title: Phase II analysis of paclitaxel and capecitabine in the treatment of recurrent or disseminated squamous cell carcinoma of the head and neck region.
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/m(2) once every third week and capecitabine 825 mg/m(2) 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.
authors.affiliation: Department of Radiotherapy and Oncology, University Hospital in Herlev, 2730 Herlev, Denmark. jeben@herlevhosp.kbhamt.dk
authors.forename: Jens D
authors.initials: JD
authors.lastname: Bentzen
authors.forename: Hanne Sand
authors.initials: HS
authors.lastname: Hansen
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D003841:Deoxycytidine; D000069287:Capecitabine; D017239:Paclitaxel; D005472:Fluorouracil