What is the procedure for intravesical Bacillus Calmette-Guérin (BCG) therapy?

From the Guidelines

Intravesical BCG therapy should be administered as an induction course of weekly treatments for 6 weeks, followed by maintenance therapy with 3 weekly instillations at 3,6,12,18,24,30, and 36 months, as this regimen has been shown to decrease the risk of bladder cancer recurrence and progression in patients with non-muscle invasive bladder cancer 1. The procedure involves instilling BCG solution directly into the bladder through a urinary catheter.

• First, the patient should empty their bladder before the procedure.
• A healthcare provider will insert a sterile catheter through the urethra into the bladder and drain any remaining urine.
• Then, a solution containing BCG (typically 50mg of BCG in 50ml of saline) is slowly instilled into the bladder through the catheter.
• The catheter is then removed, and the patient is instructed to hold the solution in their bladder for about 2 hours, changing position every 15-30 minutes to ensure the solution contacts all areas of the bladder lining.
• After 2 hours, the patient voids the solution. Patients should avoid urinating for 2 hours after instillation and should disinfect urine with bleach for 6 hours after treatment.
• Side effects may include urinary frequency, dysuria, and mild flu-like symptoms. BCG works by stimulating an immune response against cancer cells in the bladder lining, helping to prevent recurrence and progression of bladder cancer, as supported by recent guidelines 1. In patients with high-risk NMIBC, full-dose intravesical BCG for 1-3 years (at least 1 year) is recommended, with 3-year maintenance being more effective than 1 year to prevent recurrences 1. The optimal maintenance schedule and duration have yet to be determined, but high-quality randomized controlled trials have been conducted using the SWOG regimen of a six-week induction course of BCG followed by three weeks of maintenance therapy at 3,6,12,18,24,30, and 36 months (if tolerated by the patient) 1.

From the Research

Procedure for Intravesical Bacillus Calmette-Guérin (BCG) Therapy

The procedure for intravesical BCG therapy involves the following steps:

• Intravesical instillation of BCG is an accepted strategy to reduce the risk of recurrence and possibly progression of high-risk non-muscle invasive bladder cancer (NMIBC) 2.
• The standard regimen for BCG therapy includes:
  • Induction: weekly instillation for 6 weeks
  • Maintenance: weekly instillation for 3 weeks, 3,6, and 12 months after initiation of BCG therapy, plus additional instillations at 18,24,30, and 36 months for high-risk NMIBC 2.
• BCG intravesical therapy remains the most effective therapy preventing recurrence and progression of intermediate and high-risk NMIBC 3.
• Treatment should begin with the standard induction course of 6 weekly treatments, followed by maintenance courses of BCG 4.
• The inclusion of subsequent maintenance courses of BCG is imperative to optimal therapeutic response, with intermediate-risk patients receiving 1 year of maintenance therapy and high-risk patients benefiting from up to 3 years of maintenance therapy 4.

Patient Selection and Risk Stratification

• Appropriate patient selection, accurate staging, and morphological characterization are vital in risk-stratifying patients to those who would most benefit from receiving intravesical therapy 4.
• Patients with low-risk disease should not receive BCG due to its side effects, while intermediate-risk patients may be treated with either intravesical chemotherapy or BCG 5, 4.
• High-risk patients should receive BCG as the treatment of choice, with radical cystectomy considered in patients with multiple T1 tumors, T1 tumors located in difficult to resect locations, residual T1 on re-resection, and T1 with concomitant CIS 4.

Management of BCG Failure

• Patients failing BCG treatment have a poor prognosis, and cystectomy is then the recommended treatment 5.
• Alternative treatment options for BCG failure include systemic (i.v.) pembrolizumab and intravesical nadofaragene firadenovec, with ongoing randomized clinical trials evaluating the role of PD-(L)1 immune checkpoint inhibitors in combination with BCG 2, 6.