Prospective randomized study of post-operative chemotherapy with levamisole and UFT for head and neck carcinoma

Aims: A prospective randomized study was conducted to evaluate the benefit of adjuvant levamisole/UFT (futraful and uracil) chemotherapy in head and n eck 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 metasta sis, were randomized for the chemotherapy study. Thirty-one patients were r andomized for chemotherapy and two of them were subsequently excluded. In t his 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 an d 32% for control group (P = 0.06). The 5-year disease-free actuarial survi val rates for patients with and without adjuvant chemotherapy were 57% and 3.9% respectively (P = 0.207). Conclusions: A trend of better distant control in head and neck cancer pati ents with post-operative adjuvant oral chemotherapy was observed. The side effects were minimal. However, there was no statistically significant impro vement in the overall long-term survival. It may be of value to conduct a l arge-scale mufti-centre prospective randomized study to verify the efficacy of levamisole and UFT as post operative adjuvant chemotherapy for the cont rol of distant metastasis in high-risk population. (C) 2001 Harcourt Publis hers Ltd.