The effect of intravesical thiotepa on tumour 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. Medical Research Council Working Party on Urological Cancer, Subgroup on Superficial Bladder Cancer.

OBJECTIVE

To determine the role, if any, of one and five installations of intravesical thiotepa in the treatment of newly diagnosed superficial bladder cancer.

PATIENTS AND METHODS

A multicentre randomized clinical trial was carried out involving 417 patients with newly diagnosed superficial bladder cancer. After transurethral resection the patients were randomized into one of three treatment arms: no thiotepa; one instillation 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 (where failure was defined as the development of invasive disease, metastatic disease or death from bladder cancer).

RESULTS

After a median follow-up of 8 years and 9 months analysis showed no evidence of a difference 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 recommended for use outside clinical trials for patients with newly diagnosed superficial bladder cancer.