Overall Survival and Associations of Insurance Status Among Hispanic Men With High-Risk Prostate Cancer.

Objectives Our objectives were to (1) determine the association between ethnicity and high-risk prostate cancer (PCa) survival and (2) determine whether this association is modified by insurance status. Methods We performed a retrospective review of the National Cancer Database (NCDB) from 2004 to 2017 of non-Hispanic White (NHW), Hispanic White (HW), or Black men with high-risk PCa. A multivariate Cox regression model was built to test the association between overall survival (OS) and race/ethnicity, insurance status, and their interaction, controlling for various socioeconomic and disease-specific variables. Results A total of 94,708 men with high-risk PCa were included in the analysis. Both HW and Black men had lower socioeconomic status characteristics and lower rates of private insurance. Race/ethnicity was significantly associated with OS in the adjusted analysis. Only Medicare demonstrated significantly worse OS. NHW (covariate-adjusted hazard ratio (aHR): 1.83, 95% CI: 1.45-2.32) and Black (aHR: 1.71, 05% CI: 1.34-2.19) men demonstrated significantly worse survival when compared to HW men. Subgroup analysis demonstrated significant differences occurring among HW men with private insurance/managed care when compared to those not insured, Medicaid, Medicare, and other government insurance types. Conclusion Despite socioeconomic and demographic disadvantages, HW men demonstrate improved OS compared to NHW men. Furthermore, HW men demonstrated improved OS compared to NHW men within nearly each insurance status type. This finding is likely the result of a complex multifactorial web and as such serves as an interesting hypothesis-generating study.

The PINNACLE Study: A Double-blind, Randomized, Sham-controlled Study Evaluating the Optilume BPH Catheter System for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.

PURPOSE: The Optilume BPH Catheter System is a novel drug/device combination minimally invasive surgical therapy for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. The PINNACLE study is a prospective, randomized, double-blind, sham-controlled clinical trial evaluating the safety and efficacy of Optilume BPH against a sham surgical procedure. MATERIALS AND METHODS: Eligible patients were men 50 years or older with symptomatic benign prostatic hyperplasia and a prostate size between 20 and 80 g. Subjects were randomized 2:1 to receive treatment with Optilume BPH or a sham surgical procedure. Blinding was maintained for subjects in both arms and evaluating personnel through 1 year postprocedure. Follow-up assessments included the International Prostate Symptom Score, uroflowmetry, and other quality-of-life and sexual function assessments. RESULTS: A total of 148 men were randomized (100 active, 48 sham) at 18 centers in the U.S. and Canada. Subjects randomized to receive Optilume BPH saw a reduction in International Prostate Symptom Score of 11.5±7.8 points at 1 year posttreatment, as compared to a reduction of 8.0±8.3 points at 3 months in the sham arm. Flow rate was dramatically improved after treatment with Optilume BPH, with an improvement of +10.3 mL/s from baseline to 1 year (+125%). CONCLUSIONS: Treatment with Optilume BPH provides immediate and sustained improvements in obstructive symptoms and flow rate while preserving erectile and ejaculatory function. Treatment is well tolerated and can be done in an office or ambulatory setting.

Efficacy of National Comprehensive Cancer Network Guidelines in Identifying Pathogenic Germline Variants Among Unselected Patients with Prostate Cancer: The PROCLAIM Trial.

BACKGROUND: Prostate cancer (PCa) patients with pathogenic/likely pathogenic germline variants (PGVs) in cancer predisposition genes may be eligible for U.S. Food and Drug Administration-approved targeted therapies, clinical trials, or enhanced screening. Studies suggest that eligible patients are missing genetics-informed care due to restrictive testing criteria. OBJECTIVE: To establish the prevalence of actionable PGVs among prospectively accrued, unselected PCa patients, stratified by their guideline eligibility. DESIGN, SETTING, AND PARTICIPANTS: Consecutive, unselected PCa patients were enrolled at 15 sites in the USA from October 2019 to August 2021, and had multigene cancer panel testing. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Correlates between the prevalence of PGVs and clinician-reported demographic and clinical characteristics were examined. RESULTS AND LIMITATIONS: Among 958 patients (median [quartiles] age at diagnosis 65 [60, 71] yr), 627 (65%) had low- or intermediate-risk disease (grade group 1, 2, or 3). A total of 77 PGVs in 17 genes were identified in 74 patients (7.7%, 95% confidence interval [CI] 6.2-9.6%). No significant difference was found in the prevalence of PGVs among patients who met the 2019 National Comprehensive Cancer Network Prostate criteria (8.8%, 43/486, 95% CI 6.6-12%) versus those who did not (6.6%, 31/472, 95% CI 4.6-9.2%; odds ratio 1.38, 95% CI 0.85-2.23), indicating that these criteria would miss 42% of patients (31/74, 95% CI 31-53%) with PGVs. The criteria were less effective at predicting PGVs in patients from under-represented populations. Most PGVs (81%, 60/74) were potentially clinically actionable. Limitations include the inability to stratify analyses based on individual ethnicity due to low numbers of non-White patients with PGVs. CONCLUSIONS: Our results indicate that almost half of PCa patients with PGVs are missed by current testing guidelines. Comprehensive germline genetic testing should be offered to all patients with PCa. PATIENT SUMMARY: One in 13 patients with prostate cancer carries an inherited variant that may be actionable for the patient's current care or prevention of future cancer, and could benefit from expanded testing criteria.

Metastatic esophageal cancer presenting as bladder mass, a case report.

Metastatic esophageal cancer to urinary bladder is extremely rare and presents as an extremely poor prognosis. Herein, we describe the case of a 68 year-old female with history of resected adenocarcinoma of gastroesophageal junction in remission, who presented with gross hematuria and a bladder lesion. The patient underwent resection of the mass with final pathology consistent with metastatic adenocarcinoma of gastroesophageal junction.

Whole-organ transdermal photobiomodulation (PBM) of COVID-19: A 50-patient case study.

A nonrandomized 50-person case study of COVID-19-positive patients was conducted employing (for the first time) a regimen of whole-organ deep-tissue transdermal dynamic photobiomodulation (PBM) as a primary (or exclusive) therapeutic modality in the treatment of coronavirus. Therapy sessions comprised algorithmically alternating red (650 nm) and near-infrared (NIR; 850 nm) LEDs with an average irradiance of 11 mW/cm2 dynamically sequenced at multiple pulse frequencies. Delivered via 3D bendable polymeric pads maintaining orthogonal optical incidence to body contours over 1,000 cm2 , a single 84-minute session concurrently delivered 20 kJ to the sinuses and 15 kJ to each lung at skin temperatures below 42°C. Therapeutic outcomes observed include significant reductions in the duration and severity of disease symptoms. Acute conditions including fever, body aches (BA) and respiratory distress comprising paroxysmal coughing; lung congestion, dyspnea and hypoxia; sinus congestion; acute eye inflammation; and extreme malaise were eliminated in 41/50 patients within 4 days of commencing PBM treatments with 50/50 patients fully recovering within 3 weeks with no supplemental oxygen requirements. SpO2 concentrations improved as much as 9 points (average 2.5 points) across the entire study population. The PBM sessions required to completely resolve COVID-19 conditions appears monotonically correlated to the time-to-treatment (TTTx)-the delay between the onset of a patient's symptoms and commencing PBM therapy. In contrast, acute inflammatory symptoms were resolved within 4 days irrespective of TTTx.

Reassessing the Role of Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma in 2019.

Cytoreductive nephrectomy (CRN) has long been considered a standard of care in the management of mRCC. This is largely based on randomized trials in the era of interferon (IFN) that demonstrate an improvement in overall survival (OS). With the advent of targeted therapies, the role of CRN has been questioned and multiple retrospective analyses have shown a potential benefit, particularly in intermediate-risk disease. Two long-awaited prospective trials have been published in the past year that explore the role of CRN. The CARMENA trial randomly assigned patients to therapy with sunitinib with or without CRN, showing noninferiority of sunitinib alone versus sunitinib plus CRN with a median OS of 18.4 months versus 13.9 months, respectively (hazard ratio [HR] for mortality, 0.89; 95% CI, 0.71-1.1). The SURTIME trial randomly assigned patients to immediate CRN followed by sunitinib versus a deferred CRN after three cycles of sunitinib. Analysis is limited by early termination as a result of low accrual. Although there was no difference in progression-free survival (PFS), median OS was significantly improved among patients in the deferred CRN arm (HR, 0.57; 95% CI, 0.34-0.95; p = .032). Early systemic therapy is paramount, but there are patients who may derive benefit by incorporating the removal of the primary tumor in their multimodal therapy, perhaps in a deferred setting. As systemic treatment paradigms shift and immunotherapy again moves to the frontline setting with the potential for novel therapeutic approaches, the role of CRN will continue to evolve with the potential to offer surgical interventions with minimal, if any, delay in systemic treatment.

Incisional hernia after cystectomy: incidence, risk factors and anthropometric predisposition.

INTRODUCTION: Postoperative incisional hernias (PIH) are an established complication of abdominal surgery with rates after radical cystectomy (RC) poorly defined. The objective of this analysis is to compare rates and risk factors of PIH after open (ORC) and robotic-assisted (RARC) cystectomy at a tertiary-care referral center. MATERIALS AND METHODS: We performed a retrospective review of patients undergoing ORC and RARC from 2000-2015 with pre and postoperative cross-sectional imaging available. Images were evaluated for anthropometric measurements and presence of postoperative radiographic PIH (RPIH). Patient demographics, type of urinary diversion and postoperative hernia repair (PHR) were also assessed. RESULTS: Of the patients that met inclusion criteria (n = 469), the incidence of RPIH and PHR were 14.3% and 9.0%, respectively. Between ORC and RARC, analysis revealed no statistically significant differences in rates of RPIH (13.6% versus 20.3%, p = 0.152) or PHR (8.2% versus 12.5%, p = 0.214). Body mass index was associated with a slightly increased likelihood of RPIH on univariate analysis alone (OR 1.08, p = 0.008). Ileal conduit was associated with a decreased likelihood of RPIH (OR 0.42, p = 0.034) and PHR (OR 0.36, p = 0.023). Supraumbilical rectus diastasis width (RDW) was an independent predictor of both RPIH (OR 1.52, p = 0.023) and PHR (OR 1.43, p = 0.039) on multivariate analysis. CONCLUSIONS: Patients undergoing RC are at significant risk of RPIH and PHR regardless of surgical approach. Anthropomorphic factors and urinary diversion type appear to be associated with PIH risk. Further research is needed to understand how risks of PIH can be reduced in patients undergoing cystectomy.

Partial nephrectomy is not associated with an overall survival advantage over radical nephrectomy in elderly patients with stage Ib-II renal masses: An analysis of the national cancer data base.

BACKGROUND: Partial nephrectomy (PN) is recommended for localized T1a (≤4 cm) renal masses and is preferred over radical nephrectomy (RN) for amenable T1b/T2 (>4 cm) tumors. The objective of the current study was to assess overall survival (OS) differences between PN and RN in patients with T1 and T2 renal cell carcinoma (RCC). METHODS: The National Cancer Data Base was queried for patients with T1 and T2 RCC who underwent PN or RN from 2004 to 2014. Trends in surgery were evaluated using Cochran-Armitage tests. Differences in OS were assessed using adjusted Kaplan-Meier methods. The effects of procedure on OS were analyzed using propensity score-based, weighted Cox proportional hazards models. RESULTS: In total, 212,016 patients with T1 and T2 RCC who underwent either RN (59.7%) or PN (40.3%) were included. The use of PN rose from 2004 to 2014 (T1a: from 40.6% to 71.4%; T1b/T2: from 8.4% to 26.5%; P < .01). Adjusted 5-year OS was longer for patients who underwent PN in both subsets, although effect magnitude was reduced in the T1b/T2 cohort (T1a: 89.6% vs 85.1%; hazard ratio [HR], 0.73; 95% confidence interval [CI], 0.70-0.75; P < .01; T1b/T2: 82.5% vs 80.8%; HR, 0.88; 95% CI, 0.83-0.94; P = .01). The benefit of PN on OS diminished as age and time from diagnosis increased; no OS improvement was observed in patients age ≥75 years who had T1b/T2 tumors (HR, 0.89; 95% CI, 0.76-1.06). CONCLUSIONS: Receipt of PN is associated with improved OS in patients with T1a RCC. No procedure-related differences in OS were observed for patients age ≥75 years who had tumors measuring >4 cm. Decisions to undergo PN for T1b/T2 tumors should be based on individualized risk assessment.

Use of administrative data for comparative effectiveness research in the treatment of non-prostate genitourinary malignancies.

Comparative effectiveness research (CER) is imperative for objective and balanced assessment of treatment outcomes. CER that uses administrative databases (AD-CER) affords unique opportunities for large scale data analyses that potentially transcend limitations of small institutional datasets. Prostate cancer has received much attention from the AD-CER research community, whereas non-prostate genitourinary malignancies are less well-studied. The objective of this article is to review the currently available AD-CER that has been published in the non-prostate genitourinary malignancies space.

A Review of Translocation T(6;11) Renal Cell Carcinoma Tumors in the Adult Patient.

Historically, T(6;11) renal cell carcinoma (RCC) has been associated with the pediatric and adolescent populations and documentation of this tumor in adults has been rare. However, the frequency of translocation renal cell carcinoma (TRCC) may be widely underestimated in the adult population due to an inadequate immunohistochemical workup or misdiagnosis from similar gross and histological findings to other RCC. A subset of MiT family translocation carcinomas, t(6:11) (p21;q12) translocation tumors cause an alpha-TFEB gene fusion. Morphologically, this neoplasm tends to mimic the various types of RCC's, including clear cell, papillary, and even epitheloid angiomyolipomas. Adult cases of TRCC have shown to behave more aggressively than their indolent pediatric counterpart, but due to the limited number of reported cases the true nature of these tumors has yet to be determined. The aim of this review is to bring an awareness of translocation RCC to better understand its diagnoses, treatment and prognosis, and, in turn, to allow for new cases to further highlight the behavior of this rare variant.

Contemporary practice patterns and survival outcomes for locally advanced urethral malignancies: A National Cancer Database Analysis.

PURPOSE: Primary urethral carcinoma (PUC) has an aggressive natural history; however, controversy exists regarding the role of multimodal therapy for its treatment. Our objective was to examine practice patterns and survival outcomes for locally advanced urethral cancers. METHODS: The National Cancer Database was queried for patients with T2-4 or N1-2M0 PUC with urothelial, squamous, or adenocarcinoma histology from 2004 to 2013. Temporal trends for receipt of local or definitive surgery, radiotherapy (XRT), and systemic therapy were assessed. Adjusting for clinicopathologic characteristics, we evaluated the effect of tumor stage and histology on receipt of definitive multimodal therapy (cystectomy + chemotherapy ± XRT) and effects of treatment on overall survival. RESULTS: A total of 1,749 patients met inclusion criteria (22.2% adenocarcinoma, 29.3% squamous, and 48.5% urothelial). Only 29.6% underwent cystectomy ± XRT, and 15.6% underwent definitive multimodal therapy. Following adjustment, older patients (age 50-75: odds ratio [OR] = 0.42 [95% CI: 0.28-0.63]; age 75+: OR = 0.06 [95% CI: 0.03-0.13]) and those with squamous histology (OR = 0.46 [95% CI: 0.3-0.7]) were less likely to receive definitive multimodal therapy. More advanced stage (T3: OR = 1.66 [95% CI: 1.15-2.41]; T4: OR = 3.57 [95% CI: 2.47-5.16]); and N2 status (OR = 1.88 [95% CI: 1.27-2.78]) were more likely to receive definitive multimodal therapy. On adjusted analysis, an overall survival benefit was only observed with definitive multimodal therapy for PUC of urothelial origin (hazard ratio = 0.61 [95% CI: 0.45-0.83]). CONCLUSIONS: Despite a survival benefit, most patients with locally advanced PUC do not undergo definitive multimodal therapy. We advocate for a multidisciplinary-based treatment approach for these patients. Future prospective trials of multimodal therapy are crucial.

Contemporary use trends and survival outcomes in patients undergoing radical cystectomy or bladder-preservation therapy for muscle-invasive bladder cancer.

BACKGROUND: The current study was performed to examine temporal trends and compare overall survival (OS) in patients undergoing radical cystectomy (RC) or bladder-preservation therapy (BPT) for muscle-invasive urothelial carcinoma of the bladder. METHODS: The authors reviewed the National Cancer Data Base to identify patients with AJCC stage II to III urothelial carcinoma of the bladder from 2004 through 2013. Patients receiving BPT were stratified as having received any external-beam radiotherapy (any XRT), definitive XRT (50-80 grays), and definitive XRT with chemotherapy (CRT). Treatment trends and OS outcomes for the BPT and RC cohorts were evaluated using Cochran-Armitage tests, unadjusted Kaplan-Meier curves, adjusted Cox multivariate regression, and propensity score matching, using increasingly stringent selection criteria. RESULTS: A total of 32,300 patients met the inclusion criteria and were treated with RC (22,680 patients) or BPT (9620 patients). Of the patients treated with BPT, 26.4% (2540 patients) and 15.5% (1489 patients), respectively, were treated with definitive XRT and CRT. Improved OS was observed for RC in all groups. After adjustments with more rigorous statistical models controlling for confounders and with more restrictive BPT cohorts, the magnitude of the OS benefit became attenuated on multivariate (any XRT: hazard ratio [HR], 2.115 [95% confidence interval [95% CI], 2.045-2.188]; definitive XRT: HR, 1.870 [95% CI, 1.773-1.972]; and CRT: HR, 1.578 [95% CI, 1.474-1.691]) and propensity score (any XRT: HR, 2.008 [95% CI, 1.871-2.154]; definitive XRT: HR, 1.606 [95% CI, 1.453-1.776]; and CRT: HR, 1.406 [95% CI, 1.235-1.601]) analyses. CONCLUSIONS: In the National Cancer Data Base, receipt of BPT was associated with decreased OS compared with RC in patients with stage II to III urothelial carcinoma. Increasingly stringent definitions of BPT and more rigorous statistical methods adjusting for selection biases attenuated observed survival differences. Cancer 2017;123:4337-45. © 2017 American Cancer Society.

Safety and early effectiveness of robot-assisted partial nephrectomy for large angiomyolipomas.

OBJECTIVE: To evaluate a multicentre series of robot-assisted partial nephrectomy (RAPN) performed for the treatment of large angiomyolipomas (AMLs). PATIENTS AND METHODS: Between 2005 and 2016, 40 patients with large or symptomatic AMLs underwent RAPN at five academic centres in the USA. Patient demographics, AML characteristics, operative and postoperative clinical outcomes were recorded and analysed. Surgical outcomes were compared between patients who underwent selective arterial embolisation (SAE) before RAPN and patients who did not undergo pre-RAPN SAE. RESULTS: The median (interquartile range [IQR]) tumour diameter was 7.2 (5-8.5) cm, and the median (IQR) nephrometry score was 9 (7-10). Six patients (15%) had a history of tuberous sclerosis and 11 (28%) had previously undergone SAE. The median (IQR) operative time and warm ischaemia time was 207 (180-231) and 22.5 (16-28) min, respectively. A non-clamping technique was used in eight (20%) patients. The median (IQR) estimated blood loss was 200 (100-245) mL, and four patients (10%) received blood transfusion postoperatively. One intraoperative complication occurred (2.5%), and seven postoperative complications occurred in six patients (15%). During a median (IQR) follow-up of 8 (1-15) months, none of the patients developed AML-related symptoms. The median estimated glomerular filtration rate preservation rate was 95%. There were no differences in operative or perioperative outcomes between patients who underwent SAE before RAPN and those who did not. CONCLUSIONS: Robot-assisted partial nephrectomy appears to be a safe primary or secondary (post-SAE) treatment for large AMLs, with a favourable perioperative morbidity profile and excellent functional preservation. Longer follow-up is required to fully evaluate therapeutic efficacy.