What is the next step in management for a patient with complete response to initial intravesical Bacillus Calmette-Guérin (BCG) for Carcinoma In Situ (CIS) of the bladder?

Maintenance BCG Therapy for Complete Response to Initial BCG in Bladder CIS

The next step in management for this 60-year-old man with complete response to initial BCG therapy for CIS of the bladder is maintenance BCG with the first of three weekly doses at three months (option C). 1

Rationale for Maintenance BCG

The International Bladder Cancer Group (IBCG), European Society for Medical Oncology (ESMO), and National Comprehensive Cancer Network (NCCN) strongly recommend maintenance BCG therapy for high-risk non-muscle invasive bladder cancer (NMIBC) patients, including those with CIS, who have responded to induction therapy 1. This recommendation carries the highest level of evidence [I, A].

Why maintenance BCG is necessary:

• CIS is considered high-risk NMIBC with significant potential for recurrence and progression 1
• Maintenance therapy is critical for patients with CIS to prevent recurrence 1
• Three-year maintenance is more effective than one year for preventing recurrences in high-risk NMIBC patients 1

Recommended Maintenance Schedule

The maintenance schedule should follow a specific pattern:

• Three weekly instillations at months 3,6, and 12 after induction
• Continue with three weekly instillations at months 18,24,30, and 36 1

In this case, since the patient has completed the 6-week induction course and demonstrated a complete response (normal cystoscopy and negative cytology), the next step is to begin maintenance therapy with the first of three weekly doses at three months (option C).

Surveillance Protocol

While maintenance BCG is the primary intervention, regular surveillance is also essential:

• Cystoscopy and urinary cytology every 3 months for the first 2 years
• Every 6 months for years 3-4, and annually thereafter 1
• Upper tract imaging at least once within the first 2 years, and then every 1-2 years 1

Common Pitfalls to Avoid

1. Inadequate follow-up: Simple observation with regular surveillance cystoscopy and cytology (option B) without maintenance BCG is insufficient for high-risk disease like CIS 1

2. Unnecessary biopsies: Bladder biopsy to confirm complete response (option A) is not indicated when cystoscopy is normal and cytology is negative. Biopsies are recommended only when there are suspicious areas or positive cytology with negative cystoscopy 1

3. Incorrect timing: Starting maintenance BCG at 6 months (option D) delays the critical first maintenance course, which should begin at 3 months 1

4. Inappropriate dosing schedule: Single monthly doses for one year (option E) does not follow the evidence-based protocol of three weekly instillations at specific intervals 1

Response Assessment and Management of Recurrence

If recurrence is detected during follow-up:

• Consider a second course of BCG induction (maximum of 2 consecutive courses) 1
• For persistent CIS after a second course of BCG, consider cystectomy or alternative intravesical agents 1
• For progression to invasive disease, radical cystectomy is recommended 1

Historical data shows that patients with complete response to BCG have better outcomes, with studies showing 5-year progression-free survival rates of approximately 78.5% 2. However, vigilance is required as the 5-year disease-free rate in complete responders can drop to 60% 3.