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Supplementary Figure 1 from Phase I Trial of Intraperitoneal Administration of an Oncolytic Measles Virus Strain Engineered to Express Carcinoembryonic Antigen for Recurrent Ovarian Cancer

Supplementary Figure 4 from Phase I Trial of Intraperitoneal Administration of an Oncolytic Measles Virus Strain Engineered to Express Carcinoembryonic Antigen for Recurrent Ovarian Cancer

Supplementary Figure 2 from Phase I Trial of Intraperitoneal Administration of an Oncolytic Measles Virus Strain Engineered to Express Carcinoembryonic Antigen for Recurrent Ovarian Cancer

Supplementary Figure Legends 1-5 from Phase I Trial of Intraperitoneal Administration of an Oncolytic Measles Virus Strain Engineered to Express Carcinoembryonic Antigen for Recurrent Ovarian Cancer

Supplementary Figure 5 from Phase I Trial of Intraperitoneal Administration of an Oncolytic Measles Virus Strain Engineered to Express Carcinoembryonic Antigen for Recurrent Ovarian Cancer

Supplementary Figure 3 from Phase I Trial of Intraperitoneal Administration of an Oncolytic Measles Virus Strain Engineered to Express Carcinoembryonic Antigen for Recurrent Ovarian Cancer

Supplementary Table 1 from Phase I Trial of Intraperitoneal Administration of an Oncolytic Measles Virus Strain Engineered to Express Carcinoembryonic Antigen for Recurrent Ovarian Cancer

Background We previously reported a new post–radical prostatectomy (RP) prediction model for men with normal baseline erectile function (EF) using 90-d postoperative erection fullness to identify men who might benefit from early EF rehabilitation. Objective To prospectively internally and externally validate the use of this risk assessment model in predicting 1- and 2-yr post-RP EF recovery. Design, setting, and participants We randomly assigned 297 patients with a preoperative International Index of Erectile Function 5 score of 22–25 undergoing robot-assisted RP by a single surgeon to a training set and internal validation set at a ratio of 2:1. A prospective external validation set included 91 patients treated by five high-volume surgeons. Outcome measurements and statistical analysis Potency was defined as erections sufficient for intercourse. To predict 1- and 2-yr potency recovery, logistic regression models were developed in the training set based on 90-d erection fullness of 0–24% or 25–100%. The resultant models were applied to the internal and external validation sets to calculate risk scores for 1- and 2-yr potency for each patient. Predictive validity was assessed using receiver operating characteristic (ROC) curves. Results and limitations Percentage erection fullness was an independent predictor of 1- and 2-yr potency recovery in all data sets. Internal validation confirmed strong reliability in predicting 2-yr potency outcomes (area under the ROC curve [AUC] 0.87) and external validation illustrated similar reliability in predicting 1-yr potency outcomes (AUC 0.80). In the external validation, the model predicted a mean 1-yr potency recovery rate of 39.7% (standard deviation 3.2%), compared to the actual rate of 36.26%. Limitations include the short follow-up for this cohort. Conclusions We present internal and external validation of a 90-d percentage erection fullness score, confirming that this metric is a robust predictor of post-RP EF recovery. Patient summary Percentage erection fullness at 3 mo after radical prostatectomy discriminates patients with a low or a high probability of recovery of erectile function (EF), which can facilitate identification of a need for early EF rehabilitation.

Increasing numbers of robotic hysterectomies (RH) are being performed. To provide ventilation (with pneumoperitoneum and steep Trendelenburg position) for these procedures, utilization of lung protective strategies with limiting airway pressures and tidal volumes is difficult. Little is known about the effects of intraoperative mechanical ventilation and high peak airway pressures on perioperative complications. We performed a retrospective review to determine whether patients undergoing RH had increased pulmonary complications compared to total abdominal hysterectomy (TAH).We performed a single center retrospective review comparing the intraoperative, anesthetic, and immediate and 30-day postoperative course of patients undergoing RH to TAH, including intraoperative ventilatory parameters and respiratory complications. Patients undergoing TAH (201) from 2004 to 2006 were compared to RH (251) from 2009 to 2012. It was our hypothesis that patients undergoing RH would have increased incidence of postoperative pulmonary complications. A secondary hypothesis was that morbid obesity predicts pulmonary complications in patients undergoing RH. Complications were compared between groups using Fisher's exact test. To account for potential confounders, the primary analysis was performed for a subgroup of patients matched on the propensity for RH.A total of 351 RH and 201 TAH procedures are included. Higher inspiratory pressures were required in ventilation of the RH group (median [25th, 75th] 31 [26, 36] cm H2O) than the TAH group (23 [19, 27] cm H2O) (P.001) at 30 minutes after incision. Peak inspiratory pressures at 30 minutes after incision for RH increased according to increasing body mass index group (P.001). There were 163 RH and 163 TAH procedures included in the propensity matched analysis. From this analysis, there were no significant differences in cardiopulmonary complications between RH and TAH (0.6% vs 1.2%; odds ratio = 2.0, 95% confidence interval = 0.2-2.4; P = 1.00). Surgical site infection was significantly lower in the RH compared to TAH group (0.6% vs 8.6%; P.001). Hospital length of stay was longer for those who underwent TAH versus RH (median [25th, 75th] 2 [2, 3] vs 1 [0, 2] days; P.001).There was no significant difference in perioperative complications in obese and morbidly obese women compared to nonobese undergoing RH. Patients undergoing RH had shorter hospital stays, fewer infectious complications, and no increase in overall complications compared to TAH. Higher ventilatory airway pressures (RH versus TAH and obese versus nonobese) did not result in an increase in cardiopulmonary or overall complications. We believe that peritoneal insufflation attenuates the effect of high airway pressures by raising intrapleural pressure and reducing the gradient across terminal bronchioles and alveoli. Thus, we propose that lung protective strategies for patients undergoing RH account for the markedly elevated intraperitoneal and intrapleural pressures, whereas transpulmonary airway pressures remain static. This reduced transpulmonary gradient attenuates the strain on lung tissue that would otherwise be imposed by ventilation at high pressures.

Objectives To determine if eliminating the prophylactic placement of a pelvic drain (PD) after robot-assisted radical prostatectomy (RARP) affects the incidence of early (90-day) postoperative adverse events. Materials and Methods In this parallel-group, blinded, non-inferiority trial, we randomized patients planning to undergo RARP to one of two arms: no drain placement (ND) or PD placement. Patients with demonstrable intra-operative leakage upon bladder irrigation were excluded. Randomization sequence was determined a-priori using a computer algorithm, and included a stratified design with respect to low vs. intermediate/high D'Amico risk classifications. Surgeons remained blinded to the randomization arm until final eligibility was verified at the end of the RARP. The primary endpoint was overall incidence of 90-day complications which, based on our standard treatment using PD retrospectively, was estimated at 13%. The non-inferiority margin was set at 10%, and the planned sample size was 312. An interim analysis was planned and conducted when 1/3 of the planned accrual and follow-up was completed, to rule out futility if the delta margin was in excess of 0.1389. Results From 2012 to 2016, 189 patients were accrued to the study, with 92 patients allocated to the ND group and 97 patients allocated to the PD group. Due to lower than expected accrual rates, accrual to the study was halted by regulatory entities, and we did not reach the intended accrual goal. ND and PD groups were comparable in median PSA (6.3 vs 5.8 respectively, p=0.5), clinical stage (p=0.8), D'Amico risk classification (p=0.4), median lymph nodes dissected (17 vs 18, p=0.2) and proportion of patients receiving an extended pelvic lymph node dissection (70.7% vs 79.4% respectively, p=0.3). Incidence of 90-day overall and major (Clavien ≥ III) complications in the ND group (17.4% and 5.4%, respectively) was not inferior to the PD group (26.8% and 5.2%, respectively; p=0.0008 and p=0.007 for difference of proportions

The present study seeks to present a single-blind, randomized control trial of a hypothermic anti-inflammatory device, the endorectal cooling balloon (ECB), to assess whether regional hypothermia could improve 90-day and time to pad-free continence following robot-assisted radical prostatectomy (RARP). Five high-volume surgeons at three institutions had patients randomized (1:1) to regional hypothermia with ECB versus control. Patients were blinded to device use, as it was inserted and removed intraoperatively. Knowledge of device use was restricted to the operating room personnel only; recovery room and ward nursing staff were not informed of device use and instructed to indicate such if a patient inquired. An independent and blinded data acquisition contractor assessed outcomes via components of the EPIC and IPSS. The primary outcome was categorical pad-free continence at 90-days and the secondary outcome was a Kaplan-Meier time-to pad-free continence at 90 days. 100 hypothermia and 99 control patients were included. The primary outcome of 90-day pad-free continence was 50.0% (27.8–70.0%) in the hypothermia group versus 59.2% (33.3–78.6%) in the control (p = 0.194). The secondary outcome of Kaplan Meier analysis for time to 90-day continence was not statistically significant. At one year, there were also no statistically significant differences in continence recovery. Post-hoc analysis revealed a trend towards improvement in continence in one of three sites. Overall, the trial demonstrated no benefit to regional hypothermia either in our primary or secondary outcomes. It is suggested that surgical technique and prevention of surgical trauma may be more advantageous to improving continence recovery.

To evaluate how the introduction of robotic-assisted surgery affects treatment-related morbidity and cost of endometrial cancer (EC) staging.We retrospectively reviewed the records of consecutive patients with stage I-III EC undergoing surgical staging between 2007 and 2012 at our institution. Costs (from surgery to 30days after surgery) were set based on the Medicare cost-to-charge ratio for each year and inflated to 2014 values. Inverse probability weighting (IPW) was used to decrease the allocation bias when comparing outcomes between surgical groups.We focused our analysis on the 251 EC patients who had robotic-assisted surgery and the 384 who had open staging. During the study period, the use of robotic-assisted surgery increased and open staging decreased (P0.001). Correcting group imbalances by using IPW methodology, we observed that patients undergoing robotic-assisted staging had a significantly lower postoperative complication rate, lower blood transfusion rate, longer median operating time, shorter median length of stay, and lower readmission rate than patients undergoing open staging (all P0.001). Overall 30-day costs were similar between the 2 groups, with robotic-assisted surgery having significantly higher median operating room costs ($2820 difference; P0.001) but lower median room and board costs ($2929 difference; P0.001) than open surgery. Increasing experience with robotic-assisted staging was significantly associated with a decrease in median operating time (P=0.002) and length of stay (P=0.003).The implementation of robotic-assisted surgery for EC staging improves patient outcomes. It provides women the benefits of minimally invasive surgery without increasing costs and potentially improves patient turnover.

To examine the occurrence and cost burden of hospital readmission within 90 days of robot-assisted radical cystectomy (RARC). Subjects/Patients (or Materials) and Methods: From 2003 to 2012, 247 patients underwent RARC with extracorporeal urinary reconstruction at a single categorical cancer hospital. Continent diversions were performed in 67% of patients. All readmissions within 90 days were included. Readmissions were defined as early (30 days) and late (31-90 days) with multiple readmissions captured as separate events. Cost analysis was performed using average direct hospital cost. The Fisher exact test was used to determine differences in proportion of readmissions between patient groups, while logistic regression was used to identify predictors for readmission.Ninety-eight (40%) patients were readmitted to the hospital at least once within 90 days after RARC, of which 77% occurred within 30 days. Twenty-seven (11%) required two or more readmissions. Readmissions took place at a median of 13 days after initial discharge. The most common reasons for initial readmission were infections (41%) and dehydration (19%). Stratified by urinary reconstruction type, ileal conduit (dehydration), Indiana pouch (urinary-tract infection without sepsis), and Studer neobladder (sepsis and pelvic abscess) differed by readmission reason. In a multivariable analysis, estimated blood loss was a predictor for readmission (p = 0.05). Patients readmitted to the hospital had direct costs that were 1.42× those who did not require readmission. Readmissions for ileus contributed to the highest cost of readmission, although ureteral stricture, pelvic abscess, and sepsis were the most costly per day of hospitalization. Limitations include retrospective analysis as well as variable thresholds for readmission and costs.Hospital readmission rates after RARC are high and costs of readmission are significant. Most patients are readmitted within 30 days and infection and dehydration are common causes. Clinicians should be aware of diversion-specific readmission causes.

Data from an experienced center that randomized patients to open vs robotic cystectomy for urothelial cancer demonstrated locational differences in recurrence. While the study was not powered to detect survival differences, overall, cancer-specific, and recurrence-free survival were similar.

CONTEXT: Although open radical cystectomy (ORC) is still the standard approach, laparoscopic radical cystectomy (LRC) and robot-assisted radical cystectomy (RARC) are increasingly performed. \ud \ud OBJECTIVE: To report on a systematic literature review and cumulative analysis of pathologic, oncologic, and functional outcomes of RARC in comparison with ORC and LRC. \ud \ud EVIDENCE ACQUISITION: Medline, Scopus, and Web of Science databases were searched using a free-text protocol including the terms robot-assisted radical cystectomy or da Vinci radical cystectomy or robot* radical cystectomy. RARC case series and studies comparing RARC with either ORC or LRC were collected. A cumulative analysis was conducted. \ud \ud EVIDENCE SYNTHESIS: The searches retrieved 105 papers, 87 of which reported on pathologic, oncologic, or functional outcomes. Most series were retrospective and had small case numbers, short follow-up, and potential patient selection bias. The lymph node yield during lymph node dissection was 19 (range: 3-55), with half of the series following an extended template (yield range: 11-55). The lymph node-positive rate was 22%. The performance of lymphadenectomy was correlated with surgeon and institutional volume. Cumulative analyses showed no significant difference in lymph node yield between RARC and ORC. Positive surgical margin (PSM) rates were 5.6% (1-1.5% in pT2 disease and 0-25% in pT3 and higher disease). PSM rates did not appear to decrease with sequential case numbers. Cumulative analyses showed no significant difference in rates of surgical margins between RARC and ORC or RARC and LRC. Neoadjuvant chemotherapy use ranged from 0% to 31%, with adjuvant chemotherapy used in 4-29% of patients. Only six series reported a mean follow-up of >36 mo. Three-year disease-free survival (DFS), cancer-specific survival (CSS), and overall survival (OS) rates were 67-76%, 68-83%, and 61-80%, respectively. The 5-yr DFS, CSS, and OS rates were 53-74%, 66-80%, and 39-66%, respectively. Similar to ORC, disease of higher pathologic stage or evidence of lymph node involvement was associated with worse survival. Very limited data were available with respect to functional outcomes. The 12-mo continence rates with continent diversion were 83-100% in men for daytime continence and 66-76% for nighttime continence. In one series, potency was recovered in 63% of patients who were evaluable at 12 mo. \ud \ud CONCLUSIONS: Oncologic and functional data from RARC remain immature, and longer-term prospective studies are needed. Cumulative analyses demonstrated that lymph node yields and PSM rates were similar between RARC and ORC. Conclusive long-term survival outcomes for RARC were limited, although oncologic outcomes up to 5 yr were similar to those reported for ORC. \ud \ud PATIENT SUMMARY: Although open radical cystectomy (RC) is still regarded as the standard treatment for muscle-invasive bladder cancer, laparoscopic and robot-assisted RCs are becoming more popular. Templates of lymph node dissection, lymph node yields, and positive surgical margin rates are acceptable with robot-assisted RC. Although definitive comparisons with open RC with respect to oncologic or functional outcomes are lacking, early results appear comparable.

Alvimopan has been shown to improve time to return of bowel function in patients undergoing bowel resection. The objective of this study is to determine if alvimopan has similar benefits for patients undergoing robot-assisted radical cystectomy (RARC).All RARC cases were reviewed from January 2008 to March 2012. All patients during this time were administered alvimopan unless they had been receiving narcotics preoperatively. Patients receiving alvimopan received a preoperative dose of 12 mg perorally and then were dosed twice daily for 7 days or until first bowel movement. Clinicopathologic outcomes were summarized and compared, and functional outcomes of treated patients were compared with outcomes of untreated patients.One hundred seventeen RARCs meeting study criteria were performed. All urinary diversions used an extracorporeal approach. Urinary diversions consisted of 50 Studer neobladders, 22 Indiana pouches, and 45 ileal conduits. Fifty-four patients received alvimopan, and 63 did not. The median time to first bowel movement was 5 days in the alvimopan group and 6 days in the untreated group (P=.03). Median time to solid diet was 6 days in the treated group and 7 days in the untreated group (P=.03). There was a trend toward fewer hospital days in the alvimopan group (alvimopan, 8 days; untreated, 9 days; P=.1).Alvimopan administration appears to reduce the time to return of bowel function and initiation of diet following RARC. This was a trend toward shorter hospitalization in the alvimopan group. Alvimopan should be considered in ongoing research into protocols to aid in shorter convalescence following RARC.

Objective To characterise the surgical feasibility and outcomes of robot-assisted radical cystectomy (RARC) for pathological T4 bladder cancer. Patients and Methods Retrospective evaluation of a prospectively maintained International Radical Cystectomy Consortium database was conducted for 1118 patients who underwent RARC between 2003 and 2012. We dichotomised patients based on pathological stage (≤pT3 vs pT4) and evaluated demographic, operative and pathological variables in relation to morbidity and mortality. Results In all, 1000 ≤pT3 and 118 pT4 patients were evaluated. The pT4 patients were older than the ≤pT3 patients (P = 0.001). The median operating time and blood loss were 386 min and 350 mL vs 396 min and 350 mL for p T4 and ≤pT3, respectively. The complication rate was similar (54% vs 58%; P = 0.64) among ≤pT3 and pT4 patients, respectively. The overall 30- and 90-day mortality rate was 0.4% and 1.8% vs 4.2% and 8.5% for ≤pT3 vs pT4 patients (P < 0.001), respectively. The body mass index (BMI), American Society of Anesthesiology score, length of hospital stay (LOS) >10 days, and 90-day readmission were significantly associated with complications in pT4 patients. Meanwhile, BMI, LOS >10 days, grade 3–5 complications, 90-day readmission, smoking, previous abdominal surgery and neoadjuvant chemotherapy were significantly associated with mortality in pT4 patients. On multivariate analysis, BMI was an independent predictor of complications in pT4 patients, but not for mortality. Conclusions RARC for pT4 bladder cancer is surgically feasible but entails significant morbidity and mortality. BMI was independent predictor of complications in pT4 patients.

Context The role of robot-assisted radical prostatectomy (RARP) for men with high-risk (HR) prostate cancer (PCa) has not been well studied. Objective To evaluate the indications for surgical treatment, technical aspects such as nerve sparing (NS) and lymph node dissection (LND), and perioperative outcomes of men with HR PCa treated with RARP. Evidence acquisition A systematic expert review of the literature was performed in October 2012, searching the Medline, Web of Science, and Scopus databases. Studies with a precise HR definition, robotic focus, and reporting of perioperative and pathologic outcomes were included. Evidence synthesis A total of 12 papers (1360 patients) evaluating RARP in HR PCa were retrieved. Most studies (67%) used the D'Amico classification for defining HR. Biopsy Gleason grade 8–10 was the most frequent HR identifier (61%). Length of follow-up ranged from 9.7 to 37.7 mo. Incidence of NS varied, although when performed did not appear to compromise oncologic outcomes. Extended LND (ELND) revealed positive nodes in up to a third of patients. The rate of symptomatic lymphocele after ELND was 3%. Overall mean operative time was 168min, estimated blood loss was 189ml, length of hospital stay was 3.2 d, and catheterization time was 7.8 d. The 12-mo continence rates using a no-pad definition ranged from 51% to 95% with potency recovery ranging from 52% to 60%. The rate of organ-confined disease was 35%, and the positive margin rate was 35%. Three-year biochemical recurrence–free survival ranged from 45% to 86%. Conclusions Although the use of RARP for HR PCa has been relatively limited, it appears safe and effective for select patients. Short-term results are similar to the literature on open radical prostatectomy. Variability exists for NS and the template of LND, although ELND improves staging and removes a higher number of metastatic nodes. Further study is required to assess long-term outcomes.

Objective To determine the peri-operative outcomes of men undergoing salvage robot-assisted prostatectomy (RARP) and to examine the complications, functional consequences and need for additional treatments after salvage RARP. Patients and Methods At total of 51 consecutive patients underwent salvage RARP after previous failed local therapy. Biochemical recurrence (BCR) was defined as two postoperative PSA measurements ≥0.2 ng/mL. Complications at any time postoperatively were recorded prospectively using a modified Clavien system. The Kaplan–Meier method was used for survival estimation, and regression models were used to identify the predictors of BCR or progression-free survival (PFS) and complications. Results The median age at salvage RARP was 68 years and a median of 68 months had elapsed from the time of primary treatment. The median follow-up was 36 months. The median operation duration was 179 min with a median estimated blood loss of 175 mL. In all, 50% of patients had pathological stage 3 disease and positive surgical margins were found in 31% of patients. The estimated 3-year BCR-free or PFS was 57%. The overall complication rate was 47%, with a 35% major complication rate (Grade III–V). Potency was maintained in 23% of preoperatively potent patients and 45% of all patients regained urinary control. No clinical variables were predictive of major complications, but all patients with postoperative bladder neck contracture were incontinent. A higher PSA level and extracapsular extension were significantly associated with BCR or progression (P < 0.01). Conclusions Salvage RARP provides oncological control with potential avoidance of systemic non-curative therapy. Complication, incontinence and erectile dysfunction rates are significant but frequently correctable. This reinforces the need for proper patient counselling and selection.

Early diagnosis of uterine hemangiomas may direct management decisions improving long-term outcome in children, adolescents and adulthood.

An emerging literature describes the potential for long-term survival with targeted agents, but the health-related quality of life (HR-QOL) in patients who receive chronic therapy with these agents is poorly defined.From an institutional database including 562 patients with renal cell carcinoma (RCC), patients were identified who (1) were alive 3 years beyond initiation of systemic therapy for metastatic renal cell carcinoma (mRCC) and (2) received a targeted therapy as a component of their treatment. European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 36 (QLQ-C30) and Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-15) questionnaires were administered by telephone survey. Data from questionnaires were compared with historical estimates derived from pivotal studies evaluating targeted agents.A total of 38 patients met eligibility criteria for the study, and 28 patients participated in the telephone survey. Most were male patients and had clear cell histologic type (75% for both). All patients had either good- or intermediate-risk disease by Heng criteria. The mean QLQ-C30 Global QOL score in the present cohort was higher than the mean score among patients evaluated at baseline in the phase III evaluations of pazopanib (73.5 vs. 65.8; P = .07) and everolimus (73.5 vs. 61.0; P = .007). The FKSI-15 score in the present cohort was similar to the mean score among patients evaluated at baseline in the phase III evaluation of sunitinib (45.1 and 46.5, respectively; P = .41).In this small pilot study, long-term survivors with mRCC who received targeted therapies appear to have an HR-QOL comparable to that of patients who participated in relevant phase III studies. Given the many emerging treatment options for mRCC, the HR-QOL of long-term survivors warrants greater attention.

What's known on the subject? and What does the study add? Lymph node dissection and it's extend during robot-assisted radical cystectomy varies based on surgeon related factors. This study reports outcomes of robot-assisted extended lymphadenectomy based on surgeon experience in both academic and private practice settings. Objective To evaluate the incidence of, and predictors for, extended lymph node dissection (LND) in patients undergoing robot-assisted radical cystectomy (RARC) for bladder cancer, as extendedLND is critical for the treatment of bladder cancer but the role of minimally invasive surgery for extended LND has not been well-defined in a multi-institutional setting. Patients and Methods Used the International Robotic Cystectomy Consortium (IRCC) database. In all, 765 patients who underwent RARC at 17 institutions from 2003 to 2010 were evaluated for receipt of extended LND. Patients were stratified by age, sex, clinical stage, institutional volume, sequential case number, and surgeon volume. Logistic regression analyses were used to correlate variables to the likelihood of undergoing extended LND. Results In all, 445 (58%) patients underwent extended LND. Among all patients, a median (range) of 18 (0–74) LNs were examined. High-volume institutions (≥100 cases) had a higher mean LN yield (23 vs 15, P < 0.001). On univariable analysis, surgeon volume, institutional volume, and sequential case number were associated with likelihood of undergoing extended LND. On multivariable analysis, surgeon volume [odds ratio (OR) 3.46, 95% confidence interval (CI) 2.37–5.06, P < 0.001] and institution volume [OR 2.65, 95% CI 1.47–4.78, P = 0.001) were associated with undergoing extended LND. Conclusions Robot-assisted LND can achieve similar LN yields to those of open LND after RC. High-volume surgeons are more likely to perform extended LND, reflecting a correlation between their growing experience and increased comfort with advanced vascular dissection.

Background Preclinical studies suggest that signal transducer and activator of transcription 3 (STAT3)-mediated recruitment of neutrophils to premetastatic tissue occurs prior to metastatic progression. Objective We sought to determine if neutrophilic infiltration in benign nodal tissue is associated with poor clinical outcome in patients with muscle-invasive bladder cancer. Design, setting, and participants Formalin-fixed, paraffin-embedded tissue was secured from 55 patients with muscle-invasive bladder cancer who had undergone cystectomy at our institution. Sections of benign lymph nodes were obtained and stained with primary antibodies against 3-fucosyl-N-acetyl-lactosamine, phosphorylated STAT3, and interleukin-17, the latter being a key mediator of neutrophil infiltration and STAT3 activation. Outcome measurements and statistical analysis The Kaplan–Meier method was used to interrogate differences in overall survival (OS) in patients with high versus low biomarker expression. Cohorts stratified by receipt and nonreceipt of neoadjuvant chemotherapy were separately explored. Results and limitations Of the 55 patients examined, 19 patients (35%) had no prior neoadjuvant chemotherapy. Amongst these patients, median OS was improved in patients with low 3-fucosyl-N-acetyl-lactosamine + cell counts (196 mo vs 37 mo; p =0.0062) and low phosphorylated STAT3 + cell counts (278 mo vs 106 mo; p =0.025). In the same cohort, a trend towards improved OS in patients with low interleukin-17 + cell count was observed (not reached vs 117 mo; p =0.18). No differences in OS were noted in biomarker-based subgroups amongst patients that had received prior neoadjuvant chemotherapy. Conclusions The results herein support the hypothesis that bladder cancer metastasis may be driven by STAT3-mediated neutrophilic infiltration in premetastatic sites. Validation of these findings using tissues derived from a phase 3 surgical trial (Southwest Oncology Group 1011) is currently underway. Patient summary Lymph node metastases occur in up to 25% of patients with muscle-invasive cancer and it represents one of the most frequent sites of bladder cancer metastasis. This report provides preliminary evidence that neutrophil levels in benign lymph nodes may predict clinical outcome.

The most reliable and definitive means of staging lymph node involvement in prostate cancer remains dissection and removal of the pelvic nodes. Recently, increased attention to extending the limits of obturator node dissection to include the external and internal iliac nodes has been suggested. Although consensus has not been reached regarding when and how to proceed, the current recommendation is that an extended pelvic lymph node dissection is preferred because it provides enhanced staging [1]. However, even with an extended dissection, landing zones for prostate cancer can still be missed.During the anterior dissection of a radical prostatectomy, a shroud of lymphofatty tissue overlying the prostate that extends from the inner surface of the pubic bone towards the bladder is routinely encountered. This tissue is often excised to improve visualization and clearly expose the operative field. Robot-assisted laparoscopic pelvic lymph node dissection has been shown to be feasible with lymph node yields comparable to those for open dissection [2]. In addition, the three-dimensional magnification of the Da Vinci surgical robotic system (Sunnyvale, CA, USA) allows simple dissection of this fat away from the anterior prostate, apex, endopelvic fascia and bladder neck.We commonly perform excision of this tissue with pathological analysis because others have described the occasional presence of lymph nodes [3,4]. We surmised that regional lymph node removal could provide better oncological staging and define patients at greater risk for disease recurrence. Over a 6-month period we prospectively examined

Edmonston vaccine strains of measles virus (MV) have shown significant antitumor activity in preclinical models of ovarian cancer. We engineered MV to express the marker peptide carcinoembryonic antigen (MV-CEA virus) to also permit real-time monitoring of viral gene expression in tumors in the clinical setting. Patients with Taxol and platinum-refractory recurrent ovarian cancer and normal CEA levels were eligible for this phase I trial. Twenty-one patients were treated with MV-CEA i.p. every 4 weeks for up to 6 cycles at seven different dose levels (103–109 TCID50). We observed no dose-limiting toxicity, treatment-induced immunosuppression, development of anti-CEA antibodies, increase in anti-MV antibody titers, or virus shedding in urine or saliva. Dose-dependent CEA elevation in peritoneal fluid and serum was observed. Immunohistochemical analysis of patient tumor specimens revealed overexpression of measles receptor CD46 in 13 of 15 patients. Best objective response was dose-dependent disease stabilization in 14 of 21 patients with a median duration of 92.5 days (range, 54–277 days). Five patients had significant decreases in CA-125 levels. Median survival of patients on study was 12.15 months (range, 1.3–38.4 months), comparing favorably to an expected median survival of 6 months in this patient population. Our findings indicate that i.p. administration of MV-CEA is well tolerated and results in dose-dependent biological activity in a cohort of heavily pretreated recurrent ovarian cancer patients. Cancer Res; 70(3); 875–82

After observing disparate rates of cytoreduction, we initiated efforts to improve outcomes through feedback and education, and we reassessed outcomes.Outcomes from group A (2006 and 2007, n=105) were compared with those from the cohort predating quality-improvement efforts (group B, 2000 to 2003, n=132). All stage IIIC ovarian cancer patients at our institution were evaluated for tumor dissemination, age, performance status, surgical complexity, residual disease (RD), morbidity, and mortality. A surgical complexity score previously described was used to categorize extent of operation.No significant differences in age, performance status, or extent of disease were observed between cohorts. Surgical complexity increased after initiation of quality improvement (mean surgical complexity score, 5.5 to 7.1; p0.001), rates of optimal RD (1 cm) improved from 77% to 85% (p=0.157), and rates of complete resection of all gross disease rose from 31% to 43% (p=0.188). In the subset of patients with carcinomatosis most likely to benefit from extended surgical resection, radical procedures were used more frequently (63% versus 79%; p=0.028), rates of optimal debulking (RD1 cm) increased (64% to 79%), and the rate of RD=0 increased from 6% to 24% (p=0.006). When disease was noted on the diaphragm, procedures to remove the disease were more frequently used (38% to 64%; p=0.001). The rates of major perioperative morbidity (group B, 21% versus group A, 20%; p=0.819) and 3-month mortality (8% versus 6%; p=0.475) were not affected despite this more aggressive surgical approach.Analysis of outcomes with appropriate feedback and education is a powerful tool for quality improvement. We observed improvements in rates of cytoreduction and use of specific radical procedures, with no increase in morbidity as a result of this process.

The assessment of prostate weight as a determinant of a high prostate margin rate after laparoscopic radical prostatectomy has not been studied.Prospective pathologic findings of 1,500 patients who underwent laparoscopic radical prostatectomy (LRP, 399 cases) and da Vinci prostatectomy (DVP, 1,101 cases) between December 2000 to June 2006 at City of Hope National Medical Center were evaluated. Gleason score, pathologic stage, the presence or absence of positive margins, extraprostatic tumor extension, and seminal vesicle involvement by tumor were recorded in all patients. Preoperational serum prostate specific antigen (PSA) levels were recorded in all but 13 cases. These parameters were then correlated with prostate weight.Of 1,500 patients, 345 had one or more positive margins (23%). Patients with low median prostate weight (49 g) had a significantly higher positive margin rate (p0.0001) and incidence of extraprostatic extension by tumor (p = 0.04), and were 1.523 times more likely to have positive margins [95% confidence interval (CI) 1.167-1.985].We conclude that low prostate weight may be a determinant of a higher recurrence rate and more aggressive disease.

Objective. To prospectively assess pelvic and para-aortic lymph node metastases in endometrial cancer with lymphatic dissemination, emphasizing the examination of para-aortic metastases relative to the inferior mesenteric artery (IMA). Methods. Over 36 months, 422 consecutive patients were managed by predefined surgical guidelines differentiating low-risk patients from patients at risk for dissemination requiring systematic lymphadenectomy. Low risk was defined as grade 1 or 2 endometrioid type with myometrial invasion (MI) ≤50% and primary tumor diameter (PTD) ≤2 cm. Pelvic and para-aortic lymph nodes were submitted separately, with nodes identified from all 8 pelvic and 4 para-aortic node-bearing basins. Surgical quality assessments examined median node counts (primary surrogate for quality) and nodes harvested above and below the IMA and excised gonadal veins (secondary surrogates). Results. Lymphadenectomy was not required in 27% of patients (all low risk) and in 33% (n=112) of endometrioid cases. However, 22 patients (20%) of this latter cohort had lymphadenectomy and all lymph nodes were negative. Sixty-three (22%) of 281 patients undergoing lymphadenectomy had lymph node metastases: both pelvic and para-aortic in 51%, only pelvic in 33%, and isolated to the para-aortic area in 16%. Therefore, 67% of patients with lymphatic dissemination had para-aortic lymph node metastases. Furthermore, 77% of patients with para-aortic node involvement had metastases above the IMA, whereas nodes in the ipsilateral para-aortic area below the IMA and ipsilateral common iliac basin were declared negative in 60% and 71%, respectively. Gonadal veins were excised in 25 patients with para-aortic node metastases; 7 patients (28%) had documented metastatic involvement of gonadal veins or surrounding soft tissue. Conclusions. The high rate of lymphatic metastasis above the IMA indicates the need for systematic pelvic and para-aortic lymphadenectomy (vs sampling) up to the renal vessels. The latter should include consideration of excision of the gonadal veins. Conversely, lymphadenectomy does not benefit patients with grade 1 and 2 endometrioid lesions with MI ≤50% and PTD ≤2 cm.

Objectives To explore the views of experts about the development and validation of a robotic surgery training curriculum, and how this should be implemented. Materials and methods An international expert panel was invited to a structured session for discussion. The study was of a mixed design, including qualitative and quantitative components based on focus group interviews during the European Association of Urology (EAU) Robotic Urology Section (ERUS) (2012), EAU (2013) and ERUS (2013) meetings. After introduction to the aims, principles and current status of the curriculum development, group responses were elicited. After content analysis of recorded interviews generated themes were discussed at the second meeting, where consensus was achieved on each theme. This discussion also underwent content analysis, and was used to draft a curriculum proposal. At the third meeting, a quantitative questionnaire about this curriculum was disseminated to attendees to assess the level of agreement with the key points. Results In all, 150 min (19 pages) of the focus group discussion was transcribed (21 316 words). Themes were agreed by two raters (median agreement kappa 0.89) and they included: need for a training curriculum (inter-rater agreement kappa 0.85); identification of learning needs (kappa 0.83); development of the curriculum contents (kappa 0.81); an overview of available curricula (kappa 0.79); settings for robotic surgery training ((kappa 0.89); assessment and training of trainers (kappa 0.92); requirements for certification and patient safety (kappa 0.83); and need for a universally standardised curriculum (kappa 0.78). A training curriculum was proposed based on the above discussions. Conclusion This group proposes a multi-step curriculum for robotic training. Studies are in process to validate the effectiveness of the curriculum and to assess transfer of skills to the operating room.

Stage IIIC epithelial ovarian cancer is generally associated with upper abdominal tumor implants of greater than 2 cm and carries a grave prognosis. A subset of patients is upstaged to Stage IIIC because of lymph node metastases, in which prognosis is not well defined. We undertook this study to describe the clinical behavior of occult Stage IIIC.All consecutive patients found to have Stage IIIC epithelial ovarian cancer during a 9-year period (1994-2002) were analyzed for surgical procedures, pathology, and disease-free (DFS) and overall survival (OS).Thirty-six patients were upstaged to Stage IIIC by virtue of positive nodes. Nine had small volume upper abdominal disease (IIIA/B before upstaging), 15 had disease limited to the pelvis and 12 had disease confined to the ovaries. 32/36 patients had no gross residual disease at the conclusion of surgery. The 5-year DFS and OS survivals were 52% and 76% respectively, for all patients. We observed no significant difference in outcomes between patients upstaged from IIIA/B versus I-II stage disease. The outcomes were superior to a control group of patients cytoreduced to either no gross RD or RD1 cm, who had large volume upper abdominal disease at beginning of surgery (p0.001).Patients upstaged to Stage IIIC epithelial ovarian cancer for node involvement have an excellent 5-year OS relative to all patients with Stage IIIC disease. These data demonstrate the necessity for stratifying patients classified as having Stage IIIC disease based solely on nodal disease when comparing outcomes. This information is particularly valuable when counseling patients regarding prognosis.

OBJECTIVE Residual disease after initial surgery for ovarian cancer is the strongest prognostic factor for survival. However, the extent of surgical resection required to achieve optimal cytoreduction is controversial. Our goal was to estimate the effect of aggressive surgical resection on ovarian cancer patient survival. METHODS A retrospective cohort study of consecutive patients with International Federation of Gynecology and Obstetrics stage IIIC ovarian cancer undergoing primary surgery was conducted between January 1, 1994, and December 31, 1998. The main outcome measures were residual disease after cytoreduction, frequency of radical surgical resection, and 5-year disease-specific survival. RESULTS The study comprised 194 patients, including 144 with carcinomatosis. The mean patient age and follow-up time were 64.4 and 3.5 years, respectively. After surgery, 131 (67.5%) of the 194 patients had less than 1 cm of residual disease (definition of optimal cytoreduction). Considering all patients, residual disease was the only independent predictor of survival; the need to perform radical procedures to achieve optimal cytoreduction was not associated with a decrease in survival. For the subgroup of patients with carcinomatosis, residual disease and the performance of radical surgical procedures were the only independent predictors. Disease-specific survival was markedly improved for patients with carcinomatosis operated on by surgeons who most frequently used radical procedures compared with those least likely to use radical procedures (44% versus 17%, P < .001). CONCLUSION Overall, residual disease was the only independent predictor of survival. Minimizing residual disease through aggressive surgical resection was beneficial, especially in patients with carcinomatosis. LEVEL OF EVIDENCE II-2.

CONTEXT: Although open radical cystectomy (ORC) is still the standard approach, laparoscopic radical cystectomy (LRC) and robot-assisted radical cystectomy (RARC) have gained popularity. \ud \ud OBJECTIVE: To report a systematic literature review and cumulative analysis of perioperative outcomes and complications of RARC in comparison with ORC and LRC. \ud \ud EVIDENCE ACQUISITION: Medline, Scopus, and Web of Science databases were searched using a free-text protocol including the terms robot-assisted radical cystectomy or da Vinci radical cystectomy or robot* radical cystectomy. RARC case series and studies comparing RARC with either ORC or LRC were collected. Cumulative analysis was conducted. \ud \ud EVIDENCE SYNTHESIS: The searches retrieved 105 papers. According to the different diversion type, overall mean operative time ranged from 360 to 420 min. Similarly, mean blood loss ranged from 260 to 480 ml. Mean in-hospital stay was about 9 d for all diversion types, with consistently high readmission rates. In series reporting on RARC with either extracorporeal or intracorporeal conduit diversion, overall 90-d complication rates were 59% (high-grade complication: 15%). In series reporting RARC with intracorporeal continent diversion, the overall 30-d complication rate was 45.7% (high-grade complication: 28%). Reported mortality rates were ≤3% for all diversion types. Comparing RARC and ORC, cumulative analyses demonstrated shorter operative time for ORC, whereas blood loss and in-hospital stay were better with RARC (all p values

The purpose of this study was to assess changes in menstrual pattern, quality of life, and patient satisfaction after thermal balloon ablation for abnormal uterine bleeding.One hundred forty-one women who underwent thermal balloon ablation in our institution initially had their charts reviewed for demographics, procedure data, clinical history, and follow-up. Thereafter, a telephone interview was conducted to assess postprocedural menstrual pattern, quality of life, and patient satisfaction. Data were compared with the use of appropriate tests for categoric or continuous variables and logistic regression.The median follow-up time was 18 months, and a telephone interview was obtained for 119 of 141 patients. A reduction in days per cycle (9.6 vs 3.1 days, P.0001) and in pads per day (12.8 vs 2.5 pads/d, P.0001) and an improvement in self-reported quality of life scores (2.8 vs 9.0, P.0001) were observed after thermal balloon ablation. Hysterectomy was required in 21 of 141 patients (15%). Assessment of the level of satisfaction showed that 96% of patients were satisfied or very satisfied with the procedure. No major complications or deaths were related to thermal balloon ablation.Thermal balloon ablation is a safe and efficient method to treat abnormal uterine bleeding. It reduces the menstrual flow, improves the quality of life, and remarkably fulfills expectations in selected patients.

The purpose of this study was to determine the survival rates and toxicity levels that are associated with multimodal therapy (including neoadjuvant methotrexate, vinblastine, doxorubicin, and cisplatin [MVAC]) in patients with stage IIB to IVB cervical cancer.We retrospectively reviewed the cases of 49 patients who were treated between 1989 and 1997 with neoadjuvant MVAC for advanced cervical cancer.The clinical response rate was 90% (27 partial responders, 17 complete responders). Grade 3 or greater toxicity was mostly limited to neutropenia; no deaths were attributed to MVAC. Combined therapy after MVAC included operation in 34 patients (69%) and radiation in 41 patients (84%). Twenty-one patients (43%) had2 cm residual tumor at histologic evaluation. Pelvic control was achieved in 86% of patients. Five-year disease-specific survival for patients with stage III disease was 60%.For patients with advanced cervical cancer, neoadjuvant MVAC had a high response rate (90%) and an acceptable toxicity level. Compared with historic control subjects, multimodal treatment may be associated with improved rates of pelvic control.

Background In this study, we aimed to determine the feasibility of identifying CTCs in patients with HRLPC, using a modified isolation procedure using the CellSearch (Veridex) platform, and to assess the expression of stem cell and epithelial-mesenchymal transition (EMT) markers on the CTCs. Patients and Methods Thirty-five patients with HRLPC who had chosen prostatectomy for definitive management were prospectively identified. After obtaining consent, four 30-mL blood draws were performed, 2 before surgery and 2 after surgery. The CTC-containing fraction was Ficoll-purified and transferred to a CellSave (Veridex) tube containing dilution buffer before standard enumeration using the CellSearch system. Loss of E-cadherin expression, a marker of EMT, and CD133, a putative prostate cancer stem cell marker, were characterized using the open channel of the CellSearch platform. CTC fragments were also enumerated. Results Using the modified methodology, CTCs were detectable in 49% of patients before surgery. Although no correlation between CTC count and biochemical recurrence (BR) was observed, the percentages of CD133 and E-cadherin–positive CTC fragments were associated with BR at 1 year. Conclusion Our results suggest that further research into the development of CTCs as prognostic biomarkers in HRLPC is warranted.

Background: Intracorporeal urinary diversion (ICUD) has the potential benefits of a smaller incision, reduced pain, decreased bowel exposure, and reduced risk of fluid imbalance. Objective: To compare the perioperative outcomes of patients undergoing extracorporeal urinary diversion (ECUD) and ICUD following robot-assisted radical cystectomy (RARC). Design, setting, and participants: We reviewed the database of the International Robotic Cystectomy Consortium (IRCC) (18 international centers), with 935 patients who had undergone RARC and pelvic lymph node dissection (PLND) between 2003 and 2011. Intervention: All patients within the IRCC underwent RARC and PLND as indicated. The urinary diversion was performed either intracorporeally or extracorporeally. Outcome measurements and statistical analysis: Demographic data, perioperative outcomes, and complications in patients undergoing ICUD or ECUD were compared. All patients had at least a 90-d follow-up. The Fisher exact test was used to summarize categorical variables and the Wilcoxon rank sum test or Kruskal-Wallis test for continuous variables. Results and limitations: Of 935 patients who had RARC and PLND, 167 patients underwent ICUD (ileal conduit: 106; neobladder: 61), and 768 patients had an ECUD (ileal conduit: 570; neobladder: 198). Postoperative complications data were available for 817 patients, with a minimum follow-up of 90 d. There was no difference in age, gender, body mass index, American Society of Anesthesiologists grade, or rate of prior abdominal surgery between the groups. The operative time was equivalent (414 min), with the median hospital stay being marginally longer for the ICUD group (9 d vs 8 d, p = 0.086). No difference in the reoperation rates at 30 d was noted between the groups. The 90-d complication rate was not significant between the two groups, but a trend favoring ICUD over ECUD was noted (41% vs 49%, p = 0.05). Gastrointestinal complications were significantly lower in the ICUD group (p

Radical cystectomy (RC) with extended pelvic lymph node dissection is the gold standard treatment for muscleinvasive bladder cancer (MIBC), yet large series have shown recurrence rates exceeding 40% during extended follow-up [1]. Recurrence of disease often occurs early, with average presentation 10–15 mo after RC and >80% occurring within the first 2 yr after RC [2]. Survival after local (LR) or distant recurrence (DR) remains poor despite local or systemic salvage therapy. Factors consistently acknowledged to be associated with recurrence are advanced pathologic stage, margin positivity, and lymph node involvement. Use of robot-assisted RC (RARC) has increased without definitive evidence of equivalency to open RC (ORC) from a cancer control standpoint. With RARC outcomes exceeding 5 yr now becoming available, further analysis of oncologic outcome is necessary. Effects of RARC such as insufflation, pneumoperitoneum, quality of resection, lymph node dissection, methods for lymph node extraction, and their effect on oncologic efficacy remain unproven. In this issue of European Urology, Nguyen et al [3] examine a singlesurgeon cohort of 383 patients who underwent ORC (n = 120) or RARC (n = 263) and specifically evaluate the recurrence of disease. LR rates and locations were similar between the two groups (18% RARC vs 23% ORC), and although DR rates were also similar (29% RARC vs 36% ORC), the patterns of recurrence differed. The authors noted a higher incidence of extrapelvic lymph node recurrence and peritoneal carcinomatosis after RARC. Of important note, no port-site metastases occurred in the RARC group. The authors should be commended for their meticulous data collection for this large contemporary RC cohort. Their detailed assessment of the incidence and location of disease recurrence provides insight into whether ORC or RARC affects recurrence patterns. Another arguable strength is the single-surgeon experience, which may reduce variability in surgical technique (such as node dissection template) and skill. Several aspects of this retrospective analysis need to be contemplated. Selection of patients for different treatments is a nuance of surgical medicine that can limit comparative analyses. In this study as well as in our experience, patients treated with ORC had worse pathologic disease status. In addition, neoadjuvant, adjuvant, and downsizing chemotherapy were grouped into a single category, and some recurrences were not confirmed histologically. While opinions differ on the boundaries of lymph node dissection (standard vs extended vs superextended [4]), the specific locations of extrapelvic (n = 14) lymph node involvement are relevant in this study, as the proximal limit of dissection was the common iliac nodes. At the City of Hope National Cancer Center we routinely perform dissection above the aortic bifurcation, as our experience shows that 10% of patients with positive lymph nodes have nodes positive at or above this level. With reported median follow-up for RARC not quite 2 yr, this still represents more of an analysis of ‘‘earlier’’ recurrence. The rates of recurrence reported may also be misleading, as the denominator will inherently be lower in the RARC group given that the calculation accounts for patients with follow-up of 2 yr, of which there were fewer in the robotic group. As the authors recognize, even assuming that recurrence patterns do differ, we cannot presume to attribute this to the technique alone. There is debate regarding the optimal monitoring regimens after cystectomy, as detection of recurrent disease

Purpose: To investigate the prognostic significance of ribonucleotide reductase small subunit M2 (RRM2) in low- and intermediate-risk prostate cancer (PCa). Materials and methods: A retrospective outcome study was conducted on 164 eligible PCa samples from the City of Hope (n ¼ 90) and the Taipei Medical University (n ¼ 74). The RRM2 protein levels were detected by immunohistochemistry. Biochemical recurrence was assessed using Kaplan-Meier and Cox proportional hazard analyses. Cell invasion assays, Ras/Raf, and matrix metallopeptidase 9 activities were determined to evaluate the role of RRM2 on invasiveness of PCa. Results: Expression of RRM2 was significantly increased in patients with higher Gleason score, who had advanced T stage, and who were margin/capsule positive (P o 0.05). Analysis revealed that the expression of RRM2 positively associated with biochemical recurrence of PCa in the City of Hope set (hazard ratio ¼ 5.26; 95% CI 1.50–24.71) and the Taipei Medical University set (hazard ratio ¼ 2.55; 95% CI 1.30–9.22). In stratification analysis, RRM2 was significantly correlated with poor outcome in patients with lower-risk PCa, including those with Gleason score 4 to 7, margin � , capsule � , and stage T1-T2. In patients with Gleason score 4 to 7, the risk of recurrence was proportional to RRM2 protein levels. The prognostic performance of RRM2 was superior to that of pathoclinical factors, including margin/ capsule status and T stage. An in vitro study demonstrated that RRM2 could promote tumor invasion activities in PCa cell lines. Suppression of RRM2 reduced the Ras/Raf and matrix metallopeptidase 9 activities. Conclusion: RRM2 plays a critical role in proliferation and invasion of PCa. Adding RRM2 as a biomarker in clinical assessments may increase model precision in predicting recurrence in patients with low-risk PCa. r 2014 Elsevier Inc. All rights reserved.

Active surveillance is a viable patient option for prostate cancer provided that a clinical determination of low risk and presumably organ confined disease can be made. To standardize risk stratification schemes the NCCN (National Comprehensive Cancer Network®) provides guidelines for the active surveillance option. We determined the effectiveness of expressed prostatic secretion biomarkers for detecting occult risk factors in NCCN active surveillance candidates.Expressed prostatic secretion specimens were obtained before robot-assisted radical prostatectomy. Secretion capacity biomarkers, including total RNA and expressed prostatic secretion specimen volume, were measured by standard techniques. RNA expression biomarkers, including TXNRD1 mRNA, prostate specific antigen mRNA, TMPRSS2:ERG fusion mRNA and PCA3 mRNA, were measured by quantitative reverse-transcription polymerase chain reaction.Of the 528 patients from whom expressed prostatic secretions were collected 216 were eligible for active surveillance under NCCN guidelines. Variable selection on logistic regression identified 2 models, including one featuring types III and VI TMPRSS2:ERG variants, and one featuring 2 secretion capacity biomarkers. Of the 2 high performing models the secretion capacity model was most effective for detecting cases in this group that were up-staged or up-staged plus upgraded. It decreased the risk of up-staging in patients with a negative test almost eightfold and decreased the risk of up-staging plus upgrading about fivefold while doubling the prevalence of up-staging in the positive test group.Noninvasive expressed prostatic secretion testing may improve patient acceptance of active surveillance by dramatically reducing the presence of occult risk factors among those eligible for active surveillance under NCCN guidelines.

Lymph nodes in the prostatic anterior fat pad rarely harbor metastatic disease. Therefore, the characteristics of patients with prostatic anterior fat pad lymph node metastasis are not well described in the literature. We identified the perioperative characteristics and assessed the clinical outcomes of patients with prostatic anterior fat pad lymph node metastasis.At 8 tertiary care centers a total of 4,261 patients underwent complete removal and pathological analysis of the prostatic anterior fat pad. We describe preoperative and pathological characteristics, and clinical management and outcomes in patients with metastatic disease to the prostatic anterior fat pad.Metastatic disease to the prostatic anterior fat pad lymph nodes was detected in 40 patients (0.94%), of whom 37 (92.5%) had intermediate or high risk features preoperatively. Most patients with prostatic anterior fat pad metastases underwent concomitant pelvic lymph node dissection, and adjuvant therapy with radiation, androgen ablation and/or chemotherapy. A total of 27 patients (67.5%) with prostatic anterior fat pad metastatic disease were up-staged as a result of prostatic anterior fat pad pathological analysis, of whom 14 (51.8%) remained free of biochemical recurrence with observation and/or definitive adjuvant/salvage therapy.Most patients with prostatic anterior fat pad metastatic disease had intermediate to high risk features preoperatively. In some patients with such lymph node metastasis removing these lymph nodes resulted in prolonged biochemical recurrence-free survival. Therefore, we recommend that the prostatic anterior fat pad be removed in all patients undergoing radical prostatectomy. However, pathological analysis of the prostatic anterior fat pad may be limited to patients with intermediate to high risk oncological features preoperatively.

Background: Complication reporting is highly variable and nonstandardized. Therefore, it is imperative to determine the surgical outcomes of major oncologic procedures. Objective: To describe the complications after robot-assisted radical cystectomy (RARC) using a standardized and validated reporting methodology. Design, setting, and participants: Using the International Robotic Cystectomy Consortium (IRCC) database, we identified 939 patients who underwent RARC, had available complication data, and had at least 90 d of follow-up. Outcome measurements and statistical analysis: Complications were analyzed and graded according to the Memorial Sloan-Kettering Cancer Center (MSKCC) system and were defined and stratified by organ system. Secondary outcomes included identification of preoperative and intraoperative variables predicting complications. Logistic regression models were used to define predictors of complications and readmission. Results and limitations: Forty-one percent (n = 387) and 48% (n = 448) of patients experienced a complication within 30 and 90 d of surgery, respectively. The highest grade of complication was grade 0 in 52%, grade 1-2 in 29%, and grade 3-5 in 19% patients. Gastrointestinal, infectious, and genitourinary complications were most common (27%, 23%, and 17%, respectively). On multivariable analysis, increasing age group, neoadjuvant chemotherapy, and receipt of blood transfusion were independent predictors of any and high-grade complications, respectively. Thirty and 90-d mortality was 1.3% and 4.2%, respectively. As a multi-institutional database, a disparity in patient selection, operating standards, postoperative management, and reporting of complications can be considered a major limitation of the study. Conclusions: Surgical morbidity after RARC is significant when reported using a standardized reporting methodology. The majority of complications are low grade. Strict reporting of complications is necessary to advocate for radical cystectomy (RC) and helps in patient counseling. (C) 2013 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Women with recurrent endometrial carcinoma are usually not considered candidates for pelvic exenteration. To assess the efficacy of this procedure, the records of all patients undergoing pelvic exenteration for adenocarcinoma of the endometrium at four institutions from 1955 through 1988 were reviewed. Of the 31 procedures performed, 7 were for primary therapy and 4 were judged to be palliative in nature and were excluded from analysis. Of the 20 patients with recurrent endometrial cancer who underwent exenteration with curative intent, all had previously received pelvic radiotherapy, 14 as part of their primary treatment and 6 as part of the treatment of recurrent disease. Six of 20 patients also received chemotherapy or hormonal therapy prior to exenteration. The median patient age was 65 years (range 44-79 years). At most recent follow-up, 8 patients were alive and disease free, 2 were alive with disease, 6 had died of disease, and 4 had died of other causes. The median follow-up of living patients is 89 months. Twelve of 20 patients experienced major complications, the most common of which was neovaginal flap necrosis. Of the 20 patients, 1 patient (5%) died in 1963 of surgical complications. The Kaplan-Meier estimate of 5-year disease-free survival is 45%. Pelvic exenteration can produce an acceptable rate of disease-free survival in highly selected patients with local recurrence of endometrial adenocarcinoma who have exhausted other treatment modalities.

OBJECTIVE: The aims of this study were to analyze the natural history of patients with pseudomyxoma peritonei (PMP), evaluate clinical and pathologic variables as prognostic indicators, and review the authors' experience with different treatments. SUMMARY BACKGROUND DATA: PMP is an unusual form of intra-abdominal neoplasm that presents with large amounts of extracellular mucin. Diffuse peritoneal spread occurs in most patients with PMP, and distant metastasis is infrequent. Debulking surgery, radiation therapy (radioisotope and external beam), and chemotherapy (both intraperitoneal and systemic) have all been advocated for optional patient management, but the variability of patients studied, the small patient numbers, and the prolonged course of this disease make the evaluation of results difficult. METHODS: Fifty-six patients were treated for PMP at the Mayo Clinic between 1957 and 1983. The data were collected retrospectively. Univariate (log-rank test) and multivariate (Cox regression model) analyses were performed for disease recurrence and patient survival. RESULTS: Most patients with PMP had carcinomas of the appendix (52%) or ovary (34%). All gross tumor could be removed only in the 34% of patients with limited disease. Although tumor progression occurred in 76% of patients, the 1-, 5-, and 10-year survival rates were 98%, 53%, and 32%, respectively. Adverse predictors of patient survival included weight loss (p = 0.001), abdominal distention (p = 0.004), use of systemic chemotherapy (p = 0.005), diffuse disease (p = 0.038), and invasion of other organs (p = 0.04). Intraperitoneal chemotherapy (p = 0.009) and radioisotopes (p = 0.0043) both were effective in prolonging the recurrence time of symptomatic PMP. CONCLUSIONS: Although PMP is an indolent disease, aggressive surgical debulking followed by intraperitoneal radioisotopes and/or chemotherapy should be considered because of the diffuse peritoneal involvement.

Purpose of review Over the last decade there has been a changing trend in technique for radical prostatectomy from open surgery to minimally invasive robotic-assisted laparoscopic technology. This review evaluates the validity of this change by reviewing the current literature and comparing open radical retropubic prostatectomy to robotic-assisted radical prostatectomy. Recent findings Robotic-assisted radical prostatectomy shows equivalent and possibly better results when compared with radical retropubic prostatectomy with respect to intraoperative and postoperative parameters including continence, potency and quality of life. Time is still needed to determine long-term oncologic results, but initial findings are promising. Summary This review supports the current trend in shifting the standard of care for radical prostatectomy from an open to a robotic-assisted laparoscopic approach.

Nineteen patients with recurrent and two patients with locally advanced gynecologic malignancies received intraoperative radiation therapy (IORT) with electrons at the Mayo Clinic. Fourteen of the patients also received external beam irradiation. Actuarial local control with or without central control at 5 years was 71%, and actuarial control within the IORT field (central control) was 80%. The distant metastases rate at 5 years was 47%. Actuarial 2- and 5-year overall survival was 58 and 33%, respectively, and disease-free survival was 47 and 40%, respectively. Patients with microscopic disease had significantly higher 5-year disease-free and overall survival (70 and 67%, respectively). In summary, IORT in combination with maximum debulking surgery with or without external beam therapy in patients with paraaortic or pelvic sidewall recurrences of gynecologic malignancies appeared to improve long-term local control and survival. The addition of hyperthermia or hypoxic sensitizers may be a consideration to further improve local control in patients with gross residual disease. The high incidence of distant metastasis warrants the search for effective systemic chemotherapy. IORT-related toxicity was acceptable.

Facet interventions continue to be used in pain management. Computed tomographic (CT) images can be registered into a virtual world that includes images generated by an ultrasound (US) probe tracked in real time, permitting guidance of tracked needles. We acquired CT-generated 3-dimensional (3D) images of 2 models and a cadaver. Three-dimensional representations of a US probe and needle were generated. A magnetic system tracked the needle and US probe. Using the US, 3D CT images were registered to the model/cadaver. Images were fused on a single interface. Facet injections were performed in the models and cadaver with radio-opaque markers. A postprocedure CT image determined appropriate placement. The virtual reality system described demonstrates technical innovations that may lead to future advancements in the area of percutaneous interventions in the management of pain.

BACKGROUND: Recurrent ovarian torsion in a premenarchal adolescent girl is a rare event. Several methods of prevention using surgical plication have been proposed, which require varying degrees of technical expertise and can result in altered reproductive anatomy. CASE: A premenarchal adolescent girl presented with a history of salpingo-oophorectomy for torsion and recurrence treated by detorsion. She was evaluated for preventive strategies and underwent a laparoscopic oophoropexy, performed using transvaginal ultrasound guidance, to facilitate access should oocyte retrieval be indicated for future fertility. CONCLUSION: Recurrent ovarian torsion is an uncommon event, but given the possibility of permanent sterility, oophoropexy should be discussed. As assisted reproductive technology procedures become more common, oophoropexy designed to aid ovarian access should be considered before surgical intervention.

Introduction The rationale for lymphadenectomy in primary peritoneal cancer (PPC) is unclear. We sought to define the pattern of lymphatic metastasis in PPC and propose evidence-based rationale for lymphadenectomy in relevant cases. Methods Patients with PPC undergoing primary surgery at Mayo Clinic were identified. Demographics, tumor characteristics, procedures performed and follow up were analyzed. Results Forty eight patients with PPC were identified; 39 had stage IIIC (81.2%) and 9 (18.8%) had stage IV. Residual disease (RD) after primary surgery was microscopic in 6 cases (12.5%), less than 1 cm in 33 (68.8%), more than 1 cm in 9 patient (18.7%) with median survivals of 5.8, 3.2 and 1.3 years, respectively. Overall, 24 patients had lymphadenectomy performed (pelvic (PND) or paraortic (PAND) or both). Pelvic nodes were involved in 12/23 (52.7%) cases, while para-aortic nodes were involved in 5/21 (23.8%) of cases. The rate of simultaneously positive pelvic and para-aortic nodes was 20% (4/20). Nodal involvement was a poor prognostic factor with 5 year overall survival 63% vs. 25% (p = 0.014) in node positive vs. negative cases. Compared to patients with primary ovarian cancer (OC), OC cases had a higher rate of positive para-aortic nodes (57.6%: 77/132; p = 0.004). Conclusions Retroperitoneal lymph nodes are a common site of metastases in PPC, therefore it is logically consistent to perform PND and PAND if a patient can be cytoreduced to microscopic RD in other sites or remove grossly positive nodes in patients with RD