PURPOSE:We postulated that PANVAC™, a recombinant poxviral vector vaccine, could enhance the immunologic and clinical response to an additional induction course of bacillus Calmette-Guérin (BCG) in patients with recurrent high-grade non-muscle-invasive bladder cancer (NMIBC). METHODS:This was a randomized, open-label, prospective, phase II study in subjects with high-grade NMIBC who had failed at least 1 induction course of intravesical BCG. Patients were randomized to either BCG alone or BCG+PANVAC. All subjects received intravesical BCG for 6 weeks. Patients in the combination arm also received priming and booster doses of PANVAC. The primary endpoint was recurrence-free survival. Secondary endpoints included progression-free survival and radical cystectomy-free survival. We also evaluated exploratory secondary immunological response endpoints. RESULTS:Our study concluded based on preplanned futility analysis. Overall, 32 patients were enrolled; 2 withdrew. Thirty patients (15/arm) were analyzed; 5 (33.3%) in the BCG-alone arm and 5 (33.3%) in the BCG+PANVAC arm met criteria for BCG- unresponsive disease. 12-month recurrence-free survival was 53.3% for the BCG-alone arm and 40% for the BCG+PANVAC arm. Overall recurrence rate at any time point was 73.3% at a median of 10.8 months, for an overall recurrence rate of 66.7% in the BCG-alone arm and 80% in the BCG+PANVAC arm. There was no difference in median recurrence-free survival or progression-free survival. CONCLUSIONS:This phase II study demonstrated no improvement in recurrence-free survival with BCG+PANVAC compared to BCG alone in patients with NMIBC who failed to respond to intravesical BCG.

You have accessJournal of UrologyPediatrics IV (MP55)1 May 2024MP55-19 FACTORS ASSOCIATED WITH OUTCOMES AFTER PYELOPLASTY IN THE PEDIATRIC POPULATION Olamide Olawoyin, Benjamin Press, Robert Weiss, Joshua Sterling, and Angela Arlen Olamide OlawoyinOlamide Olawoyin , Benjamin PressBenjamin Press , Robert WeissRobert Weiss , Joshua SterlingJoshua Sterling , and Angela ArlenAngela Arlen View All Author Informationhttps://doi.org/10.1097/01.JU.0001008616.01808.0f.19AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Pyeloplasty is commonly performed in the pediatric population for ureteropelvic junction obstruction. Literature on patient and surgical factors associated with perioperative complications has been limited to single institution studies and mainly focused on long term outcomes. We aim to determine the patient and surgical factors that contribute to 30 days morbidity after pediatric pyeloplasty using a national database. METHODS: This retrospective cohort study used the National Surgical Quality Improvement Pediatrics database to evaluate the patient and clinical factors associated with 30 days post- surgical outcomes in pediatric patients who had undergone open and laparoscopic pyeloplasty between 2012-2021. Patient factors evaluated included age, sex, race, history of prematurity (HOP), weight, and ASA classification. Surgical factors included operative time, preop creatinine, albumin, hematocrit, WBC, and prior steroid use. Complications were categorized using the Clavien-Dindo (CD) classification. 30 days readmission rate and most frequent complications were analyzed. Multivariate logistic regressions were performed to examine associations. RESULTS: We identified 10,182 children who underwent pyeloplasty between 2012-2021. Cases with missing demographic data were excluded. 8,221 patients met inclusion criteria. There were 528 (6.4%) readmissions within 30 days. 30 cases, 0.4% were related to obstruction. UTI was the most frequent post-operative complication (n=232, 2.8%). Median age at the time of surgery was 23 months, 90 patients were<30 days old at the time of surgery. Age<23 months and HOP were associated with CD I-II (OR 1.89, p<0.01 and 5.82, p<0.05 respectively). Low weight at time of surgery was associated with CD III-V (OR 0.98, p<0.05). HOP was also associated with incidence of UTI (OR 8.09, p<0.05). Prior steroid use in 35 patients was not associated with wound dehiscence or infection. There was a modest correlation between operative time and wound dehiscence (OR 1.006, p<0.05). CONCLUSIONS: Complications after pyeloplasty are rare and most commonly due to UTI. HOP, and low weight at the time of surgery were associated with increased complications after pyeloplasty. Prior steroid use was not associated with wound dehiscence or surgical site infection. Source of Funding: None © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e924 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Olamide Olawoyin More articles by this author Benjamin Press More articles by this author Robert Weiss More articles by this author Joshua Sterling More articles by this author Angela Arlen More articles by this author Expand All Advertisement PDF downloadLoading ...

Over the past half a century, kidney transplants have increased significantly and more patients that are elderly are receiving kidney transplants. As a result, the eligibility of patients with prostate cancer who wish to receive a kidney transplant has become a significant issue facing the transplant community. Many questions have arisen because prostate cancer is an extremely variable disease that many times do not harm the patients but at other times, can cause the death of the patient.

Chromophobe renal cell carcinoma (chRCC) is one of the less common types of kidney cancer and generally portends a more favorable prognosis. RCC with sarcomatoid differentiation has a more aggressive clinical course with poor outcomes. Four cases of chRCC with varying degrees of sarcomatoid differentiation were retrospectively reviewed at our institution, and clinicopathologic data as well as clinical courses were reported. Patients with higher degrees of sarcomatoid differentiation and larger tumors at presentation generally had and worse overall survival. chRCC with sarcomatoid differentiation portends a poor prognosis with limited data on systemic treatment options for metastatic disease.

You have accessJournal of UrologyHistory of Urology Forum II (FR02)1 Apr 2019FR02-02 AGENT ORANGE - THE VIETNAM WAR’S CONTINUED HEALTH CARE COST Chrystal Chang, Michael Benson*, John Sheng, Nitin Patel, Vladislav Bargman, and Robert E. Weiss Chrystal ChangChrystal Chang More articles by this author , Michael Benson*Michael Benson* More articles by this author , John ShengJohn Sheng More articles by this author , Nitin PatelNitin Patel More articles by this author , Vladislav BargmanVladislav Bargman More articles by this author , and Robert E. WeissRobert E. Weiss More articles by this author View All Author Informationhttps://doi.org/10.1097/01.JU.0000555415.21651.5aAboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVES: Agent Orange is a herbicide widely used by the United States in Vietnam between 1962 and 1971. It is estimated that 20 million gallons were sprayed by helicopters and trucks during this time. Agent Orange was used as a defoliant to diminish cover for the Viet Cong and decrease crop supplies. It is made of two phenoxy compounds, one of which contains a dioxin compound (TCDD). TCCD has been shown to be a human carcinogen. The term “Agent Orange” comes from the orange stripe that marked it’s storage barrels. As the Vietnam War progressed, Agent Orange was targeted at civilian crops resulting in malnourishment and starvation. The United Nations tried to pass a resolution in 1966 to stop the use of this chemical weapon, however the United States defeated this measure by labeling it an herbicide. METHODS: Sources were attained from Pubmed using the words “agent orange” and “urologic cancers” and historical texbooks. RESULTS: Agent Orange’s effect on the environment and health of the Vietnamese and American soldiers was significant. Approximately, 20% of South Vietnamese forests were sprayed during the campaign. Agent Orange destroyed 5 x 1,000,000 acres of forests and thousands of acres of crops. The Vietnamese estimate that 4 million citizens were exposed to Agent Orange. Elevated levels of dioxin was found in blood samples and breast milk of Vietnamese. High levels of dioxin have been found near US airbases and storage sites where Agent Orange was kept. The Vietnamese have cited increase in the number birth defects - including cleft palate, spina bifida and neural defects. American soldiers, especially ground troops and helicopter airman were high risk for exposure. There have been reports of men using the Agent Orange barrels for washing. The US government began tracking the effects of Agent Orange on veterans in the 1990‘s. The latest update was reported in 2016. There appears to be direct evidence that Agent Orange causes sarcoma, NHL and CLL. There is suggestive evidence that it causes lung cancer, prostate and bladder cancer. The Michigan VA study in 2004 showed men with prostate cancer had a two time increased likelihood of exposure to Agent Orange. The Portland VA study showed an increase risk of high grade prostate cancer in men exposed to Agent Orange. Similarly, there have been studies linking Agent Orange to bladder cancer in veterans. CONCLUSIONS: Since 1991, the VA has been compensating Veterans who develop illness related to Agent Orange. In 2011, the United States committed 32 million dollars to clean up dioxin contamination in Vietnam. Although the war ended in 1975, the effects of Agent Orange continues to haunt the survivors. Source of Funding: None Newark, NJ© 2019 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 201Issue Supplement 4April 2019Page: e251-e251 Advertisement Copyright & Permissions© 2019 by American Urological Association Education and Research, Inc.MetricsAuthor Information Chrystal Chang More articles by this author Michael Benson* More articles by this author John Sheng More articles by this author Nitin Patel More articles by this author Vladislav Bargman More articles by this author Robert E. Weiss More articles by this author Expand All Advertisement PDF downloadLoading ...

INTRODUCTION AND OBJECTIVES: Stage III renal cell carcinoma (RCC) encompasses both node-positive (pT1-3N1M0) and node-negative (pT3N0M0) disease. However, prior institutional studies have indicated that among Stage III patients, those with nodal disease have significantly worse oncologic outcomes. Instead they experience survival similar to patients with Stage IV disease. Our study aims to validate these findings using a large, nationally representative sample of kidney cancer patients in order to further inform current RCC staging. METHODS: Using the National Cancer Database (NCDB) patients with Stage III or IV RCC were identified. Patients were categorized as Stage III node-positive (pT1-3N1M0), Stage III node-negative (pT3N0M0) disease or Stage IV metastatic disease (pT1-4N0M1). Cox proportional hazard models compared outcomes while adjusting for comorbidities. Kaplan Meier estimates illustrated relative survival when comparing each patient group. RESULTS: 19,958 patients identified from the NCDB met inclusion criteria, with n = 9,996 Stage III node-negative disease, n = 4,052 Stage III node-positive disease, and n= 257 Stage IV disease. Patients with Stage III node-negative disease had significantly improved overall survival (Median Survival = 79.5 months (95%CI = 75.9–83.1)) versus their counter parts with nodal disease (Median Survival = 18.6 months (95%CI = 17.5–19.6)). Additionally, Stage III node-positive patient had a similar survival curve but slightly worse outcomes versus those with Stage IV disease (Median Survival = 24.4 months (95%CI = 22.3–26.5)). (Figure 1). CONCLUSIONS: Current staging by the American Joint Committee on Cancer groups pT1-3N1M0 and pT3N0M0 as Stage III disease. However, our validation study – in agreement with prior smaller institutional studies – suggests the need for further stratification and even placement of pT1-3N1M0 patients into Stage IV. Pathologic staging that accurately reflects oncologic prognosis may help clinicians better counsel and select patients who will derive the most benefit from lymphadenectomy, adjuvant systemic therapy, and more rigorous imaging surveillance. Figure. No caption available. Source of Funding: none

672 Background: The benefit of a lymph node dissection (LND) in renal cell carcinoma (RCC) remains poorly defined. Despite this uncertainty, the American Urological Association (AUA) guideline on localized renal cancer recommends that LND be performed for staging purposes when there is suspicion of regional lymphadenopathy on imaging. Using the National Cancer Database (NCDB), we examined factors associated with the receipt of LND at the time of renal surgery. Methods: The NCDB was queried for non-metastatic patients who underwent partial nephrectomy or nephrectomy for RCC from 2010 to 2014. Patient socio-demographics, clinical characteristics, and treatment factors were extracted. Logistic regression models were used to examine factors associated with the receipt of LND. Results: We identified 110,963 patients who underwent surgery for RCC, of whom 11,867 (11%) had LND performed at the time of surgery. Clinical lymph node (cLN) and pathologic lymph node (pLN) information were available in 11,300 patients, of which 1,725 were preoperatively staged as having positive cLN. In the entire study population, patients who were cLN positive were approximately 19 times more likely to receive a LND at the time of surgery (OR: 18.68, 95%CI: 16.62-21.00). Factors associated with a LND in patients who are cLN negative (n = 106,370) were assessed. Clinical T (cT) stage was the strongest indicator of LND (cT2-4, OR range: 4.87-11.1). Among both cohorts, patients who received surgery at an academic/research institution or traveled farther ( > 31 miles) to a treatment center were more likely to undergo a LND. Patients from both cohorts who underwent robotic or laparoscopic surgery were less likely to receive a LND compared to open surgery. Conclusions: The greatest predictor of LND receipt is being cLN positive. Among patients who are cLN negative, the greatest predictor of LND is cT stage. Predictors of undergoing LND in all patients and those who are cLN negative include treatment center type and distance to the treatment center. Additional studies to determine the accuracy of clinical staging and assess novel preoperative imaging modalities that evaluate nodal involvement are indicated.

Intravesical BCG is a highly effective treatment for high-grade nonmuscle invasive bladder cancer and carcinoma in situ (CIS); however, for patients who are either resistant or become unresponsive to BCG therapy there is a need for alternative treatment approaches. This study examined the safety and feasibility of intravesically administered recombinant fowlpox virus encoding GM-CSF (Arm A) or TRICOM (Arm B); and the local and systemic immunologic responses generated to the vector(s). Twenty bladder cancer patients scheduled for cystectomy as their standard of care received preoperatively four weekly doses of intravesical recombinant fowlpox. Treatment was well tolerated, however, three patients experienced transient elevations of liver transaminases, with one rising to the level of a DLT. Cystectomy derived tumor and normal bladder mucosa demonstrated mRNA for the virally encoded LacZ gene supporting effective infection/transfection. Detected serum antibody to the LacZ encoding β-galactosidase indicated successful expression of vector-encoding gene products and the ability to immunize via the bladder site. H&E and IHC using a panel of immune cell specific antigens demonstrated immune cell infiltration of the bladder wall. These findings demonstrate good safety profile, successful infection/transfection, ability to generate systemic immune response, and local recruitment of immune cell populations with intravesical administration of fowlpox-based constructs encoding for GM-CSF(rF-GM-CSF) or TRICOM (rF-TRICOM), and support further evaluation of this treatment modality for bladder cancer.

648 Background: AUA guidelines on the management of renal cell carcinoma (RCC) recommend prioritizing partial nephrectomy (PN) for the treatment of clinical T1a (cT1a) tumors, using PN for clinical T1b (cT1b) tumors when feasible, and performing minimally invasive surgery (MIS) when possible. Since cT1 RCC is a heterogeneous disease, we evaluated patterns of care in this population to examine factors associated with receipt of PN and MIS. Methods: We queried the NCDB from 2010-2014 to identify patients treated surgically for cT1N0M0 RCC. Patient socio-demographics, clinical characteristics, and treatment parameters were compared between cT1a and cT1b patients. Logistic regression models examined factors associated with receiving MIS. Results: Our population included 69,694 patients (44,043 cT1a and 25,651 cT1b). For cT1a tumors, 70% of patients received PN, while 30% received RN; 35% of patients underwent an open procedure and 65% underwent MIS. For cT1b tumors, 32% of patients received PN and 68% received RN; 38% of patients underwent an open operation and 62% underwent MIS. In both cohorts, African Americans and those earning <$62,000 were less likely to have MIS. Distance to treatment was not significant in cT1b patients, but cT1a patients who traveled >31 miles were more likely to undergo MIS. Patients treated at a community hospital were less likely to receive MIS compared to those treated at academic centers (cT1a OR: 0.48, 95% CI: 0.44-0.53 and cT1b OR: 0.63, 95% CI: 0.56-0.7). cT1a patients without private insurance were less likely to receive MIS (OR range: 0.58-0.93). However, only uninsured cT1b patients were less likely to undergo MIS (OR: 0.74, 95% CI: 0.64-0.86). Conclusions: PN occurred more frequently for cT1a (70%) vs. cT1b (32%) tumors. Most cT1 tumors received MIS; 35% of cT1a patients and 38% of cT1b patients underwent an open procedure, presenting an opportunity for improvement. cT1a and cT1b patients with lower household income, without private insurance, and those treated outside academic centers were less likely to receive MIS. Based on these findings additional research on the impact of regionalization of RCC surgery on utilization of PN vs. RN, receipt of MIS, and outcomes is warranted.

You have accessJournal of UrologyKidney Cancer: Epidemiology & Evaluation/Staging II1 Apr 2018MP36-01 OUTCOMES OF LYMPHADENECTOMY FOR NON-METASTATIC RENAL CELL CARCINOMA: A PROPENSITY SCORE-WEIGHTED ANALYSIS Nicholas Farber, Zorimar Rivera-Nunez, Sinae Kim, Kushan Radadia, Parth Modi, Sharad Goyal, Rahul Parikh, Robert Weiss, Isaac Kim, Sammy Elsamra, Thomas Jang, and Eric Singer Nicholas FarberNicholas Farber More articles by this author , Zorimar Rivera-NunezZorimar Rivera-Nunez More articles by this author , Sinae KimSinae Kim More articles by this author , Kushan RadadiaKushan Radadia More articles by this author , Parth ModiParth Modi More articles by this author , Sharad GoyalSharad Goyal More articles by this author , Rahul ParikhRahul Parikh More articles by this author , Robert WeissRobert Weiss More articles by this author , Isaac KimIsaac Kim More articles by this author , Sammy ElsamraSammy Elsamra More articles by this author , Thomas JangThomas Jang More articles by this author , and Eric SingerEric Singer More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2018.02.1135AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Lymph node (LN) involvement in renal cell carcinoma (RCC) is associated with a poor prognosis. While lymph node dissection (LND) may provide diagnostic information, the therapeutic benefit remains controversial. Currently, the American Urologic Association guideline on localized renal cancer recommends performance of LND in the setting of regional lymphadenopathy. Thus, the aim of our study is to analyze survival outcomes after LND for non-metastatic RCC as well as to characterize contemporary practice patterns. METHODS The National Cancer Database was queried from 2010-2014 for patients with non-metastatic RCC who underwent renal surgery (partial or radical nephrectomy). A total of 110,963 patients were identified, of whom 11,867 underwent concurrent LND. Patient demographic and hospital characteristics were extracted. Chi square tests were used to examine group differences. To minimize selection bias, propensity score matching was used to select one control for each LND case (n=18,593). Kaplan-Meier (KM) curves and Cox regression analyses were conducted to examine overall survival (OS) in patients who did and did not receive LND. RESULTS Of all patients undergoing LND for RCC, 3264 (35.5%), 3001 (32.6%), 2360 (26.7%), and 474 (5.2%) were performed for tumors of clinical T stage 1, 2, 3, and 4, respectively. Rates of LND have not significantly changed from 2010 to 2014 (p=0.288). Surgical approach included 1659 (18%) robotic, 2256 (25%) laparoscopic, and 5284 (57%) open operations. Of 2221 patients with clinically positive LNs, 273 (12%), 504 (23%), and 1444 (65%), underwent robotic, laparoscopic, and open surgery, respectively (p<0.0001). Open surgery was associated with greater mean LN yield (5.9+/-7.1) compared to robotic (5.1+/-5.9) or laparoscopic surgery (3.9+/-4.9) (p<0.0001). Among all RCC patients, KM curves did not show a significant improvement in mean OS for patients undergoing LND compared to no LND (34.55 vs. 34.48 months, respectively; p = 0.864). Similarly, KM curves did not show a significant improvement in mean OS for patients undergoing LND compared to no LND in the clinically LN positive or clinically LN negative subgroups (p=0.578). On Cox regression analysis, LND dissection was not associated with an OS benefit (HR 1.00; 95% CI 0.97-1.04). CONCLUSIONS Among all RCC patients, LNDs are performed most often for stage 1 disease, suggesting a potential overutilization of LND. No OS benefit was seen in any subgroup of patients undergoing LND. Further investigation is needed to determine which patient populations may benefit from LND. © 2018FiguresReferencesRelatedDetails Volume 199Issue 4SApril 2018Page: e456 Advertisement Copyright & Permissions© 2018MetricsAuthor Information Nicholas Farber More articles by this author Zorimar Rivera-Nunez More articles by this author Sinae Kim More articles by this author Kushan Radadia More articles by this author Parth Modi More articles by this author Sharad Goyal More articles by this author Rahul Parikh More articles by this author Robert Weiss More articles by this author Isaac Kim More articles by this author Sammy Elsamra More articles by this author Thomas Jang More articles by this author Eric Singer More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

INTRODUCTION AND OBJECTIVES: The pathophysiology of erectile dysfunction (EF) after radical prostatectomy is believed to include neuropraxia, which leads to temporarily reduced oxygenation and subsequent structural changes in penile tissue.This results in veno-occlusive dysfunction, therefore, penile rehabilitation (PR) programmes focus on tissue oxygenation.Aim.Compare results of different types of PR such as vacuum erectile device (VED), PDE-5i pharmacotherapy (PDE-5i) and the combination therapy (CT).METHODS: We identified 83 sexually active patients who underwent nerve-sparing radical prostatectomy (NSRP).They were divided into 4 groups: the Ist without PR after NSRP (n¼24; 27.7%); the IInd taking PDE-5i after urinary catheter removal (n¼27; 32.5%); the IIIrd got VED therapy since the first month (n¼13; 22.8%) and the IVth got CT (n¼19; 18%).EF was examined by the International Index of Erectile Function (IIEF)-15 and by the Erection Hardness Score (EHS) questionnaires before and at 3, 6, and 12 months after surgery.Full recovery was defined as sexual intercourse with or without using PDE-5i; partial one as return spontaneous erections but insufficient for sexual intercourse; the development of ED as a complete lack of spontaneous erections in postoperative period.RESULTS: The IIEF score in the IIIrd group was 10.8 at 3 months and 19.4 at 12 months, compared with 7.5 and 13.8 at the same time points in the IInd group.Earlier recovery (on the 3rd month) of EF is noticed in patients got VED therapy (31%).Recovery rates of penile rigidity from baseline were 63% in the IIIrd group.CONCLUSIONS: Using VED therapy and PDE-5i after NSRP as single as in the combination leads to a significantly faster and great recovery of EF.Further studies are necessary for development of an algorithm of the choice of the PR option (VED, PDE-5i or CT) personalized for the patient after NSRP.

BACKGROUND:Radical cystectomy (RC) with ileal conduit (IC) or continent diversion (CD) is standard treatment for high-risk non-invasive and muscle-invasive bladder cancer.OBJECTIVE:Our aim is to study contemporary trends in the utilization of ICs and CDs in patients undergoing RC.METHODS:Using the National Inpatient Sample 2001-2012, we identified all patients diagnosed with a malignant bladder neoplasm who underwent RC followed by IC or CD. Patient demographics, comorbidities, length of stay (LOS), and in-hospital complications, mortality, and costs were compared. Multivariable logistic regression analysis, Chi square, and t-tests were used for analysis.RESULTS:Between 2001-2012, approximately 69,049 ICs and 6,991 CDs were performed. CDs increased from 2001 to 2008, but declined after 2008 (p < 0.0001). Patients of all ages received ICs at a higher rate than CDs (40-59 years: 79.5% vs. 20.5%; 60-69 years: 88.0% vs. 12.0%; p < 0.0001). There was a difference in males vs. females (10.2% vs. 4.0%; OR 2.36) and Caucasians vs. African Americans (9.0% vs. 6.7%; OR 1.49) when comparing CD rates. CD rates were highest in the West, urban teaching centers, and large hospitals (p < 0.001). ICs were associated with higher rates of overall postoperative complications (p = 0.0185) including infection (p = 0.002) and mortality (p < 0.0001). In-hospital costs were greater for the CD group.CONCLUSIONS:The number of CDs has declined recently. Patients of all ages are more likely to receive ICs than CDs. Gender, racial, and geographic disparities exist among those receiving CDs. CDs are associated with lower rates of in-hospital complications and mortality, but higher in-hospital costs.

You have accessJournal of UrologyBladder Cancer: Non-invasive I1 Apr 2017MP15-10 IMMUNOLOGIC RESPONSE TO A THERAPEUTIC CANCER VACCINE (PANVAC): INITIAL RESULTS FROM A RANDOMIZED PHASE 2 CLINICAL TRIAL Thomas Sanford, Renee Donahue, Caroline Jochems, Rebecca Dolan, Sonia Bellfield, Megan Anderson, Eric Singer, Robert Weiss, Sammy Elsamra, Thomas Jang, Sam Brancato, Daniel Su, Yvonne Wall, James Gulley, Jeffrey Schlom, and Piyush Agarwal Thomas SanfordThomas Sanford , Renee DonahueRenee Donahue , Caroline JochemsCaroline Jochems , Rebecca DolanRebecca Dolan , Sonia BellfieldSonia Bellfield , Megan AndersonMegan Anderson , Eric SingerEric Singer , Robert WeissRobert Weiss , Sammy ElsamraSammy Elsamra , Thomas JangThomas Jang , Sam BrancatoSam Brancato , Daniel SuDaniel Su , Yvonne WallYvonne Wall , James GulleyJames Gulley , Jeffrey SchlomJeffrey Schlom , and Piyush AgarwalPiyush Agarwal View All Author Informationhttps://doi.org/10.1016/j.juro.2017.02.495AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Patients who have recurrences of superficial urothelial carcinoma after BCG have limited therapeutic options. We are conducting a randomized phase II clinical trial in which patients who have recurrence after prior BCG undergo either repeat induction BCG or BCG combined with a cancer vaccine (PANVAC). In this study, we report our analysis of the initial immunologic response for the patients enrolled thus far. METHODS The immunologic responses of all patients enrolled thus far were assessed. Three tumor-specific antigens (Brachyury, CEA, and MUC1) were assessed using an overlapping 15-mer peptide pool spanning the entire length of each of the peptides. HLA was used as a negative control and CEFII was used as a positive control. The tumor associated antigen (TAA) response was evaluated at an early time point (1 month after therapy initiation/1 week after 2nd vaccine administration) and at a later time point (3-4 months after therapy initiation/1 week after 4th vaccine administration). A positive response was defined as antigen levels above 250 (absolute number of cells producing cytokine) after subtracting for background. RESULTS There were a total of 16 patients enrolled thus far: Eight patients were randomized to the BCG-only arm and eight patients were randomized to the BCG+PANVC arm. The median number of BCG instillations prior to enrollment in both groups was 6 (range 5-19). 25% of patients also had intravesical chemotherapy prior to enrollment (2 patient had Mitomycin C, 2 patients had Valrubicin). There was a higher rate of all responses in the BCG+PANVAC (mean TAA value 734) arm than in the BCG alone arm (mean TAA value 434) (p<0.01), and a higher rate of responses attributable to the brachyury antigen (p=0.03). There was also a higher rate of response when CEA and MUC1 were evaluated together. The CD8 response appeared to be greater than the CD4 response for patient in the PANVAC arm but not in the BCG only arm. CONCLUSIONS BCG + PANVAC appears to induce an immunological response that is greater than BCG alone in many patients. The impact of this immunological response on patient outcomes will continue to be assessed as the trial matures. © 2017FiguresReferencesRelatedDetailsCited byMeng M, Gschwend J, Shore N, Grossfeld G, Mostafid H and Black P (2019) Emerging Immunotherapy Options for bacillus Calmette-Guérin Unresponsive Nonmuscle Invasive Bladder CancerJournal of Urology, VOL. 202, NO. 6, (1111-1119), Online publication date: 1-Dec-2019. Volume 197Issue 4SApril 2017Page: e174 Advertisement Copyright & Permissions© 2017MetricsAuthor Information Thomas Sanford More articles by this author Renee Donahue More articles by this author Caroline Jochems More articles by this author Rebecca Dolan More articles by this author Sonia Bellfield More articles by this author Megan Anderson More articles by this author Eric Singer More articles by this author Robert Weiss More articles by this author Sammy Elsamra More articles by this author Thomas Jang More articles by this author Sam Brancato More articles by this author Daniel Su More articles by this author Yvonne Wall More articles by this author James Gulley More articles by this author Jeffrey Schlom More articles by this author Piyush Agarwal More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

This article aimed to assess the burden of scheduling major urologic oncology procedures if all cases were performed robotically and to determine whether this would increase the time a patient would have to wait for surgery. We retrospectively determined the number of prostatectomies, radical nephrectomies, partial nephrectomies, and cystectomies at a single institution for one calendar year. A hypothetical situation was then constructed where all procedures were performed robotically. Using the allotted number of days that each surgeon was able to schedule robotic procedures, we analyzed the amount of time it would take to schedule and complete all cases. Five fellowship-trained surgeons were included in the study and accounted for 317 surgical cases. Three of the surgeons had dedicated robotic surgery (RS) time (block time), while two surgeons scheduled when there was non-dedicated RS time (open time) available. If all cases were performed robotically an additional 32 days would be needed, which could significantly increase the wait time to surgery. The limited number of robotic systems available in most hospitals creates a bottleneck effect; whereby increasing the number of cases would considerably lengthen the waiting time patients have for surgery. As RS becomes increasingly more commonplace in urology and other surgical fields, this could create a significant problem for health care systems.

You have accessJournal of UrologyBladder Cancer: Epidemiology & Evaluation I1 Apr 2017MP04-05 DECLINING USE OF CONTINENT DIVERSIONS FOR BLADDER CANCER Nicholas Farber, Izak Faiena, Viktor Dombrovskiy, Alexandra Tabakin, Brian Shinder, Rutveej Patel, Sammy Elsamra, Thomas Jang, Eric Singer, and Robert Weiss Nicholas FarberNicholas Farber More articles by this author , Izak FaienaIzak Faiena More articles by this author , Viktor DombrovskiyViktor Dombrovskiy More articles by this author , Alexandra TabakinAlexandra Tabakin More articles by this author , Brian ShinderBrian Shinder More articles by this author , Rutveej PatelRutveej Patel More articles by this author , Sammy ElsamraSammy Elsamra More articles by this author , Thomas JangThomas Jang More articles by this author , Eric SingerEric Singer More articles by this author , and Robert WeissRobert Weiss More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.02.143AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Radical cystectomy with urinary diversion is a standard treatment for high-risk non-invasive and muscle-invasive bladder cancer. Continent diversions (CD) may allow better quality of life and body image perceptions over ileal conduits (IC) in selected patients. Our aim is to study contemporary trends in the utilization of ICs and CDs in patients undergoing radical cystectomy. METHODS Using ICD-9 codes, we identified in the National Inpatient Sample (NIS) from 2001-2012 all patients with the principal diagnosis of malignant neoplasm of bladder (188.x, 233.7) who underwent radical cystectomy (57.71) followed by either ileal conduit (56.61) or orthotopic neobladder/continent diversion (57.87). Patient sociodemographics, comorbidities and in-hospital complications, mortality, length of stay (LOS), and total cost after radical cystectomy with IC vs CD were compared. Chi square test and multivariable logistic regression were used to analyze patient and hospital characteristics. Student's t-test and Wilcoxon rank sum test were used to evaluate continuous variables. RESULTS Between 2001-2012, an estimated 69,049 ICs and 6,991 CDs were performed. The total number of CDs increased from 2001 to 2012 (p < 0.0001), but peaked in 2008 and subsequently declined every year thereafter. Patients of all ages received ICs at a higher rate than CDs (Table 1), including younger age groups (40-59 and 60-69). Males and Caucasians were more likely to have CD compared to females (p<0.001) and African Americans (p<0.0001), respectively. The rate of CDs was highest in the West (12.1%, p<0.001), at urban teaching centers (10.85%, p<0.001), and in large hospitals (9.71%, p<0.001). On logistic regression analysis, when accounting for age, gender, comorbidities, and hospital characteristics, ICs were associated with higher rates of overall (OR 1.06, p=0.0185) and infectious (OR 1.13, p=0.002) complications and in-hospital mortality (OR 1.87, p<0.0001). There was no difference in LOS between the two groups. CONCLUSIONS The number of CDs performed has declined since 2008. Patients of all ages, including young patients, are more likely to receive IC than CD. Gender, socioeconomic factors, and geographic location may influence diversion type. CDs are associated with comparable rates of complications and in-hospital mortality. Potential causes for declining incidence of continent diversions may include physician reimbursement, length of surgical time, and higher incidence of robotic surgery. These factors should be the subject for further study. © 2017FiguresReferencesRelatedDetails Volume 197Issue 4SApril 2017Page: e29-e30 Advertisement Copyright & Permissions© 2017MetricsAuthor Information Nicholas Farber More articles by this author Izak Faiena More articles by this author Viktor Dombrovskiy More articles by this author Alexandra Tabakin More articles by this author Brian Shinder More articles by this author Rutveej Patel More articles by this author Sammy Elsamra More articles by this author Thomas Jang More articles by this author Eric Singer More articles by this author Robert Weiss More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

You have accessJournal of UrologyProstate Cancer: Detection & Screening III1 Apr 2017MP33-13 THE DIAGNOSTIC VALUE OF DIGITAL RECTAL EXAMINATION FOR PROSTATE CANCER: AN ANALYSIS OF OVER 20,000 BIOPSIES Lorenzo DiGiorgio, Nitin Patel, Vladislav Bargman, and Robert Weiss Lorenzo DiGiorgioLorenzo DiGiorgio More articles by this author , Nitin PatelNitin Patel More articles by this author , Vladislav BargmanVladislav Bargman More articles by this author , and Robert WeissRobert Weiss More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.02.1009AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES In the United States a majority of prostate cancers are detected by an abnormal prostate specific antigen (PSA) level. In 2012 the U.S. Preventive Services Task Force recommended against the routine use of PSA based screening for prostate cancer, but did not fully address screening via digital rectal exam (DRE). The American Urologic Association recommends “informed decision with a doctor” starting at age 40 with baseline PSA and digital rectal exam. DRE is known to detect some prostate cancers that are missed by PSA screening. The use of DRE is controversial as there is a high inter-observer variability and is subjective in nature. An abnormal DRE is a risk factor for high grade disease. With the USPTF recommendations many primary care physicians are not including digital rectal exam as part of their routine physical diagnosis. We sought to evaluate the clinical relevance of DRE in todays practice. METHODS Based on systematic title literature search of articles including “digital rectal exam” and “prostate cancer” in pubmed, 204 studies could be identified in which the diagnostic value of DRE was studied. Only studies in which an unselected population which used biopsy as the reference standard of presence of disease were included. Biopsy prompts included abnormal DRE, elevated PSA and abnormal transrectal ultrasound. Only studies in which it was possible to calculate the true positive, true negative, false positive and false negative rates were included. Twenty-two articles met the above criteria. Statistical pooling was based on a random effects model. RESULTS Total sample size was 20,434 patients undergoing biopsy. Pooling of the studies revealed a high negative predictive value (.76). A modest sensitivity (.58) and specificity (.58) was observed. The positive predictive value (.38) was low. Heterogeneity between the studies was high. CONCLUSIONS The DRE appears to be a test with a high negative predictive value. When DRE is normal the chance of missing cancer is approximately 24%. When a patient has an abnormal DRE the chance of diagnosing prostate cancer is about 38%. This is higher than the predictive value of an elevated PSA between 4-10ng/dl. With that in mind and the fact that DRE exerts little or no cost to the system, this study suggests that DRE still has utility in patient care when evaluating for their risk for prostate cancer. © 2017FiguresReferencesRelatedDetails Volume 197Issue 4SApril 2017Page: e422 Advertisement Copyright & Permissions© 2017MetricsAuthor Information Lorenzo DiGiorgio More articles by this author Nitin Patel More articles by this author Vladislav Bargman More articles by this author Robert Weiss More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Purpose: We performed a network meta-analysis of available randomized, controlled trials to elucidate the risks of urinary tract infection associated with transurethral catheterization, suprapubic tubes and intermittent catheterization in the postoperative setting. Materials and Methods: PubMed (R), EMBASE (R) and Google Scholar (TM) searches were performed for eligible randomized, controlled trials from January 1980 to July 2015 that included patients who underwent transurethral catheterization, suprapubic tube placement or intermittent catheterization at the time of surgery and catheterization lasting up to postoperative day 30. The primary outcome of comparison was the urinary tract infection rate via a network meta-analysis with random effects model using the netmeta package in R 3.2 (www.r-project.org/). Results: Included in analysis were 14 randomized, controlled trials in a total of 1,391 patients. Intermittent catheterization and suprapubic tubes showed no evidence of decreased urinary tract infection rates compared to transurethral catheterization. Suprapubic tubes and intermittent catheterization had comparable urinary tract infection rates (OR 0.903, 95% CI 0.479-2.555). On subgroup analysis of 10 randomized, controlled trials with available mean catheterization duration data in a total of 928 patients intermittent catheterization and suprapubic tube were associated with significantly decreased risk of urinary tract infection compared to transurethral catheterization when catheterization duration was greater than 5 days (OR 0.173, 95% CI 0.073-0.412 and OR 0.142, 95% CI 0.073-0.276, respectively). Conclusions: Transurethral catheterization is not associated with an increased urinary tract infection risk compared to suprapubic tubes and intermittent catheterization if catheterization duration is 5 days or less. However, a suprapubic tube or intermittent catheterization is associated with a lower rate of urinary tract infection if longer term catheterization is expected in the postoperative period.

BACKGROUND:We evaluated the complications, mortality, hospital length of stay (LOS), and cost for patients with diabetes undergoing radical cystectomy (RC). MATERIALS AND METHODS:Data were extracted from the National (Nationwide) Inpatient Sample for 2001 to 2012 using the "International Classification of Diseases, Ninth Revision, Clinical Modification" codes for patients with uncontrolled diabetes (UD) (patients with diabetes receiving treatment that did not keep the blood glucose at acceptable levels) and controlled diabetes (CD) (patients with diabetes not otherwise stated as uncontrolled) who had undergone RC. χ2 and Wilcoxon rank sum tests and multivariable regression analysis were used for statistics. The LOS and cost are presented as the median and interquartile range. RESULTS:In the present study, 989 patients had UD, 15,693 CD, and 73,603 had no diabetes (ND). Postoperative complications were significantly more common in the UD group (73%) than in the CD (51%) and ND (52%) groups (P < .0001). On multivariable analysis, the UD group were more likely than the CD group to have any complication (odds ratio [OR], 2.3; 95% confidence interval [CI], 2.0-2.7), including renal (OR, 2.1; 95% CI, 1.8-2.4) and infectious (OR, 2.7; 95% CI, 2.3-3.1) complications. Patients with UD were also 4.3 times (95% CI, 3.1-5.8) more likely to die after surgery than were patients with CD. The ND group was slightly more likely than the CD group to experience any complication (OR, 1.13; 95% CI, 1.09-1.17) and death (OR, 1.6; 95% CI, 1.4-1.8). The LOS and cost for UD patients were greater than for CD patients. On multivariable analysis, UD patients had a 30% increase in LOS and 23% increase in cost (P < .0001). CONCLUSION:The findings from the present study have demonstrated an increase in post-RC complications rates, hospital mortality, and hospital resource usage for patients with UD undergoing RC. UD might be a modifiable preoperative risk factor for post-RC morbidity and mortality. Further studies are needed to validate this association.