The value of a comprehensive primary outcome - results of a negative randomized control trial in the non-muscle invasive bladder cancer population.

INTRODUCTION American Urological Association (AUA) guidelines recommend intravesical chemotherapy to be given following transurethral resection of a bladder tumor. Prior studies have shown the benefit of mitomycin as well as gemcitabine. However, no study has compared the two agents. MATERIALS AND METHODS: The study was designed as an open label 1:1:1 randomized controlled trial, comparing intravesical mitomycin, gemcitabine and saline as a single intraoperative instillation immediately following transurethral resection of suspected bladder tumor. Primary endpoint was any grade ≥ 3 events according to NCI CTCAE Version 4.03, this captures any return trip to the operating room for recurrence of cancer or other event (benign bladder/urethra). Secondary endpoints were progression free survival for urothelial cell carcinoma and adverse events. RESULTS: A total of 82 patients were enrolled and randomized, unfortunately the trial was suspended early due to protocol deviations. In an intention to treat analysis, freedom from grade > 3 events at 2 years was 74.8% in the no treatment arm, 51.0% in the mitomycin arm, and 56.0% in the gemcitabine arm (p = 0.81). Freedom from cancer recurrence for all patients was 62.3%. In the no treatment arm, it was 78.8%, and 50.7% and 63.6% in the mitomycin arm and gemcitabine arm respectively. (p = 0.28). In a univariate analysis, the only patient variable significantly associated with the primary outcome was pathologic T stage (p < 0.002). CONCLUSION: This study provides an example of a novel, patient centered primary outcome with the goal of determining which treatment paradigms provide the greatest oncologic and clinic benefit.

Optimizing Nutrition Prior to Radical Cystectomy.

PURPOSE OF REVIEW: Malnutrition in a prevalent problem in patients undergoing radical cystectomy. Preoperative malnutrition has been shown to contribute to increased rates of postoperative complications. Given the significant morbidity and mortality of the procedure of radical cystectomy, there is potential for improvement in patient outcomes by nutritional intervention. RECENT FINDINGS: Prospective studies have demonstrated a reduction in postoperative infection rates in patients who receive supplemental immunonutrition prior to major surgery including radical cystectomy. These initial evaluations of nutritional optimization show significant potential for improved outcomes. Additionally, several studies using enhanced recovery after surgery protocols, which include a preoperative nutritional component, have shown a benefit in reducing length of stay. Emerging literature has shown the benefits of preoperative immunonutrition in improving postoperative outcomes of radical cystectomy. However, further work is needed to determine the best mechanism to optimize nutrition prior to radical cystectomy.

Emerging Impact of Malnutrition on Surgical Patients: Literature Review and Potential Implications for Cystectomy in Bladder Cancer.

PURPOSE: Malnutrition is emerging as a significant factor in patient outcomes. A contemporary review of malnutrition has not been performed for the urologist. We review the available literature and current standards of care for malnutrition screening, assessment and intervention, focusing on patients with bladder cancer treated with cystectomy. MATERIALS AND METHODS: Our multidisciplinary team searched PubMed® for available literature on malnutrition, focusing on definition and significance, importance to urologists, screening, assessment, diagnosis, immunological and economic impacts, and interventions. RESULTS: The prevalence of malnutrition in hospitalized patients is estimated to range from 15% to 60%, reaching upward of 71% in those with cancer. Malnutrition has been shown to increase inflammatory markers, further intensifying catabolism and weight loss. Bladder cancer is catabolic and patients undergoing cystectomy have increased resting energy expenditure postoperatively. Data are emerging on the impact of malnutrition in the cystectomy population. Recent studies have identified poor nutritional status based on low albumin or sarcopenia (loss of muscle) as having an adverse impact on length of hospitalization, complications and survival. The current standard of care malnutrition assessment tool, the 2012 consensus statement of the Academy of Nutrition and Dietetics and the American Society for Parenteral and Enteral Nutrition, has not been evaluated in the urological literature. Perioperative immunonutrition in patients undergoing colorectal surgery has been associated with significant decreases in postoperative complications, and recent pilot work has identified the potential for immunonutrition to positively impact the cystectomy population. CONCLUSIONS: Malnutrition has a significant impact on surgical patients, including those with bladder cancer. There are emerging data in the urological literature regarding how best to identify and improve the nutritional status of patients undergoing cystectomy. Additional research is needed to identify malnutrition in these patients and interventions to improve surgical outcomes.

Proteinuria is a Predictor of Renal Functional Decline in Patients with Kidney Cancer.

PURPOSE: Prior studies have shown that 26% to 34% of patients with suspected renal cancers have a glomerular filtration rate less than 60 ml/minute/1.73 m(2) but limited information exists regarding proteinuria. We investigated the extent of proteinuria in patients with renal tumors to determine the impact on the classification and progression of chronic kidney disease. MATERIALS AND METHODS: Among 1,622 patients evaluated between 1999 and 2014, 1,016 had preoperative creatinine and proteinuria measurements available. Patients were classified according to the risk of chronic kidney disease progression into low, moderately increased, high and very high risk groups according to 2012 KDIGO guidelines. Predictors of risk group and chronic kidney disease progression were analyzed using univariable and multivariate models. RESULTS: Before treatment 32% had a glomerular filtration rate less than 60 ml/minute/1.73 m(2). Preoperative proteinuria was present in 22%. Proteinuria was detected in 30% with a reduced glomerular filtration rate and 18% with a normal glomerular filtration rate. Among the 44% at increased risk for chronic kidney disease progression 24%, 12% and 8% were at moderately increased, high and very high risk, respectively. The presence of proteinuria also reclassified 25% with stage III chronic kidney disease as high or very high risk. KDIGO classification predicted renal functional decline, which occurred in 2.2%, 4.4%, 9.4% and 34.6% at 3 years in low, moderately increased, high and very high risk categories, respectively. Predictors of KDIGO group included age and tumor size (each p <0.001), and the main predictors of renal functional decline were KDIGO group, tumor size and radical nephrectomy (each p <0.0001). CONCLUSIONS: Identification of chronic kidney disease using only glomerular filtration rate left 18% of patients undiagnosed. The assessment of glomerular filtration rate and proteinuria classified patients according to risk of chronic kidney disease progression, identifying 44% to be at increased risk. As proteinuria predicted renal functional decline, we advocate for routine evaluation before treatment.

Impact of Reduced Glomerular Filtration Rate and Proteinuria on Overall Survival of Patients with Renal Cancer.

PURPOSE: Although it is commonly staged according to glomerular filtration rate, an international work group recommended classifying chronic kidney disease by cause, glomerular filtration rate and albuminuria. Data on nonsurgical patients with chronic kidney disease indicate proteinuria to be an independent predictor of renal function decrease and mortality. We evaluated whether preoperative proteinuria impacted survival in patients undergoing nephrectomy. MATERIALS AND METHODS: An institutional registry was queried for information regarding preoperative creatinine/glomerular filtration rate and urinalysis in 900 patients, including 362 and 538 treated with partial and radical nephrectomy, respectively. Patients were grouped according to glomerular filtration rate level (G1 to G5), proteinuria level (A1 to A3) and chronic kidney disease risk classification (low to very high). Kaplan-Meier and Cox proportional hazards analyses of overall survival were performed. RESULTS: The preoperative glomerular filtration rate was less than 60 ml/minute/1.73 m(2) in 30% of patients (median 73, IQR 56-91) and 20% of patients had baseline proteinuria. According to the KDIGO (Kidney Disease Improving Global Outcomes) classification 23% of patients were at moderately increased, 11% were at high and 8% were at very high risk for chronic kidney disease progression. Kaplan-Meier analysis revealed that the preoperative glomerular filtration rate, proteinuria and chronic kidney disease risk group were associated with poor overall survival. In Cox proportional hazard models accounting for age, gender, race, tumor size, clinical stage and surgery type the glomerular filtration rate, proteinuria and chronic kidney disease risk group were highly significant predictors of overall survival (p <0.0001). CONCLUSIONS: Preoperative proteinuria is a significant predictor of overall survival in patients who undergo nephrectomy. Classification according to preoperative glomerular filtration rate and proteinuria more accurately predicts survival than using the glomerular filtration rate alone after accounting for cancer stage. This information supports routine evaluation of proteinuria in patients with kidney cancer.

Change in platelet count as a prognostic indicator for response to primary tyrosine kinase inhibitor therapy in metastatic renal cell carcinoma.

OBJECTIVE: To evaluate change in platelet count as an indicator of response to primary tyrosine kinase inhibitor (TKI) therapy for metastatic renal cell carcinoma (mRCC). PATIENTS AND METHODS: We conducted a multicentre retrospective analysis of patients with mRCC undergoing primary TKI therapy from May 2005 to August 2014. Change in platelet count was defined as post-treatment platelet count after the first cycle of treatment minus the pretreatment platelet count. Response Evaluation Criteria in Solid Tumours were used to define partial response (PR), stable disease (SD) and progressive disease (PD). Analysis was conducted between subgroups with stable/increased (+ΔPlt) and decreased (-ΔPlt) counts. The primary outcome was overall survival (OS), determined using Kaplan-Meier analysis. Multivariable analysis was conducted for risk factors associated with PD. RESULTS: A total of 115 patients with mRCC were analysed, of whom 19 (16.6%) had a +ΔPlt and 96 (83%) a -ΔPlt. More patients with a +ΔPlt had a Karnofsky score <80 (42.1 vs 14.6%; P = 0.005) and >2 metastatic sites (78.9 vs 51%; P = 0.041). More patients with +ΔPlt than with -ΔPlt had PD (89.4 vs 19.1%; P < 0.001) and more of those with -ΔPlt than with +ΔPlt had SD/PR (80.9 vs 10.6%; P < 0.001). Multivariable analysis showed that +ΔPlt (odds ratio [OR] 5.36, P < 0.001), Karnofsky score < 80 (OR 2.96, P = 0.002) and >2 metastatic sites at presentation (OR 1.87, P = 0.013) were risk factors for PD. Kaplan-Meier analysis showed a lower 5-year OS in patients with +ΔPlt than in those with -ΔPlt (23 vs 53%; P < 0.0001). +ΔPlt had a sensitivity of 48.6%, a specificity of 97.4%, a positive predictive value of 89.5% and a negative predictive value of 80.9% for PD. CONCLUSIONS: Patients with a -ΔPlt were more likely to respond to TKI therapy and had longer OS. +ΔPlt above baseline had a high specificity for PD after primary TKI. Further investigation is required to determine the utility of ΔPlt.

Treatment of renal angiomyolipoma: pooled analysis of individual patient data.

BACKGROUND: This study was performed to evaluate the impact of baseline characteristics and treatment methods on the outcome of sporadic renal angiomyolipoma (AML). METHODS: This was a pooled analysis of individual data of 441 patients with AML retrieved from 58 studies and 3 institutional series. RESULTS: Ninety-three patients underwent nephrectomy, 163 partial nephrectomy/enucleation, 128 embolisation, 19 cryoablation, 6 radiofrequency ablation, and 32 conservative treatment. Their mean follow-up period was 44.5 months. Patients who experienced major bleeding at presentation had significantly larger tumours than did those without bleeding (mean diameter, 10.1 vs. 5.9 cm, respectively; p < 0.0001). A total of 9.4 % and 26.4 % of bleeding tumours had a diameter of <4 and <6 cm, respectively. A tumour diameter of ≥8.0 cm (hazard ratio, 2.07; 95 % confidence interval, 1.20-4.77) and the treatment method (p = 0.001) were independent predictors of re-intervention. The risk of re-intervention was significantly higher after embolisation, particularly for large tumours (5-year rate of freedom from re-intervention: diameter of ≥8.0 cm, 49.2 %; diameter of <8.0 cm, 74.8 %; p = 0.018). Conservatively treated AMLs had a mean baseline diameter of 3.2 ± 2.7 cm; after 41 months, their mean diameter was 3.7 ± 3.1 cm (p = 0.109). CONCLUSIONS: The prevalence of major bleeding is high in sporadic AMLs with a diameter of >6 cm. These results suggest that conservative treatment can be considered in AMLs of <6 cm in diameter. Among current treatment methods, embolisation was associated with a significantly higher risk of re-intervention. Further studies are needed to define risk factors for bleeding and assess the relative benefits of different treatment modalities.

Surgeon assessment of renal preservation with partial nephrectomy provides information comparable to measurement of volume preservation with 3-dimensional image analysis.

PURPOSE: The strongest predictors of renal function after partial nephrectomy are the preoperative glomerular filtration rate and the amount of preserved parenchyma. Measuring volume preservation by 3-dimensional imaging is accurate but time-consuming. Percent functional volume preservation was designed to replace surgeon assessment of volume preservation with a less labor intensive, objective assessment. We compared volume preservation with 3-dimensional imaging, percent functional volume preservation and surgeon assessment of volume preservation as predictors of renal function after partial nephrectomy. MATERIALS AND METHODS: We calculated volume preservation with 3-dimensional imaging, percent functional volume preservation and surgeon assessment of volume preservation in 41 patients with preoperative and postoperative cross-sectional imaging available. Surgeon assessment was validated internally in another 75 patients. Short-term and long-term renal function was assessed with univariate and multivariate linear regression models. RESULTS: Median parenchymal preservation was 85% (range 37% to 105%) by 3-dimensional imaging, 91% (range 51% to 114%) by percent functional preservation and 88% (range 45% to 99%) by surgeon assessment. Each method strongly correlated with nadir glomerular filtration rate (r(2) = 0.75, 0.65 and 0.78) and latest glomerular filtration rate (r(2) = 0.65, 0.66 and 0.67, respectively, each p <0.0001). Univariate analysis revealed that age, preoperative glomerular filtration rate, renal nephrometry score and each assessment were significant predictors of renal function (p <0.05). On multivariate analysis parenchymal preservation was the strongest predictor (p <0.0001). Models using volume preservation with 3-dimensional imaging, percent functional volume preservation and surgeon assessment of volume preservation were statistically similar in the ability to predict the nadir and latest glomerular filtration rates. In an additional validation cohort surgeon assessment remained strongly correlated with nadir glomerular filtration rate (r(2) = 0.74) and latest glomerular filtration rate (r(2) = 0.73, each p <0.0001). CONCLUSIONS: Surgeon assessment of volume preservation provides a reliable estimate of renal functional preservation with characteristics comparable to those of more time intensive alternatives. We propose that surgeon assessment of volume preservation should be routinely reported to facilitate analysis of partial nephrectomy outcomes.

Do we know (or just believe) that partial nephrectomy leads to better survival than radical nephrectomy for renal cancer?

PURPOSE: Partial nephrectomy (PN) has become the gold standard for treating small renal masses amenable to such an approach. Surprisingly, the single randomized controlled trial of PN versus radical nephrectomy (RN) indicated an overall survival benefit for RN over PN. Recent studies have shed light on this discordance, and this review will attempt to discern what is known at present. RESULTS: Multiple retrospective observational studies have demonstrated superior outcomes with PN compared with RN. Whether the observed survival benefit with PN is the result of renal functional advantages or the result of selection bias and other unmeasured variables is up for discussion. A meta-analysis of 21 studies including the EORTC 30904 found a 19 % reduction in all-cause mortality (p = 0.0001) and 29 % reduction in cancer-specific mortality (p = 0.0002) with PN versus RN. Recent analysis of SEER-Medicare data revealed that patients undergoing RN had similar survival when compared with non-cancer controls, further supporting concerns about selection biases in prior observational series. DISCUSSION: Although PN is clearly of benefit for those likely to experience end-stage renal disease with RN, a survival benefit with PN in the elective setting is not proven at present. While experts may still believe PN to improve survival for these patients, the only level I evidence in the field would suggest otherwise, and selection bias is undoubtedly responsible for a significant part of the improved survival observed in retrospective studies. Given recent evidence, any further push to limit the role of RN should be tempered until we know PN is indeed superior.

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.

Differential use of partial nephrectomy for intermediate and high complexity tumors may explain variability in reported utilization rates.

PURPOSE: Partial nephrectomy has become a reference standard for tumors amenable to a kidney sparing approach but reported utilization rates vary widely. The R.E.N.A.L. (radius, exophytic/endophytic, nearness of tumor to collecting system or sinus, anterior/posterior, location relative to polar lines and hilar tumor touching main renal artery or vein) nephrometry score was developed to standardize the reporting of tumor complexity with applicability in academic and community based settings. We hypothesized that tumor and surgeon factors account for variable use of partial nephrectomy. MATERIALS AND METHODS: Clinical and R.E.N.A.L. nephrometry score data were analyzed on 1,433 cases performed between 2004 and 2011 by a total of 19 surgeons with varying partial nephrectomy utilization rates (0% to 100%) who practiced at a total of 2 academic centers and 1 community based health system. RESULTS: Partial nephrectomy use increased during the study period from 36% before 2007 to 73% for 2010 to 2012 (p <0.0001). Increasing proportions of intermediate and high R.E.N.A.L. nephrometry score tumors were treated with partial nephrectomy during this time (35% to 86% and 11% to 36%, respectively, p <0.0001). Partial nephrectomy use was stable for low complexity tumors at 91% overall. Individual surgeons performed partial nephrectomy for 0% to 100% of intermediate complexity and 0% to 45% of high complexity tumors. On multivariable analysis surgery year, tumor size, each R.E.N.A.L. nephrometry score component, surgeon and annual surgeon volume predicted partial vs radical nephrectomy (each p <0.05). On multivariable analysis several surgeon factors, including surgeon volume, setting, fellowship training, and proportional use of minimally invasive and robotic partial nephrectomy, were associated with higher partial nephrectomy use (each p <0.002). CONCLUSIONS: Surgeon and tumor factors contribute significantly to the choice of partial nephrectomy. The significant variation in partial nephrectomy use by individual surgeons appears to be caused by differential treatment for intermediate and high complexity tumors. This may be due to surgical volume, training, setting and the use of minimally invasive techniques.

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.

Growth kinetics and active surveillance for small renal masses.

PURPOSE OF REVIEW: Management options for small renal masses (SRMs) include excision, ablation, and active surveillance. Increasing interest in active surveillance, particularly for tumors of limited oncologic potential, in patients with other significant health concerns continues to rise, but precise protocols are still lacking. RECENT FINDINGS: A review of 18 retrospective series of patients undergoing active surveillance for 957 SRMs indicates that the majority grew during observation (mean 0.32  cm/year), but only 1.4% metastasized during 32 months of follow-up (median). One published prospective series of 209 SRMs reported average growth of 0.13  cm/year and only 1% metastasized. Maximal tumor diameter (or volume) at presentation is a predictor of growth rate, high-grade disease, and likelihood of metastasis. SRMs less than 3  cm are very unlikely to metastasize and deferring treatment has not been associated with increased failure to cure. SUMMARY: Active surveillance is a reasonable initial strategy in most patients with SRMs, particularly those with limited life-expectancy and increased perioperative risk. Intervention should be considered for growth to greater than 3-4  cm or by greater than 0.4-0.5  cm/year while on active surveillance.

Pelvic Lymph Node Dissection at Radical Prostatectomy for Intermediate Risk Prostate Cancer: Assessing Utility and Nodal Metastases Within a Statewide Quality Improvement Consortium.

OBJECTIVE: To assess which patients with intermediate-risk PCa would benefit from a pelvic lymph node dissection (PLND) across the Michigan Urological Surgery Improvement Collaborative, given the discrepancy in recommendations. AUA guidelines for localized prostate cancer (PCa) state that PLND is indicated for patients with unfavorable intermediate-risk and high-risk PCa and can be considered in favorable intermediate-risk patients. NCCN guidelines recommend PLND when risk for nodal disease is ≥2%. METHODS: Data regarding all robot-assisted radical prostatectomy (RARP) (March 2012-October 2020) were prospectively collected, including patient, and surgeon characteristics. Univariate and multivariate analyses of PLND rate and lymph node involvement (LN+) were performed. RESULTS: Among 8,591 men undergoing RARP for intermediate-risk PCa, 80.2% were performed with PLND (n = 6883), of which 2.9% were LN+ (n = 198). According to the current AUA risk stratification system, 1.2% of favorable intermediate-risk PCa and 4.7% of unfavorable intermediate-risk PCa demonstrated LN+. There were also differences in the LN+ rates among the subgroups of favorable (0.0%-1.3%), and unfavorable (3.5%-5.0%) categories. Additional factors associated with higher LN+ rates include ≥50% cores positive, ≥35% involvement at any core, and unfavorable genomic classifier result, none of which contribute to the favorable/unfavorable subgroups. CONCLUSION: These data support PLND at RARP for all patients with unfavorable intermediate-risk PCa. Our data also indicate patients with favorable intermediate-risk prostate cancer at greatest risk for LN+ are those with ≥50% cores positive, ≥35% involvement at any core, and/or unfavorable genomic classifier result.

Knowledge and Attitudes Regarding Surgical Castration in Men Receiving Androgen Deprivation Therapy for Metastatic Prostate Cancer and Their Relationship to Health-Related Quality of Life.

OBJECTIVE: To determine the attitudes and education regarding surgical castration in men receiving androgen deprivation therapy (ADT) for metastatic prostate cancer (mCaP). METHODS: We identified 142 patients receiving ADT for mCaP at our institution without prior orchiectomy who were then sent 2 surveys via mail: (1) A questionnaire to assess knowledge and understanding of ADT treatment alternatives and (2) the functional assessment of cancer therapy - prostate (FACT-P) questionnaire which determines health-related quality of life (HRQOL). Two cohorts were created based on the answer to "would you be interested in surgical orchiectomy?" and demographic, CaP and HRQOL were compared between the surgical castration yes (SC+) and surgical castration no (SC-) cohorts. A second analysis identified predictors of worse HRQOL. RESULTS: Of 68 (47.9%) patients that responded to the survey, only 39 (59.1%) recalled a discussion regarding treatment alternatives to ADT and only 22 (33.3%) recalled a discussion regarding orchiectomy. There were 24 (40.0%) patients that stated interest in undergoing orchiectomy (SC+) as an alternative to ADT with the only independent risk factor being "…bother from the number of clinical appointments required for ADT…" Patients most bothered by side effects and cosmetic changes associated with ADT reported lower HRQOL scores on the FACT-P. CONCLUSIONS: Few men on ADT knew about surgical alternatives, implying that educational deficits may be a significant factor in the decline in the utilization of orchiectomy. Changes in healthcare economics, utilization and delivery brought on by a global pandemic should warrant a fresh look at the use of surgical castration.

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.

Comparison of the Comprehensive Complication Index and Clavien-Dindo systems in predicting perioperative outcomes following radical nephroureterectomy.

BACKGROUND: Complications can occur following radical nephroureterectomy (RNU) in 20-40% of patients. The Comprehensive Complication Index (CCI) is an alternative grading system to the Clavien-Dindo (CD) grading system that aggregates all complications experienced by a patient on a continuous (as opposed to categorical) scale. We investigate whether the cumulative nature of CCI renders it superior to CD in predicting perioperative course after RNU. METHODS: The records of 596 patents who underwent RNU at 7 academic medical centers from 2005 to 2015 were reviewed. Complications occurring within 30 days of RNU were annotated using both the CD and CCI classification systems. Logistic regression was used to determine associations between CD and CCI with perioperative covariates as well as measures of convalescence [hospital length of stay (LOS) and readmission]. RESULTS: A total of 377 men and 219 women with a median age of 71, BMI of 27, and Charlson comorbidity score of 4 were included. Over half underwent a minimally invasive RNU. Median LOS following RNU was 6.0 days (range, 1-37 days) and readmission within 30-days occurred in 45 (8%) patients. Overall, 136 patients (23%) experienced a post-operative complication with 91 having a single complication and 45 with multiple (range, 2-6); 44 (7%) patients had Clavien III or greater complications, and the median CCI for those patients experiencing a complication was 20.9 (range, 8.7-100). Both the upper quartile of CCI (≥75th %) and major CD complications were associated with higher baseline Charlson score, ECOG ≥2, and CKD stage ≥ III (all P<0.05). However, only the upper quartile of CCI was associated with LOS (8.9 vs. 5.4 days, P<0.01) and hospital readmission (OR 3.2, 95% CI: 1.9-5.6, P=0.02) after RNU. CONCLUSIONS: The CD and CCI classification systems both are associated with similar baseline and perioperative characteristics for RNU patients. However, the cumulative nature of the CCI allows for superior prediction of postoperative course after RNU including LOS and readmission.

Enhancing Identification and Management of Hospitalized Patients Who Are Malnourished: A Pilot Evaluation of Electronic Quality Improvement Measures.

Malnutrition in hospitalized patients has long been recognized as a contributor to poor patient outcomes; malnutrition often leads to higher costs of care. Thus, it is important to improve the identification of patients who are at risk for malnutrition or already malnourished and to initiate treatment to optimize outcomes. The Malnutrition Quality Improvement Initiative (MQii) is based on a dual-pronged approach consisting of a set of four electronic clinical quality measures and a Quality Improvement Toolkit that support delivery of high-quality malnutrition care by clinicians including nurses, registered dietitian nutritionists, and physicians. A large pilot hospital validated the four malnutrition electronic clinical quality measures (screening for nutrition risk, assessment, care plan, diagnosis), demonstrating their value in support of continuous quality improvement for hospital-based malnutrition care with the ultimate goal of better patient outcomes while reducing health care costs. FUNDING/SUPPORT: Publication of this supplement was supported by Abbott. The Academy of Nutrition and Dietetics does not receive funding for the MQii. Avalere Health's work to support the MQii was funded by Abbott.

Comparison of RENAL, PADUA, CSA, and PAVP Nephrometry Scores in Predicting Functional Outcomes After Partial Nephrectomy.

OBJECTIVE: To evaluate the accuracy of radius, exophytic/endophytic, nearness to collecting system/sinus, anterior/posterior, and location relative to polar lines (RENAL), preoperative aspects and dimensions used for anatomical classification (PADUA), contact surface area (CSA), and preoperative assessment of volume preservation (PAVP) nephrometry scores in predicting postoperative renal functional outcomes after partial nephrectomy (PN). Few studies have compared the accuracy of tumor complexity systems directly in the same set of PN patients. MATERIALS AND METHODS: Patients treated with robotic, laparoscopic, or open PN having available imaging (n = 344) were examined. The ability of 4 systems to predict nadir estimated glomerular filtration rate (eGFR [median postoperative day 1]) and new baseline eGFR (median: 0.95 year) was analyzed using univariable and multivariable models. RESULTS: Median preoperative, nadir, and new baseline eGFR were 79 (interquartile range [IQR]: 63-97), 65 (IQR: 47-85), and 80 (IQR: 63-99) mL/min/1.73 m2. Multivariable models incorporating RENAL, PADUA, CSA, or PAVP were similarly predictive of postoperative renal function (nadir eGFR: R2 = 0.683-0.688, new baseline eGFR: R2 = 0.775). In univariable analysis, all 4 complexity systems were predictors of nadir GFR (each P < .05), with RENAL (P = .045), CSA (P = .027), and PAVP (P = .012) also significantly predicting nadir eGFR in multivariable models. No complexity system was significantly associated with new baseline eGFR in multivariable analysis, with only RENAL (P = .023) and PAVP (P = .049) having a statistically significant association in univariable analysis. CONCLUSION: RENAL, PADUA, CSA, and PAVP are all predictors of early postoperative renal function. RENAL and PAVP provided the greatest predictive ability for later renal functional outcomes.