Bladder Cancer Treatment (PDQ®): Treatment - Health Professional Information [NCI] - Stage 0 Bladder Cancer Treatment
TUR with fulguration followed by an immediate postoperative instillation of intravesical chemotherapy followed by periodic intravesical instillations of BCG
Intravesical BCG is the treatment of choice for reducing the risk of cancer progression and is mainly used for cancers with an intermediate or high risk of progressing.[6,11,12,13] An individual patient meta-analysis of randomized trials comparing intravesical BCG with intravesical MMC reported that there was a 32% reduction in risk of recurrence with BCG but only when the BCG treatment included a maintenance phase whereby BCG was given periodically for at least 1 year (typically an induction phase of six weekly treatments followed by three weekly treatment every 3 months). Intravesical chemotherapy is tolerated better than intravesical BCG.[14,15,16,17,18] Although BCG may not prolong overall survival for Tis disease, it appears to afford complete response rates of about 70%, thereby decreasing the need for salvage cystectomy. Studies show that intravesical BCG delays tumor recurrence and tumor progression.[18,19]
Intravesical therapy with thiotepa, MMC, doxorubicin, or BCG is most often used in patients with multiple tumors or recurrent tumors or as a prophylactic measure in high-risk patients after TUR.[20,21,22]
Evidence (TUR with fulguration followed by an immediate postoperative instillation of intravesical chemotherapy followed by periodic intravesical instillations of BCG):
- Three meta-analyses of randomized controlled trials that compared TUR alone with TUR followed by intravesical chemotherapy reported that adjuvant therapy was associated with a statistically significant increase in time to recurrence.[23,24,25] No advantage has been shown with respect to survival or prevention of progression to invasive disease or metastases.
Intravesical BCG with maintenance BCG treatments
- An individual patient meta-analysis of nine randomized trials (2,820 subjects with Ta or T1 bladder cancer) that compared intravesical BCG with intravesical MMC was published.
- Among trials in which the BCG treatment included a maintenance component, there was a 32% reduction in risk of recurrence (P < .0001) compared with MMC; BCG was associated with a 28% increase in the risk of recurrence when there was no maintenance BCG administered compared with MMC.
- There were no differences in progression or death.
- A meta-analysis of nine randomized controlled trials (2,410 subjects) that compared intravesical BCG with MMC was published.
- Progression was observed in 7.67% of the BCG subjects and 9.44% of MMC subjects at a median follow-up of 26 months (P = .08).
- When the analysis was limited to trials in which the BCG arm included a maintenance component, the progression rate was significantly lower in the BCG subjects (OR, 0.66; 95% confidence interval, 0.47-0.94; P = .02).
- A meta-analysis of the published results of nine randomized controlled trials that compared intravesical BCG with intravesical chemotherapy in 700 patients with carcinoma in situ of the bladder was published.
- With a median follow-up of 3.6 years, 47% of the BCG group had no evidence of disease and 26% of the chemotherapy group had no evidence of disease.
- BCG was superior to MMC at preventing recurrence only when maintenance BCG was part of the treatment.
- A controlled trial evaluated 384 patients randomly assigned to induction intravesical BCG or induction intravesical BCG followed by maintenance intravesical BCG.
- Median recurrence-free survival was 36 months without maintenance BCG and 77 months in the maintenance arm (P < .0001). The risk of disease worsening (progression to T2 or greater disease, use of cystectomy, systemic chemotherapy, or radiation therapy) was greater in the induction arm than in the maintenance arm (P = .04).
- Overall 5-year survival was 78% in the induction-only arm versus 83% in the maintenance arm, but this difference was not statistically significant.