Intravesical Bacillus Calmette-Guerin Immunoprophylaxis of Superficial Bladder Cancer: Results of a Controlled Prospective Trial with Modified Treatment Schedule

Abstract

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.

Role of urothelial cells in BCG immunotherapy for superficial bladder cancer

“…Contrary to well-differentiated (G1) bladder tumour cell lines, poorly differentiated (G3) cell lines exhibit significant internalisation of BCG (Bevers et al, 1998). Clinically, these data relate well to observations that show a better response to BCG treatment of high-grade compared to low-grade tumours (Table 1) (Melekos et al, 1993).…”

“…In these patients, the benefits of treatment outweigh the burden of side effects. Moreover, BCG seems to exert a better antitumour effect in CIS and high-grade cancer (Melekos et al, 1993;Kurth et al, 2000).…”

Update on the management of non-muscle invasive bladder cancer

“…Six controlled trials carried out from 1985 to 1996 showed that BCG decreases recurrence rates from 67% to 29%. [72][73][74][75][76][77][78] Six meta-analyses compared BCG with intravesical chemotherapy; all of them except 1 metaanalysis 79 showed superiority of BCG over chemotherapy in terms of decreasing recurrence. [79][80][81][82][83][84] The effect of BCG on tumour progression has been investigated by Herr and colleagues in 3 randomized trials, each of which demonstrated a significant reduction in disease progression to muscle invasion or metastasis.…”

A Six-Week Course of Bacillus Calmette-Guérin Prophylaxis Is Insufficient to Prevent Tumor Recurrence in Nonmuscle Invasive Bladder Cancer with Strong-Positive Expression of p53

“…In several early larger series, tumor recurrence after transurethral resection of bladder cancer was reduced by 20–65%, with an average of approximately 40% [24,25]. The efficacy of BCG after transurethral resection of bladder cancer for high-risk papillary urothelial carcinoma has been demonstrated in several series of T1 lesions, with recurrence rates of 16–40% and progression rates of 4.4–40%, a substantial improvement compared with TURB alone [26,27].…”