Efficacy of Intravesical Nadofaragene Firadenovec for Patients With Bacillus Calmette-Guérin-Unresponsive Nonmuscle-Invasive Bladder Cancer: 5-Year Follow-Up From a Phase 3 Trial

Purpose: Nadofaragene firadenovec-vncg is a nonreplicating adenoviral vector–based gene therapy for bacillus Calmette-Guérin (BCG)–unresponsive carcinoma in situ (CIS) with/without high-grade Ta/T1. We report outcomes following 5 years of planned follow-up. Materials and Methods: This open-label phase 3 trial (NCT02773849) enrolled patients with BCG-unresponsive nonmuscle-invasive bladder cancer in 2 cohorts: CIS ± Ta/T1 (CIS; n = 107) and Ta/T1 without CIS (Ta/T1 cohort; n = 50). Patients received 75 mL (3 × 1011 vp/mL) nadofaragene firadenovec intravesically once every 3 months with cystoscopy and cytology assessments, with continued treatment offered to those remaining high grade recurrence–free (HGRF). Results: One hundred fifty-seven patients were enrolled from 33 US sites (n = 151 included in efficacy analyses). Median follow-up was 50.8 months (interquartile range 39.1-60.0), with 27% receiving ≥ 5 instillations and 7.6% receiving treatment for ≥ 57 months. Of patients with CIS 5.8% (95% CI 2.2-12.2) were HGRF at month 57, and 15% (95% CI 6.1-27.8) of patients with high-grade Ta/T1 were HGRF at month 57. Kaplan-Meier–estimated HGRF survival at 57 months was 13% (95% CI 6.9-21.5) and 33% (95% CI 19.5-46.6) in the CIS and Ta/T1 cohorts, respectively. Cystectomy-free survival at month 60 was 49% (95% CI 40.0-57.1): 43% (95% CI 32.2-53.7) in the CIS cohort and 59% (95% CI 43.1-71.4) in the Ta/T1 cohort. Overall survival at 60 months was 80% (71.0, 86.0): 76% (64.6-84.5) and 86% (70.9-93.5) in the CIS and Ta/T1 cohorts, respectively. Only 5 patients (4 with CIS and 1 with Ta/T1) experienced clinical progression to muscle-invasive disease. Conclusions: At 60 months, nadofaragene firadenovec-vncg allowed bladder preservation in nearly half of the patients and proved to be a safe option for BCG-unresponsive nonmuscle-invasive bladder cancer

Use of SPY Elite Fluorescence Imaging in Creation of a Continent Urinary Diversion

The use of SPY Elite Fluorescence Imaging has recently grown popular among multiple surgical specialties, including colorectal, plastic, endocrine, ophthalmologic, and vascular surgery, due to its ability to quickly and accurately assess tissue perfusion and guide intraoperative decision making. To our knowledge, the use of SPY imaging in urologic reconstructive surgery has yet to be reported. We present a case in which SPY imaging was used intraoperatively to assess perfusion of an ileocecal anastomosis and a segment of bowel prior to creation of a continent urinary diversion following radical cystectomy

Survival outcomes in node-positive non-metastatic bladder cancer: An analysis of the national cancer database

Introduction: Clinically node-positive non-metastatic bladder cancer (cN+) has been the target of several studies aiming to establish a standard of care for this population. Limited studies have shown a survival benefit for various multimodal therapy approaches. The role of radiation therapy has not been well established. Our study aims to study the trends of the reported treatment options offered to patients with cN+ bladder cancer in a national database and to evaluate the effect of various treatments, including radiation, on survival. Methods: The National Cancer Database (NCDB) was used to identify cN+ bladder cancer patients who received chemotherapy alone or in combination with radical cystectomy (RC) or radiotherapy. 3,481 patients were included and divided into 4 groups: chemotherapy only, chemotherapy and RC, chemotherapy and radiation therapy, and chemotherapy, RC, and radiation therapy. Demographic data was compared using ANOVA for continuous variables, and Chi-square for categorical variables. Multivariable analysis was done to compare groups using a multinomial logistic regression model. Kaplan-Meier test was used for survival analysis and Cox-Regression was used for multivariable survival analysis. Results: Patients undergoing RC were significantly younger (P <0.001). There was a significant difference between the groups regarding racial distribution, facility-type and insurance status. There was no difference in gender, Charlson\Deyo score, financial or educational status. Patients who underwent combination therapy with chemotherapy and RC were found to have the longest median survival time at 27 months. Multivariable analysis showed that final treatment, age, sex, Charlson\Deyo comorbidity score, TNM edition and facility-type were significant survival predictors. Race, insurance and financial status failed to maintain significance. There was no survival difference between the chemotherapy group and chemo-radiotherapy group. Conclusions: The combination of surgery and chemotherapy achieves statistically significant superior survival in cN+ bladder cancer. Adding radiotherapy to chemotherapy did not improve survival in this group of patients