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.

• 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.

According to an article published in The Lancet, fractionated radiation therapy improves survival over conventional radiation therapy for patients with squamous cell head and neck cancer.

Head and neck cancer originates in sites 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 head and neck cancer, which refers to the type of cell from which the cancer originated.

Radiation therapy remains an important component in the treatment of head and neck cancer. Researchers continue to evaluate optimal types of radiation delivery and schedules for the treatment of this disease. Hyperfractionated radiation therapy refers to radiation therapy that is given two to three times per day, versus the conventional once-per-day dosing.

Hyperfractionated radiation therapy utilizes smaller doses with each administration than doses used with the once-daily administration. Accelerated radiation therapy refers to radiation that is administered over a shorter duration of time than conventional radiation. The doses with hyperfractionated or accelerated radiation therapy may be increased overall, may stay equal, or may be reduced compared to conventional radiation therapy.

Researchers on behalf of the Meta-Analysis of Radiotherapy in Carcinomas of Head and Neck (MARCH) Collaborative Group recently compiled and analyzed data from 15 clinical trials evaluating different radiation schedules and doses for the treatment of squamous cell head and neck cancer. The majority of patients had advanced head and neck cancer.

• Hyperfractionated radiation therapy improved survival by 8% at five years compared to conventional radiation therapy.

• Accelerated radiation therapy improved survival by 2% at five years compared to conventional radiation therapy.

• The benefits achieved were greatest for youngest patients.

The researchers concluded that hyperfractionated radiation therapy improves survival over conventional radiation therapy in the treatment of head and neck cancers. The authors state that further study is necessary to determine exactly which types and schedules of the fractionated radiation therapy provide the most benefit for these patients.

Patients diagnosed with squamous cell cancer of the head and neck may wish to speak with their physician regarding their individual risks and benefits of different types of radiation schedules.

Reference: Bourhis J, Overgaard J, Audry H, et al. Hyperfractionated or Accelerated Radiotherapy in Head and Neck Cancer: a Meta-Analysis. The Lancet. 2006. Early online publication. August 17. DOI: DOI:10.1016.

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