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Two Landmark Studies Show That Taxotere(R) Significantly Improves
Survival in Men With Prostate Cancer
Taxotere(R)-based regimen is the first and only treatment with proven
significant survival benefit for men with androgen-independent
(hormone-refractory) metastatic prostate cancer
BRIDGEWATER, N.J., June 7 /PRNewswire-FirstCall/ -- Aventis (NYSE:AVE)
announced today that the results of two landmark phase III trials using
Taxotere(R) (docetaxel) Injection Concentrate based regimens in the treatment
of androgen-independent (hormone-refractory) metastatic prostate cancer have
been presented at the plenary session of the annual meeting of the American
Society of Clinical Oncology (ASCO) in New Orleans, LA.
The clinical trials, TAX 327 and SWOG 9916, were led by investigators from the
Johns Hopkins Kimmel Cancer Center and NewYork-Presbyterian Hospital/Columbia
University Medical Center and the Southwest Oncology Group (SWOG). The trials
involved nearly 1,800 patients and demonstrated that Taxotere(R)-based regimens
significantly reduced the risk of death by 24 percent and 20 percent,
respectively. Investigators in the TAX 327 trial also reported that
Taxotere(R) significantly improved patients' PSA responses by 43 percent
(p=0.0005) and improved pain responses by 59 percent (p=0.0107), relative to
mitoxantrone response rates.
The SWOG trial investigators reported a 27 percent increase in disease-
progression-free survival and a 55 percent increase in objective response rate
in the Taxotere(R)-containing arm. In addition, the majority of patients had a
PSA decline of more than 50 percent.
"These studies are the first to show that a chemotherapy agent, Taxotere(R),
can deliver a significant survival benefit in androgen- independent
(hormone-refractory) metastatic prostate cancer patients, giving hope to
thousands of men worldwide," said Daniel Petrylak, MD, Associate Professor of
Medicine at Columbia University College of Physicians & Surgeons, Director of
the Genitourinary Oncology Program at NewYork-Presbyterian Hospital. "These
data represent an important new treatment option for men with prostate cancer
because it can help some patients live longer."
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.
"The results of these studies mark a significant milestone in cancer care.
Taxotere(R) is the only drug approved for patients with breast, lung and
prostate cancer, three of the most prevalent cancers in the world today," said
Frank Douglas, MD, PhD, Executive Vice President of Drug Innovation and
Approval and a Member of the Board of Management at Aventis.
TAX 327/SWOG 9916 Study Protocol
The TAX 327 study reported by Mario Eisenberger, MD, Dale Hughes Professor of
Oncology and Urology at the Johns Hopkins Kimmel Cancer Center, enrolled
patients at 240 sites in 24 countries. One thousand six (1,006) eligible
patients were randomized to receive one of three treatment regimens.
Taxotere(R) 75mg/m(2) once every three weeks plus daily prednisone, or
Taxotere(R) 30 mg/m(2) every week for five out of six weeks plus daily
prednisone, or mitoxantrone 12mg/m(2) every three weeks plus daily prednisone,
the established standard of care. The majority of the patients were over the
age of 65.
The SWOG 9916 study reported by Dr. Petrylak randomized 770 patients in the
United States to one of two treatment arms: Taxotere(R) 60 mg/m(2) every three
weeks and estramustine 280 mg three times daily for 5 days or mitoxantrone 12
mg/m(2) every three weeks and prednisone 5 mg twice daily.
Taxotere(R) was well tolerated and had a generally predictable and manageable
safety profile in both studies. The most commonly observed adverse events in
TAX 327 were alopecia, fatigue, and nausea, but the rates were comparable to
mitoxantrone. Hematological events seen in the trial were consistent with the
expected safety profile for both treatments, with grade 3- 4 neutropenia
reported more frequently in the Taxotere(R) group than the mitoxantrone group
(32 percent vs 21.7 percent, p=0.004). However, complications of neutropenia
appeared comparable in both groups.
In the SWOG 9916 study, gastrointestinal and cardiovascular events occurred
more frequently in men treated with Taxotere(R) plus estramustine than those
treated with mitoxantrone.
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
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, +1-908-243-6361, , or
Marisol Peron, +1-908-243-7592, , both of U.S.
Product Communications, for Aventis
Web site: http://www.aventis-us.com/
http://www.aventisoncology.com/