Propensity-matched analysis of patient-reported outcomes for neoadjuvant chemotherapy prior to radical cystectomy.

PURPOSE: To evaluate patient-reported outcomes (PROs) for bladder cancer patients undergoing neoadjuvant chemotherapy (NAC) prior to radical cystectomy (RC) using longitudinal data and propensity-matched scoring analyses. METHODS: 155 patients with muscle-invasive bladder cancer scheduled for RC completed the European Organization for Research and Treatment of Cancer questionnaires, EORTC QLQ-C30, EORTC QLQ-BLM30, Fear of Recurrence Scale, Mental Health Inventory and Satisfaction with Life Scale within 4 weeks of surgery. A propensity-matched analysis was performed comparing pre-surgery PROs among 101 patients who completed NAC versus 54 patients who did not receive NAC. We also compared PROs pre- and post-chemotherapy for 16 patients who had data available for both time points. RESULTS: In propensity-matched analysis, NAC-treated patients reported better emotional and sexual function, mental health, urinary function and fewer financial concerns compared to those that did not receive NAC. Longitudinal analysis showed increases in fatigue, nausea and appetite loss following chemotherapy. CONCLUSION: Propensity-matched analysis did not demonstrate a negative effect of NAC on PRO. Several positive associations of NAC were found in the propensity-matched analysis, possibly due to other confounding differences between the two groups or actual clinical benefit. Longitudinal analysis of a small number of patients found small to modest detrimental effects from NAC similar to toxicities previously reported. Our preliminary findings, along with known survival and toxicity data, should be considered in decision-making for NAC.

Patterns of surveillance imaging after nephrectomy in the Medicare population.

OBJECTIVES: To characterize patterns of imaging surveillance after nephrectomy in a population-based cohort of older patients with kidney cancer. PATIENTS AND METHODS: Using the Surveillance, Epidemiology and End Results (SEER)-Medicare database, we identified patients aged ≥ 66 years who underwent partial or radical nephrectomy for localized kidney cancer diagnosed between 2000 and 2009. Primary outcomes were chest imaging (X-ray or computed tomography [CT]) and abdominal imaging (CT, MRI or ultrasonography) in Medicare claims from 4 to 36 months after surgery. We estimated the frequency of imaging in three time periods (postoperative months 4-12, 13-24, 25-36), stratified by tumour stage. Repeated-measures logistic regression was used to identify the patient and disease characteristics associated with imaging. RESULTS: Rates of chest imaging were 65-80%, with chest X-ray surpassing CT in each time period. Rates of abdominal imaging were 58-76%, and cross-sectional imaging was more common than ultrasonography in each time period. Use of cross-sectional chest and abdominal imaging increased over time, while the use of chest X-ray decreased (P < 0.01). Ultrasonography use remained stable for patients with T1 and T2 disease, but the rate of use decreased in patients with T3 disease (P < 0.05). Rates of chest and abdominal imaging increased with tumour stage (P < 0.001). CONCLUSIONS: Patterns of imaging suggest possible overuse in patients at low risk of recurrence and underuse in those at greater risk. New surveillance imaging guidelines may reduce unwarranted variability and promote risk-based, cost-effective management after nephrectomy.

Low yield of surveillance imaging after surgery for T1 kidney cancer.

PURPOSE: To examine the mode of relapse detection and subsequent treatment after partial or radical nephrectomy in patients with low-risk (pT1, N0, Nx) kidney cancer. METHODS: Retrospective study on 1404 patients treated with partial or radical nephrectomy for low-risk kidney cancer from the years 2000-2012. Scans for chest imaging (X-ray or CT) and abdominal imaging (CT, MRI, or ultrasound) are tabulated. For those patients with relapse, the site, mode of detection, and symptoms were recorded. RESULTS: Twenty-one patients relapsed with a median follow-up of 4.1 years for patients who did not relapse. In 17 (81 %) patients, relapse was detected by imaging alone, while 4 (19 %) patients presented with symptoms. Of the patients who relapsed by imaging, 13 (76 %) were treated immediately, while 4 (24 %) continued observation. During the first 3 years of follow-up, 5762 imaging studies were performed to detect 8 relapses, with 6 patients receiving immediate treatment. The median number of imaging studies per patient per year for the first 3 years was 1.7 (interquartile range 1.0, 2.3) including 30 % CT, 3 % MRI, 36 % X-ray, and 31 % ultrasounds. CONCLUSION: We found a low yield of surveillance imaging in the first 3 years for pT1 kidney cancer. Nearly 1000 imaging studies were performed to detect one relapse that required treatment. Further studies are needed to evaluate the clinical impact of imaging surveillance according to recent guidelines.

Long-term survival rates after resection for locally advanced kidney cancer: Memorial Sloan Kettering Cancer Center 1989 to 2012 experience.

PURPOSE: We analyzed the 23-year Memorial Sloan Kettering Cancer Center experience with surgical resection, and concurrent adrenalectomy and lymphadenectomy for locally advanced nonmetastatic renal cell carcinoma. MATERIALS AND METHODS: We retrospectively reviewed the records of 802 patients who underwent nephrectomy with or without concurrent adrenalectomy or lymphadenectomy for locally advanced renal cell carcinoma, defined as stage T3 or greater and M0. Patients who received adjuvant treatment within 3 months of surgery or had fewer than 3 months of followup or bilateral renal masses at presentation were excluded from analysis. Five and 10-year progression-free and overall survival was estimated by the Kaplan-Meier method. Differences between groups were analyzed by the log rank test. RESULTS: A total of 596 (74%) and 206 patients (26%) underwent radical and partial nephrectomy, respectively. Renal cell carcinoma progressed in 189 patients and 104 died of the disease. Median followup in patients without progression was 4.6 years. Symptoms at presentation, ASA(®) classification, tumor stage, histological subtype, grade and lymph node status were significantly associated with progression-free and overall survival. On multivariate analysis adrenalectomy use decreased with time but lymphadenectomy use increased (OR 0.82 vs 1.16 per year). Larger tumors were associated with a higher likelihood of concurrent adrenalectomy and lymphadenectomy. CONCLUSIONS: In our series of patients with locally advanced nonmetastatic renal cell carcinoma survival was favorable in those in good health who were asymptomatic at presentation with T3 tumors and negative lymph nodes. Further, there has been a trend toward more selective use of adrenalectomy and increased use of lymphadenectomy.

Quality of Life Outcomes for Bladder Cancer Patients Undergoing Bladder Preservation with Radiotherapy.

For patients with muscle-invasive bladder cancer, the decision to undergo radical cystectomy or bladder preservation treatment must incorporate survival differences, toxicity, and quality of life. Our objective was to review patient-reported outcomes for bladder preservation treatment with a focus on patients eligible for radical cystectomy, for whom a comparison of patient-reported outcomes is most relevant. Peer-reviewed, English-language manuscripts in MEDLINE and PubMed databases were examined from 1996 through 2014. Subject headings included quality of life, bladder cancer, bladder sparing, bladder preservation, radiation, and radiotherapy. Prospective and retrospective studies of patient-reported outcomes in patients undergoing bladder preservation with radiotherapy for muscle-invasive bladder cancer were included. Two prospective studies and four retrospective studies were identified. Several weaknesses from these studies were identified including small sample sizes, variable time points of assessment, variation in treatment regimens, and failure to use validated or condition-specific questionnaires. From the available data, bladder preservation appears to result to similar or better general quality of life compared to radical cystectomy with satisfactory urinary and sexual function reported in most series. In general, bladder preservation resulted in more gastrointestinal symptoms than radical cystectomy. This is one of the first reviews on the subject of patient-reported outcomes for bladder preservation in muscle-invasive bladder cancer. Although the data are limited, this review may provide a framework for developing well-designed, prospective comparisons of treatment for this patient cohort.

Analysis of lymph node dissection in patients with ≥7-cm renal tumors.

PURPOSE: To analyze the role of lymph node dissection (LND) in patients with large renal tumors. METHODS: We performed a retrospective study of patients with renal cell carcinoma ≥7 cm in size undergoing surgery between 1990 and 2012. Primary outcome measures were recurrence-free and overall survival of patients who did and did not undergo LND. Cox proportional hazards regression models were created to account for known risk factors for recurrence and survival. Secondary outcomes were recurrence-free and overall survival by lymph node status, lymph node template and number of lymph nodes removed. RESULTS: Of 524 patients, 164 had disease recurrence and 197 died. Median follow-up was 5 and 5.5 years for patients who did not die or have a recurrence, respectively. A total of 334 (64 %) patients underwent LND, and node-positive disease was identified in 26 (8 %). For patients who did and did not undergo LND, 5-year recurrence-free survival was 64 and 77 %, respectively. Five-year overall survival was 75 and 78 %, respectively. LND was not a predictor of recurrence or survival in multivariate analysis. Node-positive disease was associated with recurrence (p < 0.0005) and mortality (p = 0.032), although node-positive patients had a 5-year overall survival of 65 %. CONCLUSIONS: We did not find a difference in recurrence-free or overall survival in patients with ≥7-cm tumors whether or not they underwent LND. Node-positive disease was associated with worse outcomes, suggesting that LND provides important staging information that can be important in the design of adjuvant clinical trials.

Lymph node dissection during cytoreductive nephrectomy: a retrospective analysis.

OBJECTIVE: To assess whether regional lymph node dissection could improve the prognosis of patients with metastatic renal cell carcinoma. METHODS: We reviewed data on 258 patients who underwent cytoreductive nephrectomy at Memorial Sloan Kettering Cancer Center, New York, USA, some of whom received a concurrent lymph node dissection. The primary outcome measure was overall survival. A Cox proportional hazards regression model included, age, pathological stage, lymphadenopathy, tumor size, modified Memorial Sloan Kettering Cancer Center criteria, site of metastatic disease and lymph node dissection. We created a logistic regression model to evaluate risk factors for node-positive disease. Survival analyses were carried out for lymph node template (hilar vs other) and number of nodes removed (0-3, 4-7 or ≥8). RESULTS: Of 258 patients, 177 (69%) underwent lymph node dissection, and positive nodes were found in 59 (33%). The 5-year overall survival was 21% for patients who underwent lymph node dissection and 31% for patients who did not. No significant difference in survival was found among patients receiving or not receiving lymph node dissection. The 5-year overall survival was 27% and 9% for negative and positive nodal status, respectively (P < 0.0005). For patients who underwent lymph node dissection, the presence of lymphadenopathy was a significant predictor of node-positive disease (odds ratio 25.0, 95% confidence interval 9.04-69.4, P < 0.0001). CONCLUSIONS: Lymph node dissection carried out during cytoreductive nephrectomy is not associated with a survival benefit. Lymph node-positive disease represents a poor prognostic variable; therefore, lymph node dissection should be considered as a staging procedure for clinical trials.

Interventions to improve access to clinical trials in urologic oncology.

INTRODUCTION: Most cancer patients are never enrolled in clinical trials, resulting in missed potential therapeutic benefits to patients and barriers to drug development and approval. With a focus on urologic oncology clinical trials, we reviewed the current literature on barriers to accrual and present effective interventions to overcome these barriers. METHODS: PubMed was searched for articles regarding physician referral and patient accrual to clinical trials in urologic oncology from January 2000 through June 2021. Studies were included if they were in English, related to clinical trial utilization or patient accrual in urologic oncology, peer-reviewed, primary research, survey, or systematic review, and pertained to clinical trials in the U.S. Major overlapping themes related to barriers to accrual and effective interventions were identified. RESULTS: Thirty-six studies met our inclusion criteria. Barriers fall into three categories: 1) provider; 2) patient; or 3) structural. Provider barriers include issues such as poor funding, logistical challenges, and time constraints. Patient barriers include cost, distrust of medical institutions, and lack of knowledge regarding ongoing studies. Structural barriers include lack of time and resources in community settings and difficulty with physician referrals. Effective strategies identified include increasing provider referrals through continuing education and referral pathways, increasing patient education through patient-centered marketing material, and decreasing structural barriers through patient navigation programs and community partnerships. CONCLUSIONS: We identified barriers and potential multipronged strategies targeted at patients, providers, and practices to increase clinical trial enrollment. We hope these strategies will benefit patients and providers and facilitate research development.

Systematic review of robotic radical cystectomy functional and quality of life outcomes.

This systematic review summarizes the urinary continence, male sexual function, and female sexual function outcomes after robotic-assisted radical cystectomy (RARC). Greater intracorporeal diversion use, longer followup, and clearly stated urinary continence definitions have revealed RARC urinary continence rates for orthotopic ileal neobladders that are similar to those after open radical cystectomy (ORC) when using the strictest continence definitions. Nerve-sparing technique appears to be well-used in most studies, with short-term and long-term RARC potency rates similar those after ORC when using the strictest potency definitions. Level 1 evidence using validated questionnaires suggests that quality of life outcomes are also similar.

Incidence and mortality trends of metastatic prostate cancer: Surveillance, Epidemiology, and End Results database analysis.

INTRODUCTION: In the past decade, prostate cancer screening decreased, raising the concern of delays in diagnosis and leading to an increase in new cases of metastatic prostate cancer. This study evaluated whether these changes may have impacted trends in metastatic prostate cancer incidence and survival. METHODS: Metastatic prostate cancer diagnoses from 2008-2016 were identified from the Surveillance, Epidemiology, and End Results (SEER) 18 registries. Age-adjusted incidence rates per 100 000 were calculated by time periods and demographic variables. Two-year all-cause and prostate cancer-specific mortality were calculated for patients diagnosed from 2008-2014, and multivariable Cox proportional hazards models were used to evaluate the impact of demographic and clinical variables. RESULTS: Incidence rates of metastatic prostate cancer increased by 18% from 2008-2009 to 2014-2016 (incidence rate ratio [IRR]=1.18, 95% confidence interval [CI] 1.14-1.21). This trend was observed across multiple subgroups but was greatest in non-Hispanic Whites and patients living in counties 0-10% below poverty level. There was an overall decreased risk of all-cause and prostate cancer-specific mortality, but unmarried men and men living in counties >20% below poverty level showed statistically significant increased risk of prostate cancer-specific mortality. CONCLUSIONS: Non-Hispanic Whites and the wealthiest subgroups had the largest increase in incidence of metastatic prostate cancer since 2008. Despite trends of decreased risk of prostate cancer-specific mortality, we found certain populations experienced increases in mortality risk. Studies exploring the role of socioeconomic factors on screening and access to newer treatments are needed.

Hedgehog/Gli supports androgen signaling in androgen deprived and androgen independent prostate cancer cells.

BACKGROUND: Castration resistant prostate cancer (CRPC) develops as a consequence of hormone therapies used to deplete androgens in advanced prostate cancer patients. CRPC cells are able to grow in a low androgen environment and this is associated with anomalous activity of their endogenous androgen receptor (AR) despite the low systemic androgen levels in the patients. Therefore, the reactivated tumor cell androgen signaling pathway is thought to provide a target for control of CRPC. Previously, we reported that Hedgehog (Hh) signaling was conditionally activated by androgen deprivation in androgen sensitive prostate cancer cells and here we studied the potential for cross-talk between Hh and androgen signaling activities in androgen deprived and androgen independent (AI) prostate cancer cells. RESULTS: Treatment of a variety of androgen-deprived or AI prostate cancer cells with the Hh inhibitor, cyclopamine, resulted in dose-dependent modulation of the expression of genes that are regulated by androgen. The effect of cyclopamine on endogenous androgen-regulated gene expression in androgen deprived and AI prostate cancer cells was consistent with the suppressive effects of cyclopamine on the expression of a reporter gene (luciferase) from two different androgen-dependent promoters. Similarly, reduction of smoothened (Smo) expression with siRNA co-suppressed expression of androgen-inducible KLK2 and KLK3 in androgen deprived cells without affecting the expression of androgen receptor (AR) mRNA or protein. Cyclopamine also prevented the outgrowth of AI cells from androgen growth-dependent parental LNCaP cells and suppressed the growth of an overt AI-LNCaP variant whereas supplemental androgen (R1881) restored growth to the AI cells in the presence of cyclopamine. Conversely, overexpression of Gli1 or Gli2 in LNCaP cells enhanced AR-specific gene expression in the absence of androgen. Overexpressed Gli1/Gli2 also enabled parental LNCaP cells to grow in androgen depleted medium. AR protein co-immunoprecipitates with Gli2 protein from transfected 293T cell lysates. CONCLUSIONS: Collectively, our results indicate that Hh/Gli signaling supports androgen signaling and AI growth in prostate cancer cells in a low androgen environment. The finding that Gli2 co-immunoprecipitates with AR protein suggests that an interaction between these proteins might be the basis for Hedgehog/Gli support of androgen signaling under this condition.

Prostate cancer risk group is associated with other-cause mortality in men with localized prostate cancer.

INTRODUCTION: Informed decision-making in localized prostate cancer must consider the natural history of the disease, risks of treatment, and the competing risks from other causes. Other-cause mortality has often been associated with comorbidity or treatment-related side effects. We aimed to examine the association between prostate cancer aggressiveness and other-cause mortality. METHODS: Using the Surveillance, Epidemiology, and End Results (SEER)18 registries, patients diagnosed with localized prostate cancer between 2004 and 2015 were identified. Patients were categorized into low-, intermediate- and high-risk groups. Vital status, death due to prostate cancer, and death due to other causes were based on death certificate information. Survival analyses were performed to assess the association between prostate cancer risk group and mortality while adjusting for demographic variables, year of diagnosis, and initial therapy. RESULTS: A total of 464 653 patients were identified with a median followup of 5.4 years. Cardiovascular disease was the most common cause of mortality during the study period. Compared to low-risk patients, intermediate- and high-risk patients had a higher risk of mortality from other cancers, cardiovascular disease, and other causes of death regardless of initial treatment. Men who underwent surgery as initial therapy had lower cumulative mortality rates compared to those with radiation as their initial therapy. CONCLUSIONS: Intermediate- and high-risk prostate cancers are associated with higher risk of other-cause mortality. This appears to be independent of treatment type and may not be solely explained by comorbidity status. Further studies controlling for comorbidity and treatment burden should be explored.

Comparison of Adjuvant Chemotherapy for Upper Tract versus Lower Tract Urothelial Carcinoma: A Systematic Review and Meta-Analysis.

INTRODUCTION: Principles of management for upper tract urothelial carcinoma (UTUC) are mostly derived from knowledge of lower tract urothelial carcinoma (LTUC), however recent research indicates that these may be disparate diseases. In this review, we sought to compare the responsiveness of these tumors to similar treatment, platinum-based chemotherapy used in the adjuvant setting. MATERIALS AND METHODS: PubMed, EMBASE, and Web of Science were searched using a systematic search strategy. Disease-free survival (DFS), cancer-specific survival (CSS) and overall survival (OS) in patients with LTUC and UTUC treated with adjuvant chemotherapy were compared. Review Manager V 5.3 was used for meta-analyses. RESULTS: Adjuvant chemotherapy was associated with improved DFS (HR 0.41, 95%CI 0.31-0.54), CSS (HR 0.29, 95%CI 0.17-0.50) and OS (HR 0.51, 95%CI 0.38-0.70) rates in LTUC. The effectiveness of adjuvant chemotherapy in UTUC was less pronounced with respect to DFS (HR 0.61, 95%CI 0.1-0.93) and CSS (HR 0.70, 95%CI 0.56-0.90) rates, and there was no effect on OS (HR 0.87, 95%CI 0.69-1.10). Differences in CSS and OS were significant (p < 0.0001) in favor of adjuvant chemotherapy for LTUC versus UTUC. CONCLUSION: Despite similar histology, we found significant differences in responsiveness to adjuvant chemotherapy between LTUC and UTUC. This may add to the already growing knowledge that these are disparate diseases. Newer systemic treatments for urothelial carcinoma may prove more effective than platinum-based chemotherapy in the adjuvant setting for UTUC.

Validation of a Postoperative Nomogram Predicting Recurrence in Patients with Conventional Clear Cell Renal Cell Carcinoma.

BACKGROUND: Clear cell renal cell carcinoma (RCC) continues to be the most commonly diagnosed subtype and is associated with more aggressive behavior than papillary and chromophobe RCC. Predicting disease recurrence after surgical extirpation is important for counseling and targeting those at high risk for adjuvant therapy clinical trials. OBJECTIVE: To validate a postoperative nomogram predicting 5-yr recurrence-free probability (RFP) for clinically localized clear cell RCC. DESIGN, SETTING, AND PARTICIPANTS: We identified all patients who underwent nephrectomy for clinically localized clear cell RCC from 1990 to 2009 at Memorial Sloan Kettering Cancer Center. After excluding patients with bilateral renal masses, familial RCC syndromes, and T3c or T4 tumors due to the limited number, 1642 participants were available for analysis. INTERVENTIONS: Partial or radical nephrectomy. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Disease recurrence was defined as any new tumor after nephrectomy or kidney cancer-specific mortality, whichever occurred first. A postoperative nomogram was used to calculate the predicted 5-yr RFP, and these values were compared with the actual 5-yr RFP. Nomogram performance was evaluated by concordance index and calibration plot. RESULTS AND LIMITATIONS: Median follow-up was 39 mo (interquartile range: 14-79 mo), and disease recurrence was observed in 50 patients. The nomogram concordance index was 0.81. The calibration curve showed that the nomogram underestimated the actual 5-yr RFP. We updated the nomogram by including the entire patient population, which maintained performance and significantly improved calibration. CONCLUSIONS: The updated clear cell RCC postoperative nomogram performed well in the combined cohort. Underestimation of actual 5-yr RFP by the original nomogram may be due to increased surgeon experience and other unknown variables. PATIENT SUMMARY: We updated a valuable prediction tool used for assessing the disease recurrence probability after nephrectomy for clear cell renal cell carcinoma.

Self-assessment of surgical technique leads to reduction of positive surgical margins in partial nephrectomy.

The background of the study was to examine potential causes for a positive surgical margin (PSM) and develop strategies to improve surgical outcomes. A retrospective review of consecutive partial nephrectomy cases for renal cell carcinoma was performed. We divided the patients into 2 groups. The first group consisted of the first 67 renal tumors in 65 patients that underwent our early surgical technique. The second group consisted of the next 45 renal tumors in 39 patients that underwent the revised surgical technique which included wider resections and robotically controlled ultrasound. Our primary outcome was margin status and secondary outcome was disease recurrence. Univariate and multivariate analyses were performed to determine factors that resulted in a PSM. Positive margins were detected in 19 out of 67 (28 %) renal tumors in the early technique group compared to 1 out of 45 (2 %) positive margins in the revised technique group (p < 0.001). On multivariate analysis, only technique modification (OR 0.04, p = 0.003) and larger tumor size (OR 0.41, p = 0.01) were significant predictors of a lower rate of PSM. Smaller tumors were more common in robotic assisted partial nephrectomies which had a higher rate of PSM on univariate analysis (OR 3.51, p = 0.04). Only one patient with a PSM experienced a systemic disease recurrence. In our experience, self-assessment and technique modification resulted in a dramatic PSM improvement. Smaller tumors were associated with PSM. It is important for all surgeons to periodically look at their own surgical outcomes and modify their surgical technique accordingly.

Quality of life and symptom assessment in randomized clinical trials of bladder cancer: A systematic review.

OBJECTIVES: Patient-reported outcomes (PRO) help patients, caretakers, clinicians, and policy makers make informed decisions regarding treatment effectiveness. Our objective was to assess the quality of PRO reporting and methodological strengths and weaknesses in randomized controlled trials (RCT) in bladder cancer. METHODS: A systematic literature search of bladder cancer RCT published between January 2004 and March 2014 was performed. Relevant studies were evaluated using a predetermined extraction form that included trial demographics, clinical and PRO characteristics, and standards of PRO reporting based on recommendations of the International Society for Quality of Life Research. RESULTS: In total, 9 RCTs enrolling 1,237 patients were evaluated. All studies were in patients with nonmetastatic disease. In 5 RCTs, a PRO was the primary end point. Most RCTs did not report the mode of administration of the PRO instrument or the methods of collecting data. No RCT addressed the statistical approaches for missing data. CONCLUSIONS: We found that few RCTs in bladder cancer report PRO as an outcome. Efforts to expand PRO reporting to more RCTs and improve the quality of PRO reporting according to recognized standards are necessary for facilitating clinical decision making.

Comparing Open Radical Cystectomy and Robot-assisted Laparoscopic Radical Cystectomy: A Randomized Clinical Trial.

BACKGROUND: Open radical cystectomy (ORC) and urinary diversion in patients with bladder cancer (BCa) are associated with significant perioperative complication risk. OBJECTIVE: To compare perioperative complications between robot-assisted radical cystectomy (RARC) and ORC techniques. DESIGN, SETTING, AND PARTICIPANTS: A prospective randomized controlled trial was conducted during 2010 and 2013 in BCa patients scheduled for definitive treatment by radical cystectomy (RC), pelvic lymph node dissection (PLND), and urinary diversion. Patients were randomized to ORC/PLND or RARC/PLND, both with open urinary diversion. Patients were followed for 90 d postoperatively. INTERVENTION: Standard ORC or RARC with PLND; all urinary diversions were performed via an open approach. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Primary outcomes were overall 90-d grade 2-5 complications defined by a modified Clavien system. Secondary outcomes included comparison of high-grade complications, estimated blood loss, operative time, pathologic outcomes, 3- and 6-mo patient-reported quality-of-life (QOL) outcomes, and total operative room and inpatient costs. Differences in binary outcomes were assessed with the chi-square test, with differences in continuous outcomes assessed by analysis of covariance with randomization group as covariate and, for QOL end points, baseline score. RESULTS AND LIMITATIONS: The trial enrolled 124 patients, of whom 118 were randomized and underwent RC/PLND. Sixty were randomized to RARC and 58 to ORC. At 90 d, grade 2-5 complications were observed in 62% and 66% of RARC and ORC patients, respectively (95% confidence interval for difference, -21% to -13%; p=0.7). The similar rates of grade 2-5 complications at our mandated interim analysis met futility criteria; thus, early closure of the trial occurred. The RARC group had lower mean intraoperative blood loss (p=0.027) but significantly longer operative time than the ORC group (p<0.001). Pathologic variables including positive surgical margins and lymph node yields were similar. Mean hospital stay was 8 d in both arms (standard deviation, 3 and 5 d, respectively; p=0.5). Three- and 6-mo QOL outcomes were similar between arms. Cost analysis demonstrated an advantage to ORC compared with RARC. A limitation is the setting at a single high-volume, referral center; our findings may not be generalizable to all settings. CONCLUSIONS: This trial failed to identify a large advantage for robot-assisted techniques over standard open surgery for patients undergoing RC/PLND and urinary diversion. Similar 90-d complication rates, hospital stay, pathologic outcomes, and 3- and 6-mo QOL outcomes were observed regardless of surgical technique. PATIENT SUMMARY: Of 118 patients with bladder cancer who underwent radical cystectomy, pelvic lymph node dissection, and urinary diversion, half were randomized to open surgery and half to robot-assisted laparoscopic surgery. We compared the rate of complications within 90 d after surgery for the open group versus the robotic group and found no significant difference between the two groups. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT01076387, www.clinicaltrials.gov.