The United States Food and Drug Administration (FDA) has approved the chemotherapy agent Taxotere® (docetaxel) for use in combination with Platinol® (cisplatin) and fluorouracil as initial treatment of inoperable, locally advanced squamous cell cancer of the head and neck.
Head and neck cancer originates within the head or neck. The American Cancer Society estimated that 11,000 individuals died from head and neck cancer in the United States in 2005. The most common type of head and neck cancer is squamous cell, which refers to the type of cell where the cancer originated.
Inoperable head and neck cancer refers to cancer that is too advanced for surgical removal or is located in areas where surgery would be too dangerous. Locally advanced head and neck cancer refers to cancer that has spread from its site of origin but not to distant sites in the body.
The chemotherapy regimen containing Platinol and fluorouracil is a commonly used treatment for head and neck cancer. However, researchers continue to evaluate ways to improve survival for these patients.
The trial that prompted the approval of Taxotere for the treatment of head and neck cancer was referred to as the EORTC 24971/TAX 323 trial. It enrolled 358 patients with inoperable, locally advanced squamous cell head and neck cancer. Patients had not received prior therapy. One group of patients was treated with Taxotere plus Platinol and fluorouracil, while the other group was treated with Taxotere plus Platinol only. Patients whose cancer had not progressed following chemotherapy underwent radiation therapy. Those who became eligible for surgery because their cancer had shrunk enough following chemotherapy underwent surgery either before or after radiation therapy.
- Progression-free survival was 11.4 months for patients treated with Taxotere, compared to 8.3 months for those not treated with Taxotere.
- Overall survival was nearly 19 months for patients treated with Taxotere, compared with 14.2 months for those not treated with Taxotere.
- The most common side effects associated with treatment including Taxotere were low levels of immune cells and red blood cells, loss of hair, inflammation of the mouth and esophagus, and nausea.
Patients diagnosed with inoperable head and neck cancer may wish to speak with their physician regarding their individual risks and benefits of treatment including Taxotere.
Reference: United States Food and Drug Administration. FDA Approves New Treatment for Advanced Head and Neck Cancer. Available at: fda.gov/bbs/topics/NEWS/2006/NEW01493.html. Accessed October 2006.