[Comparative study on two different types of tegafur for recurrent breast cancer]

A randomized controlled trial envelope method was conducted in 126 cases of recurrent breast cancer to compare the antitumor efficacy and toxicity of spansule (SF-SP) and gastro-soluble tegafur. Both SF-SP and gastro-soluble tegafur which is commercially available contain 200mg of tegafur per capsule. The drugs were given orally twice daily after morning and evening meal, with the total dose of 800mg/body/day, repeated for 8 weeks. Patient selection and evaluation of efficacy were assessed to the criteria of the Japan Breast Cancer Society. The results were: (1) for the 43 evaluable cases out of 65 patients on the SF-SP regimen efficacy rate was 23.3% (10/43), while for the 49 cases out of 61 patients on the control regimen efficacy rate was 6.1% (3/49); and (2) no difference in occurrence of toxicity between the two regimens was observed. These results indicate higher antitumor efficacy of SF-SP than gastro-soluble tegafur with comparable toxicity, suggesting the usefulness of SF-SP in clinical trial.