Intravesical 4'-epi-doxorubicin (epirubicin) versus bacillus Calmette-Guérin. A controlled prospective study on the prophylaxis of superficial bladder cancer.

BACKGROUND: The selection of the most appropriate antineoplastic agent and optimal treatment schedule for the prophylaxis of superficial bladder cancer against tumor recurrences is the subject of continual investigations. METHODS: A controlled prospective trial involving 161 patients evaluated and compared the efficacy of intravesical epirubicin and bacillus Calmette-Guérin (BCG) administration as prophylaxis against recurrences after complete transurethral resection of superficial bladder cancer. The treatment schedule, consisting of one 6- or 8-week course of instillations (50 mg epirubicin or 150 mg BCG per instillation) followed by single maintenance doses to the responders at follow-up examinations, was modified for those of the initial responders who were at high risk for recurrence and who received an additional separate 4-week course of treatment 6 months after the start of therapy. RESULTS: Sixty percent of the patients treated with epirubicin, 68% of the patients treated with BCG, and 41% of the control subjects, who underwent resection only, remained free of recurrences for a mean follow-up of 32.9 months. The only significant difference was found between patients treated with BCG and control subjects, in favor of the former. Conversely, recurrence rate per 100 patient-months and mean interval to recurrence showed both drugs to be superior to resection alone regarding several tumor characteristics. However, a significant benefit in favor of BCG when compared with epirubicin was shown in those patients who had Stage T1 and Grade 3 tumors at presentation. CONCLUSIONS: Intravesical epirubicin and BCG were superior to transurethral resection alone in the prophylaxis of superficial bladder cancer, but with respect to superficially invasive and high-grade tumors, BCG demonstrated a remarkable advantage.

Intravesical bacillus Calmette-Guerin immunoprophylaxis of superficial bladder cancer: results of a controlled prospective trial with modified treatment schedule.

A controlled prospective trial on 94 patients evaluated the efficacy of intravesical Pasteur strain bacillus Calmette-Guerin (BCG) administration as prophylaxis against tumor recurrences after complete endoscopic resection of superficial bladder cancer. The treatment schedule, consisting of an initial 6-week course of instillations and a single quarterly maintenance dose to the responders, was modified to those of the latter who were at high risk for recurrence and who received an additional separate 4-week course of therapy. The percentage of the patients treated prophylactically with BCG and who remained free of recurrences (68%, mean followup 33.8 months) was significantly higher than that of the controls who underwent transurethral resection only (41%, mean followup 30.2 months). In terms of relative risk of recurrences, recurrence rate per 100 patient-months and disease-free interval, comparisons between the 2 groups of patients revealed a significant benefit for the BCG group overall as for those subjects having stages Ta and T1 tumors, multifocal tumors, a history of disease, and grades 2 and 3 carcinoma. Drug-induced toxicity was acceptable. Our study suggests that our modified treatment protocol is notably safe and effective against recurrent superficial bladder cancer.