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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.
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.

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According to results presented at the 2006 annual meeting of the American Society of Clinical Oncology (ASCO), the addition of Taxotere® (docetaxel) to Platinol® (cisplatin) and 5-fluorouracil improves the rate of preservation of the larynx (voice box) in patients with advanced head and neck cancers.

Researchers affiliated with the French GORTEC (Radiotherapy Oncology Group for Head and Neck) 2000-01 trial recently evaluated the addition of the chemotherapy agent Taxotere to a standard chemotherapy combination including Platinol and 5-FU. This trial included 220 patients with advanced laryngeal or hypopharyngeal cancers who were treated with either Taxotere/Platinol/5-FU (TPF) or Platinol/5-FU (PF) as initial therapy and were directly compared.

• Overall anti-cancer responses were achieved in 83% of patients treated with TPF, compared with 61% for those treated with PF.
  
• At 3 years, 73% of patients treated with TPF were able to preserve the function of their larynx, compared with only 63% in the group treated with PF.
• There were no notable differences in side effects between the two groups of patients.
  
• There was a trend toward improved survival among patients treated with TPF.

The researchers concluded that the addition of Taxotere to PF improves the rate at which the larynx can be preserved without affecting survival among patients with advanced laryngeal or hypopharyngeal cancers. Patients diagnosed with head and neck cancer may wish to speak with their physician regarding their individual risks and benefits of treatment with Taxotere.

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According to an article recently published in the International Journal of Radiation Oncology, Biology and Physics, treatment for locally advanced head and neck cancer that includes Taxotere® (docetaxel) plus radiation therapy following initial chemotherapy significantly improves anticancer responses and provides impressive outcomes for patients with Stages III–IV head and neck cancer.

Researchers from Harvard University recently conducted a clinical trial to evaluate a treatment regimen consisting of initial chemotherapy with Platinol® (cisplatin) and 5-fluorouracil, Paraplatin® (carboplatin)/5-fluorouracil, or Taxotere/Platinol/5-fluorouracil. Following this initial (induction) chemotherapy, patients were then treated with a combination of Taxotere four times weekly and radiation therapy. This trial included 30 patients with Stages III–IV head and neck cancer; cancer at this stage has spread from its site of origin to regional sites in the body.

• Following induction chemotherapy, only 20% of patients achieved a complete disappearance of cancer.
• Following Taxotere/radiation therapy, 70% of patients had achieved a complete disappearance of cancer.
• After all planned therapy, 93% were considered to be free of cancer.
  
• At approximately 42 months follow-up, 70% of patients are alive and free of cancer.

The researchers concluded that induction chemotherapy followed by Taxotere and radiation therapy provides long-term disease-free survival among patients with Stages III–IV head and neck cancer. The authors stated that this treatment provides an alternative regimen to the standard chemotherapy and radiation and surgical approaches for patients who do not achieve a complete disappearance of their cancer with induction chemotherapy. However, it is important for patients to discuss their individual risks and benefits of treatment including Taxotere with their physician.

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Taxotere® belongs to the taxane class of chemotherapy drugs. The active ingredient in Taxotere® is derived from the needles of the European yew tree (Taxus baccata).

First approved for use in locally advanced or metastatic breast cancer after failure of prior anthracycline chemotherapy in 1996, Taxotere® is currently the #1-prescribed taxane for metastatic breast cancer in the United States.

Taxotere® continues to be tested in clinical trials for various stages of many types of cancer. Numerous studies are ongoing, that may offer promising new therapeutic options for healthcare professionals and their patients.