From the Guidelines
The next step in management for a patient with bladder CIS who has completed BCG induction and has mild atypia on cytology is to proceed with maintenance BCG therapy, as recommended by the most recent guidelines 1. The standard maintenance regimen consists of three weekly instillations of BCG at 3,6,12,18,24,30, and 36 months after completion of induction therapy.
- Each instillation typically involves intravesical administration of BCG (usually TICE strain at a dose of 50 mg reconstituted in 50 mL of saline) with a dwell time of 1-2 hours.
- The presence of mild atypia on cytology after induction is not uncommon and does not necessarily indicate treatment failure, but warrants close monitoring. In addition to maintenance BCG, the patient should undergo surveillance cystoscopy with cytology every 3-4 months for the first 2 years, then every 6 months for years 3-4, and annually thereafter.
- If the patient develops persistent or worsening atypia, a repeat transurethral resection should be performed to rule out recurrence or progression. Maintenance BCG is recommended because it significantly reduces recurrence rates and may delay progression to muscle-invasive disease in high-risk non-muscle invasive bladder cancer, including CIS, as supported by recent guidelines 1. The mechanism involves BCG-induced local immune response with T-cell infiltration and cytokine release that targets bladder cancer cells. According to the guidelines, in patients with high-risk NMIBC, full-dose intravesical BCG for 1-3 years (at least 1 year) is recommended 1, which aligns with the proposed maintenance therapy for this patient. It's worth noting that the patient's condition and response to treatment should be closely monitored, and adjustments to the treatment plan may be necessary based on individual factors, as suggested by previous studies 1.
From the FDA Drug Label
A standard treatment schedule consists of 1 intravesical instillation per week for 6 weeks This schedule may be repeated once if tumor remission has not been achieved and if the clinical circumstances warrant. Thereafter, intravesical TICE BCG administration should continue at approximately monthly intervals for at least 6 to 12 months.
The next step is monthly BCG for one year. Since the patient has completed the induction course and has mild atypia on cytology, the treatment should continue with maintenance BCG therapy. The FDA drug label recommends continuing intravesical TICE BCG administration at approximately monthly intervals for at least 6 to 12 months after the initial 6-week course 2.
From the Research
Next Steps in Management
The patient has completed an induction course of Bacillus Calmette-Guérin (BCG) for Carcinoma In Situ (CIS) of the bladder and has mild atypia on cytology. The next step in management is:
- Maintenance BCG therapy to reduce the risk of recurrence and progression 3, 4
- The American Urological Association (AUA) guidelines recommend a second induction course of BCG for patients with persistent or recurrent Ta or CIS disease after a first BCG induction course 4
- Alternating mitomycin C and BCG instillations may be considered as an alternative to BCG monotherapy, although BCG monotherapy has been shown to be more effective in reducing recurrence and progression 5
Treatment Options
The following treatment options are available:
- Monthly BCG for one year 3
- Three weeks of BCG at three and six months, then every six months for two years 3
- Intravesical mitomycin C for six weeks 6
- An additional six weeks of BCG 7
Considerations
When considering the next step in management, the following factors should be taken into account: