What is the role of Bacillus Calmette-Guérin (BCG) in the treatment of bladder cancer?

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Last updated: April 24, 2025 • View editorial policy

From the Guidelines

BCG (Bacillus Calmette-Guérin) therapy is the standard treatment for high-risk non-muscle invasive bladder cancer, with a recommended induction course of six weekly intravesical instillations, followed by maintenance therapy for 1-3 years. The standard dose is usually 50-81 mg of BCG strain (such as TICE or Connaught) mixed in 50 ml of saline, instilled into the bladder through a catheter and retained for 1-2 hours 1. Maintenance therapy typically follows a schedule of three weekly instillations at 3, 6, 12, 18, 24, 30, and 36 months after induction.

Key Considerations

  • BCG works by triggering a local immune response against cancer cells, with the live attenuated tuberculosis bacteria stimulating the body's immune system to recognize and attack the bladder cancer cells 2.
  • Side effects include urinary frequency, dysuria, and mild flu-like symptoms, which typically resolve within 48 hours.
  • More severe complications like BCG sepsis are rare but require immediate medical attention.
  • Regular cystoscopic surveillance is essential during and after treatment to monitor response and detect recurrence.

Maintenance Therapy

  • The role of maintenance BCG in those patients with intermediate to high-risk non–muscle-invasive bladder cancer is more established, although the exact regimens have varied across studies 1.
  • The strongest data support the 3-week BCG regimen used in the SWOG trial that demonstrated reduced disease progression and metastasis.
  • Most patients receive maintenance BCG for 1 to 3 years, with some studies suggesting that 3-year maintenance BCG reduced recurrence 1.

Alternative Options

  • In the event of a BCG shortage, priority for treatment should be to provide patients with high-risk non–muscle-invasive bladder cancer (cT1 high grade or CIS) with induction BCG 3.
  • Intravesical chemotherapy may be used as an alternative, with options including gemcitabine and mitomycin.
  • Another alternative to intravesical BCG for patients with non–muscle-invasive bladder cancer at high risk of recurrence and, particularly, at high risk of progression, is initial radical cystectomy 3.

From the FDA Drug Label

CLINICAL STUDIES Carcinoma in situ (Bladder Cancer) To evaluate the efficacy of intravesical administration of TICE® BCG in the treatment of carcinoma in situ, patients were identified who had been treated with TICE BCG under 6 different Investigational New Drug (IND) applications in which the most important shared aspect was the use of an induction plus maintenance schedule The median duration of response, calculated from the Kaplan-Meier curve as median time to recurrence, is estimated at 4 years or greater. The incidence of cystectomy for 90 patients who achieved a complete response (CR or CRNC) was 11%. The median time to cystectomy in patients who achieved a complete response (CR or CRNC) exceeded 74 months TaT1 Bladder Cancer The efficacy of intravesical TICE BCG in preventing the recurrence of a TaT1 bladder cancer after complete transurethral resection of all papillary tumors was evaluated in 2 open-label, randomized phase III clinical trials.

The use of bacillus calmette-guérin (BCG) for bladder cancer treatment is supported by clinical studies.

  • Carcinoma in situ (CIS): BCG has been shown to induce a complete response in patients with CIS, with a median duration of response estimated at 4 years or greater 4.
  • TaT1 bladder cancer: BCG has been evaluated in two phase III clinical trials for preventing recurrence after complete transurethral resection of all papillary tumors, demonstrating efficacy in preventing recurrence 4. Key points about BCG treatment for bladder cancer include:
  • Induction and maintenance schedule: BCG is typically administered intravesically once weekly for at least 6 weeks, followed by monthly maintenance treatments for up to 12 months 4.
  • Response rates: The overall response rate for BCG treatment in patients with CIS was 76% 4.
  • Disease-free survival: BCG treatment has been shown to improve disease-free survival in patients with TaT1 bladder cancer, with a 2-year disease-free survival rate of 57% in one study 4.

From the Research

Bladder Cancer BCG Treatment

  • BCG (Bacillus Calmette-Guérin) is considered the standard of care for intermediate and high-grade non-invasive bladder cancer 5.
  • Intravesical BCG therapy is more effective than intravesical chemotherapy in decreasing the risk of recurrence and progression to muscle invasive disease, but it is associated with more local and systemic side-effects 6.
  • Maintenance BCG is required to achieve the best therapeutic results, but the optimal dose, induction, and maintenance schedules, and duration of treatment are unknown and may vary for each patient 6.

BCG Treatment Efficacy

  • BCG intravesical therapy remains the most effective therapy in preventing recurrence and progression of intermediate and high-risk non-muscle invasive bladder cancer (NMIBC) 5.
  • Estimates of 1-yr, 2-yr, and 5-yr recurrence-free survival (RFS) rates for patients treated with BCG maintenance are 88%, 78%, and 66%, respectively 7.
  • BCG maintenance provides comparable 2-yr RFS to 40 mg MMC (mitomycin C) with maintenance (78% vs 76%) 7.

BCG Treatment Failure

  • Patients failing BCG treatment have a poor prognosis, and cystectomy is then the recommended treatment 6.
  • Adequately characterizing BCG-failure is critical in determining the next step in management, which includes radical cystectomy, additional intravesical immunotherapy, chemotherapy with intravesical gemcitabine ± docetaxel, and clinical trials 5.

Alternative Treatments

  • Mitomycin C (MMC) induction and maintenance regimens seem to provide short-term RFS rates equivalent to those for BCG maintenance in intermediate-risk non-muscle-invasive bladder cancer (IR-NMIBC) 7.
  • For adjuvant induction and maintenance, 40 mg of MMC appears to be more effective in preventing recurrence than 30 mg 7.
  • Gemcitabine and valrubicin have demonstrated modest activity in patients who have failed first-line intravesical therapy, though valrubicin remains the only agent currently FDA-approved for the treatment of BCG-refractory CIS (carcinoma in situ) 8.

References

Guideline

bladder cancer, version 3.2020, nccn clinical practice guidelines in oncology.

Journal of the National Comprehensive Cancer Network : JNCCN, 2020

Guideline

nccn guidelines® insights: bladder cancer, version 3.2024.

Journal of the National Comprehensive Cancer Network : JNCCN, 2024

Guideline

bladder cancer, version 3.2020, nccn clinical practice guidelines in oncology.

Journal of the National Comprehensive Cancer Network : JNCCN, 2020

Research

Bacillus Calmette-Guérin treatment of non-muscle invasive bladder cancer.

International journal of urology : official journal of the Japanese Urological Association, 2011

Research

Intravesical chemotherapy in non-muscle-invasive bladder cancer.

Indian journal of urology : IJU : journal of the Urological Society of India, 2015

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.