title: Prospective randomized study of post-operative chemotherapy with levamisole and UFT for head and neck carcinoma.
abstract: OBJECTIVE
  A prospective randomized study was conducted to evaluate the benefit of adjuvant levamisole/UFT (futraful and uracil) chemotherapy in head and neck squamous cell carcinoma.
  
  
  METHODS
  Sixty-five patients with stage III and IV squamous cell carcinomas of oral cavity, oropharynx, hypopharynx and larynx with no distant metastasis were randomized for the chemotherapy study. Thirty-one patients were randomized for chemotherapy and two of them were subsequently excluded. In this study, a total of 29 patients on levamisole/UFT therapy and 34 patients on the control group were analysed. The main outcome was measured by the 5-year disease-free actuarial survival rate.
  
  
  RESULTS
  The rates of distant metastasis were 10% for chemotherapy group and 32% for control group (P=0.06). The 5-year disease-free actuarial survival rates for patients with and without adjuvant chemotherapy were 57% and 39% respectively (P=0.207).
  
  
  CONCLUSIONS
  A trend of better distant control in head and neck cancer patients with post-operative adjuvant oral chemotherapy was observed. The side effects were minimal. However, there was no statistically significant improvement in the overall long-term survival. It may be of value to conduct a large-scale multi-centre prospective randomized study to verify the efficacy of levamisole and UFT as post-operative adjuvant chemotherapy for the control of distant metastasis in high-risk population.
authors.affiliation: Division of Otorhinolaryngology Head and Neck Surgery, Department of Surgery, The University of Hong Kong Medical Centre, Queen Mary Hospital, Hong Kong.
authors.forename: P
authors.initials: P
authors.lastname: Lam
authors.forename: A P
authors.initials: AP
authors.lastname: Yuen
authors.forename: C M
authors.initials: CM
authors.lastname: Ho
authors.forename: W K
authors.initials: WK
authors.lastname: Ho
authors.forename: W I
authors.initials: WI
authors.lastname: Wei
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000494:pharmacology*; D000328:Adult; D000368:Aged; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000601:surgery; D004359:Drug Therapy, Combination; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000601:surgery; D006801:Humans; D007978:Levamisole / Q000008:administration & dosage / Q000494:pharmacology*; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011446:Prospective Studies; D018714:Radiotherapy, Adjuvant; D016019:Survival Analysis; D014498:Uracil / Q000008:administration & dosage / Q000494:pharmacology*
chemical_list: D000276:Adjuvants, Immunologic; D007978:Levamisole; D014498:Uracil