Harry Anastos

Predicting Complications Following Robot-Assisted Partial Nephrectomy with the ACS NSQIP® Universal Surgical Risk Calculator

Purpose: We evaluated the predictive value of the ACS NSQIP® (American College of Surgeons National Surgical Quality Improvement Program®) surgical risk calculator in a tertiary referral cohort of patients who underwent robot‐assisted partial nephrectomy. Materials and Methods: We queried our prospectively maintained, multi‐institutional database of patients treated with robot‐assisted partial nephrectomy and input the preoperative details of 300 randomly selected patients into the calculator. Accuracy of the calculator was assessed by the ROC AUC and the Brier score. Results: The observed rate of any complication in our cohort was 14% while the mean predicted rate of any complication using the calculator was 5.42%. The observed rate of serious complications (Clavien score 3 or greater) was 3.67% compared to the predicted rate of 4.89%. Low AUC and high Brier score were calculated for any complication (0.51 and 0.1272) and serious complications (0.55 and 0.0352, respectively). The calculated AUC was low for all outcomes, including venous thromboembolism (0.67), surgical site infection (0.51) and pneumonia (0.44). Conclusions: The ACS NSQIP risk calculator poorly predicted and discriminated which patients would experience complications after robot‐assisted partial nephrectomy. These findings suggest the need for a more tailored outcome prediction model to better assist urologists risk stratify patients undergoing robot‐assisted partial nephrectomy and counsel them on individual surgical risks.

Immune phenotype of peripheral blood mononuclear cells in patients with high-risk non-muscle invasive bladder cancer

PurposeTo explore the immune phenotype of peripheral blood mononuclear cells (PBMC) in patients with high-risk non-muscle invasive bladder cancer (NMIBC).MethodsWe prospectively collected blood samples from patients with high-risk NMIBC treated at our institution. PBMC were analyzed by flow cytometry to determine the frequency of T cells and NK cells and the expression of immunoregulatory molecules (Tim-3, TIGIT and PD-1). PBMC from healthy donors (HD) were included for comparison, and associations with response to BCG were investigated.ResultsA total of 38 patients were included, 19 BCG responders and 19 BCG refractory. Compared to 16 PBMC from HD, the frequency of total NK cells was significantly higher in patients with NMIBC [15.2% (IQR: 11.4, 22.2) vs. 5.72% (IQR: 4.84, 9.79); p = 0.05], whereas the frequency of T cells was not statistically different. Both Tim-3 and TIGIT expressions were significantly higher in NMIBC compared to HD, particularly in NK cells [13.8% (11.0; 22.4) vs. 5.56% (4.20; 10.2) and 34.9% (18.9; 53.5) vs. 1.82% (0.63; 5.16), respectively; p < 0.001]. Overall, the expression of PD-1 in all cell types was low in both NMIBC patients and HD. The immune phenotype was not significantly different before and after initiation of BCG. However, the proportion of CD8+ T cells before BCG was significantly higher in responders.ConclusionThe immune phenotype of PBMC from patients with high-risk NMIBC was significantly different from HD, regardless of the presence of disease or the initiation of BCG. Peripheral CD8+ T cells could play a role in response to BCG.

Demographic and socioeconomic predictors of treatment delays, pathologic stage, and survival among patients with penile cancer: A report from the National Cancer Database

OBJECTIVES To evaluate whether socioeconomic factors affect pathologic stage, treatment delays, pathologic upstaging, and overall survival (OS) in patients with penile cancer (PC). PATIENTS AND METHODS A total of 13,283 eligible patients diagnosed with PC from 1998 to 2012 were identified from the National Cancer Database. Socioeconomic, demographic and pathologic variables were used in multivariable regression models to identify predictors of pathologic T stage ≥2, pathologic lymph node positivity, cT to pT upstaging, treatment delays, and OS. RESULTS A 5-year OS was 61.5% with a median follow-up of 41.7 months. Pathologic T stage ≥2 was identified in 3,521 patients (27.2%), 1,173 (9.2%) had ≥pN1 and 388 (7.9%) experienced cT to pT upstaging. Variables associated with a higher likelihood of pathologic T stage ≥2 included no insurance (OR = 1.79, P<0.001), lower higher education based on zip code (OR = 1.13, P = 0.027), black race (OR = 1.17, P = 0.046) and Hispanic ethnicity (OR = 1.66, P<0.001). Patients with Hispanic ethnicity (OR = 1.46; P<0.001) or living in nonmetropolitan areas were more likely to have ≥pN1 (P = 0.001). Lack of insurance was associated with cT to pT upstaging (OR = 2.05, P = 0.001) as was living in an urban vs. metropolitan area (OR = 1.35, P = 0.031). In addition to TNM stage, black vs. white race (HR = 1.56, P<0.001), living in an urban vs. metropolitan area (hazard ratio [HR] = 1.18, P = 0.022), age (HR = 1.04, P<0.001) and Charlson score (HR = 1.49, P<0.001) were associated with lower OS. CONCLUSION Socioeconomic variables including no insurance, lower education, race, Hispanic ethnicity, and nonmetropolitan residence were found to be poor prognostic factors. Increased educational awareness of this rare disease may help reduce delays in diagnosis, improve prognosis and ultimately prevent deaths among socioeconomically disadvantaged men with PC.

PD65-04 MR/US FUSION GUIDED ULTRA-FOCAL GOLD NANOPARTICLE DIRECTED LASER ABLATION OF PROSTATE TUMORS: RESULTS IN THE FIRST 11 PATIENTS (PHASE I/II TRIAL)

INTRODUCTION AND OBJECTIVES: Gold Nanoparticles (GNP) mediated laser ablation has been shown to be biocompatible and safe for the treatment of focal cancer. Herein, we report the first 11 cases in the world using GNP-directed focal laser ablation of prostate tumors using ultrasound (US) and MR/US fusion technology (NCT NCT02680535). METHODS: All patients were diagnosed with Gleason 7 or less prostate cancer with biopsy proven MR visible lesions and no disease other than appreciated on the MRI. Patients underwent ultra-focal laser ablation of the tumors using GNP with MR/US fusion guidance. Following infusion of intravenous GNP on Day 0, trans-perineal laser catheters were placed into the prostate lesions for GNP excitation/tumor ablation under MR/US fusion guidance using an electromagnetictracked MR/US fusion device (UroNav, Invivo Gainesville FL). At 48 hours post-ablation, the patient is imaged, followed by re-imaging and MR/US fusion guided biopsy (FBx) at 3 months. All patient demographics, clinical variables, and complications were recorded. RESULTS: To date, 11 patients (mean age: 69.6 yrs; range 5879 yrs) have been enrolled in the trial. All patients were diagnosed with Gleason < 7. All patients had a solitary lesion with mean tumor volume 0.73 mL (range 0.6-1.87 cc). A single patient did not tolerate the cold IV infusion of the gold nano particles and was not able to undergo ablation the following day. 8 of 10 patients have completed the 3 month followup targeted biopsy as primary endpoint. Mean pre-treatment PSA was 7.84 ng/mL (range 5.5-12.3 ng/mL). Mean post-treatment PSA was 3.9 ng/mL (range 1.5-6.1 ng/mL; 50% reduction). Five out of eight patients (62.5%) did not have any cancer detected on follow up biopsy. Only 1 out of 8 patients had clinically significant cancer as per Delphi consensus criteria (Gleason score >6 or cancer > 3mm at Gleason score 6). CONCLUSIONS: Recent trends toward less invasive image guided therapies have been seen as investigators pursue focal targeted therapies. This report is the first in-man demonstration of MR/US guided ultra-focal laser ablation of prostate tumors using GNP.

Targeted Ablative Therapies for Prostate Cancer

Men diagnosed with low- to intermediate-risk, clinically localized prostate cancer (PCa) often face a daunting and difficult decision with respect to treatment: active surveillance (AS) or radical therapy. This decision is further confounded by the fact that many of these men diagnosed, by an elevated PSA, will have indolent disease and never require intervention. Radical treatments, including radical prostatectomy and whole-gland radiation, offer greater certainty for cancer control, but at the risk of significant urinary and/or sexual morbidity. Conversely, AS preserves genitourinary function and quality of life in exchange for burdensome surveillance and the psychological impact of living with cancer.

PD59-09 MANAGEMENT OF SMALL RENAL MASSES IN RENAL TRANSPLANT RECIPIENT CANDIDATES: A MULTI-INSTITUTIONAL SURVEY ANALYSIS

validate a criterion for AS eligibility based on tumour clinical size and age on a cohort of patients treated with surgery. METHODS: 1922 patients diagnosed with a cT1cN0cM0 renal mass elected for surgical treatment and collected into a prospective database were assessed. Under the assumption that older patients with smaller tumours are optimal candidates for AS relative to younger patients with larger tumours, we relied on the ratio [R] between tumour clinical size and age in order to differentiate patients suitable for AS (R<5) from patients unsuitable for AS (R 5). X2 test was used to compare the rate of malignant histology, stage pT3-pT4 and grade G3G4 at final pathology in patients suitable vs. unsuitable for AS. Smoothed Poisson’s incidence plots were used to examine the rate of cancer specific [CSM] and other cause mortality [OCM] in patients suitable vs. unsuitable for AS. RESULTS: According to the proposed definition, the rate of patients suitable for AS was 34%. Patient suitable for AS had a lower rate of malignant histology (78 vs. 87%; p<0.001), pT3-pT4 (4 vs. 10% p1⁄40.001) and grade G3-G4 (7 vs. 17% p<0.001) relative to patients unsuitable for AS. In patients suitable for AS, the 10-year rates of CSM and OCM were 1.7 and 19%, respectively (Fig. 1A). In patients unsuitable for AS, the 10-year rates of CSM and OCM were 6.7 and 11% (Fig. 1B), respectively. CONCLUSIONS: When validated in a cohort of surgically treated patients, the ratio between tumour clinical size and age is a useful parameter to differentiate patients with adverse pathologic outcomes from patients with more favourable pathologic outcomes. These differences translate into critically different relative rates of CSM and OCM. These findings suggest that the proposed strategy criterion deserve further examination as a potential criterion for AS.

General & Epidemiological Trends & Socioeconomics: Practice Patterns, Quality of Life and Shared Decision Making IVMP76-07 PREDICTING COMPLICATIONS FOLLOWING ROBOT-ASSISTED PARTIAL NEPHRECTOMY WITH THE ACS-NSQIP UNIVERSAL SURGICAL RISK CALCULATOR

INTRODUCTION AND OBJECTIVES: Assessment of surgical risk is integral to patient counseling and shared clinical decisionmaking. The American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) surgical risk calculator is an easily accessible, online tool for predicting surgical outcomes after a variety of procedures. Little is known of the tool’s applicability to urologic surgery. We sought to evaluate the predictive value of the calculator in a tertiary referral cohort of patients undergoing robot-assisted partial nephrectomy (RAPN). METHODS: We queried our prospectively maintained multiinstitutional database of RAPN (n1⁄41260) from 2008 to 2016. Preoperative details of 300 randomly selected patients were entered into the calculator. The predicted rates of complications were compared with the actual rates of observed complications. Validation of the calculator was assessed by receiver-operator area under the curve (AUC) for discrimination and Brier score (BS) for calibration. Calculated BS was also compared to a null model (null-BS); a BS lower than the null model indicates stronger predictive power for that individual outcome where a BS of zero indicates perfect prediction. RESULTS: The observed rate of any complication in our cohort was 14%, comparable with that reported in the literature, while the mean predicted rate of any complication was 5.42%. The calculated AUC for any complications was 0.51. Our cohort demonstrated a serious complication (Clavien Score 3) rate of 3.67%, lower than the predicted rate of 4.89% (AUC 0.55). The majority of the captured complications had a low BS, indicative of good calibration. However, the calculated AUC was low for all outcomes, indicating poor discrimination ability. Venous thromboembolism (VTE) and readmission had the highest AUCs 0.67 and 0.69, respectively. CONCLUSIONS: The ACS-NSQIP risk calculator poorly predicted most complications after RAPN. The model had marginal accuracy for predicting VTE and readmissions, and good accuracy for predicting the rate of serious complications, but it lacked the power to discriminate which patients were at risk to have such outcomes. These findings suggest the need for a more tailored outcome prediction model to accurately assist surgeons in counseling patients undergoing RAPN.

MP18-03 TRANSPERINEAL MR/US FUSION-GUIDED PROSTATE BIOPSY MAINTAINS A HIGH DEGREE OF CANCER DETECTION REGARDLESS OF TARGETED LESION VOLUME

2/3/4/5 was 24% (5/21), 37% (13/35), 35% (12/34) and 56% (15/27), respectively. Lesions classified as PI-RADS 4 showed significantly more PCa with a GS 7 (3+4) than lesions classified as PI-RADS 3 (38% vs. 14%; p<0.005). CONCLUSIONS: FusPbx is associated with a higher detection rate of PCa with GS 7(3+4). Especially the combination of both biopsy modalities outperforms fusPbx and sysPbx alone. Therefore, mpMRI with consecutive targeted biopsy in combination with sysPbx should be recommended for control biopsy in patients with low-risk PCa undergoing control-biopsy for AS protocols.