Oncolytic adenoviral therapy plus pembrolizumab in BCG-unresponsive non-muscle-invasive bladder cancer: the phase 2 CORE-001 trial.

Cretostimogene grenadenorepvec is a serotype-5 oncolytic adenovirus designed to selectively replicate in cancer cells with retinoblastoma pathway alterations, previously tested as monotherapy in bacillus Calmette-Guérin (BCG)-experienced non-muscle-invasive bladder cancer. In this phase 2 study, we assessed the potential synergistic efficacy between intravesical cretostimogene and systemic pembrolizumab in patients with BCG-unresponsive non-muscle-invasive bladder cancer with carcinoma in situ (CIS). Thirty-five patients were treated with intravesical cretostimogene with systemic pembrolizumab. Induction cretostimogene was administered weekly for 6 weeks followed by three weekly maintenance infusions at months 3, 6, 9, 12 and 18 in patients maintaining complete response (CR). Patients with persistent CIS/high-grade Ta at the 3-month assessment were eligible for re-induction. Pembrolizumab was administered for up to 24 months. The primary endpoint was CR at 12 months as assessed by cystoscopy, urine cytology, cross-sectional imaging and mandatory bladder mapping biopsies. Secondary endpoints included CR at any time, duration of response, progression-free survival and safety. The CR rate in the intention-to-treat population at 12 months was 57.1% (20 out of 35, 95% confidence interval (CI) 40.7-73.5%), meeting the primary endpoint. A total of 29 out of 35 patients (82.9%, 95% CI 70.4-95.3%) derived a CR at 3 months. With a median follow-up of 26.5 months, the median duration of response has not been reached (95% CI 15.7 to not reached). The CR rate at 24 months was 51.4% (18 out of 35) (95% CI 34.9-68.0%). No patient progressed to muscle-invasive bladder cancer in this trial. Adverse events attributed to cretostimogene were low grade, self-limiting and predominantly limited to bladder-related symptoms. A total of 5 out of 35 patients (14.3%) developed grade 3 treatment-related adverse effects. There was no evidence of overlapping or synergistic toxicities. Combination intravesical cretostimogene and systemic pembrolizumab demonstrated enduring efficacy. With a toxicity profile similar to its monotherapy components, this combination may shift the benefit-to-risk ratio for patients with BCG-unresponsive CIS. ClinicalTrials.gov Identifier: NCT04387461 .

Renal Schwannoma: A Rare Case Report and Literature Review.

Schwannomas originating in the kidney are extremely rare with very few cases documented in the literature. It is difficult to distinguish them from other common renal masses based on clinical symptoms and imaging characteristics alone, as both are non-specific for this pathology. Thus, the final diagnosis of schwannoma is typically made only after surgical resection and histologic examination. We present the case of a 66-year-old female who was initially evaluated for flank pain and referred to us after a renal mass was found on CT imaging. A partial nephrectomy was performed, and subsequent pathological examination confirmed the diagnosis of renal schwannoma.

Urologic Manifestations and Hydronephrosis as Initial Presentation of Erdheim-Chester Disease: A Rare Form of Non-Langerhans Histiocytosis.

Erdheim-Chester disease (ECD) is a rare non-Langerhans histiocytosis that is classified as a malignancy of myeloid progenitor cells, with only 1,000 confirmed cases in the literature so far. It often manifests as a multi-system disorder with an initial presentation predominantly in the long bones, central nervous system (CNS), and retroperitoneal space, sometimes causing urologic symptoms as a result. ECD often presents indolently and in a spectrum of different ways, making it challenging to identify and treat. We report a case of a 63-year-old female with ECD that first presented with abdominal pain and acute renal injury due to ECD-related retroperitoneal fibrosis. We also explore the literature at large around ECD, its diagnosis, pathophysiology, and advances in treatments.

National Practice Patterns and Overall Survival After Adjuvant Radiotherapy Following Radical Cystectomy for Urothelial Bladder Cancer in the USA, 2004-2013.

BACKGROUND: Adjuvant radiation therapy (ART) after radical cystectomy (RC) for urothelial bladder cancer (UBC) may play a role in the management of muscle-invasive BC, particularly in patients with locally advanced disease and adverse pathologic features (pT3/4 or positive surgical margins [PSMs]). Evidence regarding the effect of ART on overall survival (OS) is lacking. OBJECTIVE: To evaluate national practice patterns for the use of ART and assess its impact on OS for patients with adverse pathologic features (APF) after RC. DESIGN, SETTING, AND PARTICIPANTS: Using the National Cancer Data Base, we analyzed all UBC cases with APF after RC from 2004 to 2013. Patients were divided into ART and no-ART groups. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Relationships with oncological outcomes were analyzed using multivariable Cox regression and log-rank analyses. RESULTS AND LIMITATIONS: Use of ART decreased during the study period from 3.1% in 2004 to 1.7% in 2013 (p=0.03). ART was administered in 1.4%, 4.0% and 5.2% of patients with pT3 UBC, pT4 UBC, and PSMs (any pT stage), respectively. The rate of ART was significantly higher among younger ages, female sex, low-volume hospitals, nonacademic community care centers, higher stages, PSMs, perioperative chemotherapy, and lymph node-positive disease. Predictors of ART receipt were PSMs (odds ratio [OR] 3.4; p<0.0001), pT4 (OR 2.6; p=0.02), community based centers (OR 2.1; p<0.0001), and female sex (OR 1.8; p<0.0001). Risk factors for worse OS included age, higher tumor stage and comorbidities, PSMs, positive nodes, and suboptimal lymph node dissection (<10 nodes removed; all p<0.001). ART was not independently associated with better OS in the full cohort (p=0.54). However, subgroup analyses suggested an OS benefit for patients with PSMs (hazard ratio 0.73; p=0.047). Limitations include the retrospective design and limited details regarding cancer-specific survival. CONCLUSIONS: Use of ART for APF following RC is not common in the USA and the rate of ART has been decreasing over time. ART may have an OS benefit after RC for patients with PSMs. PATIENT SUMMARY: In this report we looked at the outcomes for patients with locally advanced bladder cancer receiving adjuvant radiation therapy following cystectomy in a large US population. We found that adding radiation therapy after removing the bladder cancer may have some survival benefits for patients with positive surgical margins.

Assessing the Impact of Time to Cystectomy for Variant Histology of Urothelial Bladder Cancer.

OBJECTIVE: To determine if the timing of radical cystectomy for variant histology of urothelial carcinoma has an impact on survival. Variant histology has been associated with aberrant behavior compared to pure urothelial carcinoma, however the timing of surgery for these patients has not been studied. MATERIALS AND METHODS: We identified 363 patients with cT2-T4N0M0 urothelial carcinoma who underwent radical cystectomy without perioperative intravesical and/or systemic therapy from 2003 to 2014. Clinicopathologic data were compared between pure urothelial carcinoma and variant histology. The time from diagnosis to radical cystectomy was analyzed as a continuous variable and dichotomized at 4-, 8-, and 12-weeks to determine impact on oncologic outcomes. RESULTS: Patients with variant histology, when compared to those with pure urothelial carcinoma, were more likely to present with extravesical disease (P <.01), be upstaged (P <.01), have lymphovascular invasion (P <.01) and have lymph node metastasis at radical cystectomy (P = .02). The median days to radical cystectomy did not differ between pure urothelial and variant histology. On multivariable analysis controlling for age, comorbidities, tumor stage, lymph node status, lymphovascular invasion, and surgical margins, every month in delay was associated with a worse overall survival for variants (HR = 1.36, P = .003). At an 8-week delay or longer, those with variant histology had a statistically worse survival (P = .03). CONCLUSION: For patients with variant histology, delays in surgery were associated with an increased risk of death.

Assessing trends in urinary diversion after radical cystectomy for bladder cancer in the United States.

OBJECTIVES: We assessed recent trends in both urinary diversion after radical cystectomy for bladder cancer in the United States and patient- and hospital-related characteristics. We also identified variables associated with undergoing continent diversion. MATERIALS AND METHODS: We queried the National Cancer Database and identified 27,170 patients who underwent radical cystectomy with urinary diversion from 2004 to 2013. Patient demographics, socioeconomic variables, and hospital-related factors were compared between incontinent and continent diversion and trended over time. Multivariable logistic regression was used to identify variables associated with undergoing continent diversion. RESULTS: Overall, 23,224 (85.5%) and 3,946 (14.5%) patients underwent incontinent and continent diversion, respectively. Continent diversion declined from 17.2% in 2004 to 2006 to 12.1% in 2010 to 2013 (P < 0.01). When analyzing high-volume facilities, those performing ≥75% minimally invasive radical cystectomy had fewer continent diversions (10.2%) compared to centers with higher rate of open approach (19.7%), P < 0.01. Higher income, facility located in the West, academic programs, high-volume facilities, and patients traveling >60 miles for care were significantly associated with undergoing continent diversion. Rate of continent diversion has declined in most patient- and hospital-related subgroups. Compared to 2004 to 2006, patients in 2010 to 2013 were more likely to be older, have more comorbidities, and be operated on at a high-volume academic facility. CONCLUSION: The rate of continent diversion has declined to 12.1% in the United States. Hospital volume and type, patient income, distance traveled for care, and geography are significantly associated with undergoing continent diversion. Even among high-volume and academic centers, the rate of continent diversion is declining.

Indications, evolving technique, and early outcomes with robotic retroperitoneal lymph node dissection.

PURPOSE OF REVIEW: Examine and discuss indications, technique, and outcomes for robotic retroperitoneal lymph node dissection (RPLND) for testicular cancer. RECENT FINDINGS: Open RPLND has been the longstanding standard of care for both primary and post chemotherapy RPLND. Recently, robotic RPLND has been an attractive option with the intent of reducing the morbidity associated with open surgery while providing identical oncologic efficacy. Naysayers of robotic RPLND suggest it is often inappropriately used as a staging procedure and consequently can compromise oncologic efficacy. SUMMARY: Robotic RPLND is being evaluated as a therapeutic equivalent to open RPLND. On the basis of limited published data with modest follow-up from experienced centers, robotic RPLND appears to provide effective staging and therapeutic data mirroring that of open surgery.

Perioperative and long-term outcomes after radical cystectomy in hemodialysis patients.

PURPOSE: Patients on hemodialysis have an increased risk of developing advanced stage bladder cancer. They also have a significant risk of noncancer-related mortality. Radical cystectomy (RC) is the standard of care for nonmetastatic muscle-invasive bladder cancer, however little is known regarding outcomes in this population. MATERIALS AND METHODS: The United States Renal Disease System database was used to identify all patients on hemodialysis who underwent RC for bladder cancer in the United States between 1984 and 2013. A total of 985 patients were identified for analysis. Perioperative outcomes were evaluated. Competing risks analysis was used to estimate overall and cancer-specific mortality along with factors associated with death. RESULTS: Median hospital length of stay was 10 days and 43.1% of patients experienced a complication. Mortality within 30 days was 9.3%. Overall mortality at 1, 3, and 5 years was 51.7%, 77.3%, and 87.9%, respectively. Cancer-specific mortality at 1, 3, and 5 years was 12.3%, 18.4%, and 19.7%, respectively. Age, diabetes, and cerebrovascular disease were independently associated with overall mortality, while performance of urinary diversion was associated with a protective effect. Active smoking was the sole risk factor for cancer-specific mortality. CONCLUSIONS: RC in dialysis patients is associated with significant morbidity and mortality, with less than 15% overall survival at 5 years. Older patients, and those with a history of diabetes or cerebrovascular disease, are at an increased risk of mortality.

Continent Cutaneous Diversion.

Techniques in continent cutaneous urinary diversion (CCUD) have evolved significantly over the last 30 years resulting in several well-established procedures. CCUD is well suited for patients in whom the urethra cannot be used for orthotopic diversion due to preexisting incontinence, radiation damage, or malignancy. Reservoirs are constructed with adherence to basic principles of continent urinary diversion, including the use of detubularized bowel in a spherical conformation for pouch creation with either ileum or the right colon. The article reviews the history, patient selection, preoperative evaluation, surgical technique, and outcomes of CCUD.

Incidence, Risk Factors, and Outcomes for Rectal Injury During Radical Prostatectomy: A Population-based Study.

BACKGROUND: Rectal injury (RI) is a rare but potentially serious complication of radical prostatectomy (RP). Current evidence is limited owing to relatively small cohorts from select, tertiary referral centers. OBJECTIVE: To evaluate the incidence of and potential risk factors for RI during radical RP at a population level in the USA. DESIGN, SETTINGS, AND PARTICIPANTS: Using the National Inpatient Sample database (2003-2012), we identified patients with prostate cancer who underwent RP. Survey-weighted cohorts were created based on the diagnosis and repair of RI during initial hospitalization. Data included demographics, hospital characteristics, surgical details, complications, and perioperative outcomes. Multivariable logistic regression was used to identify risk factors for RI. RESULTS AND LIMITATIONS: Of 614 294 men who underwent RP, there were 2900 (0.5%) RIs, with a 26% decline from 2003-2006 to 2009-2012 (p<0.01). Patients with RI were slightly older (62.0 vs 61.2 yr; p<0.01) and more commonly of African ancestry (0.8% vs 0.4% Caucasians; p<0.01). RI was more common among patients with benign prostatic hyperplasia (BPH), metastatic disease, and low body mass index (BMI; p<0.05). The RI incidence was higher for open (0.6%) compared to laparoscopic (0.4%) and robotic RP (0.2%; p<0.01). RI was more common at rural (0.8% vs 0.5% urban), nonteaching (0.6% vs 0.4% teaching), and low-volume hospitals (0.6% vs 0.3% high-volume; p<0.01). Complication rates (28% vs 11%; p<0.01) and length of stay (4.8 vs 2.3 d; p<0.01) were greater in the RI group. Multivariable analysis identified African ancestry, BPH, and metastatic cancer as predictors of RI, while robotic approach, high-volume hospital, and obesity reduced the risk (p<0.05). CONCLUSIONS: RI during RP is a rare complication, but is more common among men with African ancestry and for procedures carried out using an open surgical technique or in low-volume hospitals, and among those with low BMI, BPH, or metastatic disease. PATIENT SUMMARY: In a large US population, we found that rectal injury (RI) is a rare complication of radical prostatectomy, and that the risk of RI can increase according to patient- and hospital-specific characteristics.

Impact of Perioperative Infection on Cancer Specific Survival after Nephrectomy for Renal Cell Carcinoma.

PURPOSE: Several case reports have documented rare spontaneous cancer regression following systemic infections. Immune related targeted therapies are now available for many cancers, including renal cell carcinoma. We hypothesized that perioperative infection after nephrectomy for renal cell carcinoma may impact long-term cancer specific survival. MATERIALS AND METHODS: We performed a retrospective cohort study using SEER (Surveillance, Epidemiology and End Results)-Medicare claims data from 2004 to 2011. ICD-9 and CPT codes were used to identify patients older than 65 years who underwent radical or partial nephrectomy for renal cell carcinoma. Patients hospitalized for infection within 30 days of surgery were identified. Study exclusion criteria included death within 90 days of surgery, immunodeficiency and metastatic disease at diagnosis. Kaplan-Meier curves were used to evaluate cancer specific survival between infection vs no infection groups. A Cox proportional hazards model was created to assess survival while controlling for age, gender, race, Elixhauser index, tumor grade, tumor size, histological subtype, AJCC (American Joint Committee on Cancer) stage, systemic therapy and geographic region. RESULTS: Of 8,967 patients 493 (5.5%) were hospitalized for infection after nephrectomy. Median age was 74 years (IQR 69-79), the mean ± SD Elixhauser index was 4.9 ± 7.4 and median followup was 42 months (IQR 22-67). Following nephrectomy univariable Cox regression showed a nonsignificant improvement in cancer specific survival in patients with a serious infection requiring hospitalization (HR 0.84, 95% CI 0.69-1.00, p = 0.054). Cox multivariable regression revealed significant improvement in cancer specific survival for the same population (HR 0.75, 95% CI 0.57-0.99, p = 0.04). This effect was primarily due to patients with larger (7 cm or greater) tumors (HR 0.67, 95% CI 0.44-0.99, p = 0.049). No impact was observed among patients with smaller (less than 7 cm) tumors (HR 0.82, 95% CI 0.57-1.19, p = 0.3). CONCLUSIONS: In patients with T2 (7 cm or greater) renal cell carcinoma who undergo nephrectomy perioperative infection may improve cancer specific survival.

Safety and Early Oncologic Effectiveness of Primary Robotic Retroperitoneal Lymph Node Dissection for Nonseminomatous Germ Cell Testicular Cancer.

BACKGROUND: Primary robot-assisted retroperitoneal lymph node dissection (R-RPLND) has been studied as an alternative to open RPLND in single-institution series for patients with low-stage nonseminomatous germ cell tumors (NSGCT). OBJECTIVE: To evaluate a multicenter series of primary R-RPLND for low-stage NSGCT. DESIGN, SETTING, AND PARTICIPANTS: Between 2011 and 2015, 47 patients underwent primary R-RPLND at four centers for Clinical Stage (CS) I-IIA NSGCT. SURGICAL PROCEDURE: R-RPLND was performed using the da Vinci surgical system (Intuitive Surgical Inc., Sunnyvale, CA, USA). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Data were collected regarding patient demographics, primary tumor characteristics, pathologic findings, and clinical outcomes. RESULTS AND LIMITATIONS: Forty-two patients (89%) were CS I and five (11%) were CS IIA. The median operative time was 235min (interquartile range [IQR]: 214-258min), estimated blood loss was 50ml (IQR: 50-100ml), node count was 26 (IQR: 18-32), and length of stay was 1 d. There were two intraoperative complications (4%), four early postoperative complications (9%), no late complications, and the rate of antegrade ejaculation was 100%. Of the eight patients (17%) with positive nodes (seven pN1and one pN2), five (62%) received adjuvant chemotherapy. The one recurrence was out of template in the pelvis after adjuvant chemotherapy (resected teratoma). The median follow-up was 16 mo and the 2-yr recurrence-free survival rate was 97% (95% confidence interval: 82-100%). Limitations include retrospective design and limited follow-up. CONCLUSIONS: Our multicenter experience supports R-RPLND as a potential option at experienced centers in select patients with low-stage NSGCT. Informal comparison to open and laparoscopic series suggests R-RPLND has an acceptably low morbidity profile, but oncologic efficacy evaluation requires further evaluation. PATIENT SUMMARY: We examined outcomes after robot-assisted retroperitoneal lymph node dissection for patients with low-stage nonseminomatous testicular cancer with our data suggesting the robotic approach has acceptable morbidity and early oncologic outcomes.

Extended Duration Enoxaparin Decreases the Rate of Venous Thromboembolic Events after Radical Cystectomy Compared to Inpatient Only Subcutaneous Heparin.

PURPOSE: Venous thromboembolic events are a significant source of morbidity after radical cystectomy. At our institution subcutaneous heparin was historically given to patients undergoing radical cystectomy immediately before incision and throughout the inpatient stay. In an effort to decrease the overall rate of venous thromboembolism and post-discharge venous thromboembolism, a regimen including extended duration enoxaparin was initiated for patients undergoing radical cystectomy. MATERIALS AND METHODS: In January 2013 thromboprophylaxis was modified for patients undergoing radical cystectomy by replacing a regimen of subcutaneous heparin before induction and then every 8 hours until discharge home with enoxaparin daily for postoperative prophylaxis continued until 28 days after discharge. Data from our institutional radical cystectomy database for patients undergoing surgery from January 2011 to May 2014 were reviewed. The primary outcome was clinically symptomatic postoperative venous thromboembolism. Secondary outcomes included timing of venous thromboembolism and blood transfusions. Multivariate logistic regression was used to control for differences between cohorts. RESULTS: Of the 402 patients 234 underwent radical cystectomy before the change and 168 after. The enoxaparin regimen decreased the rate of venous thromboembolism (12% vs 5%, p=0.024) with the main benefit on post-discharge venous thromboembolism (6% vs 2%, p=0.039). Overall 17 of 37 (46%) venous thromboembolisms occurred after discharge home. Multivariate analysis confirmed that the enoxaparin regimen was independently associated with reduced odds of venous thromboembolism (OR 0.33, 95% CI 0.14-0.76, p=0.009). Intraoperative and postoperative transfusion rates were similar between cohorts. CONCLUSIONS: Thromboprophylaxis with extended duration enoxaparin decreased the rate of venous thromboembolism after radical cystectomy compared to inpatient only subcutaneous heparin with no increased risk of bleeding.

Adherence to National Comprehensive Cancer Network® Guidelines for Testicular Cancer.

PURPOSE: Testicular cancer is the most common malignancy among young men and well established treatment guidelines exist to optimize outcomes. We characterized errors in the management of testicular cancer observed among patients seen at 3 referral centers in the United States. MATERIALS AND METHODS: We retrospectively reviewed data from 593 patients presenting with testicular cancer to 3 academic medical centers from 2007 to 2016. Nonguideline directed care was defined as management differing from National Comprehensive Care Network guideline recommendations. Cases of nonguideline directed care were systematically described. Patient and tumor characteristics were compared between guideline directed care and nonguideline directed care. Multivariable logistic regression was used to identify predictors of nonguideline directed care, and Cox regression modeling was used to assess the association between nonguideline directed care and relapse-free survival. RESULTS: Nonguideline directed care was identified in 177 of 593 (30%) patients. Inappropriate imaging (44%) and overtreatment (40%) were the most common classifications. Misdiagnosis (24%) and under treatment (16%) occurred relatively frequently, while inappropriate treatment (6%) was rare. Multivariable Cox regression modeling controlling for race, tumor stage and tumor histology identified nonguideline directed care as a significant predictor of relapse (HR 2.49, 95% CI 1.61-3.85, p <0.01). CONCLUSIONS: Nonguideline directed care of patients with testicular cancer is common, most frequently in the form of inappropriate imaging and overtreatment. Nonguideline directed care leads to delayed definitive therapy, unnecessary morbidity and higher rates of relapse.

Management trends for men with early-stage nonseminomatous germ cell tumors of the testicle: An analysis of the National Cancer Database.

BACKGROUND: Surveillance has been recommended more frequently as a postorchiectomy management option for men with early stage nonseminomatous germ cell tumor (NSGCT) of the testicle. It is unknown how contemporary treatment patterns reflect these recommendations. METHODS: Data from the National Cancer Database were extracted on all men who were diagnosed with clinical stage (CS) IA or CSIB NSGCT between 2004 and 2013. Temporal trends in the use of chemotherapy, retroperitoneal lymph node dissection (RPLND), and surveillance were measured; and multivariable logistic regression was used to analyze the association of patient and clinical covariates with use of surveillance. RESULTS: Of the 4080 men with CSIA NSGCT, 70%, 17%, and 13% received surveillance, RPLND, and chemotherapy, respectively. Surveillance increased in this group from 65% (2004-2005) to 74% (2012-2013: adjusted odds ratio, 1.50; 95% confidence interval, 1.14-1.98; P = .004). Of the 2580 men who had CSIB NSGCT, 46%, 20%, and 34% received surveillance, RPLND, and chemotherapy, respectively. In this group, 48% of men underwent surveillance in the years 2004 to 2005 and 2012 to 2013 (adjusted P = .8). Upon multivariable analyses, higher income and the oldest age quartile were associated with increased odds of surveillance among men with CSIA NSGCT (both P < .050). Hispanic men with CSIB NSGCT were more likely to receive surveillance compared with non-Hispanic white men (P = .001). CONCLUSIONS: Nearly 75% of men with CSIA NSGCT and nearly 50% of men with CSIB NSGCT received surveillance in 2012 and 2013. The likelihood of receiving surveillance increased from 2004 through 2013 for men with CSIA NSGCT but was unchanged for men with CSIB. Cancer 2017;123:245-252. © 2016 American Cancer Society.

Redefining the implications of nasogastric tube placement following radical cystectomy in the alvimopan era.

PURPOSE: Alvimopan has decreased ileus and need for nasogastric tube (NGT) after radical cystectomy (RC). However, the natural history of ileus versus intestinal obstruction in patients receiving alvimopan is not well defined. We sought to examine the implications of NGT placement before and after the introduction of alvimopan for RC patients. METHODS: Retrospective review identified 278 and 293 consecutive patients who underwent RC before and after instituting alvimopan between June 2009 and May 2014. Baseline characteristics and postoperative outcomes were compared by alvimopan status. Multivariate logistic regression was performed to assess the impact of alvimopan on rates of NGT placement and reoperation for bowel complications. RESULTS: The cohorts had similar age, stage, approach, and BMI. Patients receiving alvimopan had decreased ileus (16 vs 32 %, p < 0.01) but similar rates of reoperation for bowel complications (2.8 vs 2.7 %). On multivariate analysis, alvimopan was associated with lower risk of NGT placement (OR 0.30, p < 0.01). For patients requiring NGT placement, there was an increased rate of reoperation among patients receiving alvimopan compared with those who did not (28 vs 11 %, p = 0.03). Patients receiving alvimopan who needed NGT had significantly increased median length of stay (22 vs 7 days), need for TPN (66 vs 5.3 %), and readmission for ileus (10.3 vs 2.3 %) compared with those who did not require NGT. CONCLUSIONS: Alvimopan significantly reduced the incidence of ileus and NGT placement following RC. NGT placement was associated with an increased need for reoperation for bowel complications in the setting of alvimopan.

Outcomes following Thulium vapoenucleation of large prostates.

INTRODUCTION: Thulium laser VapoEnucleation of the prostate (ThuVEP) is an evolving surgical technique for BPH. Most studies have focused on outcomes in small to médium sized prostates and have originated from Europe and Asia. We sought to describe our experience with ThuVEP for very large prostates in a North American cohort. MATERIALS AND METHODS: From December 2010 to October 2014, 25 men underwent Thu-VEP using the CyberTM® (Quantastem, Italy) thulium laser, all with prostate volume >75mL. Data collected included patient demographics, comorbidities, intraoperative parameters, complications, and post-operative outcomes including maximum flow rate (Qmax), post-void residual (PVR), International Prostate Symptom Score (IPSS), and quality of life score (QoL) in one year of follow-up. Statistical analysis was done using Wilcoxon signed-rank test. RESULTS: At baseline, mean age was 70±9 years and prostate size was 163±62g. Most patients (84%) were in retention and 10 (40%) patients were on anticoagulation. Seven (28%) patients went home the day of surgery (mean hospital stay: 1.2±1.2d). There were 2 intraoperative complications (8%), both cystotomies related to morcellation. Nine patients (36%) experienced a complication, all within 30 days. There were no Clavien III complications. Significant improvements were seen in Qmax, PVR, IPSS, and QoL score at each time interval to 12-months following surgery (all p<0.05). Of 21 patients initially in retention, all were voiding at last follow-up. CONCLUSIONS: Our findings suggest that ThuVEP is an effective treatment for BPH in patients with large prostates with sustained results for one year.

Outcomes following Thulium vapoenucleation of large prostates

ABSTRACT Introduction: Thulium laser VapoEnucleation of the prostate (ThuVEP) is an evolving surgical technique for BPH. Most studies have focused on outcomes in small to medium sized prostates and have originated from Europe and Asia. We sought to describe our experience with ThuVEP for very large prostates in a North American cohort. Materials and Methods: From December 2010 to October 2014, 25 men underwent ThuVEP using the CyberTM® (Quantastem, Italy) thulium laser, all with prostate volume >75mL. Data collected included patient demographics, comorbidities, intraoperative parameters, complications, and post-operative outcomes including maximum flow rate (Qmax), post-void residual (PVR), International Prostate Symptom Score (IPSS), and quality of life score (QoL) in one year of follow-up. Statistical analysis was done using Wilcoxon signed-rank test. Results: At baseline, mean age was 70±9 years and prostate size was 163±62g. Most patients (84%) were in retention and 10 (40%) patients were on anticoagulation. Seven (28%) patients went home the day of surgery (mean hospital stay: 1.2±1.2d). There were 2 intraoperative complications (8%), both cystotomies related to morcellation. Nine patients (36%) experienced a complication, all within 30 days. There were no Clavien ≥III complications. Significant improvements were seen in Qmax, PVR, IPSS, and QoL score at each time interval to 12-months following surgery (all p<0.05). Of 21 patients initially in retention, all were voiding at last follow-up. Conclusions: Our findings suggest that ThuVEP is an effective treatment for BPH in patients with large prostates with sustained results for one year.