Table 2.
Univariable analysis of recurrence, progression-free survival (PFS) and overall survival (OS)
| Variable | Total patients (n=302) |
Recurrences (n=78) |
Non-bladder cancer deaths (n=21) |
Total deaths (n=81) |
Recurrence# SHR (95%CI) |
P | PFS$ HR (95%CI) |
P | OS$ HR (95%CI) |
P |
|---|---|---|---|---|---|---|---|---|---|---|
| Group | ||||||||||
| Open | 152 | 39 | 11 | 38 | 1 (Reference) | 1 (Reference) | 1 (Reference) | |||
| Robotic | 150 | 39 | 10 | 43 | 0.95 (0.61, 1.47) | 0.805 | 0.94 (0.63, 1.39) | 0.756 | 0.84 (0.54, 1.30) | 0.432 |
| Urinary diversion procedure | ||||||||||
| Neobladder/Continent cut. Res. | 67 | 16 | 0 | 11 | 1 (Reference) | 1 (Reference) | 1 (Reference) | |||
| Ileal conduit | 235 | 62 | 21 | 70 | 1.16 (0.67, 2.00) | 0.591 | 1.65 (0.97, 2.82) | 0.067 | 2.06 (1.09, 3.89) | 0.026 |
| Chemotherapy& | ||||||||||
| None | 113 | 32 | 12 | 20 | 1 (Reference) | 1 (Reference) | 1 (Reference) | |||
| Neoadjuvant only | 83 | 19 | 4 | 17 | 0.78 (0.45, 1.38) | 0.396 | 0.67 (0.40, 1.10) | 0.115 | 0.59 (0.33, 1.06) | 0.075 |
| Adjuvant +/− Neoadjuvant | 38 | 21 | - | 15 | 2.50 (1.42, 4.40) | 0.002 | 1.66 (0.99, 2.80) | 0.056 | 1.38 (0.77, 2.45 | 0.274 |
| Other | 68 | 6 | 5 | 10 | 0.26 (0.11, 0.62) | 0.002 | 0.33 (0.17, 0.65) | 0.001 | 0.37 (0.18, 0.74) | 0.005 |
| ECOG PS | ||||||||||
| 0–1 | 294 | 76 | 18 | 76 | 1 (Reference) | 1 (Reference) | 1 (Reference) | |||
| 2–3 | 8 | 2 | 3 | 5 | 1.01 (0.24, 4.34) | 0.989 | 2.86 (1.16, 7.04) | 0.022 | 3.44 (1.39, 8.53) | 0.008 |
| Age in years | ||||||||||
| ≤70 | 172 | 41 | 5 | 35 | 1 (Reference) | 1 (Reference) | 1 (Reference) | |||
| >70 | 130 | 37 | 16 | 46 | 1.19 (0.76, 1.85) | 0.445 | 1.61 (1.09, 2.39) | 0.018 | 1.87 (1.20, 2.90) | 0.005 |
| Sex | ||||||||||
| Men | 254 | 63 | 18 | 15 | 1 (Reference) | 1 (Reference) | 1 (Reference) | |||
| Women | 48 | 15 | 3 | 66 | 1.42 (0.80, 2.51) | 0.229 | 1.33 (0.80, 2.23) | 0.268 | 1.38 (0.79, 2.42) | 0.258 |
| BMI (kg/m2) | ||||||||||
| <25 | 77 | 21 | 5 | 22 | 1 (Reference) | 1 (Reference) | 1 (Reference) | |||
| 25–29.9 | 124 | 30 | 10 | 32 | 0.79 (0.45, 1.38) | 0.405 | 0.86 (0.53, 1.42) | 0.560 | 0.80 (0.46, 1.37) | 0.413 |
| ≥30 | 101 | 27 | 6 | 27 | 0.93 (0.52, 1.65) | 0.795 | 0.91 (0.54, 1.52) | 0.718 | 0.85 (0.48, 1.49) | 0.573 |
| Intraoperative blood loss | ||||||||||
| 500 ml increase | 1.06 (0.87, 1.28) | 0.566 | 1.18 (0.99, 1.41) | 0.055 | 1.26 (1.05, 1.51) | 0.014 | ||||
| Blood transfusion | ||||||||||
| No | 202 | 50 | 9 | 45 | 1 (Reference) | 1 (Reference) | 1 (Reference) | |||
| Yes | 100 | 28 | 12 | 36 | 1.22 (0.77, 1.94) | 0.388 | 1.57 (1.05, 2.34) | 0.029 | 1.83 (1.18, 2.84) | 0.007 |
| Lymph nodes dissection | ||||||||||
| Standard (1 not done) | 141 | 38 | 14 | 44 | 1 (Reference) | 1 (Reference) | ||||
| Extended | 161 | 40 | 7 | 37 | 0.96 (0.61, 1.48) | 0.838 | 0.78 (0.53, 1.16) | 0.229 | 0.72 (0.47, 1.12) | 0.150 |
| Pathological stage | ||||||||||
| 0/T0N0, I | 133 | 10 | 10 | 15 | 1 (Reference) | 1 (Reference) | 1 (Reference) | |||
| II | 58 | 14 | 3 | 13 | 3.72 (1.69, 8.21) | 0.001 | 2.35 (1.23, 4.50) | 0.009 | 2.37 (1.13, 4.99) | 0.023 |
| III | 50 | 23 | 1 | 21 | 8.46 (4.03, 17.79) | <.0001 | 4.38 (2.42, 7.94) | <.0001 | 4.73 (2.44, 9.19) | <.0001 |
| IV | 61 | 31 | 7 | 32 | 9.54 (4.74, 19.17) | <.0001 | 6.28 (3.65, 10.81) | <.0001 | 6.66 (3.60, 12.33) | <.0001 |
| Surgical margin status | ||||||||||
| Negative | 286 | 67 | 19 | 70 | 1 (Reference) | 1 (Reference) | 1 (Reference) | |||
| Bladder/Urethral Positive | 16 | 11 | 2 | 11 | 4.49 (2.35, 8.58) | <.0001 | 5.04 (2.80, 9.10) | <.0001 | 4.74 (2.50, 9.00) | <.0001 |
| Complications within 90 days | ||||||||||
| Grades 0-II | 235 | 60 | 12 | 57 | 1 (Reference) | 1 (Reference) | 1 (Reference) | |||
| Grades III-V | 67 | 18 | 9 | 24 | 1.12 (0.66, 1.90) | 0.672 | 1.56 (1.00, 2.43) | 0.048 | 1.77 (1.10, 2.86) | 0.019 |
Abbreviation: ECOG Eastern Cooperative Oncology Group Performance Status. SHR: subdistribution hazard ratio. HR: hazard ratio. CI: confidence interval P: two-sided p-value. NA: not applicable.
Univariable Fine-Gray subdistribution hazards model for cumulative incidence of recurrence, with non-bladder cancer death as competing risk.
Univariable Cox proportional hazards model for PFS and OS.
The first three categories under chemotherapy include a total of 234 patients with clinical or pathological stage T2 or above. Of these, 121 received platinum-based chemotherapy (83 neoadjuvant, 31 adjuvant, and 7 both).
The ”Other” category includes 68 patients as follows: 57 of stage ≤T1 who did not received chemotherapy, 7 of stage ≤T1 who received chemotherapy, and 4 who received non-platinum-based chemotherapy.