Prophylactic chemotherapy of superficial transitional cell bladder carcinoma: an EORTC randomized trial comparing thiotepa, an epipodophyllotoxin (VM26) and TUR alone.

The Urological Group of the European Organization for Research on Treatment of Cancer (EORTC) has performed a randomized clinical trial designed to compare the disease-free interval, the recurrence rate and the number of patients with increase in tumor stage after transurethral resection (TUR) only or TUR followed by prophylactic bladder instillation of thiotepa or VM26 (an epipodophyllotoxin derivative). Drug instillation was initiated 1 month after TUR and subsequently administered weekly for 4 weeks and then monthly for 1 year. 370 patients from 20 participating institutions in six different countries were admitted to this protocol. 308 eligible patients with follow-up were analyzed. There was no difference among the groups regarding the time of first recurrence (disease-free interval) but thiotepa significantly reduced the recurrence rate as compared to the control group or VM26. When adjusting for primary or recurrent patients stratification, the results remained the same.