Table 2.
Category | Definition |
---|---|
1a. BCG Unresponsive | Persistent or recurrent high-grade NMIBC (stage Tis, Ta, or T1) determined at 6-month evaluation. Patient must have had 5 out of 6 induction BCG instillations and 2 out of 3 maintenance BCG instillations |
1b. BCG Unresponsivea | Any stage progression at 3-month evaluation despite 5 out of 6 induction BCG instillations |
2. Relapsing | Recurrent high-grade NMIBC more than 6 months after diagnosis. Patient must have had at least 3 out of 6 induction BCG instillations and had a maintenance BCG instillation within the last 6 months |
3. No recent BCGa | Had at least 3 of 6 induction BCG instillations at any point in time. Must have had at least one instillation of some type of intravesical agent (induction or maintenance; postop instillation does not apply) or one administration of systemic therapy approved for NMIBC treatment in last 12 months |
NMIBC Non-muscle invasive bladder cancer, BCG Bacillus Calmette-Guérin
aTypically excluded from clinical trials