Anti-cancer drugs
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Randomized Controlled Trial Clinical Trial
A small randomized phase III single-center trial on postoperative UFT administration in patients with completely resected non-small cell lung cancer.
Our objective was to clarify the efficacy of UFT administration after the complete resection of non-small cell lung cancer (NSCLC) at a single-center institution, avoiding the biases produced by interinstitutional differences. A total of 30 patients who underwent the complete resection of NSCLC at our hospital between 1987 and 2001 were randomly assigned to a control group or to a UFT group (400 mg/day for 2 years). Thirteen patients were assigned to the control group and 17 patients were assigned to the UFT group. ⋯ Two patients suffered a relapse in the UFT group, but the relapse occurred after the discontinuation of UFT administration. We conclude that the administration of UFT as an adjuvant therapy prolonged the overall survival and disease-free survival rates of patients after the resection of NSCLC in a small study performed at a single institution. Interinstitutional differences, particularly operating procedures, should be carefully considered when performing large multicenter clinical studies.