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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 SLATE COPY Table of Contents: 3 Taxotere® (docetaxel) Injection Concentrate Facts Stephen E. Jones, MD, Medical Director, US Oncology Research, Director of Breast Cancer Research, BaylorSammons Cancer Center, Dallas, Texas B-Roll Footage 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. Visual Please see full prescribing information, including boxed WARNING. 4 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.” Slate # 5 SLATE COPY B-Roll Footage: Mechanism of Action animation footage Visual Insert Animation Suggested Animation Voice Over 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. 6 B-Roll Footage: 7 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. Insert Visuals Taxotere® in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable, node-positive breast cancer. 8 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. 9 Prostate Cancer Taxotere® in combination with prednisone is indicated for the treatment of patients with androgen independent (hormone refractory) metastatic prostate cancer. Slate # 10 SLATE COPY 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. 11 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. Visual 12 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®. Slate # 13 Visual SLATE COPY IMPORTANT SAFETY INFORMATION Before receiving Taxotere®, tell your doctor if You have any allergies 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 14 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. Slate # SLATE COPY Visual 15 This B-roll package was produced and paid for by sanofiaventis, the makers of Taxotere. Taxotere logo Job number USA.DOC.05.08.17