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Head and Neck Cancers Respond to Capecitabine and Paclitaxel: Presented at ECCO

By Michael Smith

COPENHAGEN, DENMARK -- October 1, 2003 -- A paclitaxel/capecitabine-based regimen for head and neck cancer may offer the efficacy of standard platinum-based therapies with less toxicity.

Avoiding the adverse effects and hospitalisation associated with platinum-based regimens would improve patients' quality of life, if the improved safety does not come at the cost of lessened effectiveness, said Jens Bentzen, MD, University Hospital of Copenhagen, Denmark. Dr. Bentzen presented findings on 50 patients with head and neck cancer here September 22^nd at ECCO 12: The European Cancer Conference.

In Denmark, where about 1,000 patients are diagnosed with head and neck cancer each year, chemotherapy is usually reserved for those with recurrent or disseminated disease. Frontline treatment remains radiation and occasionally surgery. There is no agreed standard for such chemotherapy, Dr. Bentzen said, but the most common regimen is cisplatin combined with 5-fluorouracil (5-FU) -- a regimen associated with "considerable toxicity" that requires hospitalisation, although its response rate is in the range of 33%, he said.

Dr. Bentzen and colleagues are testing the combination of the antimitotic paclitaxel and capecitabine, an oral prodrug that converts to 5-FU preferentially within tumour tissues. To date, 50 patients have been enrolled in the study, most with inoperable local tumours, but some with distant metastases in lung liver or bone, he said.

Patients were given 75 mg/m² of paclitaxel once every 3 weeks and 825 mg/m² of oral capecitabine twice daily for 2 weeks.

To be evaluated for the study, patients had to complete at least 3 cycles of therapy. Among them, the 50 patients had more than 300 cycles; 18 patients had more than 6, and 8 had more than 12, Dr. Bentzen said.

The responses included 1 patient with complete remission, 20 with partial remissions, and 14 with stable disease. The patient with the complete response had 6 cycles of chemotherapy and has been disease-free for more than a year.

The overall response rate was 44%, "definitely comparable to the cisplatin/5-FU regimen," said Dr. Bentzen. Toxicity was moderate, with all patients experiencing some hair loss after 2 or 3 cycles. Grades 2, 3, and 4 hand-and-foot syndrome were seen in 90% of patients, but the condition was reversible even under continuous treatment. One patient had grade 4 gastrointestinal toxicity and had his treatment discontinued, but no heart toxicity was seen, and haematological toxicity was minor.

The study is so promising, Dr. Bentzen said, that the investigators are recruiting another 100 patients to get a more robust estimate of the response and toxicity.


[Study title: Phase II Analysis of Taxol and Capecitabine in the Treatment of Recurrent or Disseminated, Squamous Cell Carcinoma of the Head and Neck Region. Abstract 116]

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