3), demonstrated a
Taxotere(R)-based regimen yielded a statistically significant survival benefit
for men with androgen-independent (hormone-refractory) metastatic prostate
cancer.

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 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
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 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 "Autorite des marches financiers". 

DATASOURCE: Aventis



CONTACT:  Lisa Kennedy, U.S. Product Communications, [phone], or

, Marisol Peron, U.S. Product Communications,

[phone], or , both of Aventis



Web site:  http://www.aventis-us.com/ 

Copyright