USE OF MAINTENANCE INTRAVESICAL BACILLUS-CALMETTE-GUERIN (BCG), WITH OR WITHOUT INTRADERMAL BCG, IN PATIENTS WITH RECURRENT SUPERFICIAL BLADDER-CANCER - LONG-TERM FOLLOW-UP OF A RANDOMIZED PHASE-2 STUDY

To study maintenance Bacillus Calmette-Guerin (BCG) therapy we treated 49 patients with recurrent superficial bladder cancer pTa and/or carc inoma in situ, failing previous intravesical chemotherapy. They receiv ed 20 intravesical instillations in 1 year, with or without 6 intrader mal inoculations. Side effects were frequent, causing treatment stop i n 14 patients (29%). Drug-induced cystitis was the most frequent side effect, seen in 29 patients (59%). Forty-two patients were evaluable f or response. During the first 2 years of the study 14 patients (33%) h ad one (n = 8) or more (n = 6) recurrences. A total of 18 patients (43 %) remained recurrence free with a median follow-up of 47 months. Prog ression was seen in 2 patients from pTa to pTl, another patient died o f metastatic bladder cancer after 47 months. PPD skin test conversion was of no prognostic value. The use of intradermal inoculations caused no significant increase of toxicity and had no effect on efficacy, ho wever, both groups were small. It caused no local side effects. We con clude that maintenance BCG therapy can be useful for patients with rec urrent superficial bladder cancer failing previous intravesical chemot herapy.