Significance of the Preoperative Intravesical Instillation of Doxorubicin and the Oral Administration of 5‐Fluorouracil in Preventing Recurrence After a Transurethral Resection of Superficial Bladder Cancer

Abstract
Background: The postoperative intravesical instillation of doxorubicin (ADM) has a preventative effect on recurrence after a transurethral resection (TUR) of superficial bladder cancer. However, the significance of preoperative ADM instillation remains unclear. Although the oral administration of 5‐fluorouracil (5‐FU) has been observed to show some clinical response against bladder cancer, its preventative effect on the recurrence of superficial bladder cancer after TUR is unknown. Methods: Patients were randomized into 4 groups. All 4 groups received postoperative ADM instillation. In addition, patients in groups C and D received preoperative ADM instillation, whereas patients in groups B and D additionally received oral 5‐FU postoperatively. The nonrecurrence rate and side effects were both compared among the 4 groups. Results: Of the 282 patients registered, 200 were evaluable, with a median follow‐up period of 21.4 months. There were no significant differences in the characteristics of the patients among the 4 groups. Group C (pre‐ and postoperative ADM) showed a significantly longer disease‐free interval than group A (postoperative ADM alone). However, there was no significant difference in the disease‐free interval between groups A and B (postoperative ADM plus 5‐FU), or between groups C and D (pre‐ and postoperative ADM plus 5‐FU). Bladder irritation symptoms were the most frequently noted side effect encountered in all groups, but the severity was generally mild. Conclusions: Preoperative ADM instillation was found to prevent recurrence to a greater extent than the usual postoperative instillation alone, whereas oral 5‐FU was found to have no additional beneficial effect on the disease‐free interval in patients with superficial bladder cancer.