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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 .

Objectives To compare survival and oncological outcomes of cisplatin‐ineligible patients (Cis‐I) and cisplatin‐eligible (Cis‐E) patients with muscle‐invasive bladder cancer (MIBC) undergoing immediate radical cystectomy (IRC), as IRC is currently considered the standard‐of‐care for Cis‐I patients with MIBC. Patients and Methods Data from patients with clinical (c)T2–4cN0–1M0 MIBC undergoing IRC, between 2006 and 2021, were retrospectively analysed from four tertiary care centres in the United States. Overall, recurrence‐free and event‐free survival were described using the Kaplan–Meier method and tested using the log‐rank test. For context, we compared survival outcomes against those in Cis‐E patients with MIBC undergoing IRC from the Southwest Oncology Group (SWOG)‐8710 trial. Results Overall, 379 Cis‐I and 125 Cis‐E patients with cT2–4cN0–1M0 MIBC who underwent IRC were included. Cis‐I patients included 44.8% cT3/4 vs 60% cT3/4 in the Cis‐E group. Overall, 83.3% of Cis‐I and 79.2% of Cis‐E patients died during follow‐up. The median event‐free and overall survival were 12.1 and 14.5 months for the Cis‐I group and 28.8 and 60.1 months for the Cis‐E group ( P < 0.001). [Correction added on 10 October 2025, after first online publication: The preceding sentence has been revised in this version.] Limitations include retrospective comparison of contemporary multi‐institutional data with that of a randomised control trial. Conclusions The Cis‐I patients with MIBC undergoing IRC fared poorly, with a median overall survival of 14.5 (95% confidence interval 11.1–17.9) months, mostly due to non‐cancer‐related deaths. These results provide a benchmark for clinical trials exploring novel agents or alternative chemotherapy regimens in Cis‐I patients with MIBC.

Abstract Introduction This study investigated the efficacy and safety of neoadjuvant chemotherapy for locally advance penile squamous cell carcinoma for which current evidence is lacking. Methods Included patients had locally advanced penile squamous cell carcinoma with clinical lymph node metastasis treated with at least 1 dose of neoadjuvant chemotherapy prior to planned consolidative lymphadenectomy. Objective response rates were assessed using Response Evaluation Criteria in Solid Tumors v1.1. The primary and secondary outcomes were overall survival and progression-free survival, estimated by the Kaplan–Meier method. Treatment-related adverse events were graded per the Common Terminology Criteria for Adverse Events v5.0. Results A total of 209 patients received neoadjuvant chemotherapy for locally advanced and clinically node-positive penile squamous cell carcinoma. The study population consisted of 7% of patients with stage II disease, 48% with stage III, and 45% with stage IV. Grade 2 treatment-related adverse events occurred in 35 (17%) patients, and no treatment-related mortality was observed. Of the patients, 201 (97%) completed planned consolidative lymphadenectomy. During follow-up, 106 (52.7%) patients expired, with a median overall survival of 37.0 months (95% confidence interval [CI] = 23.8 to 50.1 months) and median progression-free survival of 26.0 months (95% CI = 11.7 to 40.2 months). Objective response rate was 57.2%, with 87 (43.2%) having partial response and 28 (13.9%) having a complete response. Patients with objective response to neoadjuvant chemotherapy had a longer median overall survival (73.0 vs 17.0 months, P &lt; .01) compared with those who did not. The lymph node pathologic complete response rate was 24.8% in the cohort. Conclusion Neoadjuvant chemotherapy with lymphadenectomy for locally advanced penile squamous cell carcinoma is well tolerated and active to reduce the disease burden and improve long-term survival outcomes.

9 Background: The efficacy of neoadjuvant platinum-based chemotherapy (NAPC) in penile squamous cell carcinoma (PSCC) was provided by small clinical trials, leaving clinicians with scant evidence-based guidance. Thus, we aimed to analyze real-world outcomes of patients with PSCC who received NAPC prior to surgical resection. Methods: Patients from 9 tertiary care centers who had undergone NAPC prior surgical resection for PSCC were included with locally advanced (cTany, cN+), non-metastatic (M0) disease. The primary and secondary outcomes were overall survival (OS) and progression-free survival (PFS), Response was determined via best overall response measured with RECIST 1.1 criteria. Results: 167 patients were included, 137 (84%), of which received TIP prior to surgical resection. Ninety-two (55%) patients died during follow up, and the mean follow up for survivors was 57 months. The median OS was 42 months, while the median PFS was 17 months. The table details the response rates to NAPC, the associated survival, and Cox Proportional Hazards Modelling of OS and PFS. Predictors for OS and RFS included lymphovascular invasion, positive number of lymph nodes, extranodal extension, downstaging, best overall response, and ypN status. Figure 1 demonstrates OS outcomes by RECIST best response after chemotherapy, presence of downstaging after NAPC, ypN stage, and presence of extranodal extension. Conclusions: Upfront NAPC is effective in patients with lymph node metastases from penile carcinoma. Unsurprisingly, patients who demonstrated a robust response to therapy had improved survival outcomes compared to those who had not—as measured by RECIST criteria, tumor downstaging, pN staging, and presence of extranodal extension. This study represents the largest conglomeration of multi-institutional penile carcinoma patients treated with NAPC, and provides further supportive data for multimodal therapy for advanced penile cancer patients while prospective clinical trials complete accrual. [Table: see text]

Objectives To assess the safety profile of antegrade mitomycin gel instillation through a percutaneous nephrostomy tube (PCNT) for upper tract urothelial carcinoma (UTUC) with the aim of decreasing morbidity associated with therapy. Patients and Methods Patients undergoing antegrade administration of mitomycin gel via PCNT were retrospectively included for analysis from four tertiary referral centres between 2020 and 2022. The primary outcome was safety profile, as graded by Common Terminology Criteria for Adverse Events (v5.0). Post‐therapy disease burden was assessed by primary disease evaluation (PDE) via ureteroscopy. Results Thirty‐two patients received at least one dose of mitomycin gel via PCNT for UTUC, 29 of whom completed induction and underwent PDE. Thirteen patients (41%) had residual tumour present prior to induction therapy. At a median of 15.0 months following first dose of induction therapy, ureteric stenosis occurred in three patients (9%), all of whom were treated without later recurrence or chronic stenosis. Other adverse events included fatigue (27%), flank pain (19%), urinary tract infection (12%), sepsis (8%) and haematuria (8%). No patients had impaired renal function during follow‐up and there were no treatment‐related deaths. Seventeen patients (59%) had no evidence of disease at PDE and have not experienced recurrence at a median follow‐up of 13.0 months post induction. Conclusions Administration of mitomycin gel via a PCNT offers a low rate of ureteric stenosis, demonstrates a favourable safety profile, and is administered without general anaesthesia.

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.

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.