Search

Objectives To assess the association of testosterone replacement therapy (TRT) with thromboembolism, cardiovascular disease (stroke, coronary artery disease and heart failure) and obstructive sleep apnoea (OSA). Methods A cohort of 3 422 male US military service members, retirees and their dependents, aged 40-64 years, was identified, who were prescribed TRT between 2006 and 2010 for low testosterone levels. The men in this cohort were matched on a 1:1 basis for age and comorbidities to men without a prescription for TRT. Event-free survival and rates of thromboembolism, cardiovascular events and OSA were compared between men using TRT and the control group, with a median follow-up of 17 months. Results There was no difference in event-free survival with regard to thromboembolism (P = 0.239). Relative to controls, men using TRT had improved cardiovascular event-free survival (P = 0.004), mainly as a result of lower incidence of coronary artery disease (P = 0.008). The risk of OSA was higher in TRT users (2-year risk 16.5% [95% confidence interval 15.1-18.1] in the TRT group vs 12.7% [11.4-14.1] in the control group. Conclusions This study adds to growing evidence that the cardiovascular risk associated with TRT may be lower than once feared. The elevated risk of OSA in men using TRT is noteworthy.

BACKGROUND This study assessed the use of active surveillance in men with low-risk prostate cancer and evaluated institutional factors associated with the receipt of active surveillance. METHODS A retrospective, hospital-based cohort of 115,208 men with low-risk prostate cancer diagnosed between 2010 and 2014 was used. Multivariate and mixed effects models were used to examine variation and factors associated with active surveillance. RESULTS During the study period, the use of active surveillance increased from 6.8% in 2010 to 19.9% in 2014 (estimated annual percentage change, +28.8%; 95% confidence interval [CI], + 19.6% to + 38.7%; P = .002). The adjusted probability of active-surveillance receipt by institution was highly variable. Compared with patients treated at comprehensive community cancer centers, patients treated at community cancer programs (odds ratio [OR], 2.00; 95% CI, 1.50-2.67; P

BACKGROUND Neoadjuvant chemotherapy in pure urothelial bladder cancer provides a significant survival benefit. However, to the authors' knowledge, it is unknown whether this benefit persists in histological variants. The objective of the current study was to assess the effect of neoadjuvant chemotherapy on the probability of non-organ-confined disease and overall survival after radical cystectomy (RC) in patients with histological variants. METHODS Querying the National Cancer Data Base, the authors identified 2018 patients with histological variants who were undergoing RC for bladder cancer between 2003 and 2012. Variants were categorized as micropapillary or sarcomatoid differentiation, squamous cell carcinoma, adenocarcinoma, neuroendocrine tumors, and other histology. Logistic regression models estimated the odds of non-organ-confined disease at the time of RC for each histological variant, stratified by the receipt of neoadjuvant chemotherapy. Cox regression models were used to examine the effect of neoadjuvant chemotherapy on overall mortality in each variant subgroup. RESULTS Patients with neuroendocrine tumors (odds ratio [OR], 0.16; 95% confidence interval [95% CI], 0.08-0.32 [P

The ethical and economic discussions regarding the extreme costs of many new cancer therapies are familiar. The authors have long held that changes in cancer care delivery also are an important strategy, yielding large benefits at potentially far lower costs. To put this into context, the authors performed an analysis to compare the overall survival of patients receiving a complex oncologic surgery, radical cystectomy, at high-volume and low-volume centers. Propensity score weighting was performed to simulate random allocation into high-volume versus low-volume centers, as would be the case in a prospective trial. On average, patients undergoing surgery at high-volume centers survived 15 months longer than those treated at low-volume centers (57.0 months vs 41.8 months). Although there certainly are caveats in contrasting the survival benefit of different care settings with anticancer agents, this differential clearly rivals or exceeds the benefit of many expensive, recently approved agents. As the debate regarding the costs of cancer therapies continues, it is worth remembering that investments in simple systems-based changes to improve cancer care delivery remain an important and likely cost-effective strategy with which to improve the survival of patients with cancer. Cancer 2018;124:1319-21. © 2018 American Cancer Society.

Objectives To examine, using competing risks regression, differences in cancer-specific mortality (CSM) that might distinguish between local tumour ablation (LTA) and observation (OBS) for patients with kidney cancer. Patients and Methods The study focused on 1 860 patients with cT1a kidney cancer treated with either LTA or OBS between 2000 and 2009 in the Surveillance Epidemiology and End Results-Medicare database. Propensity-score matching was used. The study outcome was CSM. Multivariable competing risks regression analyses, adjusting for other-cause mortality as well as patient (including comorbidities) and tumour characteristics, were fitted. Results Overall, fewer patients underwent LTA than OBS (30 vs 70%; n = 553 vs n = 1 307). Compared with patients in the OBS group, those in the LTA group were younger (median age 77 vs 78 years; P < 0.001), more likely to be white (84 vs 78%; P = 0.005), more frequently married (59 vs 52%; P = 0.02) and more frequently of high socio-economic status (54 vs 45%; P = 0.001). After propensity-score matching, 553 patients who underwent LTA and 553 who underwent OBS remained for subsequent analyses. The mean standardized differences of patient characteristics between the two groups were

Objective To validate Caveolin-1 as an independent prognostic marker of biochemical recurrence (BCR) in a large multi-institutional cohort of patients with prostate cancer treated with radical prostatectomy (RP). Patients and Methods Caveolin-1 expression was evaluated by immunochemistry on a tissue microarray in 3 117 patients treated with RP for prostate cancer at five institutions. Univariable and multivariable Cox proportional hazards regression models assessed the association of Caveolin-1 status with BCR. Harrell's c-index quantified prognostic accuracy. Results Caveolin-1 was overexpressed in 644 (20.6%) patients and was associated with higher pathological Gleason sum (P = 0.002) and lymph node metastases (P = 0.05). Within a median (interquartile range) follow-up of 38 (21–66) months, 617 (19.8%) patients experienced BCR. Patients with overexpression of Caveolin-1 had worse BCR-free survival than those with normal expression (log-rank test, P = 0.004). Caveolin-1 was an independent predictor of BCR in multivariable analyses that adjusted for the effects of standard clinicopathological features (hazard ratio 1.21, P = 0.037). Addition of Caveolin-1 in a model for prediction of BCR based on these standard prognosticators did not significantly improve the predictive accuracy of the model. In subgroup analyses, Caveolin-1 was associated with BCR in patients with favourable pathological features (pT2pN0 and Gleason score = 6; P = 0.021). Conclusions We confirmed that overexpression of Caveolin-1 is associated with adverse pathological features in prostate cancer and independently predicts BCR after RP, especially in patients with favourable pathological features. However, it did not add prognostically relevant information to established predictors of BCR, limiting its use in clinical practice.

Objective To develop a novel postoperative prognostic tool, which attempts to integrate both pathological tumour stage and histopathological factors, for prediction of cancer-specific mortality (CSM) of squamous cell carcinoma of the penis (SCCP). Patients and Methods Patients with SCCP treated with inguinal lymph node dissection (ILND) or sentinel LN biopsy at a single institution were used for nomogram development and internal validation (n = 434), while a second cohort was used for external validation (n = 338). Multivariable Cox proportional hazards were used to examine the prognostic ability of patient age, a modified tumour staging that distinguishes between spongiosum and cavernosum body ingrowth tumours, a modified LN staging that integrates information on presence/absence of LN metastasis, extent of inguinal LN metastases, pelvic LN involvement, and extranodal involvement, and tumour grade. Model performance was quantified using measures of discrimination and calibration. Results Overall, 36% of patients had positive LN metastases (n = 156). In univariable analyses, the modified tumour and LN staging systems were statistically significantly associated with CSM, and remained in the final model with a discrimination of 89% within internal validation, and 95% within external validation. Calibration was nearly perfect. Conclusions The newly developed model integrates important prognostic factors, which existing models do not consider. Its performance was highly accurate using measures of discrimination and calibration.

Objectives To test the effect of radiotherapy administered within 6 months after radical prostatectomy on cancer-specific mortality in prostate cancer patients after stratification according to a risk score. Methods Overall, 7616 patients with pT3/4 N0/1 prostate cancer treated with radical prostatectomy between 1995 and 2009 within the Surveillance Epidemiology and End Results Medicare-linked database were included in the study. Competing-risks regression models were carried out to test the effect of early radiotherapy on cancer-specific mortality in the entire cohort, and after stratifying patients according to the risk score based on the number and nature of adverse pathological characteristics (Gleason score 8–10; pT3b/4, lymph node invasion). Results The risk score was associated with increasing 5- and 10-year cancer-specific mortality rates (P

Objective To assess in-hospital mortality in patients undergoing many commonly performed urological surgeries in light of decreasing nationwide perioperative mortality over the past decade. This phenomenon has been attributed in part to a decline in ‘failure to rescue’ (FTR) rates, e.g. death after a complication that was potentially recognisable/preventable. Patients and Methods Discharges of all patients undergoing urological surgery between 1998 and 2010 were extracted from the Nationwide Inpatient Sample and assessed for overall and FTR mortality. Admission trends were assessed with linear regression. Logistic regression models fitted with generalised estimating equations were used to estimate the impact of primary predictors on over-all and FTR mortality and changes in mortality rates. Results Between 1998 and 2010, an estimated 7 725 736 urological surgeries requiring hospitalisation were performed in the USA; admissions for urological surgery decreased 0.63% per year (P = 0.008). Odds of overall mortality decreased slightly (odds ratio [OR] 0.990, 95% confidence interval [CI] 0.988–0.993), yet the odds of mortality attributable to FTR increased 5% every year (OR 1.050, 95% CI 1.038–1.062). Patient age, race, Charlson Comorbidity Index, public insurance status, as well as urban hospital location were independent predictors of FTR mortality (P < 0.001). Conclusion A shift from inpatient to outpatient surgery for commonly performed urological procedures has coincided with increasing rates of FTR mortality. Older, sicker, minority group patients and those with public insurance were more likely to die after a potentially recognisable/preventable complication. These strata of high-risk individuals represent ideal targets for process improvement initiatives.

Objective To examine and quantify the contemporary association between androgen-deprivation therapy (ADT) and three separate endpoints: coronary artery disease (CAD), acute myocardial infarction (AMI), and sudden cardiac death (SCD), in a large USA contemporary cohort of patients with prostate cancer. Patients and Methods In all, 140 474 patients diagnosed with non-metastatic prostate cancer between 1995 and 2009 within the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database were abstracted. Patients treated with ADT and those not receiving ADT were matched using propensity score methodology. The 10-year CAD, AMI, and SCD rates were estimated. Competing-risks regression analyses tested the association between the type of ADT (GnRH agonists vs bilateral orchidectomy) and CAD, AMI, and SCD, after adjusting for the risk of dying during follow-up. Results Overall, the 10-year rates of CAD, AMI, and SCD were 25.9%, 15.6%, and 15.8%, respectively. After stratification according to ADT status (ADT-naive vs GnRH agonists vs bilateral orchidectomy), the CAD rates were 25.1% vs 26.9% vs 23.2%, the AMI rates were 14.8% vs 16.6% vs 14.8%, and the SCD rates were 14.2% vs 17.7% vs 16.4%, respectively. In competing-risks multivariable regression analyses, the administration of GnRH agonists (all P < 0.001), but not bilateral orchidectomy (all P ≥ 0.7), was associated with higher risk of CAD, AMI, and SCD. Conclusions The administration of GnRH agonists, but not orchidectomy, is still associated with a significantly increased risk of CAD, AMI, and, especially, SCD in patients with non-metastatic prostate cancer. Alternative forms of ADT should be considered in patients at higher risk of CV events.

Objective To evaluate the relationship between partial nephrectomy (PN) and hospital availability of robot-assisted surgery from a population-based cohort in the USA. Methods After merging the Nationwide Inpatient Sample (NIS) and the American Hospital Association survey from 2006 to 2008, we identified 21 179 patients who underwent either PN or radical nephrectomy (RN) for renal cell carcinoma (RCC). The primary outcome assessed was the type of nephrectomy performed. Multivariable logistic regression identified the patient and hospital characteristics associated with receipt of PN. Results We identified 4832 (22.8%) and 16 347 (77.2%) patients who were treated for RCC with PN and RN, respectively. On multivariable analysis, patients were more likely to receive PN at academic centres (odds ratio [OR] 2.77; P < 0.001), urban centres (OR 3.66; P < 0.001) and American College of Surgeons (ACOS)-designated cancer centres (OR: 1.10; P < 0.05) compared with non-academic, rural and non-ACOS-designated cancer centre hospitals, respectively. Robot-assisted surgery availability at a hospital was also associated with a higher adjusted odds of PN compared with centres without that availability (OR 1.28; P < 0.001). Conclusions Although academic and urban locations are established factors that affect the receipt of PN for RCC, the availability of robot-assisted surgery at a hospital was also independently associated with higher use of PN. Our results are informative in identifying other key hospital characteristics which may facilitate greater adoption of PN.

Objective To describe the survival benefit associated with radical prostatectomy (RP), as compared with initial observation, in patients with locally advanced prostate cancer (PCa). Patients and Methods Overall, 1382 patients with locally advanced PCa treated with RP or initial observation between 1995 and 2009 were identified from the Surveillance, Epidemiology and End Results Medicare insurance programme-linked database. Patients were matched using propensity-score methodology, then 10-year cancer-specific mortality (CSM) rates were estimated and the number needed to treat (NNT) was calculated. Competing-risks regression analyses tested the relationship between treatment type and CSM. Results Overall, the 10-year CSM rates were 11.8 and 19.3% for patients treated with RP and initial observation, respectively (P < 0.001). The corresponding 10-year NNT was 13. The 10-year CSM rates for the same treatment groups were 8.9 vs 13.9%, respectively, for Gleason score ≤7, 16.8 vs 27.8%, respectively, for Gleason score 8–10, 10.1 vs 15.8%, respectively, for clinical stage T3a, and 17.0 vs 29.3%, respectively, for T3b/T4, respectively (all P ≤ 0.04). The corresponding NNTs were 20, 9, 17 and 8, respectively. In multivariable analyses, RP was an independent predictor of more favourable CSM rates in all categories (all P ≤ 0.04). In separate sensitivity analyses, no differences were recorded when patients treated with radiotherapy were compared with those receiving RP (P = 0.4). Conversely, patients undergoing initial observation had a higher risk of CSM compared with those treated with radiotherapy (P = 0.03). Conclusions RP leads to a significant survival advantage compared with observation in patients with locally advanced disease. The highest benefit was observed in patients with T3b/T4 and Gleason score 8–10 disease.

Objective To determine the association between peri-operative blood transfusion (PBT) and oncological outcomes in a large multi-institutional cohort of patients undergoing radical cystectomy (RC) for urothelial carcinoma of the bladder (UCB). Patients and Methods We conducted a retrospective analysis of 2895 patients treated with RC for UCB. Univariable and multivariable Cox regression models were used to analyse the effect of PBT administration on disease recurrence, cancer-specific mortality, and any-cause mortality. Results Patients' median (interquartile range [IQR]) age was 67 (60, 73) years and the median (IQR) follow-up was 36.1 (15, 84) months. Patients who received PBT were more likely to have advanced disease (P < 0.001), high grade tumours (P = 0.047) and nodal metastasis (P = 0.004). PBT was associated with a higher risk of disease recurrence (P = 0.003), cancer-specific mortality (P = 0.017), and any-cause mortality (P = 0.010) in univariable, but not multivariable, analyses (P > 0.05). In multivariable analyses, pathological tumour stage, pathological nodal stage, soft tissue surgical margin, lymphovascular invasion and administration of adjuvant chemotherapy were independent predictors of disease recurrence, cancer-specific mortality and any-cause mortality (all P values

Objective To examine whether percentage of tumour volume (%TV) and percentage of high-grade tumour volume (%HGTV) help to better identify men at higher risk of early biochemical recurrence (BCR) after radical prostatectomy (RP) for non-metastatic high-risk prostate cancer, as early BCR after RP might be associated with higher risk of metastases and cancer-specific mortality. Patients and Methods We examined the data of 595 men treated with RP for non-metastatic high-risk prostate cancer between 1992 and 2011 at two European tertiary care centres. Kaplan–Meier analyses were used to graphically depict 2-year BCR-free survival. Multivariable Cox regression models addressed early BCR. We tested whether addition of %TV and %HGTV to a multivariable Cox regression model helps to increase a model's predictive accuracy (PA) for prediction of early BCR. Results In all, 32 men (10%) with specimen-confined prostate cancer (pT2–pT3a, negative surgical margin, pN0) and 67 men (24%) with non-specimen-confined prostate cancer had early BCR. After stratification according to %HGTV (%HGTV threshold: ≤33.33 vs >33.33%), the 2-year BCR-free survival rates were respectively 93 vs 60% (log-rank P < 0.001). In multivariable Cox regression models %HGTV emerged as an independent predictor of early BCR (P 0.05). However, adding %HGTV (regardless of its coding) to other covariates in multivariable Cox regression analysis did not increase the model's PA in a meaningful fashion compared with the use of the detailed Gleason grading system (6 vs 7a vs 7b vs 8 vs 9–10). Conclusions In a large cohort of patients with high-risk prostate cancer, %HGTV and %TV did not improve prediction of early BCR after RP substantially, although %HGTV was an independent predictor of early BCR. Therefore, sophisticated TV/HGTV measurements do not seem to have additional benefit for early BCR prediction relative to the use of Gleason grading. However, these results need to be confirmed in larger, prospective studies.

BACKGROUND There is few data on what constitutes the distribution of metastatic sites in prostate cancer (PCa). The aim of our study was to systematically describe the most common sites of metastases in a contemporary cohort of PCa patients. METHODS Patients with metastatic PCa were abstracted from the Nationwide Inpatient Sample (1998–2010). Most common metastatic sites within the entire population were described. Stratification was performed according to the presence of single or multiple (≥2 sites) metastases. Additionally, we evaluated the distribution of metastatic sites amongst patients with and without bone metastases. RESULTS Overall, 74,826 patients with metastatic PCa were identified. The most common metastatic sites were bone (84%), distant lymph nodes (10.6%), liver (10.2%), and thorax (9.1%). Overall, 18.4% of patients had multiple metastatic sites involved. When stratifying patients according to the site of metastases, only 19.4% of men with bone metastases had multiple sites involved. Conversely, among patients with lymph nodes, liver, thorax, brain, digestive system, retroperitoneum, and kidney and adrenal gland metastases the proportion of men with multiple sites involved was 43.4%, 76.0%, 76.7%, 73.0%, 52.2%, 60.9%, and 76.4%, respectively. When focusing exclusively on patients with bone metastases, the most common sites of secondary metastases were liver (39.1%), thorax (35.2%), distant lymph nodes (24.6%), and brain (12.4%). CONCLUSIONS Although the majority of patients with metastatic PCa experience bone location, the proportion of patients with atypical metastases is not negligible. These findings might be helpful when planning diagnostic imaging procedures in patients with advanced PCa. Prostate 74:210–216, 2014. © 2013 Wiley Periodicals, Inc.

Objective To quantify in absolute terms the potential benefit of regionalisation of care from low- to high-volume hospitals. Patients and Methods Patients with a primary diagnosis of bladder cancer treated with radical cystectomy (RC) were identified within the Nationwide Inpatient Sample, a retrospective observational population-based cohort of the USA, between 1998 and 2009. Intraoperative and postoperative complications, blood transfusions, prolonged length of stay, and in-hospital mortality rates represented the outcomes of interest. Potentially avoidable outcomes were calculated by subtracting predicted rates (i.e. estimated outcomes if care was delivered at a high-volume hospital) from observed rates (i.e. actual observed outcomes after care delivered at a low-volume hospital). Multivariable logistic regression models and number needed to treat were generated. Results Patients treated at high-volume hospitals had lower odds of complications during hospitalisation than those treated in low-volume hospitals. Potentially avoidable intraoperative complications, postoperative complications, blood transfusions, prolonged hospitalisation, and in-hospital mortality rates were 0.6, 7.4, 2.8, 9.4, and 2.0%, respectively. This corresponds to a number needed to redirect from low- to high-volume hospitals in order to avoid one adverse event of 166, 14, 36, 11 and 50, respectively. Conclusion This is the first report to quantify the potential benefit of regionalisation of RC for muscle-invasive bladder cancer to high-volume hospitals.

Objectives To examine the rates of cancer-specific mortality, other-cause and bladder cancer mortality in patients with upper-tract urothelial carcinoma undergoing radical nephroureterectomy. Methods Relying on the Surveillance, Epidemiology, and End Results database, 9899 patients treated with radical nephroureterectomy were identified. A 20-strata graphical aid was constructed using age ( 79 years) and American Joint Committee on Cancer/TNM stage (pT1N0/x, pT2N0/x, pT3N0/x, pT4N0/x, pTanypN1–3) as stratifying variables. The 5-year cancer-specific mortality, other-cause and bladder cancer mortality rates were generated through competing-risks Poisson regression methodologies. Multivariable competing-risks regression models were used to test the effect of age and stage on three different end-points: cancer-specific mortality, other-cause and bladder cancer mortality. Results Overall, 1797 (18.1%), 891 (9.1%) and 3090 (31.2%) patients died of cancer-specific mortality, other-cause and bladder cancer mortality, respectively. Following stratification according to age and stage, the proportion of patients who succumbed to cancer-specific mortality (11.7–21.9%) and other-cause mortality (8.9–30.4%) increased with age. In contrast, with increasing stage, the proportion of patients who died of cancer-specific mortality increased (7.2–37.5%), whereas the proportion of other-cause mortality remained stable (18.9–22.0%). The rate of bladder cancer mortality increased with advancing stage. At multivariable competing-risk regression model, besides age and stage, women, type of surgery, grade and location were associated with higher cancer-specific mortality. Furthermore, ureteral location, stage and grade were associated with bladder cancer mortality. Conclusions The developed graphical aid for prediction of cancer-specific mortality, other-cause, and bladder cancer mortality according to age and stage in patients with upper-tract urothelial carcinoma undergoing radical nephroureterectomy can be useful for physicians and patients during clinical counseling.

Objective To compare efficacy between radical prostatectomy (RP), radiotherapy and observation with respect to overall survival (OS) in patients with clinically localized prostate cancer (PCa). Methods Using data (1988–2005) from the Surveillance, Epidemiology, and End Results–Medicare linked database, 67 087 men with localized PCa were identified. The prevalence of the initial treatment strategy was quantified according to patients' life expectancy ([LE]

Objectives To examine utilization rates of partial nephrectomy relative to radical nephrectomy for T1b renal cell carcinoma in contemporary years, to identify sociodemographic and disease characteristics associated with partial nephrectomy use, and to compare effectiveness of partial versus radical nephrectomy with respect to cancer control. Methods Using the Surveillance, Epidemiology, and End Results database, 16 333 patients treated with partial or radical nephrectomy for T1bN0M0 renal cell carcinoma between 1988 and 2008 were identified. Logistic regression models were carried out to identify determinants of partial nephrectomy. Subsequently, cumulative incidence rates of cancer-specific and other-cause mortality between partial and radical nephrectomy were assessed, within the matched cohort. Furthermore, competing-risks regression analyses were used for prediction of cancer-specific mortality, after adjusting for other-cause mortality, and vice versa. Results The utilization rate of partial nephrectomy increased from 1.2% in 1988 to 15.9% in 2008 (P

Objective To show the underlying variability in peri-operative mortality after radical cystectomy (RC) by analysing failure-to-rescue (FTR) rates, i.e. deaths after complications. Materials and Methods Patients undergoing RC for non-metastatic bladder cancer (BCa) were identified from the Nationwide Inpatient Sample, 1999–2009, resulting in a weighted estimate of 79 972 patients. The FTR rates were assessed according to patient and hospital characteristics, as well as complication type. Generalized linear regression analyses were performed. Results Overall, 26 740 patients had a complication, corresponding to a FTR rate of 5.5%. Septicaemia (odds ratio [OR]: 13.41, P < 0.001) and cardiac (OR: 3.97, P < 0.001), wound-related (OR: 2.12, P < 0.001), genitourinary (OR: 1.62, P = 0.045) and haematological (OR: 1.78, P = 0.008) complications were associated with FTR. Older age (OR: 1.05, P < 0.001), increasing comorbidities (OR: 1.33, P < 0.001), Medicare (OR: 1.52, P = 0.016), and Medicaid insurance status (OR: 2.10, P = 0.029) were associated with higher odds of FTR. Conversely, increasing hospital volume (OR: 0.992, P = 0.014) reduced the odds of FTR. Conclusions Whereas both patient and hospital characteristics were associated with increased odds of FTR, the occurrence of septicaemia and cardiac complications were the most strongly associated with a higher risk of in-hospital mortality.

Objective To test the hypothesis that spatial distribution of positive cores at biopsy is a predictor of unfavourable prostate cancer characteristics at radical prostatectomy (RP) in active surveillance (AS) candidates. Patients and Methods We examined the data of 524 patients treated with RP, between 2000 and 2012. All fulfilled at least one of four commonly used AS criteria. Regression models tested the relationship between positive cores spatial distribution, defined as the number of positive zones at biopsy (PBxZ) and tumour laterality at biopsy and two endpoints: (i) unfavourable prostate cancer at RP (Gleason score ≥4 + 3, and/or pT3 disease), and (ii) clinically significant prostate cancer (tumour volume ≥2.5 mL). Results Unfavourable prostate cancer and clinically significant prostate cancer rates were 8 and 25%, respectively. Patients with more than one PBxZ had a 3.2-fold higher risk of harbouring unfavourable prostate cancer, and a 2.3-fold higher risk of harbouring clinically significant prostate cancer compared with their counterparts with one PBxZ (both P = 0.01). Patients with bilateral tumour at biopsy had a 3.3-fold higher risk of harbouring unfavourable prostate cancer and a 1.7-fold higher risk of harbouring clinically significant prostate cancer compared with their counterparts with unilateral tumour at biopsy (both P ≤ 0.04). Some of these results did not reach a statistically significant level, when the analyses were restricted to patients that fulfilled the most stringent AS criteria. Conclusions Positive cores spatial distribution at biopsy should be considered, when advising patients about AS. The addition of this predictor to AS inclusion criteria can help identifying patients at a higher risk of progression, and reduce the rate of inappropriate surveillance of aggressive tumours. However, the most stringent AS criteria (namely John-Hopkins criteria and Prostate Cancer Research International: Active Surveillance criteria) might not benefit from the addition of this predictor. This point warrants further investigation in future studies.

Objective To examine the presence of specific sociodemographic disparities in the treatment of individuals with small renal masses. Patients and Methods Patients diagnosed with pT1aN0M0 renal cell carcinoma (RCC) were identified from the Surveillance, Epidemiology, and End Results database (years 1988–2008). Treatment type was stratified into non-surgical and surgical management and the group of patients who underwent surgical intervention was further stratified into those who underwent partial nephrectomy (PN) and those who underwent radical nephrectomy (RN). The main variables of interest were race and gender, as well as family income and poverty and education levels. Temporal trend analyses and logistic regression models were performed. Results Of 26 468 patients with T1aN0M0 RCC, 2797 (10.6%) were non-surgically managed and 23 671 (89.4%) underwent surgery. Of the latter, 14 705 (62.1%) underwent RN and 8966 (37.9%) PN. In multivariable analyses, black patients were 23% more likely to be non-surgically managed than other ethnic groups, and if surgically managed, were 20% less likely to undergo PN (both P ≤ 0.007). Men were 19% more likely than women to be non-surgically managed, but remained 14% more likely to receive a PN (both P < 0.001). Treatment disparities according to income, education and poverty level were recorded. Poverty (odds ratio [OR]: 1.002) and education (OR: 0.998) proxies emerged as important determinants of non-surgical management, whereas income (OR: 1.08, all P ≤ 0.02) was a determinant of PN. Conclusions Social inequalities regarding access to treatment remain prevalent among patients diagnosed with small renal masses. The persistence of such a phenomenon is a concerning trend which merits further investigation.

Objective To examine the impact of length of survival on future survival probability, otherwise known as the effect of conditional survival (CS), after nephrectomy (NT) in patients diagnosed with renal cell carcinoma (RCC). Patients and Methods Overall, 42 090 patients with RCC who underwent NT were abstracted from the Surveillance, Epidemiology, and End Results database (1988–2008). Based on cumulative survival estimates, CS rates were derived according to patient and disease characteristics. Separate multivariable Cox regression analyses were performed for the prediction of cancer-specific mortality (CSM), according to 1-, 2-, 3-, 4- and 5-year survival postoperatively. Results Immediately after surgery, the 5-year cancer-specific survival rate was 83.5%. Amongst patients who survived ≥1, ≥2, ≥3, ≥4, and ≥5 years after NT, the probability rates for surviving an additional 5 years were 87.0, 89.6, 90.9, 92.0 and 92.3%, respectively. Provided that patients survived 1 and 2 years after NT, the probability of being CSM-free for another 5 years increased by +4.1 and 4.3% for stage III and +12.9 and 10.3% for stage IV disease, respectively. Similar observations were recorded for patient age, grade, nodal stage and tumour size, and were confirmed upon multivariable analyses. Conclusion Survival probabilities vary according to length of survival after NT. Specifically, even amongst patients with more advanced disease at surgery, a more favourable prognosis can be achieved after surviving for 1–2 years.

Objective To examine the discriminant properties of the most contemporary version of the Tumour-Node-Metastasis (TNM) staging for renal cell carcinoma (RCC) sub-classification of T2 lesions according to a threshold size of 10 cm. Other thresholds were also assessed. Patients and Methods Between 1988 and 2006, within the Surveillance, Epidemiology, and End Results database, patients with T2 N0–2 M0–1 RCC treated with a nephrectomy were abstracted. Tumour size was evaluated according to several thresholds: ≥8, ≥9, ≥10, ≥11, and ≥12 cm. Kaplan–Meier and life tables for cancer-specific mortality (CSM) were computed. Several Cox regression modes were fitted for prediction of CSM, using different thresholds. The predictive accuracy of various thresholds was compared using the area under the curve and methods of calibration. Results In all, 4963 patients were identified. Kaplan–Meier analyses showed statistically significant CSM-free survival differences between all examined thresholds. In multivariable Cox-regression models, all tested tumour size thresholds emerged as independent predictors of CSM. Of all thresholds, the values of 9 (0.55) and 11 cm (0.55) achieved the highest discrimination in univariable analysis, followed by 10 (0.539), 12 (0.539), and 8 cm (0.531). When the thresholds were combined with all other variables, the 11 cm (0.688) achieved the highest discrimination. Conclusion The discriminant properties of all examined thresholds showed very similar discriminant properties, which brings into questioning whether a dichotomization of pT2 tumours is really necessary.

BACKGROUND Approximately 1.7 million individuals per year are affected with health care-associated infections (HAIs) in the United States. The authors examined trends in the incidence of HAI after major cancer surgery (MCS) and risk factors for HAI to describe the effects of HAI on mortality after MCS. METHODS Patients undergoing 1 of 8 MCS procedures within the Nationwide Inpatient Sample between 1999 and 2009 were identified (n = 2,502,686). Generalized linear regression models were used to estimate the impact of the primary predictors (procedure type, age, sex, race, insurance status, Charlson comorbidity index, hospital volume, and hospital bed size) on the odds of HAI and in-hospital mortality. Trends in incidence were evaluated with linear regression. RESULTS Overall, MCS-associated HAI incidence increased 2.7% per year (P < .001), whereas mortality decreased 1.3% per year (P < .001). Male gender (odds ratio [OR], 1.12, 95% confidence interval [CI], 1.10-1.14), advancing age (OR, 1.02; 95% CI, 1.02-1.02), black race (OR, 1.26; 95% CI, 1.21-1.31), ≥1 comorbidities (OR, from 1.08 [95% CI, 1.04-1.13] to 1.31 [95% CI, 1.27-1.35]), and nonprivate insurance (OR, from 1.18 [95% CI, 1.15-1.22] to 1.67 [95% CI, 1.59-1.76]) were associated with an increased odds of HAI on multivariable analysis. Conversely, increasing hospital volume was associated with lower odds of HAI (OR, 0.999; 95% CI, 0.99-0.99). Patients with MCS-associated HAI had increased odds of mortality (OR, 8.66; 95% CI, 8.51-8.82). CONCLUSIONS Between 1999 and 2009, the incidence of MCS-associated HAI events increased; however, HAI-associated mortality decreased. That said, significant disparities exist in the hospital and demographic attributes associated with MCS-associated HAI, with attendant health policy implications. Moreover, HAI remains detrimentally linked to mortality during hospitalization. Cancer 2013;119:2317–2324. © 2013 American Cancer Society.

What's known on the subject? and What does the study add? A recent population-based analysis suggested a potential survival benefit with respect to performing lymph node dissection at nephrectomy in node-positive patients with RCC. The findings of the present study failed to corroborate the association of a survival benefit with the performance of lymph node dissection at nephrectomy. Objective Previous studies showed no survival benefit with respect to performing lymph node dissection (LND) at nephrectomy, whereas a recent population-based analysis suggested otherwise, although the latter relied on imputation. To reconcile the findings of that study by critically evaluating the handling of missing data. Patients and Methods Study participants comprised patients diagnosed with non-metastatic renal cell carcinoma (RCC) of all stages who underwent LND at nephrectomy (n = 10 596). Multivariable Cox regression models were performed to predict cancer-specific mortality (CSM), where the primary variable of interest was the extent of LND. To examine differences in approaches with respect to handling missing data, separate analyses were performed: (i) imputed population; (ii) exclusion of patients with missing data; and (iii) inclusion of patients with missing data as a sub-category. Results Overall, 2916 (28%) patients had missing tumour grade. In multivariable analyses, our findings showed that increasing the extent of LND was associated with a significant protective effect on CSM in patients with pN1 after imputation (hazard ratio [HR], 0.82; P = 0.04). By contrast, the extent of LND was no longer significantly associated with a lower risk of CSM after excluding patients with a missing tumour grade (HR, 0.83; P = 0.1) or when including patients with missing tumour grade as a sub-category (HR, 0.82; P = 0.05). Conclusions The findings of the present study failed to corroborate the association of a survival benefit with increasing extent of LND at nephrectomy. The different methodologies employed to account for missing data may introduce important biases. Such considerations are non-negligible with respect to the interpretation of results for investigators who rely on administrative cohorts.

Objective To determine trends in demographics and treatment for inpatient upper urinary tract calculi in the USA using a population-based cohort. Patients and Methods All patients with a primary or secondary diagnosis of kidney or ureteric calculus between 1999 and 2009 in the US Nationwide Inpatient Sample were extracted and weighted. Temporal trend analyses were used to determine trends in gender, race and age presentation, as well as utilization rates of interventions. Temporal trends were quantified using the estimated annual percent change (EAPC) using least squares linear regression analysis. Results Overall, 2 109 455 patients were hospitalized with upper urinary tract calculi over the 11-year period. The majority of admissions were for ureteric calculi (63.4%). Admissions for renal calculus increased by 12.1% during the study period (EAPC + 0.92%, P = 0.039, 95% CI: 0.17–1.66), whilst discharges for ureteric calculus remained stable. A significant increase (25.4%) in hospitalizations for women was found (EAPC + 2.21%, P < 0.001, 95% CI: 1.40–3.03); by 2006, more women than men were admitted to hospital (95 953 vs. 94 556, respectively). There were significant increases in hospitalization for black, Hispanic and older patients. Significant changes in the use of all studied interventions were found except for ureteroscopy, extracorporeal shockwave lithotripsy and nephrectomy. Conclusions In this nationally representative sample of inpatient discharges, significant increases were found in admissions for renal compared with ureteric calculi, and for black, Hispanic and older patients. With regard to surgical intervention, the largest increase was found in the use of procedures for kidney calculi. Women now comprise the majority in the inpatient management of stone disease.

Objectives To examine the trends of open and laparoscopic partial nephrectomy and radical nephrectomy according to sociodemographic and tumor characteristics. Methods Using the Surveillance, Epidemiology, and End Results Medicare-linked database, 6024 patients diagnosed with T1a renal cell carcinoma were abstracted. Multivariable logistic regression analyses were used for prediction of open radical nephrectomy, open partial nephrectomy, laparoscopic radical nephrectomy and laparoscopic partial nephrectomy. Covariates comprised of patient age, baseline comorbidity status, sex, race, marital status, socioeconomic status, population density, Surveillance, Epidemiology and End Results registry, tumor size, and year of diagnosis. Results Open radical nephrectomy decreased from 89% in 1988 to 66% in 2005 (P

What's known on the subject? and What does the study add? Urinary incontinence is one of the most important morbidities after radical prostatectomy that has detrimental effect on the postoperative quality of life. The present study provides an accurate and dynamic multivariable risk stratification tool that predicts the postoperative urinary incontinence risk after radical prostatectomy based on patient-related as well as surgeon-related variables. Objective To develop a multivariable risk classification tool to estimate postoperative urinary incontinence (UI) risk as UI represents one of the most disabling surgical sequelae after radical prostatectomy (RP). Patients and Methods We evaluated 1311 patients treated with nerve-sparing RP between 2006 and 2010 at our institution. Regression tree analysis was used to stratify patients according to their postoperative UI risk. Kaplan–Meier curve estimates were used to assess the UI rate in the novel UI-risk groups. The discrimination of the novel tool was measured with the area under the curve method. Results At 3, 6 and 12 months, the UI rates were 44%, 26% and 12%, respectively. Regression tree analysis stratified patients into high risk (International Index of Erectile Function – Erectile Function domain [IIEF-EF] = 1–10), intermediate risk (IIEF-EF > 10 and age ≥ 65 years), low risk (IIEF-EF > 10, age 10, age < 65 years and BMI < 25 kg/m2) groups. The 3-month UI rates in these groups were 37%, 43%, 45% and 48%, respectively. The 6-month UI rates were 19%, 23%, 29% and 34%, respectively. The 12-month UI rates were 7%, 13%, 14% and 15%, respectively (log-rank P < 0.001). The area under the curve was 71%, 70% and 68% at 3, 6 and 12 months, respectively. Conclusions We developed the first risk classification tool that predicts patients at high risk of UI after RP. These consisted mainly of individuals who were impotent before RP, elderly and/or overweight. This tool can be used for patient counselling.

What's known on the subject? and What does the study add? Previous studies have retrospectively compared functional and oncological outcomes between robot-assisted radical prostatectomy (RARP) and open retropubic radical prostatectomy (RRP), reporting non-inferior or superior outcomes associated with the use of the robotic approach. The study demonstrates that baseline selection biases makes comparisons of RARP and RRP problematic. Patients treated with RARP may have significantly better baseline characteristics than patients treated with RRP. Indeed, when both facilities are available within the same centre, patients with the most favourable clinical and cancer profile are inherently selected to RARP. In the absence of a prospective randomized trial, the decision to prefer one approach over another should be tailored according to each single patient and surgeon. Objective To evaluate the trend in robot-assisted radical prostatectomy (RARP) and open retropubic radical prostatectomy (RRP) use over time and to compare preoperative and pathological characteristics of patients treated with RARP or RRP at a single centre. Patients and Methods Between 2006 and 2010, 2511 consecutive patients treated with RP, with or without pelvic lymph node dissection (PLND), for prostate cancer (PCa) at a single tertiary care centre were analysed. Baseline patient characteristics and PCa risk distribution were compared according to treatment type (RRP vs RARP) in the overall population, as well as in three surgeons' initial 50 RARP and three surgeons' initial 50 RRP cases (n = 300). We used a chi-squared trend test to evaluate the differences in treatment type administration over time according to PCa characteristics. Logistic regression analyses focused on the prediction of PLND and adjuvant radiotherapy (RT) use. Results Overall, 1873 (74.6%) and 638 (25.4%) patients underwent RRP and RARP, respectively. Men treated with RARP were younger (mean age: 62 vs 65 years), less obese (mean BMI: 24.8 vs 26.4 kg/m2), healthier (Charlson comorbidity index = 0: 68.7 vs 53.3%) and more likely to harbour clinical low-risk PCa (51 vs 30%) than their RRP counterparts (all P < 0.001). Similar findings were observed in sub-analyses focusing on six surgeons' 50 initial patients (all P ≤ 0.02). A significant increase in the rate of patients with low-risk PCa treated with RARP vs RRP was reported over time (5 vs 95% and 66 vs 34% in 2006 and 2010, respectively). Conversely, 76% of patients with high risk PCa were still treated with RRP in 2010. Patients treated with RARP were less likely to receive PLND at RP and adjuvant RT (all P ≤ 0.01), even after adjusting for clinical and PCa characteristics. Conclusions The introduction of a robotic training programme at a high volume centre led to significant patient selection in terms of clinical and PCa characteristics. When both RRP and RARP facilities are available within the same centre, patients with the most favourable clinical and cancer profile are selected to undergo RARP. Use of RARP negatively influenced the rates and the extent of PLND as well as the use of adjuvant RT after surgery. Thus, baseline patient selection, surgical and treatment biases make any comparisons of RARP with RRP problematic.

What's known on the subject? and What does the study add? The European Association of Urology (EAU) guidelines recommend an inguinal lymph node dissection (ILND) in patients with T1G2-3 squamous cell carcinoma of the penis (SCCP). To date, only four series reported the rates of cancer-specific mortality (CSM) after primary tumor excision (PTE) without an ILND in patients with T1 clinically node-negative (cN0) SCCP. We examined CSM rates in cN0 patients with T1G1-3 SCCP, in whom an ILND was not performed, relying on competing-risks analyses. OBJECTIVE • To quantify and compare cancer-specific mortality (CSM) and other-cause mortality (OCM) in individuals with stage T1G1–3 clinically node-negative (cN0) squamous cell carcinoma of the penis (SCCP) since there is no consensus regarding the need for an inguinal lymph node dissection (ILND) in patients with T1G2–3 cN0 SCCP. METHODS • Relying on the Surveillance, Epidemiology and End Results database, we identified 655 patients diagnosed with primary SCCP between 1988 and 2006. • Cumulative incidence plots were used to graphically depict the effect of CSM relative to OCM. • Competing-risks regression analyses were used to quantify the risk of CSM or OCM after adjusting for age, race, tumour grade and surgery type. RESULTS • The 5-year CSM rates after a primary tumour excision without ILND were 2.6%, 10.0% and 15.9% in patients with respectively T1G1, T1G2 and T1G3 cN0 SCCP. • The 5-year OCM rates were 29.5%, 27.3% and 29.3% in patients with respectively T1G1, T1G2 and T1G3. • Age failed to provide additional stratification. CONCLUSIONS • The CSM rate was highest in T1G3 patients and appears to justify ILND. • Conversely, the CSM rate was lowest in T1G1 patients, which justifies active surveillance in this patient subset. • A moderate CSM rate at 5 years was recorded for T1G2 patients, which brings into question the benefits of ILND.

Objectives To examine cancer-specific mortality in patients with nodal metastases relative to patients without nodal involvement at nephrectomy for non-metastatic renal cell carcinoma in a population-based cohort. Methods A total of 11 374 non-metastatic renal cell carcinoma patients who underwent a lymph node dissection at nephrectomy were identified using the Surveillance, Epidemiology and End Results database (1988–2008). The 5-year cancer-specific mortality-free survival rates were examined according to the presence or absence of nodal involvement within the entire cohort, and stratified according to pathological tumor stage (pT1 vs pT2 vs pT3 vs pT4) and Fuhrman grade (I vs II vs III vs IV). Cox regression analyses for prediction of cancer-specific mortality were modeled to assess the effect of nodal metastases versus no nodal involvement in the entire population. Finally, separate Cox regression models were fitted within each pathological stage and grade. Results Overall, 1260 (11%) patients had nodal metastases at nephrectomy. The overall 5-year cancer-specific mortality-free survival rates were 38.4 versus 83.8% in patients with nodal metastases and without nodal metastases, respectively. In multivariable analyses, amongst pT1, pT2, pT3 and pT4, patients with nodal metastases were 6.0-, 3.6-, 3.2- and 2.0-fold, respectively, more likely to die after nephrectomy (all P

Objectives The 2004 National Comprehensive Cancer Network practice guidelines recommend pelvic lymph node dissection at radical prostatectomy. We sought to examine the adherence to the 2004 National Comprehensive Cancer Network guidelines and to test the their accuracy, as well as the accuracy of the most contemporary National Comprehensive Cancer Network, American Urological Association, and European Association of Urology guidelines to predict lymph node metastases. Methods A total of 33 037 radical prostatectomy patients were identified, between 2004 and 2006. Adherence to the 2004 National Comprehensive Cancer Network guidelines was calculated using three clinically plausible cut-offs: 2, 5 and 10%. The accuracy was tested using the area under the curve. Results Overall, 63% of patients underwent pelvic lymph node dissection. Of those, 61, 49 and 45% were managed according to the 2004 National Comprehensive Cancer Network guideline cut-off of 2, 5 and 10%, respectively. The accuracy of all the examined guidelines ranged from 61% to 71%. The highest accuracy was recorded for the European Association of Urology and the 2004 National Comprehensive Cancer Network cut-off 5% guidelines. The lowest accuracy was recorded for the most contemporary National Comprehensive Cancer Network guideline. Conclusions Adherence to the 2004 National Comprehensive Cancer Network guidelines was suboptimal. The accuracy of all the examined guidelines ranged from 61% to 71%. None of the examined guidelines can be regarded as an ideal indication for pelvic lymph node dissection.

BJU Int 2012; Epub ahead of print. Objective: To quantify the effect of partial nephrectomy (PN) vs radical nephrectomy (RN) on other-cause mortality (OCM) in elderly patients with localized renal cell carcinoma (RCC) and/or multiple comorbidities. Methods: Using the Surveillance, Epidemiology, and End Results Medicarelinked database, patients with T1 RCC, aged 75 years, or who had 2 comorbidities, were identified (1988‐2005). To adjust for inherent differences between treatment types, propensity-based matched analyses were performed. Competing-risks regression analyses for prediction of OCM were assessed according to treatment type. The effect of PN and RN on OCM was examined in three sub-groups: patients aged 75 years; patients with 2 comorbidities; and patients aged 75 years with 2 comorbidities. Results: After propensity-based matched analyses and adjustment for all covariates, PN was found to exert a protective effect relative to RN with respect to OCM in all patients (hazard ratio [HR]: 0.84, P 0.048). In subanalyses, no difference was recorded between PN and RN in patients who were aged 75 years (HR: 0.83, P 0.2), with 2 baseline comorbidities at diagnosis (HR: 0.83, P 0.1), or in patients who were aged 75 years and who had 2 baseline comorbidities (HR: 0.77, P 0.2). Conclusions: Some elderly patients and/or those with multiple comorbidities at diagnosis may not benefit from PN with respect to OCM. After rigorous patient selection, alternative treatment options could be considered. Editorial Comment: Changes in renal physiology occur as a normal part of the aging process and include reduced renal blood flow, decreased renal size and reduced overall glomerular filtration rate. In patients with renal masses that are amenable to partial nephrectomy the procedure is used to spare normal renal tissue and help preserve function. Clinical studies have demonstrated excellent oncologic outcomes compared to radical nephrectomy in appropriately selected patients. This study compared mortality from nononcologic outcomes in otherwise healthy elderly subjects, younger patients with multiple comorbidities and elderly patients with multiple comorbidities. The data showed that some elderly patients and those with multiple comorbidities did not benefit significantly from partial nephrectomy in terms of the measured outcomes. This finding raises important questions about the use of this treatment in all patients and might help guide selection of the most appropriate surgical candidates.

Objectives: To compare the mortality outcomes of radical prostatectomy and radiotherapy as treatment modalities for patients with localized prostate cancer. Methods: Our cohort consisted of 68 665 patients with localized prostate cancer, treated with radical prostatectomy or radiotherapy, between 1992 and 2005. Propensity-score matching was used to minimize potential bias related to treatment assignment. Competing-risks analyses tested the effect of treatment type on cancer-specific mortality, after accounting for other-cause mortality. All analyses were stratified according to prostate cancer risk groups, baseline Charlson Comorbidity Index and age. Results: For patients treated with radical prostatectomy versus radiotherapy, the 10-year cancer-specific mortality rates were 1.4 versus 3.9% in low-intermediate risk prostate cancer and 6.8 versus 11.5% in high-risk prostate cancer, respectively. Rates were 2.4 versus 5.9% in patients with Charlson Comorbidity Index of 0, 2.4 versus 5.1% in patients with Charlson Comorbidity Index of 1, and 2.9 versus 5.2% in patients with Charlson Comorbidity Index of ≥2. Rates were 2.1 versus 5.0% in patients aged 65–69 years, 2.8 versus 5.5% in patients aged 70–74 years, and 2.9 versus 7.6% in patients aged 75–80 years (all P

Study Type – Prognosis (cohort) Level of Evidence 2a What's known on the subject? and What does the study add? Married individuals have lower morbidity and mortality rates for all major causes of death. Cancer-specific survival is better in married patients with testis cancer, prostate cancer, breast cancer, cervical cancer, as well as head and neck cancers. We have found the effect of marital status on outcomes after radical cystectomy to be variable, depending on gender and the outcome addressed. Being married is predictive of lower all-cause mortality for both men and women relative to their separated, divorced or widowed (SDW) or never-married counterparts. It is also predictive of lower bladder-cancer-specific mortality relative to SDW individuals. Marriage also exerts a protective effect on men regarding non-organ-confined disease, with those never having married having significantly higher rates. OBJECTIVES • To examine the effect of marital status (MS) on the rate of non-organ-confined disease (NOCD) at radical cystectomy (RC) • To assess the effect of MS on the rate of bladder-cancer-specific mortality (BCSM) and all-cause mortality (ACM) after RC for urothelial carcinoma of the urinary bladder (UCUB). MATERIALS AND METHODS • A total of 14 859 patients, who underwent RC for UCUB, were captured within the Surveillance, Epidemiology, and End Results database, between 1988 and 2006. • Logistic regression analysis was used to assess the rate of NOCD (T3-4/NI-3/M0) at RC and Cox regression analyses were used to assess BCSM and ACM. • Analyses were stratified according to gender; covariates included socio-economic status, tumour stage, age, race, tumour grade and year of surgery. RESULTS • Never-married males had a higher rate of NOCD at RC (odds ratio = 1.22, P= 0.004), an effect not found in never-married females. • Separated, divorced or widowed (SDW) males (hazard ratio [HR]= 1.18, P= 0.005) and females (HR = 1.16, P= 0.002) had higher rates of BCSM than their married counterparts. • SDW and never-married males had higher rates of ACM than their married counterparts (HR = 1.22, P < 0.001 and HR = 1.26, P < 0.001, respectively). • SDW and never-married females also had higher rates of ACM than married females (HR = 1.24, P < 0.001 and HR = 1.22, P= 0.01, respectively). CONCLUSIONS • For both men and women, being SDW conveyed an increased risk of BCSM after RC. • SDW and never marrying had a deleterious effect on ACM. • Unfavourable stage at RC was also seen more commonly in never-married males.

Objectives: To test the relationship between the extent of pelvic lymph node dissection at radical prostatectomy and the rate of lymph node metastases, and to identify the ideal number of lymph nodes that should be removed to achieve an optimal staging. Methods: We assessed 20 789 prostate cancer patients treated with radical prostatectomy and pelvic lymph node dissection between 2004 and 2006. Receiver operating characteristics analyses were used to define the probability of correctly staging lymph node metastases patients according to lymph node count. Univariable and multivariable regression analyses tested the relationship between lymph node count and lymph node metastases rate. Results: The average lymph node count was 6.4 (median 5.0). Overall, the lymph node metastases rate was 2.5%; and it resulted to be 0.2, 1.5 and 6.7% in low, intermediate and high-risk tumors, respectively. The rate of lymph node metastases was 3.5 and 6.7% in patients with 10 and 20 lymph node count, respectively. Removing 20 lymph nodes yielded a 90% probability of correctly staging lymph node metastases, regardless of risk group. In multivariable analysis, lymph node count was an independent predictor of lymph node metastases stage (odds ratio: 1.07, P

BACKGROUND: The authors explored the effect of Leapfrog volume thresholds (LVTs) on 5 short-term radical prostatectomy (RP) outcomes. METHODS: Within the Health Care Utilization Project Nationwide Inpatient Sample (NIS), the authors focused on RPs performed within the 7 most contemporary years (2001-2007). They tested rates of in-hospital mortality, intraoperative complications, postoperative complications, and blood transfusions as well as the mean length of stay (LOS), stratified according to the number of LVTs that were met. Multivariable regression analyses were adjusted further for potential confounders. RESULTS: Overall, 36.2%, 17.3%, 14.9%, 15.7%, 12.9%, and 3% of RPs were performed at institutions that reached 0 LVT, 1 LVT, 2 LVTs, 3 LVTs, 4 LVTs, and 5 LVTs, respectively. Relative to patients who underwent RP at institutions that reached 0 LVTs, patients who underwent RP at institutions that reached 5 LVTs had fewer comorbidities, were younger, were more likely to hold private insurance, and were more likely to undergo concomitant pelvic lymphadenectomy (all P < .001). In multivariable analyses adjusted for hospital volume (HV), age, race, year of surgery, Charlson Comorbidity Index, hospital region and location, pelvic lymphadenectomy, and insurance status, LVT status was related inversely to LOS and the likelihood of receiving blood transfusions (both P < .001). CONCLUSIONS: The current results indicated that LVTs can provide a highly accurate prediction of the probability of 2 important, detrimental, short-term outcomes after RP, even after accounting for HV. The benefit at institutions that meet LVTs may exceed that at other institutions when short-term RP outcomes are considered. This observation should be taken into consideration when treatment decisions are made, especially because most RPs were performed at institutions that did not meet any LVTs. Cancer 2012. © 2012 American Cancer Society.

Study Type – Therapy (population cohort) Level of Evidence 2b What's known on the subject? and What does the study add? Patients with renal failure more frequently harbour RCC due to predisposing factors such as cystic disease of the kidney. The benefit of nephrectomy might be outweighed by adverse perioperative events, however, which may be more prevalent in patients with end-stage renal disease (ESRD). In a population-based study focusing on patients after non-elective colorectal surgery, patients with ESRD had an increased risk of mortality and complications. To date, small-scale studies have reported complication rates in patients with ESRD after nephrectomy for RCC with conflicting results. However, no formal contemporary analysis has been compiled within a nephrectomy cohort of adequate size. The present population-based case–control study showed that patients with ESRD are at substantially higher risk of in-hospital mortality and in-hospital complications. Specifically, we demonstrated higher cardiac-related complications, transfusion and haemorrhage/haematoma rates in patients with ESRD than in others. Moreover, patients with ESRD are more likely to have prolonged length of stay in hospital, and incur higher hospital charges. Based on the findings of the present study, use of biopsy and active surveillance for small, carefully selected renal masses might be considered in patients with ESRD at high risk of morbidity and mortality after surgery. OBJECTIVE • To examine the effect of end-stage renal disease (ESRD) on six short-term nephrectomy outcomes. PATIENTS AND METHODS • The Nationwide Inpatient Sample was used to assess the rates of blood transfusions, intra-operative and postoperative complications, length of hospital stay (LOS) within the highest quartile (>5 days), total hospital charges within the highest quartile (>$33 391) and in-hospital mortality. • Propensity-based matching was performed to adjust for potential baseline differences between patients with ESRD and others. • Multivariable logistic regression analyses further adjusted for confounding variables. RESULTS • Overall, 46 225 patients underwent open radical, open partial, laparoscopic radical or laparoscopic partial nephrectomy for non-metastatic kidney cancer between 1998 and 2007. • Of those, 941 patients with ESRD were identified (2.0%). • For patients with ESRD and others, the following rates were recorded, respectively: blood transfusions, 17.4 vs 9.1% (P < 0.001); intra-operative complications, 3.5 vs 3.3% (P= 0.81); postoperative complications, 19.2 vs 15.6% (P= 0.007); length of stay within the highest quartile, 55.4 vs 30.1% (P < 0.001); total hospital charges within the highest quartile, 50.4 vs 26.3% (P < 0.001); in-hospital mortality, 2.4 vs 0.5% (P < 0.001). • In multivariable logistic regression analyses, patients with ESRD were more likely to receive a blood transfusion (odds ratio [OR]= 2.05, P < 0.001), to experience any postoperative complication (OR = 1.25, P= 0.019), to have a LOS within the highest quartile (OR = 3.06, P < 0.001), to have hospital charges within the highest quartile (OR = 3.10, P < 0.001), and to die during hospitalization (OR = 4.85, P < 0.001). CONCLUSIONS • Patients with ESRD are at substantially higher risk of adverse outcomes after nephrectomy. • Most importantly, the in-hospital mortality rate is fivefold higher.

UNLABELLED What's known on the subject? and What does the study add? Several risk factors increase VTE after RP: advanced age, comorbidities such as cardiopulmonary disease, rheumatologic diseases, prior history of VTE, more advanced prostate cancer, and simultaneous pelvic lymph node dissection. To date, the effect of annual surgical caseload (ASC), an established determinant of various RP outcomes, has not been tested. A previous study showed in adjusted analyses that patients operated for colorectal cancer by very high ASC surgeons were 60% less likely to suffer a VTE than those operated by low ASC surgeons. Moreover, some authors hypothesized that laparoscopy may contribute to a higher risk of VTE, due to peritoneal insufflation, reverse Trendelenburg position and prolonged operative time. The VTE rates reported in the current population-based study closely reflect those reported in institutional series. Moreover, we validated the practice-makes-perfect concept, since ASC was linked to VTE. We could not detect statistically significantly differences between minimally invasive radical prostatectomy (MIRP) patients and others. Our results indicate that lower rates of VTE should be expected in patients treated by high ASC surgeons. Our findings suggest that VTE-specific processes of care need to be improved, with the intent of reaching the level recorded in patients treated by high ASC surgeons. Finally, MIRP seems to be no risk factor for VTE. OBJECTIVE To examine the effect of annual surgical caseload (ASC) on the likelihood of venous thromboembolism (VTE) after radical prostatectomy (RP). PATIENTS AND METHODS Between 1999 and 2008, 36 699 RPs were performed in the state of Florida. Logistic regression models predicting the likelihood of VTE were fitted. Covariates included year of surgery, age, race, baseline Charlson Comorbidity Index (CCI), lymph node dissection, ASC and surgical approach. RESULTS The overall VTE rate was 0.3%. It was higher in patients operated within the low (0.4%) and intermediate (0.3%) ASC tertile than in those operated within the high-ASC tertile (0.1%, P < 0.001). Mortality rate was 6.0% in patients with VTE vs 0.1% in others (P < 0.001). Median length of stay and median total hospital charges were 9 vs 3 days (P < 0.001) and $51 571 vs $24 943 (P < 0.001) in patients with VTE vs others, respectively. In multivariable analyses predicting VTE, patients operated on by low-ASC surgeons were at higher risk of VTE than those operated on by high-ASC surgeons (odds ratio [OR] = 3.78, P < 0.001). Additionally, black patients were more likely to experience a VTE (OR = 1.80, P = 0.023). Patients with CCI ≥ 1 were also more likely to experience a VTE than others (OR = 1.65, P = 0.016). Conversely, patients who had undergone minimally invasive radical prostatectomy were not more likely to experience a VTE than those who had undergone open RP (OR = 1.97, P = 0.086). CONCLUSIONS RP by high-ASC surgeons exerts a protective effect on the likelihood of VTE. Additionally, VTE is associated with higher mortality, prolonged length of stay and increased hospital charges.

BACKGROUND: Socioeconomic status represents an established barrier to health care access. Age, sex, and race may also play a role. The authors examined whether these affect the access to high-volume hospitals for uro-oncologic procedures in the United States. METHODS: Within the Nationwide Inpatient Sample (NIS), the authors focused on radical prostatectomy (RP), radical cystectomy, and nephrectomy (Nx) performed within the 5 most contemporary years (2003-2007). Logistic regression models were used to estimate the impact of the primary predictors on the likelihood of receiving care at a high-volume hospital. RESULTS: Between 2003 and 2007, 62,165 RP, 6557 radical cystectomy, and 28,062 Nx cases were recorded within the NIS. Patient age (P = .001), year of surgery (P = .001), Charlson Comorbidity Index (P ≤ .025), median Zip Code income (highest vs lowest quartile, P = .001), and insurance status (private vs Medicare, P = .008) were independent predictors of being treated at high-volume institutions. Moreover, black race was an independent predictor of decreased utilization of high-volume institutions for radical cystectomy (P = .012), and female sex was an independent predictor of decreased utilization of high-volume institutions for Nx (P = .016). CONCLUSIONS: On average, old, sick, poor, and Medicare patients were less likely to be treated at high-volume hospitals for uro-oncologic surgery. Similarly, black patients were less likely to have a radical cystectomy at a high-volume hospital, and female patients were less likely to have an Nx at a high-volume hospital. Selective referral of individuals who are less likely to receive care at such institutions may represent a health care priority intended to optimize outcomes across all population strata. Cancer 2012. © 2012 American Cancer Society.

Study Type – RCT (randomized trial) Level of Evidence 2b What's known on the subject? and What does the study add? In a previous randomized controlled trial, barbed polyglyconate suture for vesico-urethral anastomosis was associated with more frequent cystogram leaks, longer mean catheterization times and greater suture costs per case. In the current randomized controlled trial, we show that barbed polyglyconate suture is associated with decreased anastomosis time, decreased need to readjust suture tension, cost reduction, and equal continence and early/late urinary complication rates. OBJECTIVE • To examine the effectiveness of barbed polyglyconate suture (V-Loc 180; Covidien, Mansfield, MA, USA) compared with standard monofilament for posterior reconstruction (PR) and vesico-urethral anastomosis (VUA) during robot-assisted radical prostatectomy (RARP). PATIENTS AND METHODS • A prospective randomized controlled trial was conducted in 70 consecutive RARP cases by a single surgeon (K.C.Z.). • Standard VUA was performed using three 4-0 poliglecaprone 25 (Monocryl; Ethicon Endosurgery, Cincinnati, OH, USA) sutures secured with absorbable suture clips (LapraTy, Ethicon; one single 6-inch [15.2 cm] for PR and two attached 6-inch [15.2 cm] for VUA). • Barbed suture VUA was performed using two 3-0 6-inch (15.2 cm) barbed polyglyconate sutures. • Time to complete the suture set-up by the nursing team, anastomosis time and need to adjust suture tension were recorded. Suture-related complications, validated-questionnaire continence and cost were also examined. RESULTS • Compared with a conventional reconstruction technique, there was a significant reduction in mean nurse set-up time (31 vs. 294 s; P < 0.01) and reconstruction time (13.1 vs. 20.8 min; P < 0.01) for the barbed suture technique. • Need to readjust suture tension or to place additional suture clips for watertight closure was greater in the standard monofilament group than in the barbed suture group (6% vs. 24%; P= 0.03). • A cost reduction was recorded at our institution (48.05 vs. 70.25 $CAN) with the barbed suture technique. • With a mean follow-up of 6.2 months, no delayed anastomotic leak or bladder neck contracture was observed in either group. • Pad-free continence outcomes for the monofilament suture vs the barbed suture groups at 1 (64 vs. 69%, P= 0.6), 3 (76 vs. 81%, P= 0.5) and 6 months (88 vs. 92%, P= 0.7) were similar. CONCLUSIONS • Compared with standard monofilament suture, the unidirectional barbed polyglyconate suture appears to provide safe, efficient and cost-effective PR and VUA during RARP. • Use of the interlocked barbed polyglyconate suture technique prevents slippage, precluding the need for assistance, knot-tying and constant reassessment of anastomosis integrity.

UNLABELLED Study Type - Prognosis (case series) Level of Evidence 4 What's known on the subject? and What does the study add? Insulin-like growth factor II mRNA binding protein 3 (IMP3) is associated with poor outcomes in a variety of malignancies. The role of IMP3 in protate cancer remains poorly understood. IMP3 expression was associated with features of aggressive biology and aggressive prostate cancer recurrence after surgery. Although IMP3 is differentially expressed in patients with features of biologically aggressive prostate cancer, it does not have independent prognostic value in patients treated with RP. OBJECTIVE To evaluate the association of insulin-like growth factor II mRNA binding protein 3 (IMP3) with pathological features and outcomes in patients treated with radical prostatectomy (RP). PATIENTS AND METHODS Immunohistochemical staining for IMP3 was performed on archival tissue microarray specimens from 232 consecutive patients treated with RP for clinically localized disease. None of the patients received neoadjuvant or adjuvant radiation or hormone therapy. IMP3 expression was histologically categorized as normal or abnormal. Disease recurrence was classified as aggressive if metastases were present, post-recurrence prostate-specific antigen (PSA) doubling time was less than 10 months, or if the patients failed to respond to salvage local radiation therapy. RESULTS The median follow-up was 69.8 months (interquartile range [IQR]: 40.1-99.5). IMP3 expression was abnormal in 42 (18.1%) of 232 patients. IMP3 expression was associated with extracapsular extension (P= 0.020), seminal vesicle invasion (P= 0.024), lymphovascular invasion (P= 0.036) and a high pathological Gleason score (P= 0.009). The 5-year PSA recurrence-free survival for IMP3-negative patients was 83% (standard error [SE]= 3) vs 67% (SE = 8) in IMP3-positive patients (log-rank test, P= 0.015). In a multivariable analysis that adjusted for the effects of surgical margins, extracapsular extension and seminal vesicle invasion, PSA (hazard ratio [HR]: 1.04, P= 0.013), lymph node metastasis (HR: 16.7, P < 0.001) and a high pathological Gleason score (HR 4.3, P= 0.008) were significantly associated with PSA recurrence-free survival, whereas IMP3 expression was not (P= 0.11). Similarly, IMP3 expression was only associated with aggressive recurrence (HR 3.2, P= 0.006). CONCLUSION IMP3 expression is abnormal in approximately one-fifth of prostate cancers. Although IMP3 is differentially expressed in patients with features of biologically aggressive prostate cancer, it does not have an independent prognostic value in patients treated with RP.

Study Type – Prognosis (cohort series) Level of Evidence 2a What's known on the subject? and What does the study add? Nodal metastases, even in the absence of distant metastases, portend a bad prognosis. The percentage of positive nodes (PPN) represents an important predictor of cancer-specific mortality (CSM) in patients in the group TanyN1M0. In consequence, universal inclusion of PPN should be considered in prospective and retrospective CSM analyses. OBJECTIVES • To examine the outcomes of patients with node-positive renal cell carcinoma (RCC) in the absence of distant metastases in a large population-based cohort of patients • To examine the ability of standard risk factors to predict cancer-specific mortality (CSM). PATIENTS AND METHODS • Using the Surveillance, Epidemiology, and End Results database, a total of 799 patients with RCC nodal metastases and absence of distant metastases undergoing nephrectomy were identified. • Univariable and multivariable analyses was performed with the aim of identifying independent predictors of CSM in this cohort of patients. • Specifically, we examined the effect of the number of removed nodes (NRN), the number of positive nodes (NPN) and the percentage of positive nodes (PPN) on CSM. RESULTS • Actuarial survival estimates showed that 53.2, 37.8 and 25.7% of patients survived at 24, 60 and 120 months after nephrectomy. • In Kaplan–Meier analyses, NRN failed to clearly discriminate between recorded CSM rates (log rank P= 0.07). • Discrimination was noted when CSM was stratified according to NPN (log rank P= 0.02) and PPN (log rank P= 0.001). • In multivariable analyses, age, Fuhrman grade, histological subtype, T stage and PPN were independent predictors of CSM. CONCLUSIONS • Our data indicate that CSM of patients with exclusive nodal metastases differs according to PPN. • Consequently, PPN warrants consideration in future prognostic schemes.

Study Type – Therapy (cohort) Level of Evidence 2b What's known on the subject? and What does the study add? While cytoreductive nephrectomy is associated with a survival benefit in the context of metastatic renal cell carcinoma, the rates of morbidity and perioperative mortality remain non-negligible. For example, perioperative mortality may be as high as 21% in elderly patients. The study shows that perioperative death amongst the elderly was substantially lower than what was previously reported from a single institutional report. Nonetheless, postoperative adverse outcomes were non-negligible in elderly patients relative to their younger counterparts. In consequence, these rates should be discussed at informed consent and a rigorous patient selection remains essential. OBJECTIVE • To examine the rate of perioperative mortality (PM), and other adverse outcomes in ‘elderly’ patients treated with cytoreductive nephrectomy (CNT). MATERIAL AND METHODS • Patients who underwent CNT for metastatic renal cell carcinoma were abstracted from the Nationwide Inpatient Sample (1998–2007). ‘Elderly’ was defined as ≥75 years, according to previous definition. • Endpoints consisted of PM, intraoperative and postoperative complications, blood transfusions and length of stay. • We adjusted for the effect of elderly status within five separate logistic regression models. Covariates consisted of comorbidity, race, gender, year of surgery and hospital region. RESULTS • Overall, CNT was performed in 504 (15.3%) elderly patients and in 2796 (84.7%) ‘younger’ patients (

UNLABELLED Study Type--Therapy (case series). Level of Evidence 4. What's known on the subject? And what does the study add? Adverse outcomes after radical prostatectomy are more often recorded in the elderly. In the USA, elderly patients undergoing radical prostatectomy are treated at institutions where suboptimal outcomes are recorded. OBJECTIVE • To assess the rate of adverse outcomes after open radical prostatectomy (ORP) in the elderly and to examine the effect of annual hospital caseload (AHC) and academic institutional status on adverse outcomes in these of patients. PATIENTS AND METHODS • Within the Health Care Utilization Project Nationwide Inpatient Sample, we focused on ORPs performed between 1998 and 2007. Subsequently, we restricted to patients aged ≥75 years. • In both datasets, we examined transfusion rates, intra-operative and postoperative complication rates, and in-hospital mortality rates. • Stratification was performed according to AHC tertiles and academic status. • Multivariable logistic regression analyses were fitted. RESULTS • Of 115,554 ORP patients, 2109 (1.8%) were aged ≥75 years. • In multivariable analyses performed in the entire cohort, elderly age increased homologous blood transfusion rates (P < 0.001), intra-operative (P= 0.001) and postoperative (P < 0.001) complication rates, and the mortality rate (P= 0.007). • Most elderly were treated at low or intermediate AHC (68.5%) and non-academic centres (56.2%). • Within the elderly cohort, intra-operative (2.9%) and postoperative (22.2%) complications tended to be highest at low AHC institutions compared to institutions of intermediate (2.7% and 17.4%) and high AHC (1.7% and 14.5%). Similarly, intra-operative (2.7% vs 2.1%) and postoperative complications (19.1% vs 13.9%) tended to be higher at non-academic than academic centres. • In multivariable analyses performed in the elderly subgroup, low AHC predicted higher intra-operative complications and higher homologous transfusions, whereas non-academic status predicted higher postoperative complications. CONCLUSIONS • Adverse outcomes are more often recorded in the elderly. • Most elderly are treated at institutions where suboptimal outcomes are recorded.

Study Type – Therapy (cohort) Level of Evidence 2b What's known on the subject? and What does the study add? In patients treated with radical cystectomy, pelvic lymph node dissection may have a beneficial effect on cancer control outcomes. We examined the effect of pelvic lymph node dissection on stage-specific cancer control outcomes. OBJECTIVE • To examine the effect of stage-specific pelvic lymph node dissection (PLND) on cancer-specific (CSM) and overall mortality (OM) rates at radical cystectomy (RC) for bladder cancer. METHODS • Overall, 11 183 patients were treated with RC within the Surveillance, Epidemiology, and End Results database. • Univariable and multivariable Cox regression analyses tested the effect of PLND on CSM and OM rates, after stratifying according to pathological tumour stage. RESULTS • Overall, PLND was omitted in 25% of patients, and in 50, 35, 27, 16 and 23% of patients with respectively pTa/is, pT1, pT2, pT3 and pT4 disease (P

Study Type – Decision analysis (based on alternative scenarios) Level of Evidence 2b What's known on the subject? and What does the study add? Several studies have shown that abnormal levels of nuclear matrix protein 22 (NMP22) are associated with bladder cancer, and NMP22 has been approved by the FDA as a urinary biomarker for bladder cancer detection and surveillance. However, the benefit of adding NMP22 to the clinical care of patients remains unclear. Decision curve analysis incorporates the consequences of clinical decisions, such as an increased number of unnecessary cystoscopies or missed cancers. OBJECTIVE • To employ decision curve analysis to determine the impact of nuclear matrix protein 22 (NMP22) on clinical decision making in the detection of bladder cancer using data from a prospective trial. PATIENTS AND METHODS • The study included 1303 patients at risk for bladder cancer who underwent cystoscopy, urine cytology and measurement of urinary NMP22 levels. • We constructed several prediction models to estimate risk of bladder cancer. The base model was generated using patient characteristics (age, gender, race, smoking and haematuria); cytology and NMP22 were added to the base model to determine effects on predictive accuracy. • Clinical net benefit was calculated by summing the benefits and subtracting the harms and weighting these by the threshold probability at which a patient or clinician would opt for cystoscopy. RESULTS • In all, 72 patients were found to have bladder cancer (5.5%). In univariate analyses, NMP22 was the strongest predictor of bladder cancer presence (predictive accuracy 71.3%), followed by age (67.5%) and cytology (64.3%). • In multivariable prediction models, NMP22 improved the predictive accuracy of the base model by 8.2% (area under the curve 70.2–78.4%) and of the base model plus cytology by 4.2% (area under the curve 75.9–80.1%). • Decision curve analysis revealed that adding NMP22 to other models increased clinical benefit, particularly at higher threshold probabilities. CONCLUSIONS • NMP22 is a strong, independent predictor of bladder cancer. • Addition of NMP22 improves the accuracy of standard predictors by a statistically and clinically significant margin. • Decision curve analysis suggests that integration of NMP22 into clinical decision making helps avoid unnecessary cystoscopies, with minimal increased risk of missing a cancer.