A comparison of energy expenditure and perceived exertion between standard axillary crutches, knee scooters, and a hands-free crutch.

BACKGROUND: Ambulation using standard axillary crutches (SACs) is associated with increased energy expenditure (EE) and decreased ability to perform activities of daily living (ADLs). Using a hands-free crutch (HFC) displays potential for easier completion of ADLs and reduction in energy requirements. OBJECTIVES: To determine if a HFC elicits lower EE and heart rate (HR), improvement in performance of ADLs, and decreased rating of perceived exertion (RPE) compared to common ambulatory devices. DESIGN: A randomized crossover-controlled trial. SETTING: University community. PARTICIPANTS: Twenty healthy college students. MAIN OUTCOME MEASURES: Participants completed a 6-minute walk test at 50 m/min, an ADLs course, and a two-flight stair climb with SACs, HFC, knee scooter (KS), and unassisted ambulation (UA). The order of trial conditions was randomized. EE, HR, time to complete ADLs course and stair climb, and RPE during each condition were obtained. One-way analyses of variance were performed to compare EE, HR response, and RPE between the assistive devices and UA. RESULTS: In all outcomes UA resulted in lower EE, HR, and RPE compared to all the assistive devices (p < .05). For the ADLs course, EE was the same for the three assistive devices, whereas HR was significantly lower for HFC compared to SACs and KS (p < .05). RPE for HFC and KS was lower than SACs (p < .05). For the 6MWT, each device significantly differed from the other devices for EE, HR, and RPE, with KS eliciting the lowest values, followed by HFC. For the stair climbing task, HFC elicited lower EE, HR, and RPE than SACs. Fourteen participants indicated their overall preference for HFCs. CONCLUSIONS: In individuals prescribed weight-bearing restrictions, using a HFC may offer an easier and more preferred alternative to more commonly used SACs during ambulation, stair climbing, and other ADLs.

The 17-Gene Genomic Prostate Score Assay Is Prognostic for Biochemical Failure in Men With Localized Prostate Cancer After Radiation Therapy at a Community Cancer Center.

Purpose: The objective of this study was to assess the association between the Oncotype DX Genomic Prostate Score (GPS) assay and long-term outcomes in men with localized prostate cancer (PCa) after radiation therapy (RT). We hypothesized that the GPS assay is prognostic for biochemical failure (BCF), along with distant metastasis (DM) and PCa-specific mortality in patients with PCa receiving RT. Methods and Materials: We retrospectively studied men with localized PCa treated with definitive RT at Georgia Urology from 2010 to 2016. The primary objective was to assess the association between GPS results and time to BCF per the Phoenix criteria; we also assessed time to DM and PCa-specific mortality. We used Cox proportional hazards regression models for all analyses, with clinicopathologic covariates determined a priori for multivariable modeling. Results: A total of 450 patients (median age, 65 years; 35% Black) met eligibility criteria. There was a strong univariable association between GPS result and time to BCF (hazard ratio [HR] per 20-unit increase = 3.08; 95% confidence interval [CI], 2.11-4.46; P < .001), which persisted after adjusting for clinicopathologic characteristics in multivariable analyses. We also observed this association for time to DM (HR = 5.19; 95% CI, 3.06-8.77; P < .001) and PCa-specific mortality (HR = 13.07; 95% CI, 4.42-49.39; P < .001). Race was not a predictor of time to BCF or DM, and the GPS assay was strongly prognostic for all endpoints in Black and White patients. Conclusions: In a community-based cohort, the GPS assay was strongly prognostic for time to BCF as well as long-term outcomes in men treated with RT for localized PCa.

Personalizing Localized Prostate Cancer: Validation of a Combined Clinical Cell-cycle Risk (CCR) Score Threshold for Prognosticating Benefit From Multimodality Therapy.

INTRODUCTION: The combined clinical cell-cycle risk (CCR) score is a validated model that combines the cell-cycle progression (CCP) score with the University of California San Francisco Cancer of the Prostate Risk Assessment (CAPRA) score. This score determines the risk of progressive disease for men with prostate cancer. Here, we further validate the prognostic ability of the CCR score and evaluate its ability to help determine which patients may safely forgo multimodality therapy. PATIENTS AND METHODS: We evaluated the CCR and a CCR-based multimodality threshold (2.112) in a retrospective, multi-institutional cohort of men with National Comprehensive Cancer Network intermediate- or high-risk localized disease (N = 718). These men received single or multimodality therapy (androgen deprivation with radiation [RT], or surgery with adjuvant RT or hormones). RESULTS: CCR score prognosticated metastasis for single-modality therapy, as a continuous variable (hazard ratio, 3.97; 95% confidence interval [CI], 2.61-6.06) and when dichotomized at the threshold (hazard ratio, 15.90; 95% CI, 5.43-46.52). The 10-year Kaplan-Meier risk for those receiving single-modality (RT or surgical) therapy with CCR scores below and above the threshold for single-modality treatment was 4.3% (95% CI, 1.0%-17.1%) and 20.4% (95% CI, 13.2%-30.7%), respectively. Using the threshold, 27% of men with newly diagnosed high-risk and 73% with unfavorable intermediate-risk disease could avoid multimodality therapy. CONCLUSIONS: Patients with CCR scores below the multimodality threshold (2.112) may safely forgo multimodality therapy. The CCR score can be used as a decision aid to counsel men whether or not single-modality therapy would be sufficient for their intermediate- or high-risk prostate cancer.

A Contemporary Analysis of the 30-day Morbidity and Mortality Associated With Cytoreductive Nephrectomy.

OBJECTIVE: To examine the rates of adverse surgical outcomes in patients undergoing cytoreductive nephrectomy (CN) compared to patients undergoing radical nephrectomy in the nonmetastatic setting using a large administrative database. METHODS: Patients in the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) who underwent a radical nephrectomy between 2011 and 2016 were included. Patients were stratified by the preoperative variable of presence or absence of metastatic cancer. Perioperative outcomes were compared. A multivariable logistic regression analysis was performed to test the association between patients with metastatic cancer and perioperative morbidity and 30-day mortality. RESULTS: There were 15,869 total patients included in this analysis of whom 1322 (8%) patients had metastatic cancer. Of the entire cohort, the majority of patients were over 60 years old (58%) and 9621 (61%) were male. Seventy-three of the patients were Caucasian. Patients with metastatic cancer had more minor (P< .01) and major (P< .01) complications, a higher rate of reoperation (P< .01), and a higher rate of unplanned readmissions (P< .01). Finally, the cohort with metastatic cancer had a higher rate of postoperative 30-day mortality (P< .01) than patients without metastatic cancer. CONCLUSION: Patients undergoing a CN have significantly worse perioperative outcomes than patients undergoing a radical nephrectomy without evidence of metastases. Careful surgical risk stratification and appropriate patient counseling should be undertaken when selecting candidates for CN.

Novel Opiate-Free Anesthetic Technique for Major Urologic Procedures.

OBJECTIVES: We postulated that an opiate-free (OF) general anesthesia (GA) technique could adequately control a patient's pain without adversely affecting recovery. We compared patients undergoing major urologic procedures with and without opiate-based GA. METHODS: A propensity-matched analysis was performed comparing hospital length of stay, postoperative nausea and vomiting, ileus occurrence, postanesthesia care unit, and total opiate consumption, as well as sedation and hemodynamic variables. The data are expressed as medians and were analyzed with the Wilcoxon rank-sum test. P < 0.05 indicate statistical significance. RESULTS: In total, 166 patients were evaluated in both the OF group and the opiate-based treatment group. American Society of Anesthesiologists classification and age were comparable, with most surgeries being laparoscopic and confined to the bladder, kidney, and prostate gland. The median opiate consumption in morphine equivalents in the postanesthesia care unit was 7.7 mg (range 5-11.7 mg) for the OF cohort versus 11.7 mg (range 5-17.3 mg) for the control group (P < 0.001). Similarly, the median total postoperative opiate consumption in morphine equivalents was 23.9 mg (range 13.8-42.4 mg) for the OF group compared with 32.1 mg (range 17.38-57.51 mg) for the control group (P = 0.0081). The median hospital length of stay for the OF group was 1.4 days (range 1.2-2.3 days) versus 1.3 days (range 1.2-2.4 days) for the control group (P = 0.8466). CONCLUSIONS: There was a statistically significant difference in opiate consumption postoperatively for patients who underwent an OF technique compared with a conventional opiate-based technique. This technique appears to be a possible alternative approach, without any apparent untoward consequences during admission.

Modified Frailty Index Predicts Postoperative Outcomes in Patients Undergoing Radical Pelvic Surgery.

Patients undergoing radical pelvic surgery such as proctectomy or radical cystectomy are at risk of experiencing a variety of complications. Frailty renders patients vulnerable to adverse events. We hypothesize that frailty measured preoperatively using a validated scoring system correlates with increased likelihood of experiencing Clavien-Dindo grade IV complications and 30-day mortality and may be used as a predictive model for patients preoperatively. The NSQIP database was queried for patients who underwent proctectomy or radical cystectomy from 2008 to 2012. Preoperative frailty was calculated using the 11-point modified frailty index (MFI). Patients were scored based on the presence of indicators and categorized into two groups (<3 or ≥3). Major postoperative morbidities and mortality were identified and analyzed in each group. 10,048 proctectomy and cystectomy patients were identified. The MFI was found to be predictive of both 30-day mortality (P < 0.0001) and Clavien-Dindo grade IV complications (P < 0.0001). Receiver operating characteristic analysis demonstrated improved discriminative power of the MFI with the addition of American Society of Anesthesiologists class for both prediction of complications and 30-day mortality. An MFI score of ≥3 is predictive of postoperative morbidity and mortality. Providers should be encouraged to calculate frailty preoperatively to predict adverse outcomes.

Analysis of the prognostic utility of the cell cycle progression (CCP) score generated from needle biopsy in men treated with definitive therapy.

BACKGROUND: Accurate risk stratification can help guide appropriate treatment decisions in men with localized prostate cancer. Here, we evaluated the independent ability of the molecular cell cycle progression (CCP) score and the combined cell-cycle clinical risk (CCR) score to predict 10-year risk of progression to metastatic disease in a large, pooled analysis of men with definitively treated prostate cancer. METHODS: The pooled analysis included 1,062 patients from four institutions (Martini Clinic, Durham VA Medical Center, Intermountain Healthcare, Ochsner Clinic) treated definitively for localized prostate cancer by either radical prostatectomy or radiotherapy (brachytherapy or external beam radiotherapy ± hormone therapy). The CCP score was determined using the RNA expression of 46 genes from archival formalin-fixed paraffin-embedded biopsy tissue. The CCR score was calculated using a predefined linear combination of the CCP score and the Cancer of the Prostate Risk Assessment (CAPRA) score. The scores were evaluated for association with 10-year risk of metastatic disease following definitive therapy after adjusting for other clinical variables. RESULTS: The CCP score was strongly associated with 10-year risk of metastatic disease in multivariable analysis [Hazard Ratio per unit score = 2.21; 95% confidence interval (CI) 1.64, 2.98; p = 1.9 × 10-6] after adjusting for CAPRA, treatment type, and cohort. CCR was also highly prognostic (Hazard Ratio per unit score = 4.00; 95% CI 2.95, 5.42; p = 6.3 × 10-21). There was no evidence of interaction between CCP or CCR and cohort (p = 0.79 and p = 0.86, respectively) or treatment type (p = 0.55 and p = 0.78, respectively). Observed patient CCR-based predicted risks for metastatic disease by 10 years ranged from 0.1 to 99.4%, (IQR 0.7%, 4.6%). CONCLUSIONS: Both CCP and CCR scores provided independent prognostic information for predicting progression to metastatic disease after both surgery and radiation. These results further demonstrate their potential use as a risk stratification tool in patients with newly-diagnosed prostate cancer.

A randomized, controlled trial for transurethral treatment of bladder tumors using PlasmaButton vaporization electrode or monopolar loop electrocautery.

INTRODUCTION: The use of an electrocautery device (monopolar loop) for patients undergoing transurethral resection of bladder tumors (TURBT) is standard of care. The aim of this study is to establish non-inferiority of complication rates for a bipolar energy device, the PK PlasmaButton (PK Button), when compared to the monopolar loop. MATERIALS AND METHODS: Seventy-eight subjects (41 monopolar loop and 37 PK Button), were enrolled in a single-center, prospective, randomized study with cystoscopically detected bladder tumors that were judged endoscopically resectable with only one trip into the operating room. Intra and postoperative data on complication rates, operative time, catheterization time and disease recurrence rates at 3 month follow up were collected. RESULTS: Overall complication rates after TURBT with the monopolar loop or PK Button were similar, (56% versus 38% respectively, p = 0.107), however there were more bladder perforations in the monopolar loop arm compared to the PK Button arm (12.2% versus 0%, respectively, p = 0.028). There was no difference in overall operative time (p = 0.170), catheterization time (p = 0.709) and disease recurrence (p = 0.199). CONCLUSION: The results of this study demonstrated no difference between the monopolar loop and PK Button in regard to overall complications; however, there was a higher rate of bladder perforation with monopolar TURBT. PK Button vaporization for bladder tumors represents a promising alternative to traditional monopolar TURBT without compromising short term (3 month) cancer recurrence rates.

Isolated adrenal metastectomy has a low morbidity rate irrespective of performing surgical sub-specialty.

INTRODUCTION: There has been growing use of adrenalectomy as a potentially curative treatment option for patients with oligometastatic disease to the adrenal gland. We sought to compare the perioperative outcomes of patients undergoing isolated adrenalectomy in the setting of disseminated cancer using the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database. Furthermore, we examined the impact of performing surgical sub-specialty on outcomes. MATERIALS AND METHODS: Data from the ACS-NSQIP database was obtained for patients between 2011 and 2016 who underwent adrenalectomy. Patients were stratified by the presence or absence of disseminated cancer. Univariate and multivariate regression analyses were performed to test for an association between the presence or absence of disseminated cancer and perioperative outcomes. The relationship between performing specialist and outcomes was also compared. RESULTS: A total of 4,207 patients were identified, with 270 (6.4%) in the disseminated cancer group. There was no significant difference in perioperative outcomes between patients with disseminated cancer and without disseminated cancer. On multivariate analysis, neither the presence of disseminated cancer (p = 0.47) nor the surgical sub-specialty performing adrenalectomy (p = 0.52) were associated with an increased risk postoperative morbidity or mortality. Of note, there was a statistically significant increase in the number of adrenalectomies performed by urologists in the setting of disseminated cancer (19.3% versus 10.4%, p < 0.01). CONCLUSIONS: Patients undergoing adrenalectomy in the setting of disseminated cancer did not have significantly worse perioperative outcomes compared to patients undergoing adrenalectomy for other indications. The adverse perioperative event rate was similar whether the operation was performed by a urologist or a general surgeon.

Morbidity, mortality and temporal trends in the surgical management of retroperitoneal sarcoma: An ACS-NSQIP follow up analysis.

BACKGROUND: Calls for multivisceral resection (MVR) of retroperitoneal sarcoma (RPS) are increasing, although the risks and benefits remain controversial. We sought to analyze current 30-day morbidity and mortality rates, and trends in utilization of MVR in a national database. METHODS: Overall morbidity, severe morbidity, mortality rates, and temporal trends were analyzed utilizing the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP). RESULTS: From 2012 to 2015, a total of 564 patients underwent RPS resection with 233 patients (41%) undergoing MVR. The MVR group had a higher rate of preoperative weight loss and larger tumors overall. When comparing MVR to non-MVR, there was no significant difference in overall morbidity (22% vs 17%, P = .13), severe morbidity (11% vs 8%, P = .18), or mortality (<1% vs 2%, P = .25). On multivariate analysis, MVR was not associated with increased overall morbidity or severe morbidity. Mortality rates were too low for meaningful statistical analysis. Annual rates of MVR ranged from 37% to 46% with no significant change over time (P = .47). RESULTS: Short-term morbidity and mortality rates after MVR for RPS remain acceptable, but rates of MVR show little change over time in NSQIP hospitals. Concerns about increased morbidity and mortality should not be viewed as a contraindication to wider implementation of MVR for RPS.

Accuracy of the NSQIP risk calculator for predicting complications following adrenalectomy.

PURPOSE: Adrenalectomy is performed to treat functional pathology and remove tumors of malignant concern. The National Surgical Quality Improvement Program (NSQIP) risk calculator predicts 30-day complications and length of stay following index surgical procedures. We assess whether this tool accurately predicts complications following adrenalectomy procedures at a tertiary care academic medical center. METHODS: A retrospective review was performed for all adrenalectomies at a single institution from 2004 to 2016. 197 patients underwent adrenalectomy without concurrent resections. Predicted risk for NSQIP complications was calculated for each patient. The mean predicted and observed risks (%) at 30 days across all patients within each category were determined, and these were compared with two-sided one-sample t tests. RESULTS: Of 197 adrenalectomies, 180 were laparoscopic and 17 were open. For laparoscopic adrenalectomy, ten (5.5%) complications were observed including nine (5%) graded Clavien III or greater. All observed complication rates were significantly different than predicted (p values for all < 0.005). Mean observed length of stay was also significantly less than predicted (1.6 versus 2.1 days, p < 0.001). In the open adrenalectomy subgroup, there were no observed complications with observed mean length of stay equivalent to predicted (5.8 versus 5.3, p = 0.08) without a higher readmission rate (5.9 versus 6.0%). CONCLUSIONS: Statistical differences were noted between the actual complication rates of adrenalectomy versus those predicted by the NSQIP calculator. Certain observed differences may not necessarily have clinical significance. Urology procedure-specific calculators may better refine predictions for sub-specialty procedures with future work requisite to determine performance across all practice settings.

The International Penile Advanced Cancer Trial (InPACT): Rationale and Current Status.

The historic international penile cancer trial InPACT is now open and accruing patients in the UK and USA. The trial is geared to answer important questions for patients with evidence of inguinal lymph node disease at presentation. This clinical trial update provides an overview of the study and progress to date.

Ex-vivo donor partial nephrectomy at the time of donor-directed renal transplantation.

The outcome of nephron-sparing surgical management of small renal masses is generally favorable, specifically in terms of long term renal function, overall survival, and oncologic outcomes. Given the overall prognosis and renal function preservation, transplantation of kidneys with small renal masses has increasingly been accepted as a donor option for renal transplantation. We present a case of an incidental renal mass on preoperative donor transplant evaluation and subsequent ex-vivo donor partial nephrectomy at the time of renal transplantation.

Comparison of the Prognostic Utility of the Cell Cycle Progression Score for Predicting Clinical Outcomes in African American and Non-African American Men with Localized Prostate Cancer.

BACKGROUND: Better prostate cancer risk stratification is necessary to inform medical management, especially for African American (AA) men, for whom outcomes are particularly uncertain. OBJECTIVE: To evaluate the utility of both a cell cycle progression (CCP) score and a clinical cell-cycle risk (CCR) score to predict clinical outcomes in a large cohort of men with prostate cancer highly enriched in an AA patient population. DESIGN, SETTING, AND PARTICIPANTS: Patients were diagnosed with clinically localized adenocarcinoma of the prostate and treated at The Ochsner Clinic (New Orleans, LA, USA) from January 2006 to December 2011. CCP scores were derived from archival formalin-fixed, paraffin-embedded biopsy tissue. CCR scores were calculated as the combination of molecular (CCP score) and clinical (Cancer of the Prostate Risk Assessment [CAPRA] score) components. INTERVENTION: Active treatment (radical prostatectomy, radiation therapy alone, or radiation and hormone therapy) or watchful waiting. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was progression to metastatic disease. Association with outcomes was evaluated via Cox proportional hazards survival analysis and likelihood ratio tests. RESULTS AND LIMITATIONS: The final cohort included 767 men, of whom 281 (36.6%) were AA. After accounting for ancestry, treatment, and CAPRA in multivariable analysis, the CCP score remained a significant predictor of metastatic disease (hazard ratio [HR] 2.04; p<0.001), and there was no interaction with ancestry (p=0.20) or treatment (p=0.09). The CCR score was highly prognostic (HR 3.86; p<0.001), and as with the CCP score, there was no interaction with ancestry (p=0.24) or treatment (p=0.32). Limitations include the retrospective study design and the use of self-reported ancestry information. CONCLUSIONS: A CCR score provided significant prognostic information regardless of ancestry. The findings demonstrate that AA men in this study cohort appear to have similar prostate cancer outcomes to non-AA patients after accounting for all available molecular and clinicopathologic variables. PATIENT SUMMARY: In this study we evaluated the ability of a combined molecular and clinical score to predict the progression of localized prostate cancer. We found that the combined molecular and clinical score predicted progression to metastasis regardless of patient ancestry or treatment. This suggests that the combined molecular and clinical score may be a valuable tool for determining the risk of metastasis in men with newly diagnosed prostate cancer in order to make appropriate treatment decisions.

Ileocalicostomy Ureteral Substitution for Complex Ureteropelvic Junction Stricture: Technique and Initial Experience.

OBJECTIVE: To present our novel surgical technique, ileocalicostomy ureteral substitution, for the management of long upper ureteral strictures in patients without a dilated extra-renal pelvis. MATERIALS AND METHODS: Two patients were identified with long, complex proximal ureteral strictures who were treated with our novel surgical technique by a single surgeon at a single institution. Perioperative data for these two patients are presented along with a detailed description of the surgical technique. RESULTS: Ileocalicostomy ureteral substitution was successfully performed in two cases. The total operative time for these cases was 436 minutes and 246 minutes, with estimated blood loss of 300 mL and 200 mL. Length of stay for the two patients was 8 days and 6 days, respectively. There were no major (Clavien-Dindo Classification ≥ grade 3) complications. Both patients are entirely free of urinary tubes with unobstructed kidneys since reconstruction. CONCLUSION: Ileocalicostomy ureteral substitution is a feasible reconstructive option for select patients. To our knowledge this report is the initial experience in the literature presented.

Comparison of common risk stratification indices to predict outcomes among stage IV cancer patients with bowel obstruction undergoing surgery.

BACKGROUND AND OBJECTIVES: Among patients with disseminated malignancy (DMa), bowel obstruction is common with high operative morbidity. Since preoperative risk stratification is critical, we sought to compare three standard risk indices, the American Society of Anesthesiology (ASA) classification, Charlson comorbidity index (CCI), and modified frailty index (mFI). METHODS: We identified 1928 DMa patients with bowel obstruction who underwent an abdominal operation from 2007 to 2012 American College of Surgeons National Surgical Quality Improvement Program. Multivariate analyses assessed predictors of prolonged length of stay (LOS), 30-day serious morbidity and mortality. Receiver operating characteristics' areas under the curves (AUCs) for risk indices scores and 30-day mortality were assessed. RESULTS: Serious morbidity and mortality rates were 20.4% and 14.8%. ASA and CCI did not predict serious morbidity or prolonged LOS, but were predictors of mortality. The mFI did not predict prolonged LOS, but did predict serious morbidity and mortality. Subgroup analyses showed similar results. There were no significant differences between ASA, CCI, and mFI AUCs for mortality. CONCLUSIONS: ASA, CCI, and mFI are limited in their ability to predict postoperative adverse events among DMa patients undergoing surgery for bowel obstruction. These data suggest that a more tailored preoperative risk stratification tool would improve treatment planning.

Intravesical rAd-IFNα/Syn3 for Patients With High-Grade, Bacillus Calmette-Guerin-Refractory or Relapsed Non-Muscle-Invasive Bladder Cancer: A Phase II Randomized Study.

Purpose Many patients with high-risk non-muscle-invasive bladder cancer (NMIBC) are either refractory to bacillus Calmette-Guerin (BCG) treatment or may experience disease relapse. We assessed the efficacy and safety of recombinant adenovirus interferon alfa with Syn3 (rAd-IFNα/Syn3), a replication-deficient recombinant adenovirus gene transfer vector, for patients with high-grade (HG) BCG-refractory or relapsed NMIBC. Methods In this open-label, multicenter (n = 13), parallel-arm, phase II study ( ClinicalTrials.gov identifier: NCT01687244), 43 patients with HG BCG-refractory or relapsed NMIBC received intravesical rAd-IFNα/Syn3 (randomly assigned 1:1 to 1 × 1011 viral particles (vp)/mL or 3 × 1011 vp/mL). Patients who responded at months 3, 6, and 9 were retreated at months 4, 7, and 10. The primary end point was 12-month HG recurrence-free survival (RFS). All patients who received at least one dose were included in efficacy and safety analyses. Results Forty patients received rAd-IFNα/Syn3 (1 × 1011 vp/mL, n = 21; 3 × 1011 vp/mL, n = 19) between November 5, 2012, and April 8, 2015. Fourteen patients (35.0%; 90% CI, 22.6% to 49.2%) remained free of HG recurrence 12 months after initial treatment. Comparable 12-month HG RFS was noted for both doses. Of these 14 patients, two experienced recurrence at 21 and 28 months, respectively, after treatment initiation, and one died as a result of an upper tract tumor at 17 months without a recurrence. rAd-IFNα/Syn3 was well tolerated; no grade four or five adverse events (AEs) occurred, and no patient discontinued treatment because of an adverse event. The most frequently reported drug-related AEs were micturition urgency (n = 16; 40%), dysuria (n = 16; 40%), fatigue (n = 13; 32.5%), pollakiuria (n = 11; 28%), and hematuria and nocturia (n = 10 each; 25%). Conclusion rAd-IFNα/Syn3 was well tolerated. It demonstrated promising efficacy for patients with HG NMIBC after BCG therapy who were unable or unwilling to undergo radical cystectomy.

The modified frailty index to predict morbidity and mortality for retroperitoneal sarcoma resections.

BACKGROUND: The modified frailty index (mFI) is an important method to risk-stratify surgical patients and has been validated for general surgery and selected surgical subspecialties. However, there are currently no data assessing the efficacy of the mFI to predict acute morbidity and mortality in patients undergoing surgery for retroperitoneal sarcoma. METHODS: Using the American College of Surgeons' National Surgical Quality Improvement Program from 2007 to 2012, we performed a retrospective analysis of patients with a diagnosis of primary malignant retroperitoneal neoplasm who underwent surgical resection. The mFI was calculated according to standard published methods. Univariate and multivariate statistical analyses including χ2 and logistic regression were used to identify predictors of 30-d overall morbidity, 30-d severe morbidity (Clavien III/IV), and 30-d mortality. RESULTS: We identified 846 patients with the diagnosis of primary malignant retroperitoneal neoplasm who underwent surgical resection. The distribution mFI scores was 0 (48.5%) or 1 (36.3%), with only 4.5% of patients presenting with a score ≥3. Rates of 30-d overall morbidity, serious morbidity, and mortality were 22.6%, 12.9%, and 1.2%, respectively. Only selected mFI scores were associated with serious morbidity and overall morbidity on multivariate analysis (P < 0.05), and mFI did not predict 30-d mortality (P > 0.05). CONCLUSIONS: Our data demonstrate that the majority of patients undergoing retroperitoneal sarcoma resections have few, if any, comorbidities. The mFI was a limited predictor of overall and serious complications and was not a significant predictor of mortality. Better discriminators of preoperative risk stratification may be needed for this patient population.