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Objective The objective of this study was to examine the risk of immune-related adverse events (irAEs) in patients with a preexisting autoimmune disease (pAID) presenting with a cutaneous melanoma receiving an immune checkpoint inhibitor (ICI) therapy. Methods Data from the Surveillance, Epidemiology, and End Results cancer registries and linked Medicare claims between January 2010 and December 2015 was used to identify patients diagnosed with cutaneous melanoma who had pAID or received ICI or both. Patients were then stratified into 3 groups: ICI+pAID, non-ICI+pAID, and ICI+non-pAID. Inverse probability of treatment weighted Cox proportional hazards regression models were fitted to assess the risk of cardiac, pulmonary, endocrine, and neurological irAE. Results In total, 3704 individuals were included in the analysis. The majority of patients consisted of non-ICI+pAID patients (N=2706/73.1%), while 106 (2.9%) patients and 892 (24.1%) were classified as ICI+pAID and ICI+non-pAID, respectively. The risk of irAE was higher in the ICI+pAID group compared with the non-ICI+pAID and ICI+non-pAID, respectively (non-ICI: cardiac: hazard ratio [HR]=3.59, 95% confidence interval [CI]: 2.83-4.55; pulmonary: HR=3.94, 95% CI: 3.23-4.81; endocrine: HR=1.72, 95% CI: 1.53-1.93; neurological: HR=3.88, 95% CI: 2.30-6.57/non-pAID: cardiac: HR=3.83, 95% CI: 3.39-4.32; pulmonary: HR=2.08, 95% CI: 1.87-2.32; endocrine: HR=1.23, 95% CI: 1.14-1.32; neurological: HR=3.77, 95% CI: 2.75-5.18). Conclusions Patients with a pAID face a significantly higher risk of irAEs. Further research examining the clinical impact of these events on the patients' oncological outcome and quality of life is urgently needed given our findings of significantly worse rates of adverse events.

Introduction:Accountable care organizations are designed to financially incentivize efficiency and reduce low value care. To determine if accountable care organizations have impacted prosta...

INTRODUCTION AND OBJECTIVE:Herein we describe our experience in development of a mobile health app to address metabolic and cognitive effects for men treated with androgen deprivation therapy (ADT)...

Introduction Given the ongoing controversies regarding its benefit, prostate specific antigen based prostate cancer screening should be offered with patient preferences in mind. Understanding subsets of men who may or may not choose prostate specific antigen screening and their associated characteristics may allow more efficient care and may identify subsets of patients for whom additional counseling is warranted. Methods We analyzed male participants from the 2001 to 2010 cycles of the NHANES (National Health and Nutrition Examination Survey) who were 40 years old or older, and without a history of prostate cancer, recent prostate manipulation or hormone therapy use (8,133). All men were given an opportunity to undergo or refuse prostate specific antigen testing after a standardized explanation about prostate cancer screening from a physician. Univariable and multivariable logistic regressions were conducted after adjusting for survey weights to identify independent sociodemographic and clinical predictors for opting out of prostate specific antigen testing. Results A total of 7,732 men met the inclusion criteria. Overall 95.64% of the study cohort elected to undergo prostate specific antigen testing. The odds of declining prostate specific antigen testing were significantly higher in men 80 years old or older (OR 1.78, p=0.008), black men (OR 3.23, p Conclusions In the setting of the NHANES program, between 2001 and 2010 the majority of men who were offered prostate cancer screening underwent prostate specific antigen testing. Black men, a subgroup subject to more aggressive prostate cancer, were more likely to refuse prostate specific antigen testing.

Introduction Monopolar transurethral resection is the conventional surgical standard of care for bladder outlet obstruction due to benign prostatic enlargement. Bipolar resection and GreenLight™ photovaporization have emerged as options with favorable safety profiles. The literature comparing these modalities is limited by sample size and absence of cost data. We compared costs and short-term safety of monopolar, bipolar and laser vaporization techniques in an all-payer inpatient discharge database. Methods A total of 20,323 men 40 to 80 years old with a diagnosis of benign prostatic hyperplasia who underwent an outlet procedure between 2003 and 2013 were identified in the Premier Research Database. Using propensity weighted logistic regression we assessed treatment trends and perioperative safety outcomes. Results Monopolar resection remained the most commonly performed procedure between 2003 and 2013. However, its use decreased by 20% (p 0.99), length of stay (p=0.82) and 90-day complication rates (p=0.34), GreenLight photovaporization was associated with prolonged operative time (+12 minutes, 95% CI 10.25 to 13.75, p Conclusions We found a modest perioperative safety benefit with bipolar resection and GreenLight photovaporization relative to monopolar resection. However, both procedures were associated with higher costs.

Androgen deprivation therapy is associated with the development of diabetes and metabolic syndrome. To our knowledge its effect on the development of nonalcoholic fatty liver disease, a condition which frequently co-occurs with metabolic syndrome and other subsequent liver conditions such as liver cirrhosis, hepatic necrosis or any liver disease, has not been investigated.We identified 82,938 men 66 years old or older who were diagnosed with localized prostate cancer in the SEER (Surveillance, Epidemiology and End Results)-Medicare database from 1992 to 2009. Men with preexisting nonalcoholic fatty liver disease, liver disease, diabetes or metabolic syndrome were excluded from study. Propensity score adjusted, competing risk regression models were created to compare the risk of nonalcoholic fatty liver disease in men who were vs were not treated with androgen deprivation. We also explored the influence of cumulative exposure to androgen deprivation therapy, calculated as monthly equivalent doses of gonadotropin-releasing hormone agonists/antagonists (fewer than 7, 7 to 11 or more than 11 doses).Overall 37.5% of men underwent androgen deprivation therapy. They were more likely to be diagnosed with nonalcoholic fatty liver disease (HR 1.54, 95% CI 1.40-1.68), liver cirrhosis (HR 1.35, 95% CI 1.12-1.60), liver necrosis (HR 1.41, 95% CI 1.15-1.72) and any liver disease (HR 1.47, 95% CI 1.35-1.60). A dose-response relationship was observed between the number of androgen deprivation therapy doses, and nonalcoholic fatty liver disease and any liver disease.Androgen deprivation therapy in men with prostate cancer is associated with the diagnosis of nonalcoholic fatty liver disease. The usual limitations of an observational study design apply, including possible inaccuracy in defining outcomes in a population based registry.

Use of androgen deprivation therapy may increase the risk of cognitive impairment in men with prostate cancer. We performed a systematic review of the risk of overall cognitive impairment as an outcome in men receiving androgen deprivation therapy for prostate cancer.Studies were identified through PubMed®, MEDLINE®, PsycINFO®, Cochrane Library and Web of Knowledge/Science™. Articles were included if they 1) were published in English, 2) had subjects treated for prostate cancer with androgen deprivation therapy, 3) incorporated longitudinal comparisons and 4) used control groups. In addition, prospective studies were required to assess an established cognitive related end point using International Cognition and Cancer Task Force criteria defining impaired cognitive performance as scoring 1.5 or more standard deviations below published norms on 2 or more tests, or scoring 2.0 or more standard deviations below published norms on at least 1 test. The effect of androgen deprivation therapy on cognitive impairment was pooled using a random effects model.Of 221 abstracts 26 were selected for full text review, and 2 prospective and 4 retrospective studies were analyzed. Androgen deprivation therapy was not associated with overall cognitive impairment when the prospective cohort studies were pooled (OR 1.57, 95% CI 0.50 to 4.92, p = 0.44) with significant heterogeneity between estimates (IAnalyses between overall cognitive impairment and use of androgen deprivation therapy defined according to International Cognition and Cancer Task Force criteria in a pooled analysis were inconclusive. In retrospective cohort studies the risk of overall cognitive impairment after androgen deprivation therapy was not significant. Better prospective studies need to be designed for the assessment of this end point.

Purpose: Fee for service reimbursement incentives may affect care. We compared the odds of prostate specific antigen screening among former and active duty United States military service members based on receipt of primary care from integrated military health facilities vs community providers reimbursed via fee for service.Materials and Methods: We retrospectively studied the records of all active duty and retired male service members 40 to 64 years old who were covered by the TRICARE® military health benefit in 2010. Beneficiaries may receive primary care at military run facilities via the direct care system or with private physicians via the purchased care system. We compared rates of prostate specific antigen screening between propensity score weighted cohorts of 219,290 men who received primary care in the direct care system and 177,748 who received it in the purchased care system.Results: The screening rate was 35% in the direct care system vs 26% in the purchased care system. After propensity score ...

Introduction Cystectomy is a first line treatment for muscle invasive bladder cancer and a last resort option for several benign bladder conditions. It is currently unknown how the perioperative outcomes of cystectomy for cancer differ from those of cystectomy for benign conditions. Methods Using the National Surgical Quality Improvement Program database we extracted data on cystectomy between 2006 and 2013. Bivariate comparison of baseline characteristics was performed and multivariate logistic regression analyses were conducted to assess the effect of cystectomy indication on 30-day outcomes. Results Overall 3,166 and 248 cystectomies were performed for cancer and benign conditions, respectively. Patients in the noncancer group were younger (median age 62.5 vs 70.0 years), had worse American Society of Anesthesiologists scores (3-4, 81.5% vs 73.8%) and functional health status (19.0% vs 1.6%), and more frequently had preoperative sepsis (3.2% vs 1.1%) and paresis (4.8% vs 0.3%) compared to patients in the cancer group (all values p ≤0.013). On adjusted analyses patients without cancer were more likely to experience prolonged length of stay (OR 2.14, 95% CI 1.60–2.86) and to be discharged to a special care facility (OR 3.08, 95% CI 2.13–4.47) compared to patients with cancer (all values p Conclusions Cystectomy performed for benign conditions is associated with higher odds of prolonged length of stay and adverse discharge disposition, which may be the result of worse baseline functional status and comorbid conditions. Adapting postoperative pathways after cystectomy in consideration of patients’ baseline characteristics might be one approach to mitigate such outcome differences.

Introduction Controversy surrounds prostate specific antigen screening following the 2012 U.S. Preventive Services Task Force grade D recommendation. There is limited evidence evaluating patterns of prostate specific antigen counseling and patient perceptions of the prostate specific antigen test since 2012. We evaluated the association between prostate cancer screening counseling and patient sociodemographic factors in a nationally representative sample.

INTRODUCTION AND OBJECTIVES:Current recommendations suggest that nephrectomy or thermal ablation is a recommended treatment option for small renal mass (≤4 cm). This study examined long-term overal...

INTRODUCTION AND OBJECTIVES:There is limited epidemiological evidence for the association between androgen deprivation therapy (ADT) and the risk of incident dementia, yet several studies show no s...

CONTEXT: Contradictory data exist with regard to adjuvant vascular endothelial growth factor receptor (VEGFR)-targeted therapy in surgically managed patients for localized renal cell carcinoma (RCC). OBJECTIVE: To systematically evaluate the current evidence regarding the therapeutic benefit (disease-free survival [DFS] and overall survival [OS]) and grade 3–4 adverse events (AEs) for adjuvant VEGFR-targeted therapy for resected localized RCC. EVIDENCE ACQUISITION: A critical review of PubMed/Medline, Embase, and the Cochrane Library in January 2018 according to the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) statement was performed. We identified reports and reviewed them according to the Consolidated Standards of Reporting Trials and Standards for the Reporting of Diagnostic Accuracy Studies criteria. Of eight full-text articles that were eligible for inclusion, five studies (two of five were updated analyses) were retained in the final synthesis. Study characteristics were abstracted and the number needed to treat (NNT) per trial was estimated. EVIDENCE SYNTHESIS: The three randomized controlled phase III trials included the following comparisons: sunitinib versus placebo or sorafenib versus placebo (Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma [ASSURE] study, n = 1943), sunitinib versus placebo (S-TRAC, n = 615), and pazopanib versus placebo (Pazopanib As Adjuvant Therapy in Localized/Locally Advanced RCC After Nephrectomy study, n = 1135). The NNT ranged from 10 (S-TRAC) to 137 (ASSURE study). The pooled analysis showed that VEGFR-targeted therapy was not statistically significantly associated with improved DFS (hazard ratio [HR(random)]: 0.92, 95% confidence interval [CI]: 0.82–1.03, p = 0.16) or OS (HR(random): 0.98, 95% CI: 0.84–1.15, p = 0.84) compared with the control group. The adjuvant therapy group experienced significantly higher odds of grade 3–4 AEs (OR(random): 5.89, 95% CI: 4.85–7.15, p < 0.001). In exploratory analyses focusing on patients who started on the full-dose regimen, DFS was improved in patients who received adjuvant therapy (HR(random): 0.83, 95% CI: 0.73–0.95, p = 0.005). CONCLUSIONS: This pooled analysis of reported randomized trials did not reveal a statistically significant effect between adjuvant VEGFR-targeted therapy and improved DFS or OS in patients with intermediate/high-risk local or regional fully resected RCC. Improvement in DFS may be more likely with the use of full-dose regimens, pending further results. However, adjuvant treatment was associated with high-grade AEs. PATIENT SUMMARY: Vascular endothelial growth factor receptor-targeted therapy after nephrectomy for localized kidney cancer is not associated with consistent improvements in delaying cancer recurrence or prolonging life and comes at the expense of potentially significant side effects.

Robotic-assisted radical prostatectomy (RARP) has been shown to reduce blood loss, peri-operative complications and length of stay when compared to open radical prostatectomy (ORP). We sought to determine whether the reported benefits of RARP over ORP translate to obese patients.We utilized the 2009-2010 Nationwide Inpatient Sample to identify all obese men with prostate cancer who underwent ORP and RARP. Our primary outcome was the presence of a peri-operative adverse event (i.e. blood transfusion, complication, prolonged length of stay). We fit multivariable logistic regression models to examine whether RARP in obese patients was independently associated with decreased odds of all three outcomes.We identified 9,108 obese patients who underwent radical prostatectomy. On multivariable analysis, the use of RARP in the obese population was not independently associated with decreased odds of developing a peri-operative complication (OR = 0.81, CI: 0.58-1.13, p = 0.209). RARP was, however, associated with decreased odds of blood transfusion (OR = 0.17, CI: 0.10-0.30, p0.001) and prolonged length of stay (OR = 0.28, CI: 0.20-0.40, p0.001).Our findings suggest that in obese patients, the use of RARP may reduce length of stay and blood transfusions compared to ORP. Both approaches, however, are associated with similar odds of developing a complication.

With the growing concerns about overtreatment in prostate cancer, the extent to which radiation oncologists and urologists perceive active surveillance (AS) as effective and recommend it to patients are unknown.To assess opinions of radiation oncologists and urologists about their perceptions of AS and treatment recommendations for low-risk prostate cancer.National survey of specialists.Radiation oncologists and urologists practicing in the United States.A total of 1366 respondents were asked whether AS was effective and whether it was underused nationally, whether their patients were interested in AS, and treatment recommendations for low-risk prostate cancer. Pearson's χ test and multivariate logistic regression were used to test for differences in physician perceptions on AS and treatment recommendations.Overall, 717 (52.5%) of physicians completed the survey with minimal differences between specialties (P=0.92). Although most physicians reported that AS is effective (71.9%) and underused in the United States (80.0%), 71.0% stated that their patients were not interested in AS. For low-risk prostate cancer, more physicians recommended radical prostatectomy (44.9%) or brachytherapy (35.4%); fewer endorsed AS (22.1%). On multivariable analysis, urologists were more likely to recommend surgery [odds ratio (OR): 4.19; P0.001] and AS (OR: 2.55; P0.001), but less likely to recommend brachytherapy (OR: 0.13; P0.001) and external beam radiation therapy (OR: 0.11; P0.001) compared with radiation oncologists.Most prostate cancer specialists in the United States believe AS effective and underused for low-risk prostate cancer, yet continue to recommend the primary treatments their specialties deliver.

We examined temporal trends in skeletal related events and associated charges in patients with renal cell carcinoma metastatic to bone. We also identified patient and hospital characteristics associated with skeletal related events and related mortality.Using the Nationwide Inpatient Sample we abstracted data on patients with renal cell carcinoma who were diagnosed with concomitant bone metastasis between 1998 and 2010. Patients who experienced a skeletal related event were identified and hospital charges were calculated. Multivariate regression models fitted with generalized estimating equations were used to examine predictors of skeletal related events and related in-hospital mortality.Between 1998 and 2010 a weighted estimate of 144,889 renal cell carcinoma hospital visits of patients with bone metastasis was identified in the Nationwide Inpatient Sample, of which 20.8% involved a skeletal related event. In these cases from 1998 to 2010 the inflation adjusted mean yearly costs associated with hospital admission increased by 207% in 2013 United States dollars (estimated annual percent change 8.94%, p0.001). Conversely, the rates of skeletal related events and skeletal related event associated mortality decreased significantly (estimated annual percent change -1.11% and -2.9%, respectively, each p0.001).The prevalence and in-hospital mortality of skeletal related event associated hospitalization for metastatic renal cell carcinoma is decreasing but such charges to health care in the United States are increasing at an alarming rate. These findings highlight the need for cost-effective treatment strategies to prevent or treat these morbid complications.

Using the Nationwide Emergency Department Sample (NEDS) we examined trends in visits, hospitalization and charges for patients with upper urinary tract stones who presented to the emergency department in the United States.All visits with a primary diagnosis of kidney calculus (ICD-9-CM code 592.0), ureter calculus (592.1) or urinary calculus unspecified (592.9) were extracted from NEDS between 2006 and 2009. A weighted sample was used to calculate incidence rates. Temporal trends were quantified by the estimated annual percent change. Patient and hospital characteristics associated with hospitalization were evaluated using logistic regression models adjusted for clustering.Between 2006 and 2009 there were 3,635,054 emergency department visits for upper urinary tract stones. The incidence increased from 289 to 306/100,000 individuals. More men visited than women but women showed significant increases in visits (estimated annual percent change 2.85%, p = 0.018). Total monthly emergency department visits ranged from 5.8% in February to 8.4% in August. Overall 12.0% of patients were hospitalized and the hospitalization rate remained stable (estimated annual percent change -1.02%, p = 0.634). Patients were more likely to be hospitalized if they were female, more ill, seen at an urban teaching or low volume hospital, or had Medicaid or Medicare (each p0.001). Sepsis was associated with the highest likelihood of hospital admission (OR 69.64, p0.001). In 2009 charges for emergency department visits increased to $5 billion (estimated annual percent change 10.06%, p = 0.003).Women showed significant annual increases in emergency department visits for upper urinary tract stones. While emergency department charges increased substantially, hospitalization rates remained stable. Greater use of computerized tomography and medical expulsive therapy could be the reasons for this observation, which warrants further study.

Purpose: Priapism is a complex medical emergency that often requires prompt management. In this study, we examine the incidence of this condition in a United States population based setting, and assess patient and emergency department attributes associated with an increased likelihood of hospitalization. Materials and Methods: Emergency department visits with a primary diagnosis of priapism between 2006 and 2009 were abstracted from the Nationwide Emergency Department Sample. Univariable and multivariable analyses were performed of patient and hospital characteristics of those admitted with priapism. Results: Between 2006 and 2009 a weighted estimate of 32,462 visits to the emergency department for priapism was recorded in the United States, which represents a national incidence of 5.34 per 100,000 male subjects per year. The incidence of emergency department visits increased by 31.4% during the summer compared to the winter months. Overall 4,320 visits (13.3%) resulted in hospitalization/admission for further management. On multivariable analyses independent predictors of admission included Charlson comorbidity index score 3 or greater (OR 5.67, p

Statins are cholesterol lowering agents used to prevent cardiovascular disease. Evidence suggests a dichotomous effect of statins with cancer inhibiting and promoting properties. To our knowledge the effect of statins on the prognosis of muscle invasive urothelial carcinoma of the bladder remains uninvestigated to date. We tested the hypothesis that statin use impacts oncological outcomes in patients treated with radical cystectomy for urothelial carcinoma of the bladder.We retrospectively evaluated the records of 1,502 patients treated with radical cystectomy and pelvic lymphadenectomy without neoadjuvant therapy at a total of 4 institutions. Cox regression models were used to determine the association of statins with disease recurrence and cancer specific mortality.A total of 642 patients (42.7%) were on statins. At a median followup of 34 months 509 patients (33.9%) experienced disease recurrence and 402 (26.8%) had died of urothelial carcinoma of the bladder. Statin users were older (p = 0.003), had a higher body mass index (median 32 vs 28 kg/m(2), p0.001) and were more likely to have positive soft tissue surgical margins (9% vs 4%, p0.001). On univariable Cox regression analysis statins, female gender, advanced age, higher body mass index, smoking status, tumor stage, tumor grade, soft tissue surgical margin status, lymphovascular invasion, lymph node metastasis and adjuvant chemotherapy were associated with disease recurrence (p ≤ 0.05) and cancer specific mortality (p ≤ 0.02). On multivariable Cox regression analysis statin use was not associated with either outcome.Statin users were at higher risk for disease recurrence and cancer specific mortality on univariable but not multivariable analysis. These data do not support modification of statin use in patients with high risk urothelial carcinoma of the bladder who will be treated with radical cystectomy.

Purpose: The use of robot-assisted radical prostatectomy has increased rapidly despite the absence of randomized, controlled trials showing the superiority of this approach. While recent studies suggest an advantage for perioperative complication rates, they fail to account for the volume-outcome relationship. We compared perioperative outcomes after robot-assisted and open radical prostatectomy, while considering the impact of this established relationship.Materials and Methods: Using the NIS (Nationwide Inpatient Sample), we abstracted data on patients treated with radical prostatectomy in 2009. Univariable and multivariable logistic regression analyses were done to compare the rates of blood transfusion, intraoperative and postoperative complications, prolonged length of stay, increased hospital charges and mortality between robot-assisted and open radical prostatectomy overall and across volume quartiles.Results: An estimated 77,616 men underwent radical prostatectomy, including a robot-assisted and a...

INTRODUCTION AND OBJECTIVES: The treatment of metastatic renal cell carcinoma (mRCC) has profoundly changed over the last decade. There is little comprehensive evidence evaluating the role of metastasectomy (MSx) in in this context. We assessed trends and predictors of MSx and their impact on overall survival in a large national cohort. METHODS: The National Cancer Data Base from 1998-2012 was queried to identify 25455 mRCC patients with 5315 undergoing MSx. Covariates included the application of targeted chemotherapy (CTX) and immunotherapy (ITX). Baseline descriptive and multivariable logistic regression analyzes for prediction of MSx were conducted. Trends for chemo(CTX) and immunotherapy (ITX) as well as MSx were assessed using the annual percent change linear regression technique (EAPC). Kaplan-Meier curves and adjusted Cox-proportional hazard models assessed the impact of MSx on overall survival. RESULTS: Compared to controls, MSx patients were significantly younger (p