Carcinoma of the urinary bladder. Long-term prognosis and results of intravesical bacillus Calmette-Guérin treatment

Abstract: Aims: To study prognostic factors in bladder cancer in relation to BCG immunotherapy and to evaluate a new method of reducing the side-effects of such treatment.Patients and methods: We identified 121 patients with stage T1 tumours diagnosed with bladder cancer between 1987 and 1988. We studied the prognostic value of depth of invasion, tumour pattern, vascular invasion, presence of carcinoma in situ (CIS) and grade (Paper I). The clinical records from 173 patients with CIS treated with BCG between 1986 and 1997 in four hospitals were reviewed. Eighteen variables of possible significance for time to recurrence and progression were studied (Paper II). The clinical records of 236 patients with stage Ta/T1 bladder cancer treated with BCG between 1986 and 2000 were reviewed. The influence of 13 variables on the time to recurrence and progression was evaluated (Paper III). We studied 51 patients treated with BCG between 1997 and 2002. BCG dwell-time was shortened from two hours to less than 30 minutes aiming at a reduction of the side-effects. Results: In the multivariate analysis, only vascular invasion and tumour pattern had significance for time to progression and were also independent prognostic factors for disease-specific survival (Paper I). The result of the first cystoscopy had a strong prognostic significance for the risk of progression (Paper II). A negative first cystoscopy and subsequent maintenance BCG led to significantly longer time to recurrence. The result of the first cystoscopy, tumour grade and six or less initial instillations had prognostic importance for time to progression (Paper III). When reducing BCG dwell-time for patients with pronounced side-effects, fever, chills, dysuria and the overall time-to-recovery were significantly less but frequency and haematuria were not influenced. The treatment results did not differ between patients who had a normal dwell-time and a reduced dwell-time, determined at the first and second follow-up cystoscopy (Paper IV).Conclusion: The progression rate is very high among patients who have a solid stage T1 bladder cancer or vascular invasion at initial diagnosis or a high-grade recurrence at the first cystoscopy after BCG treatment (Papers I, II, III). We suggest that a cystectomy is offered to these patients. Reducing the dwell-time to < 30 minutes is an alternative to modify toxicity during BCG treatment (Paper IV).