Download Taxotere® Facts

Taxotere B-roll Treatment
DRAFT 8.5.05
Slate #1: Title
A Randomized Phase III Study Demonstrates Improved Survival in Women With
Metastatic Breast Cancer Treated With Taxotere® Versus Paclitaxel
-- Head-to-Head Study Findings Comparing Two of the Most Widely Used
Chemotherapy Agents in Breast Cancer Published in the Journal of Clinical Oncology --
B-Roll
TRT: XX
AUGUST 18, 2005
CONTACT INFORMATION:
Nancy Smith
Rowland Communications
Phone (212) 527-8839
Slate #
2
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Table of Contents:
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Taxotere® (docetaxel) Injection Concentrate Facts
Stephen E. Jones, MD, Medical Director, US Oncology
Research, Director of Breast Cancer Research, BaylorSammons Cancer Center, Dallas, Texas
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Important safety Information
Taxotere® Facts:
Taxotere® is currently approved in the U.S. to treat patients with
locally advanced or metastatic breast cancer after failure of prior
chemotherapy, and it is also approved in combination with
doxorubicin and cyclophosphamide (TAC regimen) for the
adjuvant (post surgery) treatment of patients with operable,
node-positive breast cancer.
Taxotere® is approved for the treatment of patients with
unresectable locally advanced or metastatic non-small cell lung
cancer (NSCLC) in combination with cisplatin, who had not
received prior chemotherapy, and it also is approved for patients
with unresectable locally advanced or metastatic NSCLC after
failure of prior platinum-based chemotherapy. In addition, the
U.S. Food and Drug Administration has approved Taxotere® for
use in combination with prednisone as a treatment for men with
androgen-independent (hormone-refractory) metastatic prostate
cancer.
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Please see full prescribing information, including
boxed WARNING.
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SOT:
Stephen E. Jones, MD, Medical Director, US Oncology
Research, Director of Breast Cancer Research, BaylorSammons Cancer Center, Dallas, Texas
Dr. Jones
“We did a head to head
comparison of Taxotere
with paclitaxel, and we
studied the FDAapproved standard every
three-week dosing. In the
context of the study, we
learned that Taxotere
was a more active drug.”
“There is a higher chance
of patients' having
shrinkage of their tumor,
the time to the cancer
progressing is longer if
you receive Taxotere,
and also the overall
survival.”
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5
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 Mechanism of Action animation footage
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As a chemotherapeutic agent, Taxotere® is a taxane that
inhibits cell division by preventing microtubule disassembly
during the cell cycle. Microtubules play an important structural
role during cell growth and replication. Many chemotherapy
drugs stop cancer cells from dividing by interfering with the cell's
DNA, but Taxotere acts quite differently. By inhibiting the
structural activity of the microtubules, Taxotere® treatment
interferes with a vital component of some cancer cells'
replication and results in cell death.
Taxotere is injected into a vein every three weeks with each
treatment lasting about an hour.
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Nurse handling vials
Researcher looking through microscope
Slides under microscope
Taxotere® being packaged
Taxotere® on conveyor belt/assembly line
Indications and Usage
Breast Cancer
Taxotere® is indicated for the treatment of patients with locally
advanced or metastatic breast cancer after failure of prior
chemotherapy.
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Taxotere® in combination with doxorubicin and
cyclophosphamide is indicated for the adjuvant treatment of
patients with operable, node-positive breast cancer.
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Non-Small Cell Lung Cancer (NSCLC)
Taxotere®, as a single agent, is indicated for the treatment of
patients with locally advanced or metastatic non-small cell lung
cancer (NSCLC) after failure of prior platinum-based
chemotherapy.
Taxotere® in combination with cisplatin is indicated for the
treatment of patients with unresectable, locally advanced or
metastatic NSCLC who have not previously received
chemotherapy for this condition.
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Prostate Cancer
Taxotere® in combination with prednisone is indicated for the
treatment of patients with androgen independent (hormone
refractory) metastatic prostate cancer.
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10
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IMPORTANT SAFETY INFORMATION
WARNING: Taxotere® treatment can cause serious,
physically limiting, and potentially life-threatening side
effects, such as infection, low blood-cell counts, allergic
reaction, and retention of excess fluid (edema).
Taxotere® should not be given to patients with low white–
blood-cell counts, abnormal liver function, or a history of
allergic reactions to Taxotere® or any of the ingredients in
Taxotere®.
Before each Taxotere® treatment, all patients treated with
Taxotere® must receive another medicine called
dexamethasone. This drug can help reduce the risk of fluid
retention (edema) and allergic reactions.
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IMPORTANT SAFETY INFORMATION
Taxotere® should be administered only under the
supervision of a qualified physician experienced in the use
of anticancer treatments. Appropriate management of
complications is possible only when adequate diagnostic
and treatment facilities are readily available.
Treatment-related acute myeloid leukemia (AML) has occurred
in patients given anthracyclines and/or cyclophosphamide,
including use with Taxotere® in adjuvant therapy for breast
cancer.
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IMPORTANT SAFETY INFORMATION
The most common severe side effects are low white–bloodcell count, anemia, fatigue, diarrhea, and mouth and throat
irritation. Low white–blood-cell count can lead to life-threatening
infections. The earliest sign of infection may be fever, so tell
your doctor right away if you have a fever.
Other common side effects from Taxotere® include nausea,
vomiting, hair loss, rash, infusion-site reactions, odd sensations
(such as numbness, tingling, or burning) or weakness in the
hands and feet, nail changes, muscle and/or bone pain, or
excessive tearing.
Patients 65 years of age or older may experience some side
effects more frequently than younger patients.
Because of the potential risk of fetal harm, pregnant women
should not receive Taxotere®. Women of childbearing potential
should avoid becoming pregnant during treatment with
Taxotere®.
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IMPORTANT SAFETY INFORMATION
Before receiving Taxotere®, tell your doctor if
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You have any allergies
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You are taking any other medicines — including
nonprescription (over-the-counter) drugs, vitamins, and
dietary or herbal supplements
When taking Taxotere®, contact your doctor if
 You have symptoms of an allergic reaction (warm sensation,
tightness in your chest, itching/hives, or shortness of breath)
 You experience any other side effects
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IMPORTANT SAFETY INFORMATION
Please see accompanying patient information leaflet for
detailed information about these side effects, and talk to your
doctor about any questions you may have.
For more information about Taxotere®, visit 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 www.aventisoncology.com.
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This B-roll package was produced and paid for by sanofiaventis, the makers of Taxotere.
Taxotere logo
Job number
USA.DOC.05.08.17