HEALTH PROFESSIONAL · SOURCE READING
TUR with fulguration followed by an immediate postoperative instillation of intravesical chemotherapy followed by periodic intravesical instillations of BCG
Source: Bladder Cancer Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: May 2, 2025 · Captured 2026-09-09.
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Context: Treatment of Stage I Bladder Cancer / Treatment Options for Stage I Bladder Cancer
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.[6,13-15] An individual patient meta-analysis of randomized trials that compared intravesical BCG with intravesical mitomycin (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 treatments every 3 months).[14] Intravesical chemotherapy is tolerated better than intravesical BCG.[16-20] 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.[19] Studies show that intravesical BCG delays tumor recurrence and tumor progression.[20,21]
Evidence (immediate intravesical chemotherapy after transurethral resection):
A 2004 meta-analysis of seven randomized controlled trials (1,476 patients with Ta or T1 bladder cancer) compared TUR alone with TUR followed by a single immediate intravesical instillation of chemotherapy. Agents studied included epirubicin, MMC, thiotepa, and pirarubicin.[7]
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A 2004 meta-analysis of seven randomized controlled trials (1,476 patients with Ta or T1 bladder cancer) compared TUR alone with TUR followed by a single immediate intravesical instillation of chemotherapy. Agents studied included epirubicin, MMC, thiotepa, and pirarubicin.[7]
The relapse rates were 48% for patients who received TUR alone and 37% for patients who received TUR plus intravesical chemotherapy (OR, 0.61; P < .0001). The risk of recurrence declined for patients with single (OR, 0.61) or multiple (OR, 0.44) tumors, but 65% of those with multiple tumors relapsed despite intravesical chemotherapy.
A subsequent multicenter randomized controlled trial confirmed the reduction in risk of recurrence. A study that included 404 patients reported a relapse rate of 51% for patients who received epirubicin immediately after TUR and 63% for patients who received placebo immediately after TUR (P = .04). However, only small recurrences were prevented in this study, drawing into question the magnitude of benefit.[22]
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Similarly, another multicenter randomized controlled trial confirmed the reduction in risk of recurrence. One study randomly assigned patients (N = 305) to receive either an instillation of epirubicin or no further treatment after TUR.[8]
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Similarly, another multicenter randomized controlled trial confirmed the reduction in risk of recurrence. One study randomly assigned patients (N = 305) to receive either an instillation of epirubicin or no further treatment after TUR.[8]
The relapse rates were 62% for patients who received epirubicin and 77% for patients in the control arm (P = .016).
Similarly, another multicenter randomized controlled trial confirmed the reduction in risk of recurrence. One study randomly assigned patients (N = 305) to receive either an instillation of epirubicin or no further treatment after TUR.[8]
The hazard ratio for recurrence was 0.56 (P = .002) with epirubicin. However, the main benefit was seen in patients at lower risk of relapse. Among patients at intermediate or high risk of relapse, the relapse rates were 81% with epirubicin versus 85% with no further treatment (P = .35).
Evidence (intravesical BCG with maintenance BCG treatments):
An individual patient meta-analysis of nine randomized trials (2,820 patients with Ta or T1 bladder cancer) that compared intravesical BCG with intravesical MMC was published.[14]
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An individual patient meta-analysis of nine randomized trials (2,820 patients with Ta or T1 bladder cancer) that compared intravesical BCG with intravesical MMC was published.[14]
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 no maintenance BCG was given compared with MMC.
An individual patient meta-analysis of nine randomized trials (2,820 patients with Ta or T1 bladder cancer) that compared intravesical BCG with intravesical MMC was published.[14]
There were no differences in progression or death.
A meta-analysis of nine randomized controlled trials (2,410 patients) that compared intravesical BCG with MMC was published.[23]
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A meta-analysis of nine randomized controlled trials (2,410 patients) that compared intravesical BCG with MMC was published.[23]
Progression was seen in 7.67% of the patients who received BCG and 9.44% of patients who received MMC at a median follow-up of 26 months (P = .08).
A meta-analysis of nine randomized controlled trials (2,410 patients) that compared intravesical BCG with MMC was published.[23]
When the analysis was limited to trials in which the BCG arm included a maintenance component, the progression rate was significantly lower in the patients who received BCG (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.[13]
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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.[13]
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.
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.[13]
In this meta-analysis, 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.[24]
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A controlled trial evaluated 384 patients randomly assigned to induction intravesical BCG or induction intravesical BCG followed by maintenance intravesical BCG.[24]
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).
A controlled trial evaluated 384 patients randomly assigned to induction intravesical BCG or induction intravesical BCG followed by maintenance intravesical BCG.[24]
The 5-year overall survival rate was 78% in the induction arm versus 83% in the maintenance arm, but this difference was not statistically significant.
BCG is associated with a risk of significant toxicity, including rare deaths from BCG sepsis. Compared with MMC, BCG produces more local toxicity (44% with BCG vs. 30% with MMC) and systemic side effects (19% with BCG vs. 12% with MMC). Because of concerns about side effects and toxicity, BCG is not generally used for patients with a low risk of progression to more-advanced–stage disease.[6,23]
Evidence (two treatment courses of intravesical BCG):
Two nonconsecutive 6-week courses with BCG may be necessary to obtain optimal response.[25] Patients with a T1 tumor at the 3-month evaluation after a 6-week course of BCG and patients with Tis that persists after a second 6-week BCG course have a high likelihood of developing muscle-invasive disease and should be considered for cystectomy.[18,25,26]
Publication references
Read the original reference and check its publication notices.
- PubMed 10737480 · Original source
- PubMed 15072879 · Original source
- PubMed 15126782 · Original source
- PubMed 1552578 · Original source
- PubMed 1565903 · Original source
- PubMed 15947584 · Original source
- PubMed 17997459 · Original source
- PubMed 1836081 · Original source
- PubMed 19153001 · Original source
- PubMed 19409692 · Original source
- PubMed 1984096 · Original source
- PubMed 21454009 · Original source
- PubMed 21458150 · Original source
- PubMed 2388321 · Original source
- PubMed 3806806 · Original source
- PubMed 7751885 · Original source
Preserved source evidence · Not medical advice
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