THE EFFECT OF INTRAVESICAL THIOTEPA ON TUMOR RECURRENCE AFTER ENDOSCOPIC TREATMENT OF NEWLY-DIAGNOSED SUPERFICIAL BLADDER-CANCER - A FURTHER REPORT WITH LONG-TERM FOLLOW-UP OF A MEDICAL-RESEARCH-COUNCIL RANDOMIZED TRIAL

Objective To determine the role, if any, of one and five instillations of intravesical thiotepa in the treatment of newly diagnosed superfic ial bladder cancer. Patients and methods A multicentre randomized clin ical trial was carried out involving 417 patients with newly diagnosed superficial bladder cancer. After transurethral resection the patient s were randomized into one of three treatment arms: no thiotepa; one i nstillation of thiotepa at the time of resection; one instillation at time of resection and then at 3-monthly intervals for one year (giving a total of five instillations). In all treatment arms the dosage was 30 mg thiotepa in 50 ml saline. The main outcome measures were time to first superficial recurrence, recurrence rate (defined as the number of possible cystoscopies per annum) and failure-free interval rate (wh ere failure was defined as the development of invasive disease, metast atic disease or death from bladder cancer). Results After a median fol low-up of 8 years and 9 months analysis showed no evidence of a differ ence between the three groups with respect to time to first recurrence , recurrence rates or the failure-free interval rate. Conclusions This analysis confirms that the thiotepa regimens tested cannot be recomme nded for use outside clinical trials for patients with newly diagnosed superficial bladder cancer.