Investigators Report Taxotere(R) Offers Significant Survival Benefits for Head and Neck Cancer Patients
June 05 2004 - 9:00AM
PR Newswire (US)
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,
+1-908-243-6361, or , Marisol Peron, U.S. Product Communications,
+1-908-243-7592, or , both of Aventis Web site:
http://www.aventis-us.com/
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