Predicting Oncologic Outcomes in Renal Cell Carcinoma After Surgery.

BACKGROUND: Predicting oncologic outcomes is important for patient counseling, clinical trial design, and biomarker study testing. OBJECTIVE: To develop prognostic models for progression-free (PFS) and cancer-specific survival (CSS) in patients with clear cell renal cell carcinoma (ccRCC), papillary RCC (papRCC), and chromophobe RCC (chrRCC). DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort review of the Mayo Clinic Nephrectomy registry from 1980 to 2010, for patients with nonmetastatic ccRCC, papRCC, and chrRCC. INTERVENTION: Partial or radical nephrectomy. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: PFS and CSS from date of surgery. Multivariable Cox proportional hazards regression was used to develop parsimonious models based on clinicopathologic features to predict oncologic outcomes and were evaluated with c-indexes. Models were converted into risk scores/groupings and used to predict PFS and CSS rates after accounting for competing risks. RESULTS AND LIMITATIONS: A total of 3633 patients were identified, of whom 2726 (75%) had ccRCC, 607 (17%) had papRCC, and 222 (6%) had chrRCC. Models were generated for each histologic subtype and a risk score/grouping was developed for each subtype and outcome (PFS/CSS). For PFS, the c-indexes were 0.83, 0.77, and 0.78 for ccRCC, papRCC, and chrRCC, respectively. For CSS, c-indexes were 0.86 and 0.83 for ccRCC and papRCC. Due to only 22 deaths from RCC, we did not assess a multivariable model for chrRCC. Limitations include the single institution study, lack of external validation, and its retrospective nature. CONCLUSIONS: Using a large institutional experience, we generated specific prognostic models for oncologic outcomes in ccRCC, papRCC, and chrRCC that rely on features previously shown-and validated-to be associated with survival. These updated models should inform patient prognosis, biomarker design, and clinical trial enrollment. PATIENT SUMMARY: We identified routinely available clinical and pathologic features that can accurately predict progression and death from renal cell carcinoma following surgery. These updated models should inform patient prognosis, biomarker design, and clinical trial enrollment.

Adverse Pathology After Neoadjuvant Chemotherapy and Radical Cystectomy: The Role of Adjuvant Chemotherapy.

BACKGROUND: The current guidelines do not recommend adjuvant chemotherapy (AC) for patients with adverse pathologic findings after neoadjuvant chemotherapy (NAC) and radical cystectomy (RC) for bladder cancer. We sought to evaluate the association of AC with overall survival (OS) in these patients. MATERIALS AND METHODS: The National Cancer Database was used to identify patients with adverse pathologic findings (ypT3N0, ypT4N0, or ypTanyN1-N3) after NAC and RC for bladder cancer from 2006 to 2012. The clinicopathologic variables were abstracted, and the patients were stratified according to the receipt of AC. OS was estimated using the Kaplan-Meier method and log-rank test. Associations between AC and OS were evaluated in multivariable Cox proportional hazards regression models among all patients and stratified by pathologic classification. RESULTS: A total of 1361 patients were identified: 444 (32.6%) with ypT3N0, 162 (11.9%) with ypT4N0, and 755 (55.5%) with ypTanyN1-N3. The median OS for the entire cohort was 22.9 months, which differed by pathologic classification: 34.6 months with ypT3N0, 21.4 months with ypT4N0, and 19.3 months with ypTanyN1-N3 (P < .01). AC was used in 328 patients (24.1%), and no difference in OS was observed by receipt of AC (24.6 months with AC vs. 22.0 months without; P = .18). On multivariable analysis, AC was not independently associated with OS (hazard ratio, 0.86; 95% confidence interval, 0.74-1.01; P = .06). CONCLUSION: Patients with adverse pathologic findings at RC after previous NAC have a median OS of approximately 2 years, which was not significantly improved with AC. Clinical trials with newer systemic agents are warranted for patients in this setting to guide future therapy.

Utilization and Outcomes of Radical Cystectomy for High-grade Non-muscle-invasive Bladder Cancer in Elderly Patients.

BACKGROUND: Radical cystectomy (RC) represents a treatment option for patients with high-grade non-muscle-invasive bladder cancer (HG-NMIBC); however, perioperative morbidity is not insignificant, particularly in elderly patients. We sought to evaluate the associations of age with utilization and outcomes of RC for HG-NMIBC. PATIENTS AND METHODS: Patients with HG-NMIBC diagnosed between 2004 and 2013 were identified in the National Cancer Database and stratified by age: ≤ 60, 61-70, 71-80, and > 80 years. Association between age and treatment with RC was assessed by multivariable logistic regression. Associations between age and overall survival were assessed using the Kaplan-Meier method. A multi-institutional analysis was performed to evaluate the associations of age with perioperative outcomes and survival among patients managed with RC for HG-NMIBC. RESULTS: On multivariable analysis, age was associated with RC utilization, with the lowest usage in patients > 80 years (2.1%; P < .01). Upstaging at RC occurred in 40% of patients with HG-NMIBC, and no association of age with upstaging risk was noted. Significantly inferior overall survival was observed in the patients who were upstaged across age strata (all P < .01). In the multi-institutional cohort, age was not associated with risks of upstaging, receipt of transfusion, 30-/90-day complications, or recurrence-free or cancer-specific survival (all P > .05), whereas upstaging was associated with inferior recurrence-free and cancer-specific survival regardless of age. CONCLUSION: RC for HG-NMIBC is used less frequently in older adults, despite similar risks of pathologic upstaging. As upstaging is associated with inferior survival regardless of age, these data suggest that elderly patients with HG-NMIBC may be at risk for undertreatment.

Severity of Preoperative Proteinuria is a Risk Factor for Overall Mortality in Patients Undergoing Nephrectomy.

PURPOSE: Chronic kidney disease may adversely affect survival following nephrectomy. Proteinuria is increasingly used as a marker of kidney disease. However, the relationship between preoperative proteinuria and survival after nephrectomy remains incompletely characterized. We evaluated the association of preoperative proteinuria with overall and cancer specific survival using our institutional nephrectomy registry. MATERIALS AND METHODS: We identified 1,846 patients with localized clear cell renal cell carcinoma treated with curative intent (radical or partial nephrectomy) between 1995 and 2010. Patients were categorized for analysis based on preoperative proteinuria severity (mild, moderate or severe). Overall and cancer specific survival was estimated by the Kaplan-Meier method. Cox proportional hazards regression models were used to assess for variables associated with overall and cancer specific mortality. RESULTS: Preoperative urine protein testing was available in 1,347 patients (73%). A total of 804 patients (60%) were classified with mild proteinuria (less than 150 mg per day), 332 (25%) were classified with moderate proteinuria (150 to 500 mg per day) and 211 (16%) were classified with severe proteinuria (greater than 500 mg per day). On multivariable analysis with mild proteinuria as the reference category the adjusted HR for all cause mortality was 1.18 (95% CI 0.95-1.48, p = 0.14) for moderate proteinuria and 1.61 (95% CI 1.26-2.07, p <0.001) for severe proteinuria. However, the proteinuria level was not associated with cancer specific survival. CONCLUSIONS: Severe preoperative proteinuria is associated with worse overall survival following radical or partial nephrectomy for localized clear cell renal cell carcinoma. Preoperative proteinuria should be evaluated in patients undergoing nephrectomy and considered when estimating overall patient health status.

Outcomes Following Complete Surgical Metastasectomy for Patients with Metastatic Renal Cell Carcinoma: A Systematic Review and Meta-Analysis.

PURPOSE: The benefit of complete surgical metastasectomy for patients with metastatic renal cell carcinoma remains controversial due to limited outcome data. We performed a systematic review and meta-analysis to determine whether complete surgical metastasectomy confers a survival benefit compared to incomplete or no metastasectomy for patients with metastatic renal cell carcinoma. MATERIALS AND METHODS: Ovid Embase®, MEDLINE®, Cochrane and Scopus® databases were searched for studies evaluating complete surgical metastasectomy for metastatic renal cell carcinoma through January 19, 2016. Only comparative studies reporting adjusted hazard ratios (aHRs) for all cause mortality of incomplete surgical metastasectomy vs complete surgical metastasectomy were included in the analysis. Generic inverse variance with random effects models was used to determine the pooled aHR. Risk of bias was assessed with the Newcastle-Ottawa Scale. RESULTS: Eight published cohort studies with a low or moderate potential for bias were included in the final analysis. The studies reported on a total of 2,267 patients (958 undergoing complete surgical metastasectomy and 1,309 incomplete surgical metastasectomy). Median overall survival ranged between 36.5 and 142 months for those undergoing complete surgical metastasectomy, compared to 8.4 to 27 months for incomplete surgical metastasectomy. Complete surgical metastasectomy was associated with a reduced risk of all cause mortality compared with incomplete surgical metastasectomy (pooled aHR 2.37, 95% CI 2.03-2.87, p <0.001), with low heterogeneity (I2 = 0%). Complete surgical metastasectomy remained independently associated with a reduction in mortality across a priori subgroup and sensitivity analyses, and regardless of whether we adjusted for performance status. CONCLUSIONS: Complete surgical metastasectomy for metastatic renal cell carcinoma is associated with improved survival compared with incomplete surgical metastasectomy based on meta-analysis of observational data. Consideration should be given to performing complete surgical metastasectomy, when technically feasible, in patients with metastatic renal cell carcinoma who are surgical candidates.

Contemporary Mapping of Post-Prostatectomy Prostate Cancer Relapse with 11C-Choline Positron Emission Tomography and Multiparametric Magnetic Resonance Imaging.

PURPOSE: We identify sites and patterns of cancer recurrence in patients with post-prostatectomy biochemical relapse using 11C-choline positron emission tomography/computerized tomography and endorectal coil multiparametric magnetic resonance imaging. MATERIALS AND METHODS: Between January 2008 and June 2015, 2,466 men underwent choline positron emission tomography for suspected prostate cancer relapse at our institution. Of these men 202 did not receive hormone or radiation therapy, underwent imaging with choline positron emission tomography and multiparametric magnetic resonance imaging, and were found to have disease recurrence. Overall patterns of recurrence were described, and factors associated with local only recurrence were evaluated using univariable and multivariable logistic regression. RESULTS: Median prostate specific antigen at positive scan was 2.3 ng/ml (IQR 1.4-5.5) with a median time from prostate specific antigen relapse to lesion visualization of 15 months (IQR 4.8-34.2). Of these 202 men 68 (33%) exhibited local only, 45 (22%) local plus metastatic and 89 (45%) metastatic only relapse. Pelvic node only relapse was observed in 39 (19%) men. Median prostate specific antigen at positive imaging for patients with local only, metastatic only and local plus metastatic relapse was 2.3, 2.7 and 2.2 ng/ml (p=0.46), with a median interval from biochemical recurrence to positive scan of 33.5, 7.0 and 15.0 months, respectively (p <0.001). On multivariable analysis time from biochemical recurrence to positive imaging was independently associated with local only recurrence (OR 1.10 for every 6-month increase, p=0.012). CONCLUSIONS: Combined choline positron emission tomography and multiparametric magnetic resonance imaging evaluation of biochemical recurrence after prostatectomy reveals an anatomically diverse pattern of recurrence. These findings have implications for optimizing the salvage treatment of patients with prostate cancer with relapse following surgery.

Application of the Stage, Size, Grade, and Necrosis (SSIGN) Score for Clear Cell Renal Cell Carcinoma in Contemporary Patients.

BACKGROUND: The tumor stage, size, grade, and necrosis (SSIGN) score was originally defined using patients treated with radical nephrectomy (RN) between 1970 and 1998 for clear cell renal cell carcinoma (ccRCC), excluding patients treated with partial nephrectomy (PN). OBJECTIVE: To characterize the original SSIGN score cohort with longer follow-up and evaluate a contemporary series of patients treated with RN and PN. DESIGN, SETTING, AND PARTICIPANTS: Retrospective single-institution review of 3600 consecutive surgically treated ccRCC patients grouped into three cohorts: original RN, contemporary (1999-2010) RN, and contemporary PN. INTERVENTION: RN or PN. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The association of the SSIGN score with risk of death from RCC was assessed using a Cox proportional hazards regression model, and predictive ability was summarized with a C-index. RESULTS AND LIMITATIONS: The SSIGN scores differed significantly between the original RN, contemporary RN, and contemporary PN cohorts (p<0.001), with SSIGN ≥4 in 53.5%, 62.7%, and 4.7%, respectively (p<0.001). The median durations of follow-up for these groups were 20.1, 9.2, and 7.6 yr, respectively. Each increase in the SSIGN score was predictive of death from RCC (hazard ratios [HRs]: 1.41 for original RN, 1.37 for contemporary RN, and 1.70 for contemporary PN; all p<0.001). The C-indexes for these models were 0.82, 0.84, and 0.82 for original RN, contemporary RN, and contemporary PN, respectively. After accounting for an era-specific improvement in survival among RN patients (HR: 0.53 for contemporary vs original RN; p<0.001), the SSIGN score remained predictive of death from RCC (HR: 1.40; p<0.001). CONCLUSIONS: The SSIGN score remains a useful prediction tool for patients undergoing RN with 20-yr follow-up. When applied to contemporary RN and PN patients, the score retained strong predictive ability. These results should assist in patient counseling and help guide surveillance for ccRCC patients treated with RN or PN. PATIENT SUMMARY: We evaluated the validity of a previously described tool to predict survival following surgery in contemporary patients with kidney cancer. We found that this tool remains valid even when extended to patients significantly different than were initially used to create the tool.

Patient factors associated with 30-day complications after partial nephrectomy: A contemporary update.

INTRODUCTION: Patient-level factors associated with perioperative complications after partial nephrectomy (PN) have not been well described in a contemporary series. METHODS: Single-institution retrospective study evaluating patients undergoing open, laparoscopic, and robotic PN between 2001 and 2012. Univariable and multivariable logistic regression models were evaluated to assess factors associated with complications within 30 days of surgery. RESULTS: We identified 1,763 patients who underwent 1,773 PNs between 2001 and 2012. From 2001 to 2006, 766 PNs were performed (85% open, 15% laparoscopic, and<1% robotic); in contrast, from 2007 to 2012, 1,007 PNs were performed (75% open, 8% laparoscopic, and 17% robotic); P<0.001. Overall, 241 (14%) PNs resulted in an early surgical complication. Patients undergoing a minimally invasive approach had smaller tumors (P<0.001), were less likely to have a solitary kidney (P<0.001), and had a lower Charlson score (P = 0.004). On multivariable analysis, factors independently associated with an increased risk of any complication included male sex (odds ratio [OR] = 1.40), solitary kidney (OR = 1.71), estimated glomerular filtration rate (OR = 2.89 for estimated glomerular filtration rate<30), Charlson score (OR = 1.97 for Charlson score≥3), and tumor size (OR = 1.12 for each 1-cm increase in tumor size); meanwhile, laparoscopic and robotic approaches were associated with a lower risk for complication (OR = 0.017 and 0.016, respectively), all P< 0.05. CONCLUSION: Several patient-level factors are associated with 30-day complications after PN, regardless of surgical approach. These data may inform counseling before PN, including potential identification and selection of high-risk surgical candidates for percutaneous ablative approaches.

Identification of Site-specific Recurrence Following Primary Radiation Therapy for Prostate Cancer Using C-11 Choline Positron Emission Tomography/Computed Tomography: A Nomogram for Predicting Extrapelvic Disease.

BACKGROUND: Management of recurrent prostate cancer (CaP) after radiotherapy (RT) is dependent on accurate localization of the site of recurrent disease. OBJECTIVE: To describe the anatomic patterns and clinical features associated with CaP recurrence following RT identified on advanced imaging. DESIGN, SETTING, AND PARTICIPANTS: Retrospective review of 184 patients with a rising prostate-specific antigen (PSA) after RT for CaP. INTERVENTION: C-11 choline positron emission tomography/computed tomography (CholPET). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Recurrence patterns were classified as pelvic soft tissue only (as a surrogate for potentially salvageable disease) versus any extrapelvic disease, and clinical features were compared between patterns. Multivariable logistic regression was used to generate a predictive nomogram for extrapelvic recurrence. Discrimination was assessed with a c-index. RESULTS AND LIMITATIONS: Recurrence site was identified in 161 (87%) patients, with 95 (59%) sites histologically confirmed. Factors associated with the detection of recurrence included the difference between PSA nadir and PSA at CholPET (odds ratio: 1.30, p<0.01) and National Comprehensive Cancer Network high-risk classification (odds ratio: 10.83, p=0.03). One hundred (54.3%) patients recurred in the pelvic soft tissue only, while 61 (33%) had extrapelvic recurrence. Of 21 patients who underwent CholPET prior to meeting the Phoenix criteria of biochemical failure, 15 (71%) had recurrence identified on CholPET with 11 localized to the pelvis. On multivariable analysis, the difference between PSA nadir and PSA at CholPET, time from RT, and National Comprehensive Cancer Network risk group were predictive of recurrence outside of the pelvis, and a nomogram was generated with a c-index of 0.79. CONCLUSIONS: CholPET identified the site of recurrence in 87% of patients with a rising PSA after RT; most commonly within the pelvis in potentially salvageable locations. A predictive nomogram was generated, and pending external validation, this may aid in assessing the risk of disease beyond the pelvis. These findings underscore the importance of advanced imaging when considering management strategies for patients with a rising PSA following primary RT. PATIENT SUMMARY: We identified anatomic patterns of recurrence in patients with a rising prostate-specific antigen after radiotherapy using C-11 choline positron emission tomography/computed tomography. Most recurrences were localized to the pelvis and we were able to generate a tool to aid in disease localization prior to evaluation with advanced imaging.

Evaluation of beta-blockers and survival among hypertensive patients with renal cell carcinoma.

OBJECTIVES: Beta-blocker use is associated with improved survival for multiple nonurologic malignancies. Our objective was to evaluate the association between beta-blocker use and survival among surgically managed hypertensive patients with clear-cell renal cell carcinoma (ccRCC). METHODS: Hypertensive patients with ccRCC treated with either radical or partial nephrectomy between 2000 and 2010 were identified from our Nephrectomy Registry. Beta-blocker use within 90 days before surgery was identified. The associations between beta-blocker use and risk of disease progression, death from renal cell carcinoma (RCC), and all-cause mortality were assessed using Cox proportional hazards regression models. RESULTS: In total, 913 hypertensive patients were identified who underwent either partial or radical nephrectomy for ccRCC. Of these, 104 (11%) had documented beta-blocker use within 90 days before surgery. At last follow-up (median 8.2y among survivors), 258 patients showed progression (median 1.6y following surgery), and 369 patients had died (median 4.1y following surgery), including 138 who died of RCC. After adjusting for PROG (progression-free survival) and SSIGN (cancer-specific survival) scores, beta-blocker use was not significantly associated with the risk of disease progression (hazard ratio [HR] = 0.94; 95% CI: 0.61-1.47; P = 0.80) or the risk of death from RCC (HR = 0.74; 95% CI: 0.38-1.41; P = 0.35). Similarly, on multivariable analysis adjusting for clinicopathologic features, there was not a significant association between beta-blocker use and the risk of all-cause mortality (HR = 0.83; 95% CI: 0.59-1.16; P = 0.27). CONCLUSIONS: Beta-blocker use for hypertension within 90 days before surgery was not associated with the risk of progression, death from RCC, or death from any cause.

Characterization of perioperative infection risk among patients undergoing radical cystectomy: Results from the national surgical quality improvement program.

OBJECTIVES: To evaluate the incidence, risk factors, and timing of infections following radical cystectomy (RC). METHODS: The American College of Surgeons National Surgical Quality Improvement Project database was queried to identify patients undergoing RC for bladder cancer from 2006 to 2013. Characteristics including year of surgery, age, sex body mass index, diabetes, smoking, renal function, steroid usage, preoperative albumin, preoperative hematocrit, perioperative blood transfusion (PBT), and operative time were assessed for association with the risk of infection within 30 days of RC using multivariable logistic regression. RESULTS: A total of 3,187 patients who had undergone RC were identified, of whom 766 (24.0%) were diagnosed with a postoperative infection, at a median of 13 days (interquartile ranges 8-19) after RC. Infections included surgical site infection (SSI) (404; 12.7%), sepsis/septic shock (405; 12.7%), and urinary tract infection (UTI) (309; 9.7%). On multivariable analysis, body mass index≥30kg/m2 (odds ratios [OR] = 1.52; P<0.01), receipt of a PBT (OR = 1.27; P<0.01), and operative time≥480 minutes (OR = 1.72; P<0.01) were significantly associated with the risk of infection. When the outcomes of UTI, SSI, and sepsis were analyzed separately, operative time≥480 minutes remained independently associated with increased infection risk in each model (OR = 2.11 for UTI, OR = 1.63 for SSI, and OR = 1.80 for sepsis/septic shock; all P<0.05), whereas PBT was associated with SSI and sepsis/septic shock (OR = 1.33 and OR = 1.29, respectively; both P< 0.05). CONCLUSIONS: Approximately 25% of patients undergoing RC experience an infection within 30 days of surgery. Several potentially modifiable risk factors for infection were identified, specifically PBT and prolonged operative time, which may represent opportunities for future care improvement.

Oncological Outcomes of Patients with Concomitant Bladder and Urethral Carcinoma.

INTRODUCTION: The study aimed to investigate oncological outcomes of patients with concomitant bladder cancer (BC) and urethral carcinoma. METHODS: This is a multicenter series of 110 patients (74 men, 36 women) diagnosed with urethral carcinoma at 10 referral centers between 1993 and 2012. Kaplan-Meier analysis was used to investigate the impact of BC on survival, and Cox regression multivariable analysis was performed to identify predictors of recurrence. RESULTS: Synchronous BC was diagnosed in 13 (12%) patients, and the median follow-up was 21 months (interquartile range 4-48). Urethral cancers were of higher grade in patients with synchronous BC compared to patients with non-synchronous BC (p = 0.020). Patients with synchronous BC exhibited significantly inferior 3-year recurrence-free survival (RFS) compared to patients with non-synchronous BC (63.2 vs. 34.4%; p = 0.026). In multivariable analysis, inferior RFS was associated with clinically advanced nodal stage (p < 0.001), proximal tumor location (p < 0.001) and synchronous BC (p = 0.020). CONCLUSION: The synchronous presence of BC in patients diagnosed with urethral carcinoma has a significant adverse impact on RFS and should be an impetus for a multimodal approach.

Risk Factors and Microbial Distribution of Urinary Tract Infections Following Radical Cystectomy.

OBJECTIVE: To evaluate clinicopathologic features associated with the risk of urinary tract infection (UTI) after radical cystectomy (RC), and determine the underlying organisms responsible for these events. MATERIALS AND METHODS: We reviewed 1248 patients treated with RC for bladder cancer from 2000 to 2010 at Mayo Clinic. UTIs diagnosed within 90 days of surgery were recorded. Multivariable logistic regression analysis was performed to evaluate the association of clinicopathologic features with postoperative UTI. RESULTS: UTI was diagnosed in 129 (10.3%) patients within 90 days of RC. Median time to UTI was 22.5 days (interquartile range 14,42). On multivariable analysis, factors associated with a significantly increased UTI risk were diabetes (odds ratio [OR] 2.27; P < .001), receipt of a perioperative blood transfusion (OR 1.58; P = .03), continent urinary diversion (OR 2.17;P < .001), and development of a urine leak (OR 3.42;P < .001). Culture-specific infection data were available for 88 of the patients, with a total of 113 UTIs diagnosed among this cohort. Of these, 36.8% of UTIs were polymicrobial. Drug-resistant Staphylococcus aureus and Enterococcus were isolated in 45.0% and 12.8% of infections, respectively. Fungal elements were present in 27 (23.9%) cultures, and were the sole organism in 15 (13.3%). No significant differences in microbial distribution or timing of infections were detected between patients who underwent conduit vs continent diversion. CONCLUSION: We found that diabetes, perioperative blood transfusion, continent diversion, and urine leak were associated with UTI risk following RC. Multiple organisms, drug resistance, and fungal elements were commonly identified, supporting the use of initial broad-spectrum coverage, including consideration of antifungal therapy, upon diagnosis of UTI after RC.

Efficacy and Safety of Intraoperative Tranexamic Acid Infusion for Reducing Blood Transfusion During Open Radical Cystectomy.

OBJECTIVE: To evaluate the safety and efficacy of intraoperative tranexamic acid (TA), an antifibrinolytic, in reducing perioperative blood transfusion (PBT) for patients undergoing open radical cystectomy (RC) for bladder cancer. MATERIALS AND METHODS: We instituted a change in our institutional clinical practice starting in April 2013, whereby all patients undergoing open RC were administered intraoperative intravenous TA. Patients with a history of venous thromboembolism (VTE) or coronary stent insertion within the year prior to RC did not receive TA. Receipt of a PBT, defined as transfusion of red blood cells during RC or within the postoperative hospitalization, and VTE within 30 days of RC were recorded and compared with a matched cohort of patients treated with RC at our center prior to the initiation of TA utilization. RESULTS: A total of 103 patients received TA during open RC between April 2013 and July 2015. These patients were matched 1:2 to historic controls. We found that TA infusion was associated with a significantly decreased rate of PBT, as 32 of 103 (31.1%) patients treated with TA received a PBT, versus 115 of 200 (57.7%) matched controls (P < .0001). Importantly, TA did not significantly increase the rate of perioperative VTE, as 5 patients (4.9%) who received TA were diagnosed with a VTE within 30 days of RC, compared with 6 (3.0%) of the matched controls (P = .52). CONCLUSION: We noted that the use of intraoperative TA during open RC was associated with a significant reduction in PBT, and did not significantly increase perioperative VTE risk.

Safety and Efficacy of Extended Duration of Thromboembolic Prophylaxis Following Radical Cystectomy: An Initial Institutional Experience.

INTRODUCTION: We evaluated the safety and efficacy of extended duration of pharmacological prophylaxis for preventing symptomatic venous thromboembolism following radical cystectomy. METHODS: We recorded symptomatic venous thromboembolism and lymphocele events within 30 days of radical cystectomy among patients treated with extended duration of pharmacological prophylaxis (enoxaparin 40 mg subcutaneously daily for 30 days). We compared these outcomes to those in the cohort of patients who underwent radical cystectomy at our institution in the year prior to extended prophylaxis implementation. Unadjusted descriptive statistics and univariate analyses were performed using the Pearson test or the Fisher chi-square test for categorical variables and the Wilcoxon rank sum test for continuous variables. RESULTS: We analyzed the records of 52 patients who did and 82 who did not receive extended duration of pharmacological prophylaxis after radical cystectomy. Only 1 patient (1.9%) discharged home on extended prophylaxis was diagnosed with venous thromboembolism within 30 days of RC compared to 5 (6.1%) who had not received extended prophylaxis. In 3 patients symptomatic lymphocele developed within 30 days of radical cystectomy, including 1 (1.9%) who had received extended prophylaxis and 2 (2.4%) who had not. No patient in either cohort was rehospitalized for bleeding complications. CONCLUSIONS: Our initial experience suggests that extended duration of pharmacological prophylaxis is associated with a lower rate of venous thromboembolism following radical cystectomy and it does not increase the risk of bleeding or symptomatic lymphocele. These data warrant validation in larger patient cohorts, ideally in the prospective clinical trial setting.