Associations Between Female Sex and Treatment Patterns and Outcomes for Muscle-invasive Bladder Cancer.

OBJECTIVE: To investigate the association of female sex with the selected treatment for patients with nonmetastatic muscle-invasive bladder cancer. Sex is a known independent predictor of death from bladder cancer. A potential explanation for this survival disparity is difference in treatment pattern and stage presentation among males and females. MATERIALS AND METHODS: Using the surveillance, epidemiology, and end results-medicare data set, we identified 6809 patients initially diagnosed with nonmetastatic muscle-invasive bladder cancer between 2004 and 2014. We fit multivariable logistic regression and Cox models to assess the relationship of sex with treatment modality and survival adjusting for differences in patient characteristics. RESULTS: Of the 6809 patients with nonmetastatic muscle invasive bladder cancer, 2528 (37%) received a radical cystectomy while 4281 (63%) received an alternative bladder sparing intervention. Women were significantly more likely to receive a cystectomy (odds ratios [OR] 1.39; 95% confidence intervals [CI] 1.20-1.61), present at an older age with less comorbidities compared to men (P <.001). Women were also found to have worse bladder cancer-specific survival (CSS) than men (hazard ratio [HR] 1.18; 95% CI 1.05-1.32), no difference in overall survival (OS) (female HR 0.93; 0.86-1.01) and lower mortality from other causes (HR 0.78; 95% CI 0.70-0.86). There were no differences in OS and CSS by sex in patients with stage pT4a. CONCLUSION: Female sex predicted more aggressive treatment with radical cystectomy yet worse cancer-specific survival than males. This sex disparity in CSS reduced the known OS advantage observed in women.

Increasing use of positron emission tomography among medicare beneficiaries undergoing radical cystectomy.

OBJECTIVE: To examine factors associated with PET scan use in the pre-operative evaluation of patients diagnosed with bladder cancer. METHODS: Using SEER-Medicare data, we identified bladder cancer patients who underwent radical cystectomy from 2006 to 2011 (n = 4,138). The primary outcome was PET scan use within 6 months before surgery. To examine predictors of PET scan use, we fit a mixed logit model with health service area as a random effect to account for patients nested within health service areas. We also calculated the adjusted probability of use over time and examined variation among the highest volume surgeons. RESULTS: Among the 4,138 patients, 406 (10%) received a pre-operative PET scan. The adjusted probability of a patient undergoing a PET scan increased from 0.04 in 2004 to 0.10 in 2011 (p < .001). Among the 78 highest volume surgeons, there was significant variation in PET scan use (p < .001). Patients with non-urothelial histology, measurement of alkaline phosphatase levels, and receipt of neoadjuvant chemotherapy were more likely to receive PET scan (all p < .05). CONCLUSION: Use of PET prior to radical cystectomy doubled over a 5-year period, suggesting its increased use in patients with muscle-invasive bladder cancer, particularly those with high-risk disease. Whether its use is warranted and improves patient outcomes is not clear and requires further studies.

Comparison of Neoadjuvant and Adjuvant Chemotherapy in Muscle-invasive Bladder Cancer.

BACKGROUND: We use observational methods to compare impact of perioperative chemotherapy timing (ie, neoadjuvant and adjuvant) on overall survival (OS) in muscle-invasive bladder cancer because there is no head-to-head randomized trial, and patient factors may influence decision-making. PATIENTS AND METHODS: Using Surveillance, Epidemiology, and End Results-Medicare data, we identified patients receiving cystectomy for muscle-invasive bladder cancer diagnosed between 2004 and 2013. Patients were classified as receiving neoadjuvant or adjuvant chemotherapy. Propensity of receiving neoadjuvant chemotherapy was determined using gradient boosted models. Inverse probability of treatment weighted survival curves were adjusted for 13 demographic, socioeconomic, temporal, and oncologic covariates. RESULTS: We identified 1342 patients who received neoadjuvant (n = 676) or adjuvant chemotherapy (n = 666) with a median follow-up of 23 months (interquartile range, 9-55 months). Inverse probability of treatment weighted adjustment allows comparison of the groups head-to-head as well as counterfactual scenarios (eg, effect if those getting one treatment were to receive the other). The average treatment effect (ie, "head-to-head" comparison) of adjuvant compared with neoadjuvant on OS was not significant (hazard ratio, 1.14; 95% confidence interval, 0.99-1.31). However, the average treatment effect of the treated (ie, the effect if the neoadjuvant patients were to receive adjuvant instead) was associated with a 33% increase in risk of mortality if they were given adjuvant therapy instead (hazard ratio, 1.33; 95% confidence interval, 1.12-1.57). CONCLUSION: Significant treatment selection bias was noted in peri-cystectomy timing, which limits the ability to discriminate differential efficacy of these 2 approaches with observational data. However, patients with higher propensity to receive neoadjuvant therapy were predicted to have increased OS with approach, in keeping with existing paradigms from trial data.

Implications of Cystectomy Travel Distance for Hospital Readmission and Survival.

BACKGROUND: Regionalization of complex surgical care results in increasing need for patients to travel for complex oncologic procedures such as cystectomy in bladder cancer. We examined the association between travel distance to a cystectomy center, readmission, and survival. PATIENTS AND METHODS: Using Surveillance, Epidemiology, and End Results (SEER)-Medicare data, we identified bladder cancer patients undergoing radical cystectomy during 2004-2011. Patients were grouped into quartiles of distance to cystectomy center in miles (< 6 [close], 6-16.9 [moderately close], 17-47.9 [moderately far], ≥ 48 [far]). Multivariable logistic regression, accounting for clustering within hospitals, was used to assess the association between travel distance and readmission. A secondary analysis examined the association between travel distance and survival using multivariable proportional hazard regression. RESULTS: Among 4556 patients who underwent cystectomy, 1857 (41%) were readmitted, and 1251 (67%) of readmissions were to the index hospital. With increasing travel distance there was no significant difference in the overall rate of 90-day readmission. However, the farther a patient traveled, the lower the odds of being readmitted to the index hospital (adjusted odds ratio [95% confidence interval] as follows: moderately close, 0.43 miles [0.29-0.63]; moderately far, 0.14 miles [0.10-0.19]; and far, 0.07 [0.05-0.11]). Increasing travel distance was associated with improved survival. CONCLUSION: With greater distance traveled to a cystectomy center, rates of readmission to nonindex centers increased. Survival differences may be explained by the impact of travel burden on processes of care and case mix. Future efforts should focus on improving care coordination between index and nonindex hospitals and ensuring equitable access to cystectomy and other critical cancer services.

Trends and appropriateness of perioperative chemotherapy for muscle-invasive bladder cancer.

INTRODUCTION: Contemporary guidelines recommend cystectomy with neoadjuvant or adjuvant cisplatin-based chemotherapy given with curative intent for patients with resectable muscle-invasive bladder cancer (MIBC). However, rates and appropriateness of perioperative chemotherapy utilization remain unclear. We therefore sought to characterize use of perioperative chemotherapy in older radical cystectomy MIBC patients and examine factors associated with use. METHODS: Using Surveillance, Epidemiology, and End Results (SEER)-Medicare data, we identified patients with MIBC diagnosed between 2004 and 2013 and treated with radical cystectomy. We classified patients into 3 treatment groups: cystectomy alone, neoadjuvant, or adjuvant chemotherapy. Chemotherapy was classified by regimen. We then fit a multinomial multivariable logistic regression model to assess association between patient factors with the receipt of each treatment. RESULTS: We identified 3,826 eligible patients. The majority (484; 65%) received cystectomy alone. Neoadjuvant (676; 18% overall, 69% cisplatin-based), and adjuvant chemotherapy (666, 17% overall, 55% cisplatin-based) were used in similar proportions of cystectomy patients. Over the study period, the odds of receiving adjuvant chemotherapy decreased by 7.5%, whereas neoadjuvant therapy increased by 27.5% (both P < 0.001). There was an increase in use of cisplatin-based regimens in the neoadjuvant setting (35 to 72%, P < 0.001), but not the adjuvant setting. Female gender, lower comorbidity, married status, and lower stage disease were associated with greater odds of receiving neoadjuvant chemotherapy (all P < 0.05). CONCLUSION: From 2004 to 2013 use of neoadjuvant chemotherapy for MIBC increased while use of adjuvant chemotherapy decreased. Future studies examining barriers to appropriate chemotherapy use, and the comparative effectiveness of neoadjuvant versus adjuvant chemotherapy are warranted.

Increasing Utilization of Multiparametric Magnetic Resonance Imaging in Prostate Cancer Active Surveillance.

OBJECTIVE: To characterize the use of multiparametric magnetic resonance imaging (mpMRI) in male Medicare beneficiaries electing active surveillance for prostate cancer. mpMRI has emerged as a tool that may improve risk-stratification and decrease repeated biopsies in men electing active surveillance. However, the extent to which mpMRI has been implemented in active surveillance has not been established. METHODS: Using Surveillance, Epidemiology, and End Results registry data linked to Medicare claims data, we identified men with localized prostate cancer diagnosed between 2008 and 2013 and managed with active surveillance. We classified men into 2 treatment groups: active surveillance without mpMRI and active surveillance with mpMRI. We then fit a multivariable logistic regression models to examine changing mpMRI utilization over time, and factors associated with the receipt of mpMRI. RESULTS: We identified 9467 men on active surveillance. Of these, 8178 (86%) did not receive mpMRI and 1289 (14%) received mpMRI. The likelihood of receiving mpMRI over the entire study period increased by 3.7% (P = .004). On multivariable logistic regression, patients who were younger, white, had lower comorbidity burden, lived in the northeast and west, had higher incomes and lived in more urban areas had greater odds of receiving mpMRI (all P < .05). CONCLUSION: From 2008 to 2013, use of mpMRI in active surveillance increased gradually but significantly. Receipt of mpMRI among men on surveillance for prostate cancer varied significantly across demographic, geographic, and socioeconomic strata. Going forward, studies should investigate causes for this variation and define ideal strategies for equitable, cost-effective dissemination of mpMRI technology.

Downstream Studies Following the Use of Bone Scan in the Staging of Muscle-invasive Bladder Cancer.

OBJECTIVE: To quantify the use of downstream studies following staging bone scans in patients with muscle-invasive bladder cancer. Bone scans may be obtained in high-risk bladder cancer patients prior to radical cystectomy to exclude bone metastases. However, false-positive bone scans can occur, resulting in the need for additional studies. PATIENTS AND METHODS: Using Surveillance, Epidemiology, and End Results (SEER)-Medicare data, we identified 4404 patients diagnosed with muscle-invasive bladder cancer from 2004 to 2011. We further identified those who underwent a bone scan prior to treatment within 6 months of diagnosis and prior to any treatment with cystectomy, radiotherapy, or chemotherapy. We determined the proportion of patients who underwent a subsequent study (bone X-ray, bone CT, bone MRI, and/or bone biopsy) within 3 months of the bone scan and prior to treatment. RESULTS: Among patients diagnosed with muscle-invasive bladder cancer, 1373 (31%) had a staging bone scan of whom 26% received a downstream study (n = 213). Overall, 61 patients (7%) received downstream bone-specific X-rays, more than 141 patients (>17%) received bone-specific CTs, and 28 patients (3%) received bone-specific MRIs. The use of bone biopsy was rare (n < 11; <1%). The total cost of all downstream studies was $103,468. Furthermore, there was a one-month delay in treatment for those who received a downstream study compared to those who did not (P < 0.001). CONCLUSION: Use of bone scan in the staging of muscle-invasive bladder cancer often results in the need for additional downstream studies. The delay in treatment and cost burden of downstream studies highlights a potential disadvantage of the routine use of this staging modality.

Palliative care use amongst patients with bladder cancer.

OBJECTIVES: To describe the rate and determinants of palliative care use amongst Medicare beneficiaries with bladder cancer and encourage a national dialogue on improving coordinated urological, oncological, and palliative care in patients with genitourinary malignancies. PATIENTS AND METHODS: Using Surveillance, Epidemiology, and End Results-Medicare data, we identified patients diagnosed with muscle-invasive bladder cancer (MIBC) between 2008 and 2013. Our primary outcome was receipt of palliative care, defined as the presence of a claim submitted by a Hospice and Palliative Medicine subspecialist. We examined determinants of palliative care use using logistic regression analysis. RESULTS: Over the study period, 7303 patients were diagnosed with MIBC and 262 (3.6%) received palliative care. Of 2185 patients with advanced bladder cancer, defined as either T4, N+ , or M+ disease, 90 (4.1%) received palliative care. Most patients that received palliative care (>80%, >210/262) did so within 24 months of diagnosis. On multivariable analysis, patients receiving palliative care were more likely to be younger, female, have greater comorbidity, live in the central USA, and have undergone radical cystectomy as opposed to a bladder-sparing approach. The adjusted probability of receiving palliative care did not significantly change over time. CONCLUSIONS: Palliative care provides a host of benefits for patients with cancer, including improved spirituality, decrease in disease-specific symptoms, and better functional status. However, despite strong evidence for incorporating palliative care into standard oncological care, use in patients with bladder cancer is low at 4%. This study provides a conservative baseline estimate of current palliative care use and should serve as a foundation to further investigate physician-, patient-, and system-level barriers to this care.

Maintenance of epigenetic landscape requires CIZ1 and is corrupted in differentiated fibroblasts in long-term culture.

The inactive X chromosome (Xi) serves as a model for establishment and maintenance of repressed chromatin and the function of polycomb repressive complexes (PRC1/2). Here we show that Xi transiently relocates from the nuclear periphery towards the interior during its replication, in a process dependent on CIZ1. Compromised relocation of Xi in CIZ1-null primary mouse embryonic fibroblasts is accompanied by loss of PRC-mediated H2AK119Ub1 and H3K27me3, increased solubility of PRC2 catalytic subunit EZH2, and genome-wide deregulation of polycomb-regulated genes. Xi position in S phase is also corrupted in cells adapted to long-term culture (WT or CIZ1-null), and also accompanied by specific changes in EZH2 and its targets. The data are consistent with the idea that chromatin relocation during S phase contributes to maintenance of epigenetic landscape in primary cells, and that elevated soluble EZH2 is part of an error-prone mechanism by which modifying enzyme meets template when chromatin relocation is compromised.

Rate and Determinants of Completing Neoadjuvant Chemotherapy in Medicare Beneficiaries With Bladder Cancer: A SEER-Medicare Analysis.

OBJECTIVE: To determine the rate and determinants of neoadjuvant chemotherapy noncompletion in patients with muscle-invasive bladder cancer. METHODS: Using Surveillance, Epidemiology, and End Results-Medicare data, we identified all patients who underwent cystectomy between 2008-2013 and received chemotherapy within 6 months. Of these, 594 patients received neoadjuvant chemotherapy, defined as the presence of a claim for chemotherapy within the 180 days preceding cystectomy. Our primary outcome was noncompletion of neoadjuvant chemotherapy. We determined regimen-specific cut points for noncompletion based on clinical trials and national guidelines. RESULTS: Over the study period, 174 of 594 patients (29%) did not complete neoadjuvant chemotherapy. Noncompleters and completers received a median interquartile range of 4.4 (3.0-8.0) and 10.0 (7.7-11.2) weeks of chemotherapy, respectively. A total of 391 (66%) patients received a cisplatin-based regimen and 203 (34%) patients received an alternative regimen, with 27% and 33% not completing chemotherapy, respectively. After adjusting for covariates, age and geographic region were independently associated with failing to complete chemotherapy. CONCLUSION: Nearly 30% of patients who received neoadjuvant chemotherapy did not complete their regimen. Advanced age and nonclinical factors, such as practice patterns in certain geographic regions, may influence a patient's likelihood of successfully completing chemotherapy.

Small cell bladder cancer: should we consider prophylactic cranial irradiation?

PURPOSE: To describe the clinical characteristics, treatment patterns, and outcomes in patients with small cell bladder cancer at our institution, including those who received prophylactic cranial irradiation (PCI) for the prevention of intracranial recurrence. MATERIALS AND METHODS: Patients with small cell bladder cancer treated at a single institution between January 1990 and August 2015 were identified and analyzed retrospectively for demographics, tumor stage, treatment, and overall survival. RESULTS: Of 44 patients diagnosed with small cell bladder cancer, 11 (25%) had metastatic disease at the time of presentation. Treatment included systemic chemotherapy (70%), radical surgery (59%), and local radiation (39%). Six patients (14%) received PCI. Median overall survival was 10 months (IQR 4 - 41). Patients with extensive disease had worse overall survival than those with organ confined disease (8 months vs. 36 months, respectively, p = 0.04). Among those who received PCI, 33% achieved 5 - year survival. CONCLUSION: Outcomes for patients with small cell bladder cancer remain poor. Further research is indicated to determine if PCI increases overall survival in small call bladder cancer patients, especially those with extensive disease who respond to chemotherapy.

Effect of multimodal analgesia with paravertebral blocks on biochemical recurrence in men undergoing open radical prostatectomy.

BACKGROUND: Recent studies suggest that anesthetic technique during radical prostatectomy for prostate cancer may affect recurrence or progression. This association has previously been investigated in series that employ epidural analgesia. The objective of this study is to determine the association between the use of a multimodal analgesic approach incorporating paravertebral blocks and risk of biochemical recurrence following open radical prostatectomy. PATIENTS AND METHODS: Using a prospective database of 3,029 men undergoing open radical prostatectomy by a single surgeon, we identified 2,909 men who received no neoadjuvant androgen deprivation and had at least 1 year of follow up. We retrospectively compared patients who received general analgesia with opioid analgesia (1999-2003, n = 662) to those who received general analgesia with multimodal analgesia incorporating paravertebral blocks (2003-2014, n = 2,247). The primary outcome was time to biochemical recurrence. Biochemical recurrence-free interval was assessed using the Kaplan-Meier technique and compared using a multivariate Cox-proportional hazards regression model. RESULTS: In total, 395 patients (14%) experienced biochemical recurrence following radical prostatectomy, including 265 (12%) who received multimodal analgesia and 130 (20%) who did not (adjusted P = 0.27). After adjusting for age, race, body mass index, preoperative prostate specific antigen, grade, stage, perineural invasion, margin status, percent of tumor in the gland, and diameter of the dominant nodule, there was no difference in recurrence-free interval between groups (HR = 0.92, 95% CI: 0.73-1.17). CONCLUSION: Use of a multimodal analgesic approach incorporating paravertebral blocks is not associated with a reduced risk of biochemical recurrence following radical prostatectomy.

Cowper's Gland Syringocele.

Cowper's gland syringoceles are rare cystic dilations of the Cowper's gland duct. They are typically diagnosed in childhood but occasionally occur in adults. We report the case of a 28-year-old man who presented with a painful perineal and inferior scrotal mass and was found to have a large Cowper's gland syringocele extending into the scrotum associated with a scrotal abscess. Treatment consisted of surgical excision. The magnetic resonance imaging findings of this case are described.

The lack of a relationship between physician payments from drug manufacturers and Medicare claims for abiraterone and enzalutamide.

BACKGROUND: Interactions between industry and prescribers have raised concerns regarding conflicts of interest. To the best of the authors' knowledge, quantitative data measuring these interactions have been limited until recently. In the current study, the authors sought to determine whether an association exists between industry payments and prescriber behavior with regard to abiraterone and enzalutamide. METHODS: Two Centers for Medicare and Medicaid Services databases were combined to analyze oncologists and urologists who received industry payments and/or prescribed abiraterone and enzalutamide. Correlation analysis was constructed on prescription count and industry payments. Multivariable median regression examined predictors of change in prescription count per dollar of industry payment. Stratifying prescribers by quantile evaluated threshold effects on prescribers. RESULTS: The number of prescriptions was similar between prescribers who did and those who did not receive industry payment for both drugs. The median industry payment amount to prescribers differed between prescribers and nonprescribers for abiraterone ($72 vs $56) and enzalutamide ($59 vs $31). Although no statistical association was found to exist between industry payment amount and prescription count for abiraterone prescribers, an association was found to exist for enzalutamide prescribers (rho = 0.31). A small change was found with regard to prescription count per dollar of industry payment for abiraterone (0.0007 prescriptions) and enzalutamide (0.0006 prescriptions). The amount of industry payment needed to predict one additional prescription was found to be lower in the fourth and fifth quantiles compared with the first through third quantiles. CONCLUSIONS: No difference in prescription count was found to exist between prescribers who received industry payments and those who did not. A positive correlation was noted between industry payments and prescription count for enzalutamide. Ease of adoption may affect differences between the 2 drugs. Cancer 2017;123:4356-62. © 2017 American Cancer Society.

Epidemiology of the Small Renal Mass and the Treatment Disconnect Phenomenon.

The incidence of kidney cancer has steadily increased over recent decades, with most new cases now found when lesions are asymptomatic and small. This downward stage migration relates to the increasing use of abdominal imaging. Three public health epidemics-smoking, hypertension, and obesity-also play roles in the increase. Treatment mirrors the rise in incidence, with increasing interest in nephron-sparing therapies. Despite earlier detection and increasing treatment, the mortality rate has not decreased. This treatment disconnect phenomenon highlights the need to decrease unnecessary treatment of indolent tumors and address modifiable risk factors to reduce incidence and mortality.

Variations in Preoperative Use of Bone Scan Among Medicare Beneficiaries Undergoing Radical Cystectomy.

OBJECTIVE: To examine factors associated with bone scan use in patients undergoing radical cystectomy and to assess trends in use over time. MATERIALS AND METHODS: Using Surveillance, Epidemiology, and End Results-Medicare data, we identified 5573 patients who underwent radical cystectomy from 2004 to 2011. The primary outcome was completion of a bone scan within 6 months prior to surgery. Demographic, regional, and clinicopathologic predictors of bone scan use were examined using a mixed logit model with health service area as a random effect. RESULTS: Among radical cystectomy patients, 1754 (31%) completed a preoperative bone scan. Urologists ordered most of these studies (69%). The adjusted probability of a patient undergoing a bone scan decreased from 0.40 in 2004 to 0.29 in 2011 (P = .01). Compared with patients in the northeast region, those in the south, central, and west regions were less likely to have a bone scan (P <.001). Compared with those with stage ≤T1, patients with higher stage disease were more likely to have a bone scan (P <.001). Among the highest volume surgeons, there was significant variation in the proportion of patients who completed preoperative bone scans (P < .001). CONCLUSION: Despite a recent decline, bone scans are used frequently in the preoperative staging of bladder cancer. Although some clinical factors are associated with bone scan use, significant regional and provider variation suggest areas to improve standardization of practice.

The Relationship of Industry Payments to Prescribing Behavior: A Study of Degarelix and Denosumab.

INTRODUCTION: The influence of financial ties to pharmaceutical companies remains controversial. We aimed to assess a potential relationship between pharmaceutical payments and prescription patterns for degarelix and denosumab. MATERIALS AND METHODS: Medicare Provider Utilization and Payment Data: Physician and Other Supplier Public Use File (Medicare B) data containing 2012 claims compared to OpenPayments (Sunshine Act) data for the second half of 2013. Urologists and medical oncologists who billed Medicare for degarelix or denosumab were cross referenced in both databases and payments were aggregated into a consolidated dataset. Adjusted beneficiary count and total Medicare reimbursement were compared according to receipt of Sunshine payment, and an association between Sunshine payment amount and total Medicare reimbursement was also assessed. RESULTS: Of the 160 prescribers of degarelix and 1,507 prescribers of denosumab, 91 (57%) and 854 (57%) received Sunshine payment, respectively. Degarelix prescribers who received Sunshine payment had higher median total Medicare reimbursement ($13,257 vs. $9,554, p = 0.01). Denosumab prescribers who received Sunshine payment had both higher median adjusted beneficiary count (55 vs. 50, p < 0.001) and median total Medicare reimbursement ($69,620 vs. $60,732, p < 0.001). On multivariable analysis, both receipt of Sunshine payment (adjusted median difference $5,844, 95% CI $937 - $10,749) and oncology specialty (adjusted median difference $34,380, 95% CI $26,715 - $42,045) were independently associated with total Medicare reimbursement for denosumab. CONCLUSIONS: In the case of degarelix and denosumab, there is a weak association between pharmaceutical company payments on prescribers' prescription behavior patterns.

Biopsy Perineural Invasion in Prostate Cancer Patients Who Are Candidates for Active Surveillance by Strict and Expanded Criteria.

OBJECTIVE: To evaluate the association of biopsy perineural invasion (PNI) with adverse pathologic findings on radical prostatectomy in patients who would have been candidates for active surveillance (AS). METHODS: Using a prospectively populated database of 3084 men who underwent open radical prostatectomy, candidates for AS by strict (Johns Hopkins) and expanded (University of Toronto) criteria were identified. The presence of adverse pathologic features at radical prostatectomy was compared between those men with and without biopsy PNI. RESULTS: Of 596 men who met strict criteria for AS, 16 (3%) had biopsy PNI. In the strict AS cohort, there were no differences in adverse pathologic features at radical prostatectomy between those with and without PNI. Of 1197 men who were candidates for AS by expanded criteria, 102 (9%) had biopsy PNI. Men with biopsy PNI in the expanded AS cohort were more likely to have extraprostatic extension (P < .001) and pathologic upgrading (P = .01) at prostatectomy. In addition, those with PNI had larger dominant nodules (P < .001), and cancer comprised a greater percentage of their prostate glands (P < .001). There was no difference in the proportion with a positive margin between the 2 groups (P = .77). CONCLUSION: Biopsy PNI was rare in patients who met strict criteria for AS. Among those men who met expanded criteria, PNI was associated with adverse pathologic findings upon prostatectomy. The presence of biopsy PNI may have a role in further risk stratifying patients who meet expanded criteria for AS.

Urology Payments from Industry in the Sunshine Act.

INTRODUCTION: Payments to practitioners from drug and device manufacturers or group purchasing organizations are reported in the Centers for Medicare and Medicaid Services (CMS) databases as a part of the Sunshine Act. Characterizing these payments is a necessary step to identifying conflicts of interest and the influence of payments on practice patterns, if any. Payments have never been analyzed in detail amongst Urologists. MATERIALS AND METHODS: We reviewed the most recent CMS Open Payments database for the full year 2014, released on June 30, 2015. Urology practitioners were extracted and the database was analyzed for number of total payments, total dollar value of payments, mean, median, number of physicians, number of manufacturers, and number of drugs/biologicals. Data were further categorized according to provider specialty, form of payment, nature of payment, practitioner ownership, and dispute status. RESULTS: Payments totaled $32,450,382. Practitioner payments were unevenly distributed, with a median payment of $15. The majority of payments were in the form of food and beverage. Female pelvic medicine practitioners received the highest payments out of the provider specialties. The largest categorical difference from the median was in the form of stock, options, and other ownership interests ($24,050). Ownership status and disputed payments were associated with payment values above median values ($400 and $61, respectively). CONCLUSIONS: There are major disparities in industry payments to urology practitioners. Whether or not this influences practice patterns remains to be seen, though identifying categorical differences in payments is an important first step in the process.