What is BCG (Bacillus Calmette-Guérin) with maintenance in a Urology note?

From the Guidelines

BCG with maintenance in a urology note refers to a treatment regimen for non-muscle invasive bladder cancer using Bacillus Calmette-Guérin (BCG) immunotherapy, which involves an induction course of six weekly BCG instillations into the bladder, followed by maintenance therapy with three weekly instillations at 3,6,12,18,24,30, and 36 months after completing induction, for a total treatment duration of 3 years, as recommended by the SWOG protocol 1. This maintenance approach significantly reduces cancer recurrence and progression compared to induction therapy alone, by stimulating a local immune response against cancer cells in the bladder 1. The optimal maintenance schedule and duration have been determined through high-quality randomized controlled trials, which have shown that the SWOG regimen is effective in decreasing recurrence and possibly decreasing progression of Ta, T1, and/or Tis bladder tumors in high-risk patients 1. Patients should be monitored for side effects including urinary frequency, dysuria, hematuria, and flu-like symptoms, which typically resolve within 48 hours after each instillation, and more severe reactions like severe systemic inflammation or BCG infection are rare but require immediate medical attention 1. Some key points to consider when implementing BCG with maintenance include:

• The importance of using the full dose of BCG, as reduced doses may not be as effective in preventing recurrence and progression 1
• The need for careful patient selection, as BCG is not suitable for all patients with non-muscle invasive bladder cancer 1
• The potential for side effects and the importance of monitoring patients closely during treatment 1
• The role of maintenance BCG in reducing cancer recurrence and progression, and the need for long-term follow-up to ensure the best possible outcomes 1

From the FDA Drug Label

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 Patients received TICE BCG (50 mg; 1 to 8 x 108 CFU) intravesically, once weekly for at least 6 weeks and once monthly thereafter for up to 12 months. In the SWOG trial (study 8795) patients were randomized to TICE BCG or mitomycin C (MMC). Both drugs were given intravesically weekly for 6 weeks, at 8 and 12 weeks, and then monthly for a total treatment duration of 1 year

BCG with maintenance refers to a treatment schedule where BCG (Bacillus Calmette-Guerin) is administered intravesically once weekly for at least 6 weeks (induction phase), followed by monthly maintenance doses for up to 12 months or even longer in some cases 2. This treatment approach is used to prevent the recurrence of bladder cancer, particularly carcinoma in situ (CIS) and TaT1 bladder cancer, after complete transurethral resection of all papillary tumors. The maintenance phase is crucial in sustaining the treatment's efficacy and preventing disease recurrence. Key points about BCG with maintenance include:

• Induction phase: Weekly intravesical BCG administration for at least 6 weeks
• Maintenance phase: Monthly intravesical BCG administration for up to 12 months or longer
• Purpose: To prevent recurrence of bladder cancer, particularly CIS and TaT1 bladder cancer
• Importance of maintenance: Sustaining treatment efficacy and preventing disease recurrence 2

From the Research

Definition of "BCG with maintenance"

• "BCG with maintenance" refers to a treatment regimen for non-muscle-invasive bladder cancer (NMIBC) that involves an initial induction course of Bacillus Calmette-Guérin (BCG) therapy, followed by periodic maintenance instillations of BCG 3, 4, 5.
• The goal of maintenance BCG is to reduce the risk of disease recurrence and progression, and to minimize the need for more invasive treatments such as cystectomy 3, 6, 5.

Rationale for maintenance BCG

• Studies have shown that maintenance BCG can be effective in reducing disease recurrence and progression in patients with NMIBC, particularly those at high risk of progression 3, 4, 5.
• However, the optimal duration and schedule of maintenance BCG are still unknown, and may vary depending on individual patient factors 5.
• Maintenance BCG is associated with a higher risk of side effects, including local and systemic toxicity, which can impact patient quality of life 3, 4.

Clinical guidelines and recommendations

• Clinical guidelines recommend the use of maintenance BCG in patients with NMIBC who are at high risk of progression, although the optimal duration and schedule of treatment are still debated 4, 5.
• Patients who fail BCG treatment, either due to recurrence or progression, may require alternative treatments, including cystectomy or other salvage therapies 6, 7.