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Keywords:

  • paclitaxel;
  • capecitabine;
  • head and neck cancer;
  • squamous cell carcinoma;
  • toxicity

Abstract

Background.

The aim of this phase II study was to evaluate the antitumor activity and toxicity of a non-platin–containing regimen with paclitaxel and capecitabine.

Methods.

Fifty patients with recurrent or disseminated squamous cell carcinoma were included in the study. The treatment consisted of paclitaxel 175 mg/m2 once every third week and capecitabine 825 mg/m2 per oral (p.o.) twice daily (bid) for 2 weeks.

Results.

The overall response rate according to the World Health Organization (WHO) criteria was 42%. Two patients had a complete response (CR), 19 patients had a partial response (PR), 14 patients had no change (NC), 12 patients had progressive disease (PD), and 3 patients were not evaluable (NE). The median survival time was 8 months. Toxicity was very moderate. Only 10% of 315 delivered treatments had to be given in reduced dose or postponed for a week or more.

Conclusions.

The toxicity was low and manageable. The overall response rate was comparable to the commonly used cisplatin/5-fluorouracil regimen. © 2006 Wiley Periodicals, Inc. Head Neck 2007