Clinical outcome and safety of bacillus Calmette-Guérin immunotherapy for superficial bladder cancer

Background: The objectives of this study were to evaluate the effectiveness, the patients compliance and tolerability to bacillus Calmette-Guérin (BCG) intravesical instillation after transurethral resection of bladder tumour (TURBT) for stage Ta-T1, grade G1-G3 transitional cell carcinoma (TCC) of the urinary bladder. Methods: Between January 1995 and May 2002, 127 patients (110 males and 17 females) aged between 40 and 81 years (mean ± SD 66.5 ± 8.4 years) with Ta-T1, G1-G3 TCC of the urinary bladder were treated by TURBT and adjuvant intravesical instillation with BCG. The following details were recorded and evaluated: the disease-free survival rates, the tumour recurrence, age, gender, morphology, the size and number of tumours and side effects of BCG instillation. Results: Eighty (63%) and fourty seven (37%) patients were presented multifocality and monofocality at the baseline, respectively. Follow-up periods were 3-48 months (median, 18 months) for 110 of the 127 patients enrolled. At 3 months follow-up 40 multifocality patients (59.7%) and 27 monofocality patients (40.3%) were disease free. At 18 months follow-up, tumour disease-free survival rate was 63% while at 48 months we had 44 drop out and intravesical recurrence was noted in 43 patients (39.1%). We had 47 patients with side effects by BCG instillation in free disease patients and 15 in the not disease free ones. Twentyseven patients (40.3%) of the disease free patients had no side effects versus 28 patients (65.1%) in the not disease free ones. Of the patients, 28.3% were withdrawn for the side effects of therapy while 32.2% were discontinued for recurrence of disease. Conclusion: These findings confirm that intravesical instillation with BCG combined with TURBT is effective and safe for treatment of bladder cancer. This treatment facilitates bladder preservation by reducing recurrences and delaying the progression in many patients, however, further experience and longer follow-up studies of this treatment are required.