Pathological and Clinical Outcomes in a Large Surveillance and Intervention Cohort of Radiographically Cystic Renal Masses.

PURPOSE: We evaluated oncologic risks in a large cohort of patients with radiographic cystic renal masses who underwent active surveillance or intervention. MATERIALS AND METHODS: A single-institutional database of 4,340 kidney lesions managed with either active surveillance or intervention between 2000-2020 was queried for radiographically cystic renal masses. Association of radiographic tumor characteristics and high-grade pathology was evaluated. RESULTS: We identified 387 radiographically confirmed cystic lesions in 367 patients. Of these, 247 were resected (n=240) or ablated (n=7; n=247, 203 immediate vs 44 delayed intervention). Pathologically, 23% (n=56) demonstrated high-grade pathology. Cystic features were explicitly described by pathology in only 18% (n=33) of all lesions and in 7% (n=4) of high-grade lesions. Of the intervention cohort, African American race, male gender, and Bosniak score were associated with high-grade pathology (P < .05). On active surveillance (n=184), Bosniak IV lesions demonstrated faster growth rates than IIF and III lesions (2.7 vs 0.6 and 0.5 mm/y, P ≤ .001); however, growth rates were not associated with high-grade pathology (P = .5). No difference in cancer-specific survival was identified when comparing intervention vs active surveillance at 5 years (99% vs 100%, P = .2). No difference in recurrence was observed between immediate intervention vs delayed intervention (P > .9). CONCLUSIONS: A disconnect between "cystic" designation on imaging and pathology exists for renal lesions. Over 80% of radiographic Bosniak cystic lesions are not described as "cystic" on pathology reports. More than 1 in 5 resected cystic renal lesions demonstrated high-grade disease. Despite this finding, judiciously managed active surveillance ± delayed intervention is a safe and effective management option for most radiographic cystic renal masses.

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.

External Validation of Contact Surface Area as a Predictor of Postoperative Renal Function in Patients Undergoing Partial Nephrectomy.

PURPOSE: We sought to externally validate a mathematical formula for tumor contact surface area as a predictor of postoperative renal function in patients undergoing partial nephrectomy for renal cell carcinoma. MATERIALS AND METHODS: We queried a prospectively maintained kidney cancer database for patients who underwent partial nephrectomy between 2014 and 2016. Contact surface area was calculated using data obtained from preoperative cross-sectional imaging. The correlation between contact surface area and perioperative variables was examined. The correlation between postoperative renal functional outcomes, contact surface area and the R.E.N.A.L. (radius, exophytic/endophytic properties, nearness of tumor to collecting system or sinus, anterior/posterior, location relative to polar lines and tumor touches main renal artery or vein) nephrometry score was also assessed. RESULTS: A total of 257 patients who underwent partial nephrectomy had sufficient data to enter the study. Median contact surface area was 14.5 cm2 (IQR 6.2-36) and the median nephrometry score was 9 (IQR 7-10). Spearman correlation analysis showed that contact surface area correlated with estimated blood loss (rs = 0.42, p <0.001), length of stay (rs = 0.18, p = 0.005), and percent and absolute change in the estimated glomerular filtration rate (rs = -0.77 and -0.78, respectively, each p <0.001). On multivariable analysis contact surface area and nephrometry score were independent predictors of the absolute change in the estimated glomerular filtration rate (each p <0.001). ROC curve analysis revealed that contact surface area was a better predictor of a greater than 20% postoperative decline in the estimated glomerular filtration rate compared with the nephrometry score (AUC 0.94 vs 0.80). CONCLUSIONS: Contact surface area correlated with the change in postoperative renal function after partial nephrectomy. It can be used in conjunction with the nephrometry score to counsel patients about the risk of renal functional decline after partial nephrectomy.

Retroperitoneal Lymphadenectomy for High Risk, Nonmetastatic Renal Cell Carcinoma: An Analysis of the ASSURE (ECOG-ACRIN 2805) Adjuvant Trial.

PURPOSE: Lymphadenectomy is a well established practice for many urological malignancies but its role in renal cell carcinoma is less clear. Our primary objective was to determine whether lymphadenectomy impacted survival in patients with fully resected, high risk renal cell carcinoma. MATERIALS AND METHODS: Patients with fully resected, high risk, nonmetastatic renal cell carcinoma were randomized to adjuvant sorafenib, sunitinib or placebo in the ASSURE (Adjuvant Sorafenib and Sunitinib for Unfavorable Renal Carcinoma) trial. Lymphadenectomy was performed for cN+ disease or at surgeon discretion. Patients treated with lymphadenectomy were compared to patients in the trial who did not undergo lymphadenectomy. The primary outcome was overall survival associated with lymphadenectomy. Secondary outcomes were disease free survival, factors associated with performing lymphadenectomy and surgical complications. RESULTS: Of the 1,943 patients in ASSURE 701 (36.1%) underwent lymphadenectomy, including all resectable patients with cN+ and 30.1% of those with cN0 disease. A median of 3 lymph nodes (IQR 1-8) were removed and the rate of pN+ disease in the lymphadenectomy group was 23.4%. There was no overall survival benefit for lymphadenectomy relative to no lymphadenectomy (HR 1.14, 95% CI 0.93-1.39, p = 0.20). In patients with pN+ disease who underwent lymphadenectomy no improvement in overall or disease-free survival was observed for adjuvant therapy relative to placebo. Lymphadenectomy did not confer an increased risk of surgical complications (14.2% vs 13.4%, p = 0.63). CONCLUSIONS: The benefit of lymphadenectomy in patients undergoing surgery for high risk renal cell carcinoma remains uncertain. Future strategies to answer this question should include a prospective trial in which patients with high risk renal cell carcinoma are randomized to specific lymphadenectomy templates.

Defining Novel and Practical Metrics to Assess the Deliverables of Multiparametric Magnetic Resonance Imaging/Ultrasound Fusion Prostate Biopsy.

PURPOSE: Multiparametric magnetic resonance/ultrasound targeted prostate biopsy is touted as a tool to improve prostate cancer care and yet its true clinical usefulness over transrectal ultrasound guided prostate biopsy has not been systematically analyzed. We introduce 2 metrics to better quantify and report the deliverables of targeted biopsy. MATERIALS AND METHODS: We reviewed our prospective database of patients who underwent simultaneous multiparametric magnetic resonance/ultrasound targeted prostate biopsy and transrectal ultrasound guided prostate biopsy. Actionable intelligence metric was defined as the proportion of patients in whom targeted biopsy provided actionable information over transrectal ultrasound guided prostate biopsy. Reduction metric was defined as the proportion of men in whom transrectal ultrasound guided prostate biopsy could have been omitted. We compared metrics in our cohort with those in prior reports. RESULTS: A total of 371 men were included in study. The actionable intelligence and reduction metrics were 22.2% and 83.6% in biopsy naïve cases, 26.7% and 84.2% in prior negative transrectal ultrasound guided prostate biopsy cases, and 24% and 77.5%, respectively, in active surveillance cases. No significant differences were observed among the groups in the actionable intelligence metric and the reduction metric (p = 0.89 and 0.27, respectively). The actionable intelligence metric was 25.0% for PI-RADS™ (Prostate Imaging Reporting and Data System) 3, 27.5% for PI-RADS 4 and 21.7% for PI-RADS 5 lesions (p = 0.73). Transrectal ultrasound guided prostate biopsy could have been avoided in more patients with PI-RADS 3 compared to PI-RADS 4/5 lesions (reduction metric 92.0% vs 76.7%, p <0.01). Our results compare favorably to those of other reported series. CONCLUSIONS: The actionable intelligence metric and the reduction metric are novel, clinically relevant quantification metrics to standardize the reporting of multiparametric magnetic resonance/ultrasound targeted prostate biopsy deliverables. Targeted biopsy provides actionable information in about 25% of men. Reduction metric assessment highlights that transrectal ultrasound guided prostate biopsy may only be omitted after carefully considering the risk of missing clinically significant cancers.

Performance Measurement and Quality Improvement Initiatives for Bladder Cancer Care.

PURPOSE OF REVIEW: Bladder cancer care is costly due to long surveillance periods for non-muscle-invasive bladder cancer (NMIBC) and comorbidities associated with the surgical treatment of muscle-invasive bladder cancer (MIBC). We reviewed current evidence-based practices and propose quality metrics for NMIBC and MIBC. RECENT FINDINGS: For patients with NMIBC, we propose four categories of candidate quality metrics: (1) appropriate use of imaging, (2) re-staging transurethral resection of bladder tumor, (3) perioperative intravesical chemotherapy, and (4) induction and maintenance BCG in high-risk NMIBC. For patients with MIBC, we propose eight candidate quality measures: (1) neoadjuvant chemotherapy, (2) multidisciplinary consultation, (3) urinary diversion teaching, (4) appropriate perioperative antibiotics, (5) venous thromboembolic prophylaxis, (6) lymphadenectomy, (7) monitoring of complications, and (8) inclusion of enhanced recovery after surgery protocols. Marked variation in evidence-based practice exists among patients with bladder cancer and represents opportunity for quality improvement. Regional and national physician-led collaboratives may be the best vehicle to achieve quality improvement in bladder cancer.

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.

The role of radical prostatectomy in high-risk localized, node-positive and metastatic prostate cancer.

A lack of quality evidence comparing management strategies confounds complex treatment decisions for patients with high-risk prostate cancers. No randomized trial comparing surgery to radiation has been successfully completed. Despite inherent selection biases, however, observational and registry data suggest improved outcomes for patients initially managed with prostatectomy. As consensus shifts away from aggressive treatment for low-risk disease and toward multimodal treatment of locally advanced and metastatic disease, there is renewed interest in surgery for local control in patients presenting with high-risk localized, node-positive and minimally metastatic disease. The objective of this review is to examine the evidence evaluating clinical outcomes of patients with high-risk clinically localized, node-positive and metastatic prostate cancer treated with radical prostatectomy.

Prostate biopsy perineural invasion is not independently associated with positive surgical margins following radical retropubic prostatectomy.

PURPOSE: Perineural invasion (PNI) in prostate cancer has been associated with poor prognosis. We sought to determine whether biopsy and radical prostatectomy (RP) PNI are associated with adverse outcomes. A secondary objective was to determine whether prostate biopsy PNI should alter surgical technique. METHODS: Patients were categorized by PNI on biopsy and RP specimens. Associations between PNI, clinicopathologic characteristics, and biochemical recurrence (BCR) rates were assessed. RESULTS: A total of 2,500 patients undergoing open RP by a single-surgeon from 1999 to 2011 were analyzed. In unadjusted univariate analyses, biopsy PNI was significantly associated with Gleason score, clinical stage, positive surgical margins, extraprostatic extension (EPE), seminal vesicle invasion (SVI), positive lymph nodes, and BCR (p < 0.001). On multivariate analysis, EPE (p < 0.001), and SVI (p = 0.022) remained associated with biopsy PNI. Biopsy PNI was not associated with positive margins at RP (OR 1.3, 95 % CI 0.92-1.9). The presence of PNI in the final RP specimen conferred a greater than 4 times increased odds of positive margin (OR 4.6, 95 % CI 2.30-9.22; p < 0.0001). Men with PNI on biopsy were 1.5 times more likely to experience BCR (OR 1.5, 1.06-2.01). PNI on biopsy or RP specimens was not associated with overall survival. CONCLUSIONS: In men undergoing open RP for clinically localized prostate adenocarcinoma, biopsy PNI is associated with an increased risk of BCR. PNI on prostate biopsy was not associated with positive surgical margins after adjusting for related co-variables. The presence of PNI on prostate biopsy should not preclude utilization of a nerve-sparing approach.

De novo Angiosarcoma of a Renal Allograft.

Prolonged exposure to immunosuppressive medication is a known risk factor for the development of post-transplant malignancies. De novo angiosarcoma in the post-transplant population is extremely rare. We present an 81-year-old female who developed an angiosarcoma at the site of a functioning renal allograft and review contemporary treatment strategies for this devastating disease. The report underscores the importance of periodic surveillance for the development of malignancy in the immunosuppressed population.

Simultaneous cuff revision and placement of an AdVance male sling for persistent post-prostatectomy urinary incontinence initially managed with AMS 800 artificial urinary sphincter.

Placement of an artificial urinary sphincter (AUS) remains the gold standard for treatment of stress urinary incontinence after radical prostatectomy. Persistent or recurrent incontinence after AUS placement can occur. Options then include cuff revision or placement of a retrourethral transobturator sling (RTS), among other alternatives. This report describes simultaneous cuff revision and placement of a RTS for management of refractory stress urinary incontinence after radical prostatectomy. This approach obviates the need for additional procedures if one approach fails. This is especially valuable for patients averse to operative intervention and those at high risk for general anesthesia.

Transperineal Versus Transrectal Magnetic Resonance Imaging-targeted and Systematic Prostate Biopsy to Prevent Infectious Complications: The PREVENT Randomized Trial.

BACKGROUND AND OBJECTIVE: The transrectal biopsy approach is traditionally used to detect prostate cancer. An alternative transperineal approach is historically performed under general anesthesia, but recent advances enable transperineal biopsy to be performed under local anesthesia. We sought to compare infectious complications of transperineal biopsy without antibiotic prophylaxis versus transrectal biopsy with targeted prophylaxis. METHODS: We assigned biopsy-naïve participants to undergo transperineal biopsy without antibiotic prophylaxis versus transrectal biopsy with targeted prophylaxis (rectal culture screening for fluoroquinolone-resistant bacteria and antibiotic targeting to culture and sensitivity results) through a multicenter, randomized trial. The primary outcome was post-biopsy infection captured by a prospective medical review and patient report on a 7-d survey. The secondary outcomes included cancer detection, noninfectious complications, and a numerical rating scale (0-10) for biopsy-related pain and discomfort during and 7-d after biopsy. KEY FINDINGS AND LIMITATIONS: A total of 658 participants were randomized, with zero transperineal versus four (1.4%) transrectal biopsy infections (difference -1.4%; 95% confidence interval [CI] -3.2%, 0.3%; p = 0.059). The rates of other complications were very low and similar. Importantly, detection of clinically significant cancer was similar (53% transperineal vs 50% transrectal, adjusted difference 2.0%; 95% CI -6.0, 10). Participants in the transperineal arm experienced worse periprocedural pain (0.6 adjusted difference [0-10 scale], 95% CI 0.2, 0.9), but the effect was small and resolved by 7-d. CONCLUSIONS AND CLINICAL IMPLICATIONS: Office-based transperineal biopsy is tolerable, does not compromise cancer detection, and did not result in infectious complications. Transrectal biopsy with targeted prophylaxis achieved similar infection rates, but requires rectal cultures and careful attention to antibiotic selection and administration. Consideration of these factors and antibiotic stewardship should guide clinical decision-making. PATIENT SUMMARY: In this multicenter randomized trial, we compare prostate biopsy infectious complications for the transperineal versus transrectal approach. The absence of infectious complications with transperineal biopsy without the use of preventative antibiotics is noteworthy, but not significantly different from transrectal biopsy with targeted antibiotic prophylaxis.

Adjuvant Therapy for High-Risk Localized Renal Cell Carcinoma: Current Landscape and Future Direction.

Locally and regionally advanced renal cell carcinoma (RCC) can recur at high rates even after visually complete resection of primary disease. Both targeted therapies and immunotherapies represent potential agents that might help reduce recurrence of RCC in these patients. This paper reviews the current body of evidence defining their potential impact and examines the large Phase III randomized clinical trials that have been performed to assess the safety and efficacy of these systemic therapies in the adjuvant setting. Given that the findings from these trials have been predominantly negative, this paper also explores the role of other potential adjuvant agents, including single and combination agent targeted therapies and immunotherapies, whose use is currently limited to metastatic RCC. Finally, the use of radiation therapy and the use of advanced imaging modalities in RCC are also considered.

Incidental detection of pheochromocytoma during workup for symptomatic aortic stenosis: A case report and management discussion.

Pheochromocytoma patients with high levels of circulating catecholamines are at risk of cardiovascular complications related to hypertensive emergencies and subsequent organ damage. A patient with concomitant aortic stenosis and pheochromocytoma has compounded risk of cardiovascular complications, especially during surgery, which complicates medical decision-making. We report a patient with Turner syndrome and congenital heart defects (CHDs) who was incidentally discovered to have a pheochromocytoma during workup of symptomatic severe bioprosthetic aortic stenosis. Management included laparoscopic adrenalectomy followed by Transcatheter Aortic Valve Replacement (TAVR). We describe considerations for multidisciplinary management in this complex clinical case.

Protocol of a multicentre randomised controlled trial assessing transperineal prostate biopsy to reduce infectiouscomplications.

INTRODUCTION: Approximately one million prostate biopsies are performed annually in the USA, and most are performed using a transrectal approach under local anaesthesia. The risk of postbiopsy infection is increasing due to increasing antibiotic resistance of rectal flora. Single-centre studies suggest that a clean, percutaneous transperineal approach to prostate biopsy may have a lower risk of infection. To date, there is no high-level evidence comparing transperineal versus transrectal prostate biopsy. We hypothesise that transperineal versus transrectal prostate biopsy under local anaesthesia has a significantly lower risk of infection, similar pain/discomfort levels and comparable detection of non-low-grade prostate cancer. METHODS AND ANALYSIS: We will perform a multicentre, prospective randomised clinical trial to compare transperineal versus transrectal prostate biopsy for elevated prostate-specific antigen in the first biopsy, prior negative biopsy and active surveillance biopsy setting. Prostate MRI will be performed prior to biopsy, and targeted biopsy will be conducted for suspicious MRI lesions in addition to systematic biopsy (12 cores). Approximately 1700 men will be recruited and randomised in a 1:1 ratio to transperineal versus transrectal biopsy. A streamlined design to collect data and to determine trial eligibility along with the two-stage consent process will be used to facilitate subject recruitment and retention. The primary outcome is postbiopsy infection, and secondary outcomes include other adverse events (bleeding, urinary retention), pain/discomfort/anxiety and critically, detection of non-low-grade (grade group ≥2) prostate cancer. ETHICS AND DISSEMINATION: The Institutional Review Board of the Biomedical Research Alliance of New York approved the research protocol (protocol number #18-02-365, approved 20 April 2020). The results of the trial will be presented at scientific conferences and published in peer-reviewed medical journals. TRIAL REGISTRATION NUMBER: NCT04815876.