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Docetaxel Said to Be Highly Effective and and Well Tolerated in Advanced Head and Neck cancer.

Docetaxel Said to Be Highly Effective and and Well Tolerated in Advanced Head and Neck cancer.

Docetaxel {Taxotere) demonstrated significant activity and was well tolerated in the treatment of advanced head and neck cancer, according to preliminary results of a phase II clinical trial presented at the Eighth Annual European Congress for Clinical Oncology (ECCO-8) in Paris.

"Taxotere appears to be highly effective in squamous cell carcinoma of the head and neck and warrants further testing as a single agent and in combination with other chemotherapy programs," reported Dr. Marshall Posner, principal investigator of the study at the Head and Neck Oncology Program at the Dana-Farber Cancer Institute in Boston.

The study enrolled 31 patients with metastatic or recurrent malignant growths within the oral cavity. Of the patients treated, 10 had received cisplatin (Platinol)-fluorouracil-based chemotherapy--a standard treatment for this type of cancer--more than 12 months prior to the beginning of the study and the other 21 had not previously undergone chemotherapy.

Each patient was premedicated with corticosteroids and antihistamines prior to docetaxel treatment. A 100-mg/m² dose of docetaxel was administered as a 1-hour infusion every 3 weeks. Among the 30 evaluable patients, there was a 42% response rate. The median duration of response was 5 months. One patient with a complete response has been off therapy for more than 14 months.

Side effects were predictable and manageable; the most frequently observed adverse effect was neutropenia. Four patients had hypersensitivity reactions, but two of these individuals were successfully retreated with docetaxel. No patient experienced significant fluid retention.

"These results indicate that Taxotere is well tolerated in these difficult-to-treat patients, and that a premedication regimen which includes corticosteroids can be employed successfully to manage fluid retention," said Dr. Posner.

Docetaxel inhibits cancer cell division by essentially "freezing" the cell's internal skeleton, which is made up of elements called microtubules. Microtubules assemble and disassemble during the cell cycle, but docetaxel promotes the assembly and blocks the disassembly,thus preventing cancer cells from dividing. This action can lead to cancer cell death .

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