Table 2.
Observed response rate (ORR), Overall Survival (mOS) and Progression-Free Survival (mPFS) according to prior history of intravesical BCG treatment, stratified by treatment line
| Treatment Line | History of BCG treatment? | ORR (%) (95% CI) | Adjusted OR (95% CI) | p-value |
|---|---|---|---|---|
| First Line | No (n = 273) | 31 (26–37) | Reference | 0.08 |
| Yes (n = 71) | 23 (14–34) | 0.55 (0.28–1.06) | ||
| Subsequent Line | No (n = 198) | 24 (18–30) | Reference | 0.12 |
| Yes (n = 72) | 31 (21–42) | 1.65 (0.95–2.58) | ||
| Median Overall Survival (mOS) | ||||
| History of BCG treatment? | mOS, months (95% CI) | Adjusted HR (95% CI) | p-value | |
| First Line | No (n = 279) | 11 (8–14) | Reference | 0.79 |
| Yes (n = 74) | 11 (6–15) | 1.05 (0.71–1.56) | ||
| Subsequent Line | No (n = 191) | 10 (8–12) | Reference | 0.49 |
| Yes (n = 73) | 7 (5–12) | 1.13 (0.79–1.63) | ||
| Median Progression-Free Survival (mPFS) | ||||
| History of BCG treatment? | mPFS, months (95% CI) | Adjusted HR (95% CI) | p-value | |
| First Line | No (n = 286) | 4 (4–6) | Reference | 0.55 |
| Yes (n = 77) | 3 (2–7) | 1.12 (0.77–1.62) | ||
| Subsequent Line | No (n = 203) | 4 (3–4) | Reference | 0.39 |
| Yes (n = 72) | 4 (3–7) | 0.87 (0.63–1.19) | ||