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

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

"Taxotere appears to be highly effective in squamous cellcarcinoma of the head and neck and warrants further testing asa single agent and in combination with other chemotherapy programs,"reported Dr. Marshall Posner, principal investigator of the studyat the Head and Neck Oncology Program at the Dana-Farber CancerInstitute in Boston.

The study enrolled 31 patients with metastatic or recurrent malignantgrowths within the oral cavity. Of the patients treated, 10 hadreceived cisplatin (Platinol)-fluorouracil-based chemotherapy--astandard treatment for this type of cancer--more than 12 monthsprior to the beginning of the study and the other 21 had not previouslyundergone chemotherapy.

Each patient was premedicated with corticosteroids and antihistaminesprior to docetaxel treatment. A 100-mg/m² dose of docetaxelwas administered as a 1-hour infusion every 3 weeks. Among the30 evaluable patients, there was a 42% response rate. The medianduration of response was 5 months. One patient with a completeresponse has been off therapy for more than 14 months.

Side effects were predictable and manageable; the most frequentlyobserved adverse effect was neutropenia. Four patients had hypersensitivityreactions, but two of these individuals were successfully retreatedwith docetaxel. No patient experienced significant fluid retention.

"These results indicate that Taxotere is well tolerated inthese difficult-to-treat patients, and that a premedication regimenwhich includes corticosteroids can be employed successfully tomanage fluid retention," said Dr. Posner.

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