Development and validation of a multicenter Cox regression model to predict all-cause mortality in patients with renal masses suspicious for renal cancer.

OBJECTIVE: Life expectancy models are useful tools to support clinical decision-making. Prior models have not been used widely in clinical practice for patients with renal masses. We sought to develop and validate a model to predict life expectancy following the detection of a localized renal mass suspicious for renal cell carcinoma. MATERIALS AND METHODS: Using retrospective data from 2 large centers, we identified patients diagnosed with clinically localized renal parenchymal masses from 1998 to 2018. After 2:1 random sampling into a derivation and validation cohort stratified by site, we used age, sex, log-transformed tumor size, simplified cardiovascular index and planned treatment to fit a Cox regression model to predict all-cause mortality from the time of diagnosis. The model's discrimination was evaluated using a C-statistic, and calibration was evaluated visually at 1, 5, and 10 years. RESULTS: We identified 2,667 patients (1,386 at Corewell Health and 1,281 at Johns Hopkins) with renal masses. Of these, 420 (16%) died with a median follow-up of 5.2 years (interquartile range 2.2-8.3). Statistically significant predictors in the multivariable Cox regression model were age (hazard ratio [HR] 1.04; 95% confidence interval [CI] 1.03-1.05); male sex (HR 1.40; 95% CI 1.08-1.81); log-transformed tumor size (HR 1.71; 95% CI 1.30-2.24); cardiovascular index (HR 1.48; 95% CI 1.32-1.67), and planned treatment (HR: 0.10, 95% CI: 0.06-0.18 for kidney-sparing intervention and HR: 0.20, 95% CI: 0.11-0.35 for radical nephrectomy vs. no intervention). The model achieved a C-statistic of 0.74 in the derivation cohort and 0.73 in the validation cohort. The model was well-calibrated at 1, 5, and 10 years of follow-up. CONCLUSIONS: For patients with localized renal masses, accurate determination of life expectancy is essential for decision-making regarding intervention vs. active surveillance as a primary treatment modality. We have made available a simple tool for this purpose.

Incidental discovery of metastatic renal cell carcinoma at the vaginal wall: A case report.

Metastasis of renal cell carcinoma (RCC) to the vaginal wall has rarely been reported in the literature. We present a case of a 48-year-old who was found to have a solitary RCC metastasis at the vaginal wall, five years following radical nephrectomy. This case is noteworthy because this late presentation is unique, with prior reports of synchronous metastasis or metastasis within two years of nephrectomy, highlighting the need to consider metastatic RCC to the vagina a possibility even many years after treatment.

Simplified cardiovascular index may be the best comorbidity index for clinical use in prediction of mortality for renal cancer patients.

OBJECTIVE: Understanding the relationship between comorbidities and life expectancy is important in cancer patients who carry risks of cancer and noncancer-related mortality. Comorbidity indices (CI) are tools to provide an objective measure of competing risks of death. We sought to determine which CI might be best incorporated into clinical practice for patients with suspected renal cancer. MATERIALS AND METHODS: 1572 patients diagnosed with renal masses (stage I-IV) between 1998 and 2016 were analyzed for this study. Patient data were gathered from a community-based health center. Comorbidities were evaluated individually, and with 1 of 4 CI: Charlson (CCI), updated CCI (uCCI), age-adjusted CCI (aCCI), and simplified cardiovascular index (CVI). Cox-proportional hazard analysis of all-cause mortality was performed using the four CI, adjusting for the 4 CI, adjusting for age, gender, race, tumor size, and tumor stage. RESULTS: Univariable analyses revealed the four CI were significant predictors of mortality (P < 0.05), as were age, gender, tumor size, and stage. Comorbid conditions at diagnosis included hypertension (47.8%), diabetes mellitus (47.2%), coronary artery disease (41.1%), chronic kidney disease (31.8%), peripheral vascular disease (8.0%), congestive heart failure (5.7%), chronic obstructive pulmonary disease (5.7%), and cerebrovascular disease (2.0%). When analyzing the 4 CI in multivariable survival analyses accounting for factors available at diagnosis, and analyses incorporating pathologic and recurrence data, only CVI score and uCCI remained statistically significant (P < 0.05). Limitations of this work are the retrospective nature of data collection and data from a single institution, limiting the generalizability. CONCLUSION: Increasing comorbidity, age, tumor size, and cM stage are predictors of ACM for suspected renal cancer patients. CVI appears to provide comparable information to various iterations of CCI (uCCI, aCCI) while being the simplest to use. Utilization of CVI may assist clinicians and patients when considering between interventional and noninterventional approaches for suspected renal cancer.

Development of a novel score (RENSAFE) to determine probability of acute kidney injury and renal functional decline post surgery: A multicenter analysis.

OBJECTIVE: To create and validate 2 models called RENSAFE (RENalSAFEty) to predict postoperative acute kidney injury (AKI) and development of chronic kidney disease (CKD) stage 3b in patients undergoing partial (PN) or radical nephrectomy (RN) for kidney cancer. METHODS: Primary objective was to develop a predictive model for AKI (reduction >25% of preoperative eGFR) and de novo CKD≥3b (<45 ml/min/1.73m2), through stepwise logistic regression. Secondary outcomes include elucidation of the relationship between AKI and de novo CKD≥3a (<60 ml/min/1.73m2). Accuracy was tested with receiver operator characteristic area under the curve (AUC). RESULTS: AKI occurred in 452/1,517 patients (29.8%) and CKD≥3b in 116/903 patients (12.8%). Logistic regression demonstrated male sex (OR = 1.3, P = 0.02), ASA score (OR = 1.3, P < 0.01), hypertension (OR = 1.6, P < 0.001), R.E.N.A.L. score (OR = 1.2, P < 0.001), preoperative eGFR<60 (OR = 1.8, P = 0.009), and RN (OR = 10.4, P < 0.0001) as predictors for AKI. Age (OR 1.0, P < 0.001), diabetes mellitus (OR 2.5, P < 0.001), preoperative eGFR <60 (OR 3.6, P < 0.001) and RN (OR 2.2, P < 0.01) were predictors for CKD≥3b. AUC for RENSAFE AKI was 0.80 and 0.76 for CKD≥3b. AKI was predictive for CKD≥3a (OR = 2.2, P < 0.001), but not CKD≥3b (P = 0.1). Using 21% threshold probability for AKI achieved sensitivity: 80.3%, specificity: 61.7% and negative predictive value (NPV): 88.1%. Using 8% cutoff for CKD≥3b achieved sensitivity: 75%, specificity: 65.7%, and NPV: 96%. CONCLUSION: RENSAFE models utilizing perioperative variables that can predict AKI and CKD may help guide shared decision making. Impact of postsurgical AKI was limited to less severe CKD (eGFR<60 ml/min 71.73m2). Confirmatory studies are requisite.

Incidence and clinical relevance of paraneoplastic syndromes in patients with renal cell carcinoma.

BACKGROUND: Paraneoplastic syndromes (PNS) are defined as the signs and symptoms attributed to cytokines or hormones released from a tumor or a patient's immune system. PNS have been reported with many cancers for decades and data supporting their relevance in renal cell carcinoma (RCC) are largely historical. The widespread use of electronic medical record (EMR) systems provides a more robust method to capture data. The objective of this study was to establish contemporary data regarding the incidence and relevance of PNS in patients undergoing nephrectomy for suspected RCC. METHODS: In this retrospective single-institution study, 851 patients undergoing nephrectomy for suspected RCC between 2011 and 2018 were assessed for the presence or absence of PNS as defined by laboratory abnormalities. Factors associated with PNS and with all-cause mortality were examined. RESULTS: The incidence of PNS was 33.1% among 851 patients prior to nephrectomy. The most prevalent PNS were anemia (22.4%), thrombocytosis (7.5%), and elevated C-reactive protein (CRP) (7.4%). PNS were more common in women (39.2% vs. 29.4%, p = 0.0032) and higher stage RCC (31.1% of stage I vs. 54.2% of stage IV, p = 0.0036). Factors associated with the presence of PNS in multivariable analysis included female gender, high comorbidity, and stage IV RCC. Prenephrectomy PNS were associated with poorer survival in multivariable analysis (HR: 2.12, p = 0.0002). Resolution of PNS occurred in 52.1% of patients after nephrectomy, including 55.2% with stage I to III and 38.5% with stage IV RCC (p = 0.10). CONCLUSIONS: Using EMR data, laboratory evidence of PNS was present in one-third of a contemporary cohort of patients undergoing nephrectomy, with >50% of PNS resolving after surgery. Consistent with prior reports, PNS are more common in higher-stage RCC and are associated with poorer survival in RCC patients.

Diabetes, Obesity, and Pathological Upstaging in Renal Cell Carcinoma: Results From a Large Multi-institutional Consortium.

PURPOSE: We sought to determine whether clinical risk factors and morphometric features on preoperative imaging can be utilized to identify those patients with cT1 tumors who are at higher risk of upstaging (pT3a). MATERIALS AND METHODS: We performed a retrospective international case-control study of consecutive patients treated surgically with radical or partial nephrectomy for nonmetastatic renal cell carcinoma (cT1 N0) conducted between January 2010 and December 2018. Multivariable logistic regression models were used to study associations of preoperative risk factors on pT3a pathological upstaging among all patients, as well as subsets with those with preoperative tumors ≤4 cm, renal nephrometry scores, tumors ≤4 cm with nephrometry scores, and clear cell histology. We also examined association with pT3a subsets (renal vein, sinus fat, perinephric fat). RESULTS: Among the 4,092 partial nephrectomy and 2,056 radical nephrectomy patients, pathological upstaging occurred in 4.9% and 23.3%, respectively. Among each group independent factors associated with pT3a upstaging were increasing preoperative tumor size, increasing age, and the presence of diabetes. Specifically, among partial nephrectomy subjects diabetes (OR=1.65; 95% CI 1.17, 2.29), male sex (OR=1.62; 95% CI 1.14, 2.33), and increasing BMI (OR=1.03; 95% CI 1.00, 1.05 per 1 unit BMI) were statistically associated with upstaging. Subset analyses identified hilar tumors as more likely to be upstaged (partial nephrectomy OR=1.91; 95% CI 1.12, 3.16; radical nephrectomy OR=2.16; 95% CI 1.44, 3.25). CONCLUSIONS: Diabetes and higher BMI were associated with pathological upstaging, as were preoperative tumor size, increased age, and male sex. Similarly, hilar tumors were frequently upstaged.

Utilization of a Virtual Tumor Board for the Care of Patients With Renal Masses: Experience From a Quality Improvement Collaborative.

INTRODUCTION: Multidisciplinary tumor board meetings are useful sources of insight and collaboration when establishing treatment approaches for oncologic cases. However, such meetings can be time intensive and inconvenient. We implemented a virtual tumor board within the Michigan Urological Surgery Improvement Collaborative to discuss and improve the management of complicated renal masses. METHODS: Urologists were invited to discuss decision-making for renal masses through voluntary engagement. Communication was performed exclusively through email. Case details were collected and responses were tabulated. All participants were surveyed about their perceptions of the virtual tumor board. RESULTS: Fifty renal mass cases were reviewed in a virtual tumor board that included 53 urologists. Patients ranged from 20-90 years old and 94% had localized renal mass. The cases generated 355 messages, ranging from 2-16 (median 7) per case; 144 responses (40.6%) were sent via smartphone. All urologists (100%) who submitted to the virtual tumor board had their questions answered. The virtual tumor board provided suggestions to those with no stated treatment plan in 42% of cases, confirmed the physician's initial approach to their case in 36%, and offered alternative approaches in 16% of cases. Eighty-three percent of survey respondents felt the experience was "Beneficial" or "Very Beneficial," and 93% stated increased confidence in their case management. CONCLUSIONS: Michigan Urological Surgery Improvement Collaborative's initial experience with a virtual tumor board showed good engagement. The format reduced barriers to multi-institutional and multi-disciplinary discussions and improved the quality of care for selected patients with complex renal masses.

Guideline Compliance Regarding Chest Imaging of Suspicious cT1 Renal Masses in MUSIC-KIDNEY.

INTRODUCTION: Multiple urological societies recommend chest imaging for suspicious renal masses using chest x-ray or CT as clinically indicated. The purpose of chest imaging is to assess for thoracic metastasis at the time of renal mass diagnosis. Ideally, imaging use and type are commensurate with risk related to tumor size and clinical stage. We examined current practice patterns with chest imaging compliance in the state of Michigan and implemented clinician education and value-based reimbursement incentivization on guideline adherence. METHODS: MUSIC (Michigan Urological Surgery Improvement Collaborative)-KIDNEY (Kidney mass: Identifying and Defining Necessary Evaluation and therapY) is a statewide initiative focusing on quality improvement for patients with cT1 renal masses. Data regarding chest imaging in MUSIC and panel discussion occurred at an in-person MUSIC meeting in October 2019. Adherence to chest imaging guidelines was made a value-based reimbursement metric at the triannual MUSIC meeting in January 2020. Adherence was defined as optional in renal masses <3 cm (CT not indicated), recommended in renal masses 3-5 cm (chest x-ray preferred), and required in renal masses >5 cm (CT preferred). The MUSIC registry was queried for percentage of patients receiving chest imaging by type. Factors associated with adherence were assessed. RESULTS: There was significant practice-level variation in chest imaging rates across the 14 contributing practices, ranging from 11% to 68%. Compliance with MUSIC guidelines for chest imaging during evaluation of T1 renal masses was 81.8% overall, with only 61.8% of patients with masses >5 cm meeting the guideline requiring imaging with preference for CT. Factors associated with increased adherence included larger tumor size (T1b vs T1a) and solid (vs cystic or indeterminate) tumor (P < .05 for each). Prior to value-based reimbursement introduction, 46.7% of patients underwent imaging of either type, compared to 49.0% post-intervention. Imaging rates only slightly increased in masses >5 cm (58.3% before value-based reimbursement vs 61.2% after, P = .56) and 3-5 cm (50.0% before value-based reimbursement vs 56.2% after, P = .0585). CONCLUSIONS: Chest imaging guideline adherence during the initial evaluation of cT1 renal masses is acceptable, particularly given that most masses are <3 cm, for which metastatic risk is low. However, despite consensus from major urological societies regarding imaging for masses >4-5 cm, imaging rates were low across MUSIC. After educational and value-based reimbursement incentive initiation, rates of imaging for 3-5-cm and >5-cm masses changed only slightly. There remains significant practice variability and room for improvement.

Initial Management of Indeterminate Renal Lesions in a Statewide Collaborative: A MUSIC-KIDNEY Analysis.

PURPOSE: Renal masses can be characterized as "indeterminate" due to lack of differentiating imaging characteristics. Optimal management of indeterminate renal lesions remains nebulous and poorly defined. We assess management of indeterminate renal lesions within the MUSIC-KIDNEY (Michigan Urological Surgery Improvement Collaborative-Kidney mass: Identifying and Defining Necessary Evaluation and therapY) collaborative. MATERIALS AND METHODS: Each renal mass is classified as suspicious, benign, or indeterminate based on radiologist and urologist assessment. Objectives were to assess initial management of indeterminate renal lesions and the impact of additional imaging and biopsy on characterization prior to treatment. RESULTS: Of 2,109 patients, 444 (21.1%) had indeterminate renal lesions on their initial imaging, which included CT without contrast (36.2%), CT with contrast (54.1%), and MRI (9.7%). Eighty-nine patients (20.0%) underwent additional imaging within 90 days, 8.3% (37/444) underwent renal mass biopsy, and 3.6% (16/444) had reimaging and renal mass biopsy. Additional imaging reclassified 58.1% (61/105) of indeterminate renal lesions as suspicious and 21.0% (22/105) as benign, with only 20.9% (22/105) remaining indeterminate. Renal mass biopsy yielded a definitive diagnosis for 87%. Treatment was performed for 149 indeterminate renal lesions (33.6%), including 117 without reimaging and 123 without renal mass biopsy. At surgery for indeterminate renal lesions, benign pathology was more common in patients who did not have repeat imaging (9.9%) than in those who did (6.7%); for ≤4 cm indeterminate renal lesions, these rates were 11.8% and 4.3%. CONCLUSIONS: About 33% of patients diagnosed with an indeterminate renal lesion underwent immediate treatment without subsequent imaging or renal mass biopsy, with a 10% rate of nonmalignant pathology. This highlights a quality improvement opportunity for patients with cT1 renal masses: confirmation that the lesion is suspicious for renal cell carcinoma based on high-quality, multiphase, cross-sectional imaging and/or histopathological features prior to surgery, even if obtaining subsequent follow-up imaging and/or renal mass biopsy is necessary. When performed, these steps lead to reclassification in 79% and 87% of indeterminate renal lesions, respectively.

Renal Functional Outcomes in Patients With Angiomyolipomas: Surveillance vs Embolization vs Nephrectomy.

OBJECTIVE: To investigate renal functional outcomes of surveillance, embolization, and surgery for angiomyolipomas (AML). METHODS: Longitudinal data regarding patients with AML were analyzed retrospectively in this 2-center study. Demographic, radiographic, and functional data were tabulated according to treatment type. Primary outcome was change in renal function from diagnosis to within 6 months postdiagnosis (interim) and to latest glomerular filtration rate (GFR) assessment. RESULTS: 318 patients were diagnosed with AMLs; mean follow-up was 6.2 years. 184 patients (57.9%) were managed with surveillance, 30 (9.4%) underwent embolization, and 103 (32.4%) underwent surgery (91 partial nephrectomy; 12 radical nephrectomy). Baseline characteristics, including tumor size, age, and race differed between the 3 groups (P<.05). Surveilled AMLs were smaller (P<.001) than the intervention groups: 1.9 cm vs 5.4 cm (embolization) and 4.9 cm (surgery). Greater interim decreases in GFR were observed following intervention with embolization (-14.0%) or surgery (-11.8%), when compared with surveillance (-4.1%); however, this was not statistically significant (P=.19). Latest GFR was also reduced more (P=.02) with embolization (-14.1%) and surgery (-14.7%) when compared to surveillance (-6.0%). At latest determination, chronic kidney disease progression by at least one stage occurred in 37.8% overall, including 33.7% of surveilled patients, and was not statistically different across the three cohorts (P=.074). CONCLUSION: Within the study limitations, surveillance appears to be appropriate for most AML patients; embolization and surgical intervention should be reserved for selected patients with large and/or symptomatic AML. Renal functional deterioration is common in patients with AML, whether managed with surveillance, embolization, or surgery. Long-term monitoring of renal function should be obligatory for all AML patients.

Metastatic renal cell carcinoma in the bladder following complex partial nephrectomy: A case report.

Metastasis of renal cell carcinoma (RCC) to the bladder is rare. We present a case of a 74-year-old patient with a metachronous, solitary metastasis of RCC to the bladder twenty months after partial nephrectomy and JJ-stent placement for a complex renal tumor. The mechanism of RCC metastasis to the bladder remains controversial, and we believe this case adds support to the drop metastasis theory.

Predictors of Positive Surgical Margins after Robot-Assisted Partial Nephrectomy for Localized Renal Tumors: Insights from a Large Multicenter International Prospective Observational Project (The Surface-Intermediate-Base Margin Score Consortium).

Background: To explore predictors of positive surgical margins (PSM) after robotic partial nephrectomy (PN) in a large multicenter international observational project, harnessing the Surface-Intermediate-Base (SIB) margin score to report the resection technique after PN in a standardized way. Methods: Data from consecutive patients with cT1-2N0M0 renal masses treated with PN from September 2014 to March 2015 at 16 tertiary referral centers and included in the SIB margin score International Consortium were prospectively collected. For the present study, only patients treated with robotic PN were included. Uni- and multivariable analysis were fitted to explore clinical and surgical predictors of PSMs after PN. Results: Overall, 289 patients were enrolled. Median (IQR) preoperative tumor size was 3.0 (2.3−4.2) cm and median (IQR) PADUA score was 8 (7−9). SIB scores of 0−2 (enucleation), 3−4 (enucleoresection) and 5 (resection) were reported in 53.3%, 27.3% and 19.4% of cases, respectively. A PSM was recorded in 18 (6.2%) patients. PSM rate was 4.5%, 11.4% and 3.6% in case of enucleation, enucleoresection and resection, respectively. Patients with PSMs had tumors with a higher rate of contact with the urinary collecting system (55.6% vs. 27.3%; p < 0.001) and a longer median warm ischemia time (22 vs. 16 min; p = 0.02) compared with patients with negative surgical margins, while no differences emerged between the two groups in terms of other tumor features (i.e., pathological diameter, PADUA score). In multivariable analysis, only enucleoresection (SIB score 3−4) versus enucleation (SIB score 0−2) was found to be an independent predictor of PSM at final pathology (HR: 2.68; 95% CI: 1.25−7.63; p = 0.04), while resection (SIB score 5) was not. Conclusions: In our experience, enucleoresection led to a higher risk of PSMs as compared to enucleation. Further studies are needed to assess the differential impacts of resection technique and surgeon's experience on margin status after robotic PN.

Impact of Trifecta definition on rates and predictors of "successful" robotic partial nephrectomy for localized renal masses: results from the Surface-Intermediate-Base Margin Score International Consortium.

BACKGROUND: Over the years, five different Trifecta score definitions have been proposed to optimize the framing of "success" in partial nephrectomy (PN) field. However, such classifications rely on different metrics. The aim of the present study was to explore how the success rate of robotic PN, as well as its drivers, vary according to the currently available definitions of Trifecta. METHODS: Data from consecutive patients with cT1-2N0M0 renal masses treated with robotic PN at 16 referral centers from September 2014 to March 2015 were prospectively collected. Trifecta rate was defined for each of the currently available definitions. Multivariable logistic regression analysis was used to evaluate possible predictors of "Trifecta failure" according to the different adopted formulation. RESULTS: Overall, 289 patients met the inclusion criteria. Among the definitions, Trifecta rates ranged between 66.4% and 85.9%. Multivariable analysis showed that predictors for "Trifecta failure" were mainly tumor-related (i.e. tumor's nephrometry) for those Trifecta scores relying on WIT as a surrogate metric for postoperative renal function deterioration (definitions 1,2), while mainly surgery-related (i.e. ischemia time and excision strategy) for those including the percentage change in postoperative eGFR as the functional cornerstone of Trifecta (definitions 3-5). CONCLUSIONS: There was large variability in rates and predictors of "unsuccessful PN" when using different Trifecta scores. Further research is needed to improve the value of the Trifecta metrics, integrating them into routine patient counseling and standardized assessment of surgical quality across institutions.

Practice-Level Variation in the Decision to Biopsy Prostate Imaging-Reporting and Data System 3 Lesions in Favorable-Risk Prostate Cancer Patients.

OBJECTIVE: To examine practice-level variation in the management of magnetic resonance imaging (MRI) Prostate Imaging-Reporting and Data System (PI-RADS) 3 lesions in men with favorable-risk prostate cancer (FRPC) considering or on active surveillance (AS). PATIENTS AND METHODS: We reviewed the Michigan Urological Surgery Improvement Collaborative registry for FRPC men (GG1 and low-volume GG2) undergoing MRI from January 2013 to March 2020. The primary outcome was to assess practice-level variation in time from MRI to biopsy and MRI to treatment for PI-RADS 3 lesions. Both MRIs obtained after the diagnostic biopsy and while on AS were included. The Kaplan-Meier method was used to estimate biopsy-free survival for time from MRI to surveillance biopsy and multivariable Cox proportional hazards models identified clinical and demographic factors associated with time obtaining a biopsy after finding PI-RADS 3 lesions. RESULTS: We identified 3172 FRPC men with a MRI, of whom 473 had a PI-RADS 3. There was significant practice-level variation in biopsy rates among patients with PI-RADS 3 MRI results (log-rank test, P <.001), with biopsy-free probability at 6 months ranging from 28% to 69% (median: 59%). We were unable to identify factors with significant associations with time to biopsy. Conversely, there was less variation in time from PI-RADS 3 to treatment (log-rank test, P = .2), while several clinical factors had statistically-significant associations: age (P = .018), Prostate Specific Antigen-Density 0.1-0.2 (P = .035), ISUP-GG 2 (P = .002), and number of positive cores (P <.001), as expected. CONCLUSION: Urology practice, rather than GG or extent of biopsy positivity, is the largest factor affecting the decision for biopsy of PI-RADS 3 lesions in FRPC men considering or on AS. Future work to assist with decision-making and reduce variability is needed.

Impact of surgical approach and resection technique on the risk of Trifecta Failure after partial nephrectomy for highly complex renal masses.

INTRODUCTION: We aimed to compare the outcomes of open vs robotic partial nephrectomy (PN), focusing on predictors of Trifecta failure in patients with highly complex renal masses. PATIENTS AND METHODS: We queried the prospectively collected database from the SIB International Consortium, including 507 consecutive patients with cT1-2N0M0 renal masses treated at 16 high-volume referral centres, to select those with highly complex (PADUA score ≥10) tumors undergoing PN. RT was classified as enucleation, enucleoresection or resection according to the SIB score. Trifecta was defined as achievement of negative surgical margins, no acute kidney injury and no Clavien-Dindo grade ≥2 postoperative surgical complications. Multivariable logistic regression analysis was used to assess independent predictors of Trifecta failure. RESULTS: 113 patients were included. Patients undergoing open PN (n = 47, 41.6%) and robotic PN (n = 66, 58.4%) were comparable in baseline characteristics. RT was classified as enucleation, enucleoresection and resection in 46.9%, 34.0% and 19.1% of open PN, and in 50.0%, 40.9% and 9.1% of robotic PN (p = 0.28). Trifecta was achieved in significantly more patients after robotic PN (69.7% vs. 42.6%, p = 0.004). On multivariable analysis, surgical approach (open vs robotic, OR: 2.62; 95%CI: 1.11-6.15, p = 0.027) and tumor complexity (OR for each additional unit of the PADUA score: 2.27; 95%CI: 1.27-4.06, p = 0.006) were significant predictors of Trifecta failure, while RT was not. The study is limited by lack of randomization; as such, selection bias and confounding cannot be entirely ruled out. CONCLUSIONS: Tumor complexity and surgical approach were independent predictors of Trifecta failure after PN for highly complex renal masses.

Initial Observation of a Large Proportion of Patients Presenting with Clinical Stage T1 Renal Masses: Results from the MUSIC-KIDNEY Statewide Collaborative.

BACKGROUND: While surgical excision remains the principal management strategy for clinical T1 renal masses (cT1RMs), the rates of noninterventional approaches are not well known. Most single-institution and population-based series suggest rates below 10%. OBJECTIVE: To evaluate the use of observation for newly diagnosed cT1RM patients in academic and community-based practices across a statewide collaborative. DESIGN SETTING AND PARTICIPANTS: The Michigan Urological Surgery Improvement Collaborative-Kidney mass: Identifying and Defining Necessary Evaluation and therapY (MUSIC-KIDNEY) commenced data collection in September 2017 by recording clinical, radiographic, pathologic, and short-term follow-up data for cT1RM patients at 13 diverse practices. Patients with complete data were assessed at >90 d after initial evaluation as to whether observation or treatment was performed. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Relationships with outcomes were analyzed using multivariable logistic regression, chi-square test, and Wilcoxon rank-sum test. RESULTS AND LIMITATIONS: Out of 965 patients, observation was employed in 48% (n = 459), with practice-level rates ranging from 0% to 68%. Patients managed with observation (vs treatment) were significantly older (71.2 vs 62.8 yr, p < 0.0001) and had smaller tumors (2.3 vs 3.4 cm, p < 0.0001). Observation was used for 53.5% of cT1a renal masses, for 29.9% of cT1b renal masses, and for 42.5%, 53.7%, and 63.9% of radiographically solid, Bosniak III-IV cystic, and indeterminate cT1RMs, respectively. Factors significantly associated with observation in multivariable analysis included lesion type (Bosniak III-IV vs solid, p = 0.017), tumor stage (cT1a vs cT1b, p < 0.001), and higher age (p < 0.001). A short duration of follow-up limits the assessment of longer-term patient management. CONCLUSIONS: Noninterventional management of cT1RMs is common across the MUSIC-KIDNEY collaborative, with wide variability across practices. Factors associated with observation were advanced age, smaller tumor size, and cystic tumor type. Durability of the initial decision for observation (delayed intervention vs active surveillance vs less active surveillance) will be a focus of subsequent study. PATIENT SUMMARY: The Michigan Urological Surgery Improvement Collaborative: Kidney mass: Identifying and Defining Necessary Evaluation and therapY (MUSIC-KIDNEY) quality improvement collaborative assessed the current utilization of initial observation of a renal mass ≤7 cm across a diverse group of urology practices and found it to be used in 48% of patients. We found that the factors predicting observation were advanced age, smaller tumor size, and cystic tumor type.

Comparison of Side Effects and Tolerability Between Intravesical Bacillus Calmette-Guerin, Reduced-Dose BCG and Gemcitabine for Non-Muscle Invasive Bladder Cancer.

OBJECTIVES: To compare patient-reported side effects and tolerability of full-dose Bacillus Calmette-Guérin (BCG), reduced-dose BCG, and gemcitabine one week after administration. METHODS: All patients from July 2019 to November 2020 receiving intravesical therapy (IVT) for non-muscle invasive bladder cancer (NMIBC) at our institution were surveyed before repeat instillation. Survey questions recorded IVT retention times and the duration and severity of the following side effects: bladder symptoms, fatigue, body aches, hematuria, fever, chills, and other. All responses were collected and quantified in a de-identified, password-protected database. Statistical analysis was performed using SAS JMP 13. RESULTS: Of 592 surveys completed, symptoms of any kind were reported on 463 surveys (78%) with the most common symptoms including bladder symptoms (59%), fatigue (52%), body aches (26%), and hematuria (18%). Patients were able to hold full-dose BCG, reduced-dose BCG, and gemcitabine for the protocol-specified duration 87%, 95%, and 71% of the time (P <0.05). The prevalence, severity, and duration of body aches were highest with gemcitabine (P <0.05) while the prevalence and duration of hematuria were higher with BCG (P <0.05). Reduced-dose BCG had the lowest prevalence, severity, and duration of fatigue (P <0.05). CONCLUSION: Significant differences in the side effects and tolerability of full-dose BCG, reduced-dose BCG, and gemcitabine were demonstrated using this novel survey, and these differences are of value for informing IVT selection. Evaluation of IVTs other than gemcitabine and BCG will further inform selection of therapies for NMIBC.