Thromboprophylaxis during neoadjuvant chemotherapy for bladder cancer reduces thromboembolism and bleeding.

OBJECTIVES: To assess the risk of venous thromboembolic events (VTEs) and bleeding with or without thromboprophylaxis during neoadjuvant chemotherapy in bladder cancer patients scheduled for radical cystectomy. MATERIALS AND METHODS: We conducted a retrospective cohort study in 4886 patients with non-metastatic bladder cancer undergoing cystectomy across 28 centres in 13 countries between 1990 and 2021. Inverse probability weighting analyses were performed to estimate the effect of thromboprophylaxis on VTE and bleeding. RESULTS: In 147 patients (3%) VTEs were recorded within the first year. These occurred a median (interquartile range [IQR]) of 127 (82-198) days after bladder cancer diagnosis. Bleeding events occurred in 131 patients (3%) within the first year. These occurred a median (IQR) of 101 (83-171) days after cancer diagnosis. In inverse probability weighting analyses, compared to patients without thromboprophylaxis during chemotherapy, patients with thromboprophylaxis had not only a lower risk of VTE (hazard ratio [HR] 0.32, 95% confidence interval [CI] 0.12-0.81; P = 0.016) but also a lower bleeding risk (HR 0.03, 95% CI 0.09-0.12; P <0.0001). The retrospective nature of the study was its main limitation. CONCLUSIONS: In this retrospective analysis, the benefit of thromboprophylaxis during neoadjuvant chemotherapy before cystectomy is in line with data from randomised trials in other malignancies. Our data suggest thromboprophylaxis is protective against VTEs and should be the standard of care during neoadjuvant chemotherapy.

Development of the multivariate administrative data cystectomy model and its impact on misclassification bias.

BACKGROUND: Misclassification bias (MB) is the deviation of measured from true values due to incorrect case assignment. This study compared MB when cystectomy status was determined using administrative database codes vs. predicted cystectomy probability. METHODS: We identified every primary cystectomy-diversion type at a single hospital 2009-2019. We linked to claims data to measure true association of cystectomy with 30 patient and hospitalization factors. Associations were also measured when cystectomy status was assigned using billing codes and by cystectomy probability from multivariate logistic regression model with covariates from administrative data. MB was the difference between measured and true associations. RESULTS: 500 people underwent cystectomy (0.12% of 428 677 hospitalizations). Sensitivity and positive predictive values for cystectomy codes were 97.1% and 58.6% for incontinent diversions and 100.0% and 48.4% for continent diversions, respectively. The model accurately predicted cystectomy-incontinent diversion (c-statistic [C] 0.999, Integrated Calibration Index [ICI] 0.000) and cystectomy-continent diversion (C:1.000, ICI 0.000) probabilities. MB was significantly lower when model-based predictions was used to impute cystectomy-diversion type status using for both incontinent cystectomy (F = 12.75; p < .0001) and continent cystectomy (F = 11.25; p < .0001). CONCLUSIONS: A model using administrative data accurately returned the probability that cystectomy by diversion type occurred during a hospitalization. Using this model to impute cystectomy status minimized MB. Accuracy of administrative database research can be increased by using probabilistic imputation to determine case status instead of individual codes.

Estimated glomerular filtration rate from the renal hypothermia trial: clinical implications.

OBJECTIVE: To assess if estimated glomerular filtration rate (eGFR) can replace measured GFR (mGFR) in partial nephrectomy (PN) trials, using data from a randomised clinical trial. PATIENTS AND METHODS: We conducted a post hoc analysis of the renal hypothermia trial. Patients underwent mGFR with diethylenetriaminepentaacetic acid (DTPA) plasma clearance preoperatively and 1 year after PN. The eGFR was calculated using the 2009 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equations incorporating age and sex, with and without race: 2009 eGFRcr(ASR) and 2009 eGFRcr(AS), and the 2021 equation that only incorporates age and sex: 2021 eGFRcr(AS). Performance was evaluated by determining the median bias, precision (interquartile range [IQR] of median bias), and accuracy (percentage of eGFR within 30% of mGFR). RESULTS: Overall, 183 patients were included. Pre- and postoperative median bias and precision were similar between the 2009 eGFRcr(ASR) (-0.2 mL/min/1.73 m2 , 95% confidence interval [CI] -2.2 to 1.7, IQR 18.8; and -2.9, 95% CI -5.1 to -1.5, IQR 15, respectively) and 2009 eGFRcr(AS) (-0.3 mL/min/1.73 m2 , 95% CI -2.4 to 1.5, IQR 18.8; and -3.0, 95% CI -5.7 to -1.7, IQR 15.0, respectively). Bias and precision were worse for the 2021 eGFRcr(AS) (-8.8 mL/min/1.73 m2 , 95% CI -10.9 to -6.3, IQR 24.7; and -12.0, 95% CI -15.8 to -8.9, IQR 23.5, respectively). Similarly, pre- and postoperative accuracy was >90% for the 2009 eGFRcr(ASR) and 2009 eGFRcr(AS) equations. Accuracy was 78.6% preoperatively and 66.5% postoperatively for 2021 eGFRcr(AS). CONCLUSION: The 2009 eGFRcr(AS) can accurately estimate GFR in PN trials and could be used instead of mGFR to reduce cost and patient burden.

Perineural Invasion and Spread in Common Abdominopelvic Diseases: Imaging Diagnosis and Clinical Significance.

Malignancies and other diseases may spread by multiple pathways, including direct extension, hematogenous spread, or via lymphatic vessels. A less-well-understood route is the peripheral nervous system, which is known as perineural spread (PNS). In addition to accounting for pain and other neurologic symptoms, PNS affects both disease prognosis and management. Although PNS is commonly discussed in relation to head and neck tumors, there is emerging data regarding PNS in abdominopelvic malignancies and other conditions such as endometriosis. Due to improved contrast and spatial resolution, perineural invasion, a finding heretofore diagnosed only at pathologic examination, can be detected at CT, MRI, and PET/CT. PNS most commonly manifests as abnormal soft-tissue attenuation extending along neural structures, and diagnosis of it is aided by optimizing imaging parameters, understanding pertinent anatomy, and becoming familiar with the typical neural pathways of spread that largely depend on the disease type and location. In the abdomen, the celiac plexus is a central structure that innervates the major abdominal organs and is the principal route of PNS in patients with pancreatic and biliary carcinomas. In the pelvis, the lumbosacral plexus and inferior hypogastric plexus are the central structures and principal routes of PNS in patients with pelvic malignancies. Although the imaging findings of PNS may be subtle, a radiologic diagnosis can have a substantial effect on patient care. Knowledge of anatomy and known routes of PNS and optimizing imaging parameters is of utmost importance in providing key information for prognosis and treatment planning. © RSNA, 2023 Supplemental material and the slide presentation from the RSNA Annual Meeting are available for this article. Quiz questions for this article are available through the Online Learning Center.

Barriers and facilitators to participation in exercise prehabilitation before cancer surgery for older adults with frailty: a qualitative study.

BACKGROUND: Older adults with frailty are at an increased risk of adverse outcomes after surgery. Exercise before surgery (exercise prehabilitation) may reduce adverse events and improve recovery after surgery. However, adherence with exercise therapy is often low, especially in older populations. The purpose of this study was to qualitatively assess the barriers and facilitators to participating in exercise prehabilitation from the perspective of older people with frailty participating in the intervention arm of a randomized trial. METHODS: This was a research ethics approved, nested descriptive qualitative study within a randomized controlled trial of home-based exercise prehabilitation vs. standard care with older patients (≥ 60 years) having elective cancer surgery, and who were living with frailty (Clinical Frailty Scale ≥ 4). The intervention was a home-based prehabilitation program for at least 3 weeks before surgery that involved aerobic activity, strength and stretching, and nutritional advice. After completing the prehabilitation program, participants were asked to partake in a semi-structured interview informed by the Theoretical Domains Framework (TDF). Qualitative analysis was guided by the TDF. RESULTS: Fifteen qualitative interviews were completed. Facilitators included: 1) the program being manageable and suitable to older adults with frailty, 2) adequate resources to support engagement, 3) support from others, 4) a sense of control, intrinsic value, noticing progress and improving health outcomes and 5) the program was enjoyable and facilitated by previous experience. Barriers included: 1) pre-existing conditions, fatigue and baseline fitness, 2) weather, and 3) guilt and frustration when unable to exercise. A need for individualization and variety was offered as a suggestion by participants and was therefore described as both a barrier and facilitator. CONCLUSIONS: Home-based exercise prehabilitation is feasible and acceptable to older people with frailty preparing for cancer surgery. Participants identified that a home-based program was manageable, easy to follow with helpful resources, included valuable support from the research team, and they reported self-perceived health benefits and a sense of control over their health. Future studies and implementation should consider increased personalization based on health and fitness, psychosocial support and modifications to aerobic exercises in response to adverse weather conditions.

Effect of 18F-DCFPyL PET/CT on the Management of Patients with Recurrent Prostate Cancer: Results of a Prospective Multicenter Registry Trial.

Background The high positivity rate of prostate-specific membrane antigen (PSMA) PET in the setting of biochemical failure (BCF), even when conventional imaging is negative, is promising. Purpose To assess the disease detection rate of PSMA-based PET/CT with fluorine 18-DCFPyL as a radiotracer and the PET-directed management change in men with suspected limited recurrent prostate cancer. Materials and Methods This prospective multicenter registry (Ontario PSMA-PET Registry for Recurrent Prostate Cancer, or PREP) enrolled men with BCF after primary therapy (radical prostatectomy plus or minus salvage radiation therapy or primary radiation therapy) and zero to four disease sites at conventional imaging (CT and bone scintigraphy). The positivity rate of PSMA PET according to serum prostate-specific antigen (PSA) level; frequency of local-egional, oligometastatic, and extensive metastatic recurrence; and rate of change in management after PET findings were recorded. The nonparametric Mood median test was used to assess the association between serum PSA level and change in management. Results A total of 1289 men (median age, 71 years [interquartile range, 65-75 years]) were evaluated. PSMA PET helped detect disease in 841 of 1289 men (65%) and in 615 of 999 men (62%) with negative conventional imaging. The recurrence detection rates according to serum PSA level at enrollment were 38% (160 of 424 men), 63% (107 of 171 men), and 83% (573 of 692 men) for PSA under 0.5 ng/mL, 0.5-1.0 ng/mL, and above 1.0 ng/mL, respectively. At PSMA PET, 399 of 1289 men (31%) had local-regional recurrence, 314 (24%) had oligometastatic disease, and 128 (10%) had extensive metastases. Following PET examination, a change in planned management was recorded in 748 of 1289 men (58%), and in 371 of 1250 men (30%), there was a change in management intent, more commonly from palliative to potentially curative intent (255 of 1289 men [20%]). Conclusion Prostate-specific membrane antigen PET helped detect additional sites of disease compared with conventional imaging in approximately 60% of men with biochemical failure and suspected low-volume metastatic disease, resulting in frequent change in management, including a change from palliative to curative or radical intent therapy in 20% of men. Long-term follow-up is needed to determine whether this impacts disease control. Clinical trial registration no. NCT03718260 © RSNA, 2022 Online supplemental material is available for this article. See also the editorial by Civelek in this issue.

A Comparison of Percutaneous Ablation Therapy to Partial Nephrectomy for cT1a Renal Cancers: Results from the Canadian Kidney Cancer Information System.

PURPOSE: Percutaneous ablation therapy (AT) and partial nephrectomy (PN) are successful management strategies for T1a renal cancer. Our objective was to compare AT to PN with respect to recurrence-free survival (RFS) and overall survival (OS). MATERIALS AND METHODS: Patients post-PN or -AT for cT1aN0M0 renal cancer from 2011 to 2021 were identified from the national Canadian Kidney Cancer information system. Inverse probability of treatment weighting (IPTW) using propensity score (PS) was used. The primary outcomes, RFS and OS, were compared using Kaplan-Meier log-rank test analyses and Cox proportional hazard regression models. RESULTS: A total of 275 patients underwent AT and 2,001 underwent PN, with a median followup of 2.0 years (IQR 0.6-4.1). Covariates were well balanced between the AT and PN cohorts following PS matching. Two-year RFS following IPTW PS analysis for patients undergoing AT and PN was 88.1% and 97.4% (p <0.0001), respectively, while 2-year OS was 97.4% and 99.0% (p=0.7), respectively. Five-year RFS following IPTW PS analysis for patients undergoing AT and PN was 86.0% and 95.1%, respectively (p=0.003), while 5-year OS was 94.2% and 95.1%, respectively (p=0.9). Following IPTW PS analysis, treatment modality (PN vs AT) was a predictor of disease recurrence (HR 0.36, p=0.003) but not for OS (HR 0.96, p=0.9). CONCLUSIONS: With short followup, PN offers better RFS than AT, although no significant difference in OS was detected following PS adjustments. Both modalities can be offered to appropriately selected patients while we await prospective randomized data.

Low Serum Testosterone in Men with Newly Diagnosed Androgen-Deprivation Therapy-Naïve Prostate Cancer and Its Relationship to Cardiovascular Risk Factors: A RADICAL-PC Substudy.

PURPOSE: Cardiovascular disease is a common cause of death in prostate cancer patients. Low testosterone is associated with increased cardiovascular risk in the general male population. We investigated the relationship between serum testosterone, cardiovascular disease and risk factors in androgen-deprivation therapy-naïve prostate cancer patients. MATERIALS AND METHODS: We performed a cross-sectional analysis of a subgroup of 1,326 androgen-deprivation therapy-naïve men from RADICAL-PC (Role of Androgen-Deprivation Therapy In CArdiovascular Disease-A Longitudinal Prostate Cancer study) in whom serum testosterone was measured at baseline. RADICAL-PC is a prospective multicenter cohort study of men (2,565) enrolled within 1 year of prostate cancer diagnosis, or within 6 months of commencing androgen-deprivation therapy for the first time. Cardiovascular risk factors, cancer characteristics and total serum testosterone were collected at baseline. Low testosterone was defined as total serum testosterone <11 nmol/L (<320 ng/dL). A Framingham cardiovascular risk score ≥15 was considered high risk for future cardiovascular events. We performed logistic regression to calculate odds ratios for the association between testosterone and cardiovascular risk. RESULTS: Among 1,326 participants (median age 67 years, range 45-93), 553 (42%) had low testosterone. Low testosterone was associated with existing cardiovascular disease, diabetes, elevated hemoglobin A1c, obesity, hypertriglyceridemia, low high-density lipoprotein cholesterol, hypertension and Framingham score >15. Among patients with low testosterone, the odds ratio for high cardiovascular risk was 1.33 (1.02-1.73) after adjusting for ethnicity, education, alcohol use, cancer characteristics, physical activity and body mass index. CONCLUSIONS: Among androgen-deprivation therapy-naïve prostate cancer patients, low testosterone is common and associated with increased cardiovascular risk factors.

Development of a Multiparametric Renal CT Algorithm for Diagnosis of Clear Cell Renal Cell Carcinoma Among Small (≤ 4 cm) Solid Renal Masses.

BACKGROUND. The MRI clear cell likelihood score predicts the likelihood that a renal mass is clear cell renal cell carcinoma (ccRCC). A CT-based algorithm has not yet been established. OBJECTIVE. The purpose of our study was to develop and evaluate a CT-based algorithm for diagnosing ccRCC among small (≤ 4 cm) solid renal masses. METHODS. This retrospective study included 148 patients (73 men, 75 women; mean age, 58 ± 12 [SD] years) with 148 small (≤ 4 cm) solid (> 25% enhancing tissue) renal masses that underwent renal mass CT (unenhanced, corticomedullary, and nephrographic phases) before resection between January 2016 and December 2019. Two radiologists independently evaluated CT examinations and recorded calcification, mass attenuation in all phases, mass-to-cortex corticomedullary attenuation ratio, and heterogeneity score (score on a 5-point Likert scale, assessed in corticomedullary phase). Features associated with ccRCC were identified by multivariable logistic regression analysis and then used to create a five-tiered CT score for diagnosing ccRCC. RESULTS. The masses comprised 53% (78/148) ccRCC and 47% (70/148) other histologic diagnoses. The mass-to-cortex corticomedullary attenuation ratio was higher for ccRCC than for other diagnoses (reader 1: 0.84 ± 0.68 vs 0.68 ± 0.65, p = .02; reader 2: 0.75 ± 0.29 vs 0.59 ± 0.25, p = .02). The heterogeneity score was higher for ccRCC than other diagnoses (reader 1: 4.0 ± 1.1 vs 1.5 ± 1.6, p < .001; reader 2: 4.4 ± 0.9 vs 3.3 ± 1.5, p < .001). Other features showed no difference. A five-tiered diagnostic algorithm including the mass-to-cortex corticomedullary attenuation ratio and heterogeneity score had interobserver agreement of 0.71 (weighted κ) and achieved an AUC for diagnosing ccRCC of 0.75 (95% CI, 0.68-0.82) for reader 1 and 0.72 (95% CI, 0.66-0.82) for reader 2. A CT score of 4 or greater achieved sensitivity, specificity, and PPV of 71% (95% CI, 59-80%), 79% (95% CI, 67-87%), and 79% (95% CI, 67-87%) for reader 1 and 42% (95% CI, 31-54%), 81% (95% CI, 70-90%), and 72% (95% CI, 56-84%) for reader 2. A CT score of 2 or less had NPV of 85% (95% CI, 69-95%) for reader 1 and 88% (95% CI, 69-97%) for reader 2. CONCLUSION. A five-tiered renal CT algorithm, including the mass-to-cortex corticomedullary attenuation ratio and heterogeneity score, had substantial interobserver agreement, moderate AUC and PPV, and high NPV for diagnosing ccRCC. CLINICAL IMPACT. The CT algorithm, if validated, may represent a useful clinical tool for diagnosing ccRCC.

Home-based prehabilitation with exercise to improve postoperative recovery for older adults with frailty having cancer surgery: the PREHAB randomised clinical trial.

BACKGROUND: Frailty is a state of vulnerability as a result of decreased reserves. Prehabilitation may increase reserve and improve postoperative outcomes. Our objective was to determine if home-based prehabilitation improves postoperative functional recovery in older adults with frailty having cancer surgery. METHODS: This double blind randomised trial enrolled people ≥60 yr having elective cancer surgery and ≥3 weeks from enrolment to surgery as eligible. Participation in a remotely supported, home-based exercise prehabilitation program plus nutritional guidance was compared with standard care plus written advice on age-appropriate activity and nutrition. The primary outcome was 6-min walk test (6MWT) distance at the first postoperative clinic visit. Secondary outcomes included physical performance, quality of life, disability, length of stay, non-home discharge, and 30-day readmission. RESULTS: Of 543 patients assessed, 254 were eligible and 204 (80%) were randomised (102 per arm); 182 (94 intervention and 88 control) had surgery and were analysed. Mean age was 74 yr and 57% were female. Mean duration of participation was 5 weeks, mean adherence was 61% (range 0%-100%). We found no significant difference in 6MWT at follow-up (+14 m, 95% confidence interval -26-55 m, P=0.486), or for secondary outcomes. Analyses using a prespecified adherence definition of ≥80% supported improvements in 6MWT distance, complication count, and disability. CONCLUSIONS: A home-based prehabilitation program did not significantly improve postoperative recovery or other outcomes in older adults with frailty having cancer surgery. Program adherence may be a key mediator of prehabilitation efficacy. CLINICAL TRIAL REGISTRATION: NCT02934230.

Identifying barriers and facilitators to routine preoperative frailty assessment: a qualitative interview study.

PURPOSE: Preoperative frailty assessment is recommended by multiple practice guidelines and may improve outcomes, but it is not routinely performed. The barriers and facilitators of routine preoperative frailty assessment have not been formally assessed. Our objective was to perform a theory-guided evaluation of barriers and facilitators to preoperative frailty assessment. METHODS: This was a research ethics board-approved qualitative study involving physicians who perform preoperative assessment (consultant and resident anesthesiologists and consultant surgeons). Semistructured interviews were conducted by a trained research assistant informed by the Theoretical Domains Framework to identify barriers and facilitators to frailty assessment. Interview transcripts were independently coded by two research assistants to identify specific beliefs relevant to each theoretical domain. RESULTS: We interviewed 28 clinicians (nine consultant anesthesiologists, nine consultant surgeons, and ten anesthesiology residents). Six domains (Knowledge [100%], Social Influences [96%], Social Professional Role and Identity [96%], Beliefs about Capabilities [93%], Goals [93%], and Intentions [93%]) were identified by > 90% of respondents. The most common barriers identified were prioritization of other aspects of assessment (e.g., cardio/respiratory) and a lack of awareness of evidence and guidelines supporting frailty assessment. The most common facilitators were a high degree of familiarity with frailty, recognition of the importance of frailty assessment, and strong intentions to perform frailty assessment. CONCLUSION: Barriers and facilitators to preoperative frailty assessment are multidimensional, but generally consistent across different types of perioperative physicians. Knowledge of barriers and facilitators can guide development of evidence-based strategies to increase frailty assessment.

RéSUMé: OBJECTIF: L'évaluation préopératoire de la fragilité est recommandée par plusieurs lignes directrices de pratique et pourrait améliorer les devenirs, mais elle n'est pas systématiquement réalisée. Les obstacles et les facilitateurs de l'évaluation de routine de la fragilité préopératoire n'ont pas été officiellement évalués. Notre objectif était de mener une évaluation théorique des obstacles et des facilitateurs de l'évaluation préopératoire de la fragilité. MéTHODE: Il s'agissait d'une étude qualitative approuvée par le comité d'éthique de la recherche impliquant des médecins menant des évaluations préopératoires (anesthésiologistes, résidents en anesthésiologie et chirurgiens). Des entrevues semi-structurées ont été réalisées par un assistant de recherche formé en se fondant sur le Cadre des domaines théoriques afin d'identifier les obstacles et les facilitateurs à l'évaluation de la fragilité. Les transcriptions des entrevues ont été codées de manière indépendante par deux assistants de recherche afin d'identifier les croyances spécifiques pertinentes à chaque domaine théorique. RéSULTATS: Nous avons interrogé 28 cliniciens (neuf anesthésiologistes, neuf chirurgiens et dix résidents en anesthésiologie). Six domaines (Connaissances [100 %], Influences sociales [96 %], Rôle et identité socio-professionnels [96 %], Croyances concernant les capacités [93 %], Objectifs [93 %] et Intentions [93 %]) ont été identifiés par > 90 % des répondants. Les obstacles les plus fréquemment cités étaient la priorisation accordée à d'autres aspects de l'évaluation (p. ex., cardio/respiratoire) et le manque de connaissances des données probantes et des lignes directrices à l'appui de l'évaluation de la fragilité. Les facilitateurs les plus courants étaient un degré élevé de familiarité avec la fragilité, la reconnaissance de l'importance de l'évaluation de la fragilité et de fortes intentions de réaliser une évaluation de la fragilité. CONCLUSION: Les obstacles et les facilitateurs de l'évaluation préopératoire de la fragilité sont multidimensionnels, mais généralement uniformes parmi les différents types de médecins périopératoires. La connaissance des obstacles et des facilitateurs peut guider l'élaboration de stratégies fondées sur des données probantes pour augmenter l'évaluation de la fragilité.

Performance Feedback May Not Improve Radical Prostatectomy Outcomes: The Surgical Report Card (SuRep) Study.

PURPOSE: Oncologic, urinary, and sexual outcomes are important to patients receiving prostate cancer surgery. The objective of this study was to determine if providing surgical report cards (SuReps) to surgeons resulted in improved patient outcomes. MATERIALS AND METHODS: A prospective before-and-after study was conducted at The Ottawa Hospital. A total of 422 consecutive patients undergoing radical prostatectomy were enrolled. The intervention was provision of report cards to surgeons. The control cohort was patients treated before report card feedback (pre-SuRep), and the intervention cohort was patients treated after report card feedback (post-SuRep). The primary outcomes were postoperative erectile function, urinary continence, and positive surgical margins. RESULTS: Baseline characteristics were similar between groups. Almost all patients (99%) were continent and the majority (59%) were potent prior to surgery. Complete 1-year followup was available for 400 patients (95%). Nerve sparing surgery increased from 70% pre-SuRep to 82% post-SuRep (p=0.01). There was a nonstatistically significant increase in the proportion of patients with a positive surgical margin post-SuRep (31% pre-SuRep vs 39% post-SuRep, p=0.08). There was no difference in postoperative erectile function (17% vs 18%, p=0.7) and a decrease in continence (75% vs 65%, p=0.02) at 1 year postoperatively. CONCLUSIONS: The SuRep platform allows accurate reporting of surgical outcomes that can be used for patient counseling. However, the provision of surgical report cards did not improve functional or oncologic outcomes. Longer durations of feedback, report card modifications, or targeted interventions are likely necessary to improve outcomes.

Hypothermia During Partial Nephrectomy for Patients with Renal Tumors: A Randomized Controlled Trial.

PURPOSE: Surgeons induce renal hypothermia during partial nephrectomy to preserve kidney function, without strong evidence of benefit. This trial examined the effectiveness and safety of renal hypothermia during partial nephrectomy. MATERIALS AND METHODS: We conducted a parallel randomized controlled trial of hypothermia versus no hypothermia (control group) during partial nephrectomy at 6 academic hospitals. Eligible patients had a planned open partial nephrectomy for the treatment of a renal tumor. During surgery, after clamping the renal hilum, patients were randomized to the intervention or control arm in a 1:1 ratio using permuted blocks of variable lengths (2 and 4), stratified by institution, using a computer-based program. Surgeons and study coordinators were masked to treatment allocation until the renal hilum was clamped. Overall glomerular filtration rates were determined before, and 1-year after, surgery. The primary outcome was measured glomerular filtration rate (mGFR) assessed by the plasma clearance of 99mTc-DTPA. The trial (NCT01529658) was designed with 90% power to detect a minimal clinically important difference in mGFR of 10 ml/minute/1.73 m2 at a 5% significance level. RESULTS: Of the 184 patients randomized, hypothermia and control patients had similar baseline mean mGFR (87.1 vs 81.0 ml/minute/1.73 m2). One hundred and sixty-one (79 hypothermia, 82 control) were alive with primary outcome data 1 year after surgery. The change in mGFR 1 year after surgery was -6.6 ml/minute/1.73 m2 in the hypothermia group and -7.8 ml/minute/1.73 m2 in the control group (mean difference 1.2 ml/minute/1.73 m2, 95% CI -3.3 to 5.6). Operated-kidney change in mGFR was similar between groups (-5.8 vs -6.3 ml/minute/1.73 m2; mean difference 0.5 ml/minute/1.73 m2, 95% CI -2.9 to 3.8). No clinically significant difference in the mGFR was observed when patients were stratified by pre-planned subgroups. Renal hypothermia did not impact the secondary outcomes of surgical complications and patient reported quality of life. CONCLUSIONS: Renal hypothermia during partial nephrectomy does not preserve kidney function in patients with normal or mildly impaired renal function.

Impact of Time to Surgery and Surgical Delay on Oncologic Outcomes for Renal Cell Carcinoma.

PURPOSE: The time between radiographic identification of a renal tumor and surgery can be concerning for patients and clinicians due to fears of tumor progression while awaiting treatment. This study aimed to evaluate the association between surgical wait time and oncologic outcomes for patients with renal cell carcinoma. MATERIALS AND METHODS: The Canadian Kidney Cancer Information System is a multi-institutional prospective cohort initiated in January 2011. Patients with clinical stage T1b or greater renal cell carcinoma diagnosed between January 2011 and December 2019 were included in this analysis. Outcomes of interest were pathological up staging, cancer recurrence, cancer specific survival and overall survival. Time to recurrence and death were estimated using Kaplan-Meier estimates and associations were determined using Cox proportional hazards models. RESULTS: A total of 1,769 patients satisfied the study criteria. Median wait times were 54 days (IQR 29-86) for the overall cohort and 81 days (IQR 49-127) for cT1b tumors (1,166 patients), 45 days (IQR 27-71) for cT2 tumors (672 cases) and 35 days (IQR 18-61) for cT3/4 tumors (563). Adjusting for comorbidity, tumor size, grade, histological subtype, margin status and pathological stage, there was no association between prolonged wait time and cancer recurrence or death. CONCLUSIONS: In the context of current surgeon triaging practices surgical wait times up to 24 weeks were not associated with adverse oncologic outcomes after 2 years of followup.

Achieving the "trifecta" with open versus minimally invasive partial nephrectomy.

INTRODUCTION: The "trifecta" is a summary measure of outcome after partial nephrectomy (PN) that encompasses three parameters: negative surgical margin, ≤ 10% decrease in post-operative estimated glomerular filtration rate (eGFR) and absence of urological complications. We assessed trifecta rates in patients undergoing open (OPN), laparoscopic (LPN), and robotic PN (RPN) for a clinical T1 renal mass (≤ 7 cm). METHODS: Clinical and pathologic parameters were extracted from the prospectively maintained Canadian Kidney Cancer Information System for patients treated between January 2011 and October 2018. Comparisons between groups were made using Kruskal-Wallis test for continuous variables and Chi-squared independence test for categorical variables. Multivariable analysis was performed to identify predictors of each component of the trifecta and the trifecta itself. RESULTS: Of 1708 total patients, 746 underwent OPN, 678 LPN, and 284 RPN for a T1 renal mass. A 'trifecta' was achieved in 53% OPN, 52% LPN and 47% RPN (p = 0.194). On multivariable analysis, OPN and LPN were associated with less frequent post-operative decline in eGFR and more frequent trifecta when compared to RPN, but there was no difference between OPN and LPN. OPN also predicted a higher rate of negative margins compared to RPN but not LPN. CONCLUSION: After correction for confounding variables, OPN and LPN were more likely than RPN to achieve the trifecta, which appeared to be due primarily to loss of renal function. No difference was observed between OPN and LPN. Analyses were limited by the lack of nephrometry score.

Frailty as a Predictor of Death or New Disability After Surgery: A Prospective Cohort Study.

OBJECTIVE: To compare the accuracy of the modified Fried Index (mFI) and the Clinical Frailty Scale (CFS) to predict death or patient-reported new disability 90 days after major elective surgery. BACKGROUND: The association of frailty with patient-reported outcomes, and comparisons between preoperative frailty instruments are poorly described. METHODS: This was a prospective multicenter cohort study. We determined frailty status in individuals ≥65 years having elective noncardiac surgery using the mFI and CFS. Outcomes included death or patient-reported new disability (primary); safety incidents, length of stay (LOS), and institutional discharge (secondary); ease of use, usefulness, benefit, clinical importance, and feasibility (tertiary). We measured the adjusted association of frailty with outcomes using regression analysis and compared true positive and false positive rates (TPR/FPR). RESULTS: Of 702 participants, 645 had complete follow up. The CFS identified 297 (42.3%) with frailty, the mFI 257 (36.6%); 72 (11.1%) died or experienced a new disability. Frailty was significantly associated with the primary outcome (CFS adjusted odds ratio, OR, 2.51, 95% confidence interval, CI, 1.50-4.21; mFI adjusted-OR 2.60, 95% CI 1.57-4.31). TPR and FPR were not significantly different between instruments. Frailty was the only significant predictor of death or new disability in a multivariable analysis. Need for institutional discharge, costs and LOS were significantly increased in individuals with frailty. The CFS was easier to use, required less time and had less missing data. CONCLUSIONS: Older people with frailty are significantly more likely to die or experience a new patient-reported disability after surgery. Clinicians performing frailty assessments before surgery should consider the CFS over the mFI as accuracy was similar, but ease of use and feasibility were higher.

Cardiovascular Risk in Men with Prostate Cancer: Insights from the RADICAL PC Study.

PURPOSE: We describe the cardiovascular risk profile in a representative cohort of patients with prostate cancer treated with or without androgen deprivation therapy. MATERIALS AND METHODS: We prospectively characterized in detail 2,492 consecutive men (mean age 68 years) with prostate cancer (newly diagnosed or with a plan to prescribe androgen deprivation therapy for the first time) from 16 Canadian sites. Cardiovascular risk was estimated by calculating Framingham risk scores. RESULTS: Most men (92%) had new prostate cancer (intermediate risk 41%, high risk 50%). The highest level of education achieved was primary school in 12%. Most (58%) were current or former smokers, 22% had known cardiovascular disease, 16% diabetes, 45% hypertension, 31% body mass index 30 kg/m2 or greater, 24% low levels of physical activity, mean handgrip strength was 37.3 kg and 69% had a Framingham risk score consistent with high cardiovascular risk. Participants in whom androgen deprivation therapy was planned had higher Framingham risk scores than those not intending to receive androgen deprivation therapy, and this risk was abolished after adjustment for confounders. CONCLUSIONS: Two-thirds of men with prostate cancer are at high cardiovascular risk. There is a positive association between a plan to use androgen deprivation therapy and baseline cardiovascular risk factors. However, this association is explained by confounding factors.

Perioperative venous thromboembolism prophylaxis in prostate cancer surgery.

PURPOSE: To describe a patient and procedure specific approach to selecting Venous thromboembolism (VTE) prophylaxis for men who undergo radical prostatectomy. METHODS: We performed a literature search and narrative review of VTE after radical prostatectomy. We describe the current paradigm of perioperative thromboprophylaxis and underlying rationale. Relevant findings from the European Association of Urology thromboprophylaxis guidelines are interpreted and summarized. RESULTS: The use of extended post-operative thromboprophylaxis for patients who undergo radical prostatectomy is appropriate when the risk of symptomatic VTE outweighs the risk of major bleeding. Patient and procedure factors impact VTE risk. Patient risk can be stratified as low, moderate or high based on 4 factors; age > 75, BMI > 35, VTE in a first degree relative, and personal history of VTE. Procedure risk of VTE and bleeding can be stratified by modality of surgery (open, laparoscopic, robotic) and extent of pelvic lymphadenectomy. Using these factors, patients at the lowest risk for VTE will have an expected incidence of VTE of 0.4-0.8% and those at highest risk from 1.5 to 15.7%. Incidence of major bleeding ranges from 0.4 to 1.4%. These ranges emphasize the need to consider the net benefit for each specific patient. Use of mechanical prophylaxis is supported by weaker evidence but has fewer harms and is likely reasonable for most patients. CONCLUSION: Many patients who undergo radical prostatectomy will benefit from extended post-operative thromboprophylaxis. Risk of thrombosis is likely higher with open approach and extended lymph node dissection. The net benefit of treatment should be considered using patient- and procedure-specific criteria. When the net benefit is negligible or possibly harmful no pharmacological thromboprophylaxis should be used.

Evidence-based approach to active surveillance of prostate cancer.

Active surveillance is a good management option for some men with non-metastatic prostate cancer. In this review, we examine the evidence for several topics related to active surveillance. We examine: (1) which patients should be eligible for active surveillance, (2) what follow-up (monitoring) protocols should be used for men on surveillance, (3) what is the role of prostate magnetic resonance imaging (MRI) for men on surveillance, and (4) what is the prognosis for men who choose surveillance compared to radical treatment. In many instances, the evidence is evolving or lacking. In these situations, we highlight the limitations of the data.

Correction to: Evidence-based approach to active surveillance of prostate cancer.

Correction to: In the original publication of the article, the values in the columns "Gleason Score" and "Clinical Stage" under the section Urologic Organization.