Andrew A. Wagner

Five-year Analysis of a Multi-institutional Prospective Clinical Trial of Delayed Intervention and Surveillance for Small Renal Masses: The DISSRM Registry ☆

BACKGROUND A growing body of retrospective literature is emerging regarding active surveillance (AS) for patients with small renal masses (SRMs). There are limited prospective data evaluating the effectiveness of AS compared to primary intervention (PI). OBJECTIVE To determine the characteristics and clinical outcomes of patients who chose AS for management of their SRM. DESIGN, SETTING, AND PARTICIPANTS From 2009 to 2014, the multi-institutional Delayed Intervention and Surveillance for Small Renal Masses (DISSRM) registry prospectively enrolled 497 patients with solid renal masses ≤4.0cm who chose PI or AS. INTERVENTION AS versus PI. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS The registry was designed and powered as a noninferiority study based on historic recurrence rates for PI. Analyses were performed in an intention-to-treat manner. Primary outcomes were overall survival (OS) and cancer-specific survival (CSS). RESULTS AND LIMITATIONS Of the 497 patients enrolled, 274 (55%) chose PI and 223 (45%) chose AS, of whom 21 (9%) crossed over to delayed intervention. AS patients were older, had worse Eastern Cooperative Oncology Group scores, total comorbidities, and cardiovascular comorbidities, had smaller tumors, and more often had multiple and bilateral lesions. OS for PI and AS was 98% and 96% at 2 yr, and 92% and 75% at 5 yr, respectively (log rank, p=0.06). At 5 yr, CSS was 99% and 100% for PI and AS, respectively (p=0.3). AS was not predictive of OS or CSS in regression modeling with relatively short follow-up. CONCLUSIONS In a well-selected cohort with up to 5 yr of prospective follow-up, AS was not inferior to PI. PATIENT SUMMARY The current report is among the first prospective analyses of patients electing for active surveillance of a small renal mass. Discussion of active surveillance should become part of the standard discussion for management of small renal masses.

Expanded Prostate Cancer Index Composite for Clinical Practice: Development and Validation of a Practical Health Related Quality of Life Instrument for Use in the Routine Clinical Care of Patients With Prostate Cancer

PURPOSE Measuring the health related quality of life of patients with prostate cancer in routine clinical practice is hindered by the lack of instruments enabling efficient, real-time, point of care scoring of multiple health related quality of life domains. Thus, we developed an instrument for this purpose. MATERIALS AND METHODS The Expanded Prostate Cancer Index Composite for Clinical Practice is a 1-page, 16-item questionnaire that we constructed to measure urinary incontinence, urinary irritation, and the bowel, sexual and hormonal health related quality of life domains. We eliminated conceptually overlapping items from the 3-page Expanded Prostate Cancer Index Composite-26 and revised the questionnaire format to mirror the AUA symptom index, thereby enabling practitioners to calculate health related quality of life scores at the point of care. We administered the Expanded Prostate Cancer Index Composite for Clinical Practice to a new cohort of patients with prostate cancer in community based and academic oncology, radiation, and urology practices to evaluate instrument validity as well as ease of use in clinical practice. RESULTS A total of 175 treated and 132 untreated subjects with prostate cancer completed the Expanded Prostate Cancer Index Composite for Clinical Practice. The domain scores of the Expanded Prostate Cancer Index Composite for Clinical Practice correlated highly with the respective domain scores from longer versions of the Expanded Prostate Cancer Index Composite (r≥0.93 for all domains). The Expanded Prostate Cancer Index Composite for Clinical Practice showed high internal consistency (Cronbachs α 0.64-0.84) and sensitivity to prostate cancer treatment related effects (p<0.05 in each of 5 health related quality of life domains). Patients completed the Expanded Prostate Cancer Index Composite for Clinical Practice efficiently (96% in less than 10 minutes and with 11% missing items). It was deemed very convenient by clinicians in 87% of routine clinical encounters and clinicians accurately scored completed questionnaires 94% of the time. CONCLUSIONS The Expanded Prostate Cancer Index Composite for Clinical Practice is a valid instrument that enables patient reported, health related quality of life to be measured efficiently and accurately at the point of care, and thereby facilitates improved emphasis and management of patient reported outcomes.

Arterial Spin-labeling MR Imaging of Renal Masses: Correlation with Histopathologic Findings

PURPOSE To assess the value of arterial spin-labeling (ASL) perfusion magnetic resonance (MR) imaging in the characterization of solid renal masses by using histopathologic findings as the standard of reference. MATERIALS AND METHODS This prospective study was compliant with HIPAA and approved by the institutional review board. Informed consent was obtained from all patients before imaging. Forty-two consecutive patients suspected of having renal masses underwent ASL MR imaging before their routine 1.5-T clinical MR examination. Mean and peak tumor perfusion levels were obtained by one radiologist, who was blinded to the final histologic diagnosis, by using region of interest analysis. Perfusion values were correlated with histopathologic findings by using analysis of variance. A linear correlation model was used to evaluate the relationship between tumor size and perfusion in clear cell renal cell carcinoma (RCC). P < .05 was considered indicative of a statistically significant difference. RESULTS Histopathologic findings were available in 34 patients (28 men, six women; mean age ± standard deviation, 60.4 years ± 11.7). The mean perfusion of papillary RCC (27.0 mL/min/100 g ± 15.1) was lower than that of clear cell RCC (171.6 mL/min/100 g ± 61.2, P = .001), chromophobe RCC (152.9 mL/min/100 g ± 80.7, P = .04), unclassified RCC (208.0 mL/min/100 g ± 41.1, P = .001), and oncocytoma (373.9 mL/min/100 g ± 99.2, P < .001). The mean and peak perfusion levels of oncocytoma (373.9 mL/min/100 g ± 99.2 and 512.3 mL/min/100 g ± 146.0, respectively) were higher than those of papillary RCC (27.0 mL/min/100 g ± 15.1 and 78.2 mL/min/100 g ± 39.7, P < .001 for both), chromophobe RCC (152.9 mL/min/100 g ± 80.7 and 260.9 mL/min/100 g ± 61.9; P < .001 and P = .02, respectively), and unclassified RCC (208.0 mL/min/100 g ± 41.1 and 273.3 mL/min/100 g ± 83.4; P = .01 and P = .03, respectively). The mean tumor perfusion of oncocytoma was higher than that of clear cell RCC (P < .001). CONCLUSION ASL MR imaging enables distinction among different histopathologic diagnoses in renal masses on the basis of their perfusion level. Oncocytomas demonstrate higher perfusion levels than RCCs, and papillary RCCs exhibit lower perfusion levels than other RCC subtypes.

Iatrogenic vascular lesions after minimally invasive partial nephrectomy: a multi-institutional study of clinical and renal functional outcomes.

OBJECTIVES To report the first large multi-institutional experience, including clinical and renal functional outcomes after treatment of iatrogenic vascular lesions (eg, renal artery pseudoaneurysm, arteriovenous fistula). These lesions are uncommon after minimally invasive partial nephrectomy (MIPN) but can be associated with significant morbidity. METHODS A retrospective review of MIPN was performed at 4 centers. Patients developing pseudoaneurysm or arteriovenous fistula in the postoperative period were identified. The demographic, disease, and perioperative details and data regarding the presentation and treatment of vascular lesions were collected. RESULTS Of the 998 patients undergoing MIPN, 20 (2.0%) presented with iatrogenic vascular lesions (17 with pseudoaneurysm and 3 with arteriovenous fistula). The mean age was 55.9 years, the tumor size was 2.6 cm, and the body mass index was 30.8 kg/m(2). Twelve patients (60%) had >50% endophytic tumors, 7 patients (35%) had undergone collecting system repair, and the mean warm ischemia time was 26 minutes. All patients presented with gross hematuria at a mean of 14.5 days postoperatively. The diagnosis was made using urgent computed tomography scan in all cases. Selective embolization was performed in 16 patients; 2 required no intervention and had spontaneous resolution, and 2 had negative angiography findings. Four patients required transfusion during rehospitalization. Although 4 patients had categorical worsening of the glomerular filtration rate after MIPN, all patients had stable function acutely after angioembolization, and 3 patients had categorical glomerular filtration rate improvement through a mean follow-up of 20 months. No patients had recurrent hemorrhagic events. CONCLUSIONS Iatrogenic vascular lesions occur in ∼2% of MIPN cases. Although a subset of patients will have resolution with observation only, most require angioembolization, with excellent clinical and renal function outcomes.

Comparing costs of robotic, laparoscopic, and open partial nephrectomy.

UNLABELLED Abstract Background and Purpose: Laparoscopic and robot-assisted partial nephrectomy (LPN and RPN) are common minimally invasive alternatives to open partial nephrectomy (OPN) for management of renal tumors. Cost discrepancies of these approaches warrants evaluation. We compared hospital costs associated with RPN, LPN, and OPN. PATIENTS AND METHODS Costs were captured for 25 patients in each group who underwent RPN, LPN, or OPN at our institution between November 2008 and September 2010. Variable costs included operating room (OR) time, supplies, anesthesia, and inpatient care costs. Fixed costs included equipment purchase and maintenance. Impact of variable and fixed costs were estimated using sensitivity analysis. RESULTS Overall variable costs were similar for RPN, LPN, and OPN (

Precision Medicine in Active Surveillance for Prostate Cancer: Development of the Canary-Early Detection Research Network Active Surveillance Biopsy Risk Calculator.

6375 vs

Robot-Assisted Partial Nephrectomy: Early Unclamping Technique

6075 vs

3-Year Actuarial Biochemical Recurrence-Free Survival Following Laparoscopic Radical Prostatectomy: Experience From a Tertiary Referral Center in the United States

5774, P=0.117, respectively). OR supplies contributed a greater cost for RPN and LPN than OPN (

Active Surveillance is Superior to Radical Nephrectomy and Equivalent to Partial Nephrectomy for Preserving Renal Function in Patients with Small Renal Masses: Results from the DISSRM Registry

2179 vs

Use of a validated quality of life questionnaire to assess sexual function following laparoscopic radical prostatectomy

1987 vs