1988 Volume 79 Issue 3 Pages 521-526
Thirty-one patients were entered into our protocol which was designed to evaluate the ablative and prophylactic effects of intravesical bacillus Calmette-Guerin (BCG) on superficial papillary transitional cell carcinoma of the bladder. These patients initially received the induction regimen which consisted of 12 intravesical instillations of 80mg BCG (Tokyo strain) at the frequency of 1 or 3×/week. Seventeen patients (55%) achieved a complete response and 7 (23%) achieved a partial response. The complete responders as well as the partial and non-responders who underwent a complete transurethral resection of the residual tumors were subsequently placed on the maintenance regimen which consisted of 6 biweekly instillations followed by monthly instillations for 21 months. Four patients experienced tumor recurrence at 3, 4, 6 and 18 months, while 27 remained free of disease during 3 to 32 months (average 22 months) of follow-up. The recurrence rate, when determined by the Kaplan-Meier method, was 9.6% at 12 months and 14.5% at 24 months.
Tumor recurrence was observed in 2 of 17 patients with persistently positive PPD skin test, in 1 of 2 with persistently negative skin test, and in 1 of 2 whose skin test converted from negative to postive during the induction period but reverted to negative during the maintenance period. None of 10 patients whose skin test showed positive conversion and remained positive during the maintenance period had recurrent tumors.
Side-effects during the induction period included cystitis in 27 patients (87%) and fever in 5 (16%). During the maintenance period, cystitis was seen in 31 patients (100%), fever in 5(16%), prostatitis in 1 (3.2%), epididymitis in 1 (3.2%), and hepatic dysfunction in 1 (3.2%). All the patients tolerated the induction regimen but the maintenance regimen was discontinued before 2 years in 10 patients (32%) because of intolerable irritative bladder symptoms.
Our results indicate the efficacy of intravesical BCG in eradicating existing tumors and preventing tumor recurrence in patients with superficial papillary bladder tumors.
