Results of 6 Weekly Intravesical Bacillus Calmette-Guerin Instillations on the Treatment of Superficial Bladder Tumors

Abstract

We evaluated 104 patients with superficial bladder tumors for response to intravesical bacillus Calmett-Guerin therapy. Patients received 6 weekly intravesical bacillus Calmette-Guerin instillations and they were followed for response every 3 months with urinary cytology, cystoscopy and bladder biopsy. Patients were considered treatment failures if either the cytology studies or biopsies were positive for tumor. Of 65 patients who failed the initial treatment course 57 were given an additional 6-week course of therapy. One 6-week course of bacillus Calmette-Guerin was successful in 20 of 55 patients (36 per cent) treated for prophylaxis, 12 of 32 (37 per cent) treated for carcinoma in situ and 7 of 17 (41 per cent) treated for residual tumor. The response rate for the total patient population treated with 1, 6-week course was 37.5 per cent (39 of 104). A second 6-week course was successful in 19 of 29 patients (65 per cent) treated for prophylaxis, 11 of 18 (71 per cent) treated for carcinoma in situ and 4 of 10 (40 per cent) treated for residual tumor. The response rate for all patients receiving a second course of bacillus Calmette-Guerin was 59.6 per cent (34 of 57). Of 6 patients who refused another 6-week course of bacillus Calmette-Guerin 4 had additional recurrences and 3 of these 4 suffered invasive disease. The over-all therapeutic response rate for patients treated with either 6 or 12 weeks of therapy was 70 per cent. These results suggest that 6 weeks of intravesical bacillus Calmette-Guerin do not provide optimal therapy for superficial bladder tumors. The data further suggest that more intensive regimens may increase therapeutic efficacy.

Update on the management of non-muscle invasive bladder cancer

“…Treatment schedules have not been established, but most experts agree that 6 weekly inductions is not enough. 94 A second induction has shown additional benefit of about 25% when used for prophylaxis and 30% when used for CIS, 94,95 but this is inferior to the additional 67% response rate seen in patients with CIS who are treated with maintenance therapy. Lamm and colleagues randomized patients with intermediate/highrisk NMIBC to receive 6 weekly inductions with BCG versus 6 weekly inductions followed by maintenance (3 weekly cycles at 3 months and 6 months then every 6 months up to 3 years).…”

Promoting the effects of intravesical instillation of saline on bladder lesion development in rats pre‐treated with BBN

“…22 Clearly, this is an area which deserves further attention in the human situation including the NHE1 mechanism in urological malignancies. The influence of increased concentrations of the Cl -ion, in the absence of Na + , might not be expected as NH 4 Cl did not exert any modification potential when administered in the second stage in earlier experiments. 17 Immunohistochemical staining of PCNA, which is a marker of DNA synthesis, is reported to correlate with tumor behavior, but we could find no difference among the tumors in our series.…”

“…These therapeutic approaches have become the standard for both therapeutic and prophylactic control of superficial bladder carcinomas as well as in the therapy of carcinoma in situ (CIS) using saline as vehicle. [1][2][3][4][5][6][7] Possibly of more significance, however, is the possibility that the saline vehicle may itself promote carcinoma development in the bladder. This is supported by findings with an experimental system using F344 rats, initiated with the carcinogen N-butyl-N-(4-hydroxybutyl)nitrosamine (BBN) and given anti-tumor chemotherapeutic agents in saline.…”

Canadian guidelines for treatment of non-muscle invasive bladder cancer: a focus on intravesical therapy

“…Treatment schedules have not been established, but there is a universal agreement that only 6 weekly inductions are not enough. 59 A second induction has been shown to have an additional benefit of about 25% when used for prophylaxis and 30% when used for CIS (Level of evidence 3). 59,60 However, there is sufficient evidence that BCG maintenance, in addition to induction confer reductions in both recurrence and progression (Level of evidence 1).…”