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Original Articles

Clinical Outcome and Safety of Bacillus Calmette-Guérin Immunotherapy for Superficial Bladder Cancer

Pages 145-150 | Received 25 May 2004, Accepted 02 Jun 2004, Published online: 16 Jul 2015
 

Abstract

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 tumor (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 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 tumor recurrence, age, gender, morphology, the size and number of tumors and side effects of BCG instillation.

Results: 80 (63%) and 47 patients (37%) initially presented with multifocality and monofocality, respectively, were analyzed. 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, tumor disease-free survival rate was 63% while at 48 months intravesical recurrence was noted in 43 patients (39.1%). We had 47 patients with side effects by BCG instillation in disease free patients and 15 in the disease positive ones. Twenty seven patients (40.3%) of the disease free patients vs. 28 patients (65.1%) in the disease positive ones had no side effects. For side effects of therapy 28.3% of the patients were withdrawn while 32.2% for recurrence of disease.

Conclusion: These findings confirm that intravesical instillation with BCG combined with TURBT is effective and safe for the treatment of bladder cancer. This treatment facilitates bladder preservation by reducing recurrences and delaying the progression in many patients. Longer follow-up studies of this treatment are required.

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