Table 2.
Baseline patient and tumor characteristics of the NBCS study population used for replication
| n (%) | NMIBC | MIBC | |
| n = 1,284 | n = 275 | ||
| Male gender | 1,078 (84) | 198 (72) | |
| Median age (range; in yrs) | 64 (25–92) | 64 (27–93) | |
| Smoking status | Never cigarette smoker | 200 (16) | 30 (11) |
| Ever cigarette smoker | 955 (74) | 166 (60) | |
| Unknown | 129 (10) | 79 (29) | |
| Tumor stage | 0a | 865 (67) | – |
| 0is | 50 (3.9) | – | |
| I | 352 (27) | – | |
| II | – | 136 (49) | |
| III | – | 51 (19) | |
| IV | – | 88 (32) | |
| Unknown | 17 (1.3) | – | |
| Concomitant CIS | No | 1157 (90) | 121 (44) |
| Yes | 113 (8.8) | 71 (26) | |
| Unknown | 14 (1.1) | 83 (30) | |
| Tumor gradea | Low grade | 774 (60) | 15 (5.5) |
| High grade | 497 (39) | 238 (86) | |
| Unknown | 13 (1.0) | 22 (8.0) | |
| Tumor histology | UCC | 1,272 (99) | 242 (88) |
| SCC | – | 11 (4.0) | |
| AC | 1 (0.1) | 9 (3.3) | |
| Other | 2 (0.2) | 11 (4.0) | |
| Unknown | 9 (0.7) | 2 (0.7) | |
| Tumor size | <3 cm | 182 (14) | 15 (5.5) |
| ≥ 3 cm | 94 (7.3) | 39 (14) | |
| Unknown | 1008 (79) | 221 (80) | |
| Tumor focality | Solitary | 700 (55) | 179 (65) |
| Multifocal | 504 (39) | 69 (25) | |
| Unknown | 80 (6.2) | 27 (9.8) | |
| Initial treatment NMIBCb | TUR only (±one immediate p.o. i.v. CT instillation) | 586 (46) | – |
| TUR + adjuvant i.v. CT | 366 (29) | – | |
| TUR + adjuvant i.v. IT | 243 (19) | – | |
| TUR + both adjuvant i.v. CT and IT | 23 (1.8) | – | |
| Immediate radical cystectomy | 19 (1.5) | – | |
| Other | 1 (0.1) | – | |
| Unknown | 46 (3.6) | – | |
| Median time at risk (IQR; in yrs) | Recurrencec | 2.9 (1.2–5.1) | – |
| Progressionc | 4.9 (3.0–7.6) | – | |
| Overall deathc | – | 6.2 (3.0–9.7) |
aLow grade: WHO 1973 differentiation grade 1 or 2, WHO/ISUP 2004 low-grade, or Malmström (Modified Bergkvist) grade 1 or 2a; High grade: WHO 1973 differentiation grade 3, WHO/ISUP 2004 high-grade, or Malmström (Modified Bergkvist) grade 2b or 3. bReplication among NMIBC treatment subgroups was performed among 463 patients treated with TUR only (without one p.o. i.v. CT instillation), and 192 and 311 patients initially treated with ≥6 intravesical instillations of BCG or chemotherapy, respectively. cFive-year Kaplan-Meier risk of recurrence, progression (NMIBC), and overall death (MIBC) is 50.5% , 17.2% , and 32.4% , respectively. Abbreviations: AC: adenocarcinoma; CIS: carcinoma in situ; CT: chemotherapy; IT: immunotherapy; i.v.: intravesical; MIBC: muscle-invasive bladder cancer; NMIBC: non-muscle-invasive bladder cancer; p.o.: post-operative; SCC: squamous cell carcinoma; TUR: transurethral resection; UCC: urothelial cell carcinoma.