Table 1.
Oncological aspects, surgical details and complications
| BSP with BT N = 30 |
BSP without BT N = 10 |
p value | |
|---|---|---|---|
| Demographics | |||
| Age at surgery [months] | 25.5 (9–191) | 38,5 (12–59) | 0.770 |
| Length of FU [months] | 32.5 (6–125) | 40 (13–125) | 0.363 |
| Interval diagnosis – local therapy [months] | 5 (0–32) | 4,5 (3–29) | 0.866 |
| Gender male | 29 | 6 | |
| Tumor size | |||
| < 5 cm | 16 | 7 | 0.356 |
| > 5 cm | 14 | 3 | |
| Cranio-caudal median diameter [mm], (range) | 41.5 (23–140) | 38.5 (9–77) | 0.325 |
| Tumor localization | |||
| Bladder | 9 | 7 | 0.071 |
| Bladder/prostate | 18 | 3 | |
| Prostate | 3 | 0 | |
| Risk group | |||
| Standard risk | 15 | 7 | 0.271 |
| High risk | 15 | 3 | |
| Histology | |||
| Embryonal RMS | 20 | 7 | 0.336 |
| Botryoid subtype | 9 | 3 | |
| Focal anaplasia | 1 | 0 | |
| Surgery | |||
| Resection trigonum, total | 10 | 6 | |
| Partial trigone resection | 0 | 3 | |
| Ureteral reimplantation patients/sides | 5/7 | 8/10 | |
| Ureteroureterostomy | 1 | 1 | |
| Prostatectomy, total | 1 | 3 | |
| Prostatectomy, 50% | 9 | 1 | |
| Bladder neck reconstruction | 20 | 4 | |
| Biopsy only | 2 | 0 | |
| Complications | |||
| Urinary leakage (Clavien–Dindo grade I) | 8 | 3 | |
| Rectourethral fistula (Clavien–Dindo grade IIIb) | 1 | 0 | |
| Fibrotic ureter (Clavien–Dindo grade IIIb) | 1 | 0 | |
| Radiation urethritis (Clavien–Dindo grade I) | 3 | 0 | |
| Resection status | |||
| R0 (microscopically complete) | 17 | 10 | 0.40 |
| R1 (macroscopically complete) | 12 | 0 | |
| R2 (macroscopically incomplete) | 2 | 0 | |
| Outcome | |||
| 5y-OS (95% CI) | 94.7% (84.7–100) | 100% | 0.491 |
| 5y-EFS (95% CI) | 74.4%** (56–92.8) | 65.6%*** (33.5–97.7) | 0.724 |
BT brachytherapy, SR standard risk, HR high risk, EFS event-free survival, OS overall survival, CI confidence interval
**6 relapses 3, 6, 7,8,10 and 14 months after surgery and BT
***3 relapses 4, 14, and 17 months after surgery microscopic residuals (R1)