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Taxotere® Chemotherapy Benefits: Head and Neck Cancer

In 2006, Taxotere® (docetaxel) in combination with cisplatin and fluorouracil (TPF) was approved by the Food and Drug Administration (FDA) as induction treatment of patients with Inoperable, locally advanced Squamous Cell Carcinoma of Head and Neck (SCCHN). When chemotherapy is used before surgery and/or radiation, it is called induction therapy or neoadjuvant therapy.

This indication was updated in 2007 with an expanded label based on a (multicenter, open-label, randomized, phase III clinical trial comparing Taxotere® + cisplatin + fluorouracil (TPF) vs cisplatin + fluorouracil (PF), followed by concurrent chemoradiotherapy.

Taxotere® now maintains the following expanded approval by the U.S. Food and Drug Administration (FDA):

Taxotere® in combination with cisplatin and fluorouracil for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN).

Induction Therapy offers several potential benefits:

  • Extending a patient's life
  • Slowing of the growth or spread of cancer
  • Shrinking of the tumor
  • Relieving from the symptoms of head and neck cancer

Treatment Team

Head and neck specialists often work together as a team to plan your treatment. The specialists you need will vary depending on the location and extent of your cancer. Your team may include medical oncologists (responsible for chemotherapy), radiation oncologists, otolaryngologists (ear, nose, and throat surgeons who are also called ENT surgeons or head and neck surgeons), plastic surgeons, maxillofacial prosthodontists (experts in dental reconstruction), dentists, physical therapists, speech therapists, audiologists (hearing specialists), psychiatrists, nurses, physician assistants, nurse practitioners, dieticians, and social workers. A team approach is critical to help optimize all the available treatment options for Head and Neck cancers.

Taxotere® Chemotherapy Proven Effective in SCCHN Study

In 2007, the FDA approved the Taxotere® based regimen TPF to treat locally advanced SCCHN based on a study that proved superior efficacy of TPF over PF.2 Induction chemotherapy with TPF vs PF was followed by chemoradiation.

The TPF group demonstrated the following advantages over the PF group:3

  • Patients receiving TPF lived significantly longer (70.6 month median survival in the TPF group vs 30.1 month median survival in the PF group).
  • The TPF group had a 30% reduced chance of death from the cancer.
  • More patients in the TPF arm (82.4%) remained on their planned treatment dose and schedule than patients in the PF arm (64.4%).
  • A similar percentage of patients stopped treatment because of side effects in the TPF (7.5%) and PF (7.7%) groups.

For more information, visit the Taxotere® side effects page in this section.

Reference

  1. Sanofi-aventis Indication Letter, "Taxotere® (docetaxel) Injection Concentrate Receives FDA Approval for the induction Treatment of Locally Advanced Head and Neck Cancer." Bridgewater, NJ.
  2. Taxotere® Prescribing Information. Bridgewater, NJ: sanofi-aventis U.S. LLC; September 2007.
  3. Data on file. Clinical study report: A randomized phase III multicenter trial of neoadjuvant docetaxel (Taxotere) plus cisplatin and 5-fluorouracil (TPF) versus neoadjuvant cisplatin plus 5-fluorouracil followed by concomitant chemoradiotherapy to improve the overall survival and progression free survival in patients with locally advanced squamous cell carcinoma of the head and neck. XRP6976F-324 (EFC6043). Aventis Pharma, a division of the sanofi-aventis Group. January 25, 2007.
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US.DOC.08.05.069  Last update:  May 2008
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.

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) or myelodysplasia has occurred in patients given anthracyclines and/or cyclophosphamide, including use with Taxotere® in adjuvant therapy for breast cancer.

The most common severe side effects are low white–blood-cell 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.

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®.

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

Please see adjacent page for patient information leaflet for detailed information about these side effects, and talk to your doctor about any questions you may have.

Taxotere Indications

Breast Cancer
TAXOTERE® is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy
TAXOTERE® in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer

Non-Small Cell Lung Cancer
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.

Prostate Cancer
TAXOTERE® in combination with prednisone is indicated for the treatment of patients with androgen independent (hormone refractory) metastatic prostate cancer.

Gastric Cancer
TAXOTERE® in combination with cisplatin and flouroucil is indicated for the treatment of patients with advanced gastric adenocercinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for advanced disease.

Head and neck Cancer
TAXOTERE® in combination with cisplatin and flourouracil is indicated for the induction treatment of patients with locally advanced squamous cell cercinoma of the head and neck (SCCHN).