Long-term outcome of intravesical bacillus Calmette-Guérin therapy with maintenance for urinary bladder carcinoma in situ: About 47 cases.

INTRODUCTION: Data concerning the efficacy of intravesical Bacillus Calmette-Guerin (BCG) on carcinoma in situ (CIS) of the bladder are limited.

OBJECTIVES: We analyzed long-term outcomes of instillation therapy with BCG to treat bladder CIS, evaluated its effectiveness and safety and searched for prognostic factors that could predict disease recurrence and progression.

METHODS: Between March 1994 and December 2010, 47 patients (male: 40; female: 7) with median age of 59,5 years (range 40-76 years), diagnosed with bladder CIS underwent weekly BCG instillations (75 mg of Pasteur strain) for six weeks followed by 6 monthly instillations. Patients were collected from four different institututions.Proven bladder CIS diagnosis was made through random biopsy (n=19), macroscopic lesion (n=28) and urinary cytology (n=6).Primary, concomitant, and secondary CIS was found in 13 (27,6%), 28 (59,6%) and 6 (12,7%), patients, respectively.

RESULTS: The median follow up period was 67.5 months (range 60-116 months).The recurence rates were 15,4%, 35,7% and 50% respectively in group I,II and III at 5 years follow-up. The overall complete response rate was 68%.The five-year progression-free survival rate was 87.2%.Several factors, such as age (<60 or >60 years), gender, previous transurethral resection and type of CIS, were examined by multivariate analysis to predict recurrence and progression. None of them was an independent prognostic factor.Bladder irritation symptoms were the main BCG adverse effects. There were no severe adverse effects requiring discontinuation of drug administration.Radical cystectomy was performed in 5 patients. Extravesical involvement was identified in only one patient. During follow-up period, none died of bladder cancer.

CONCLUSION: Therapy with BCG is remarkably effective and safe for primary CIS and concomittent CIS, which might be a prognostic factor. We didn't find any significant risk factor. Recurrence and disease progression including extravesical involvement should be carefully monitored over the long-term after BCG therapy.