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FDA Approves Taxotere for Inoperable Head & Neck Cancer

FDA Approves Taxotere for Inoperable Head & Neck Cancer

ROCKVILLE, Maryland--The
FDA has approved Taxotere (docetaxel
for injection, Sanofi-Aventis), in combination
with cisplatin and fluorouracil and
administered prior to radiotherapy, for
the treatment of patients with inoperable,
locally advanced squamous cell carcinoma
of the head and neck (SCCHN).

The agency granted marketing approval
to the drug on the basis of phase
III trial results showing patients treated
with Taxotere and the two chemotherapeutic
agents had a longer progressionfree
survival and overall survival than
those who received only the two cytotoxic
drugs. The difference in both endpoints
was statistically significant.

SCCHN, a group of related cancers,
accounts for approximately 3% of all new
cancers diagnosed in the United States,
according to the FDA. These malignancies
mostly develop in the cells lining the
mucosal surfaces in the head and neck,
including those of the mouth, nose, and
throat.

"Survival rates for advanced head and
neck cancer have historically been low,"
noted Marshall Posner, MD, medical
director of the Head and Neck Oncology
Program at the Dana-Farber Cancer
Institute. "This study has shown that
induction therapy with a Taxotere,
cisplatin, and 5-fluorouracil [TPF] regimen
increases survival. With this approval,
I hope to see TPF become the
standard of care for induction therapy
for patients with this type of cancer."

The new indication for SCCHN is
Taxotere's seventh in the United States
since the drug received its initial approval
in 1996 as a treatment for breast cancer.
Taxotere is a member of the taxoid family,
and produces its antineoplastic effect
by disrupting the network of microtubules
that cells require for mitotic and
interphase cellular functions.

TAX323
Sanofi-Aventis submitted data from a
multicenter, open-label, randomized
phase III trial, designated EORTC 24971/
TAX323, which was conducted under the
auspices of the European Organization
for Research and Treatment of Cancer
(EORTC).

Investigators enrolled 358 patients
with previously untreated inoperable, locally
advanced SCCHN who had a WHO
performance status of 0 or 1. They randomized
177 participants to receive Taxotere 75 mg/m2 followed by cisplatin
75 mg/m2 on day 1, followed by fluorouracil
750 mg/m2/d as a continuous infusion
on days 1 to 5 (TPF arm). They
assigned another 181 patients to receive
cisplatin 100 mg/m2 on day 1, followed
by fluorouracil 1,000 mg/m2/d as a continuous
infusion on days 1 to 5 (PF arm).

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