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According to results presented at the 42nd annual meeting of the American Society of Clinical Oncology (ASCO), the addition of Taxotere® (docetaxel) to cisplatin (Platinol®) and fluorouracil (5-FU) as initial therapy significantly improves survival in patients with advanced head and neck cancer.

Approximately 40,000 people in the U.S. are diagnosed with head and neck cancer every year. Cancers of the head and neck include several types of cancers affecting the nasal cavity and sinuses, oral cavity, nasopharynx (upper part of throat, behind ear), oropharynx (middle part of throat, including soft palate, base of tongue, and tonsils), and other sites throughout the head and neck. In 2005 the American Cancer Society estimated that 11,000 people would die from head and neck cancer.

Advanced head and neck cancer refers to cancer that spreads from its site of origin to other sites in the body. Standard treatment for advanced head and neck cancer often includes the use of several chemotherapy agents, the targeted agent Erbitux® (cetuximab), and/or radiation therapy. Some patients are able to undergo the surgical removal of their cancer following treatment. Since long-term survival for advanced head and neck cancer remains suboptimal, researchers continue to evaluate new therapeutic and chemotherapy combinations to determine optimal treatment strategies for patients with head and neck cancer.

Researchers from Harvard Medical School reported results from a phase III trial (phase of trials prior to FDA review) comparing Taxotere/cisplatin/fluorouracil to cisplatin/fluoruracil only in patients with advanced head and neck cancer.

This trial included 538 patients with squamous cell advanced head and neck cancer. Approximately half of the patients were treated with Taxotere/cisplatin/fluorouracil and the other half received cisplatin/fluorouracil (control group). All patients were then treated with the chemotherapy agent carboplatin (Paraplatin®), radiation therapy, and in some cases, surgery.

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  • Overall, patients were followed for a median of 42 months.
  • Patients initially treated with the addition of Taxotere had significantly improved survival.
  • At three years, 62% of patients treated with Taxotere/cisplatin/fluorouracil were alive, compared with only 48% of patients in the control group.
  • The side effects were comparable between the two treatment groups.
  • The most common side effects related to chemotherapy include mouth sores, nausea, vomiting, and low blood cell levels.

The researchers concluded that the addition of Taxotere to the standard cisplatin/fluorouracil as initial therapy in advanced head and neck cancer significantly improves survival when patients undergo subsequent chemotherapy and radiation therapy. The authors stated that the addition of Taxotere as initial therapy should now be considered the standard of care in advanced head and neck cancer. However, it is important for patients to discuss their individual risks and benefits of treatment including Taxotere with their physician.

Reference: Posner MR, Herchock D, Le Lann L, Devlin PM, Haddad RI. TAX 324: a phase III trial of TPF vs PF induction chemotherapy followed by chemoradiotherapy in locally advanced SCCHN: preliminary results of GORTEC 2000-1. Proceedings from the 42nd Annual Meeting of the American Society of Clinical Oncology; June 2-6, 2006; Atlanta, Georgia. Special session.

Related News:Erbitux® plus Induction Chemotherapy Results in 100% Response Rate for Head and Neck Cancer (6/9/2006)

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