SWOG 2427: Single arm phase II study of bladder preservation with immunoradiotherapy after a clinically meaningful response to neoadjuvant therapy in patients with muscle invasive bladder cancer (BRIGHT).
TPS913 Background: A subset of patients with MIBC who receive neoadjuvant therapy (NAT) prior to radical cystectomy (RC) have a pathologic complete response (pCR) at the time of RC. With pCR rates of 22-42% in patients with MIBC following NAT (+/- ICI), whether a subset of patients with good clinical response to NAT can avoid RC is an important unanswered question, especially with the development of more active systemic therapies. HCRN 16-257 evaluated maintenance nivolumab in lieu of cystectomy in patients with MIBC who experienced clinical complete response (cCR) following neoadjuvant GC and nivolumab. The cCR rate was 48%, but 8/33 (24%) patients who elected bladder preservation subsequently underwent cystectomy for local disease recurrence. The RETAIN trial also evaluated omission of local therapy following neoadjuvant therapy with a 2-year bladder preservation rate in patients with ≤T1 disease following NAC of 54% (22/41). Of the 9/25 (36%) patients on that trial developed metastatic disease, 8/9 developed localized disease before metastasizing. These data illustrate the critical role that local therapy plays in patients with MIBC. For this reason, we believe that radiotherapy to the bladder combined with ICI will improve bladder intact event-free survival (BI-EFS). This trial also allows for patients to opt for bladder preservation based on a good clinical response to NAT. Methods: This is a single arm, phase 2 trial (NCT07061964) evaluating risk-adapted bladder preservation therapy for patients with MIBC following NAT. NAT consists of any NCCN guideline concordant therapy for MIBC. Patients with cT2-T4aN0M0 MIBC who complete NAT will be eligible if they have ≤T1 disease on post-NAT TURBT, confirmed by biopsies of prior tumor sites and systematic sampling (left/right lateral walls, dome, posterior wall, trigone). Patients will receive 55 Gray (Gy) in 20 fractions of radiotherapy (RT) to the bladder with 1 year of pembrolizumab. The primary objective is to evaluate whether 3-year BI-EFS is at least 70% in participants with < = T1 (without multifocal CIS) following NAT and RT with 1 year of pembrolizumab. Secondary objectives include local muscle invasive recurrence-free survival, metastasis-free survival (MFS), overall survival (OS), the rate of salvage cystectomy, and evaluation of the frequency and severity of toxicities in participants who receive RT and pembrolizumab. Plasma and urine will be banked for future correlative studies. S2427 was activated in September 2025 with an accrual goal of 111 patients. Clinical trial information: NCT07061964 .
Effect of intracorporeal urinary diversion on the incidence of benign ureteroenteric stricture after cystectomy
ObjectivesTo compare ureteroenteric stricture rates after radical cystectomy in patients who undergo an intracorporeal urinary diversion versus other surgical approaches.MethodsWe retrospectively reviewed health records of all patients who underwent cystectomy with urinary diversion at Mayo Clinic Hospital (Phoenix, AZ, USA) from 1 January 2007 through 1 January 2018. Ureteroenteric stricture was identified by surveillance imaging. Patients were stratified by surgical approach: open radical cystectomy, robot‐assisted radical cystectomy with extracorporeal urinary diversion and robot‐assisted radical cystectomy‐intracorporeal urinary diversion. A Cox proportional hazards model was fitted that included independent predictors of stricture development.ResultsOf the 573 cystectomies assessed, 236 (41.2%) were carried out robotically. In the robot‐assisted radical cystectomy cohort, 39 patients (16.5%) underwent intracorporeal urinary diversion. The median follow‐up period was 55, 70 and 71 months for the open radical cystectomy, robot‐assisted radical cystectomy‐extracorporeal urinary diversion and robot‐assisted radical cystectomy‐intracorporeal urinary diversion groups, respectively. Subgroup stricture rates were as follows: open radical cystectomy, 8.0%; robot‐assisted radical cystectomy‐extracorporeal urinary diversion, 9.6%; and robot‐assisted radical cystectomy‐intracorporeal urinary diversion, 2.6% (P = 0.33). The median time to stricture was 5 months (interquartile range 3.3–11.5 months). In the bivariable analysis, factors that were associated with the development of ureteroenteric stricture were postoperative urinary leak (hazard ratio 3.177, 95% confidence interval 1.129–8.935; P = 0.03) and body mass index (hazard ratio 1.078, 95% confidence interval 1.027–1.132; P = 0.002). On multivariable logistic regression analysis, intracorporeal urinary diversion approach was not associated with the development of ureteroenteric stricture (hazard ratio 0.272, 95% confidence interval 0.036–2.066; P = 0.21).ConclusionsUreteroenteric stricture is a complication that typically occurs within the first postoperative year. Although our results did not support major differences in outcomes between intracorporeal urinary diversion and extracorporeal urinary diversion, the small sample size did not exclude the possibility of a type 2 statistical error.
Robot Assisted Surgery of the Vena Cava: Perioperative Outcomes, Technique, and Lessons Learned at The Mayo Clinic
Introduction: This study aims to describe robot assisted surgery of the inferior vena cava (IVC) by assessing techniques utilized, perioperative outcomes, complications, and long-term patency of the IVC. Methods: A retrospective review was performed on all robotic surgeries involving dissection and repair of the IVC at our institution. Patient characteristics, operative reports, and follow-up visits were analyzed. Preoperative and postoperative imaging was independently reviewed by a single radiologist to determine changes in IVC diameter. Complications were analyzed according to early (<30 days) vs late (>30 days). Results: Thirty-four patients underwent robot assisted surgery of the vena cava from 2008 to 2018. Twenty-six cases were performed for urologic malignancy, four were performed for IVC filter explantation, and four renal vein transpositions were performed for nutcracker syndrome. Twenty-four of the 26 patients with urologic malignancy underwent radical nephrectomy with IVC tumor thrombectomy. Three cases were converted to open. Median length of stay was two nights, and mean estimated blood loss (EBL) was 375 mL. There were five complications, ranging from Clavien-Dindo grade II–IIIa, four of which were early complications. No patients required return to the operating room, and there were no perioperative mortalities. IVC diameter was reduced by 41% on axial diameter, with no patients experiencing compromised venous return. Conclusion: Robot assisted surgery offers the advantage of minimally invasive surgery with the ability to apply open surgical principles. In our series, an experienced multidisciplinary team approach yielded low EBL, short length of stay, and low complication rates.