The indication for laparoscopic tumor nephrectomy for small renal masses (< 7 cm, category T1) is similar to open surgery and mainly includes centrally localized tumors in which an organ-preserving concept is technically not possible. Renal masses between 7 and 10 cm can be treated with the laparoscopic approach, but the size of the renal mass often limits access to the renal hilum and the intraoperative handling of the organ. Therefore, indication should be strict and the surgeon should be well experienced with laparoscopic procedures. Renal masses larger than 10 cm or tumors with preoperatively diagnosed renal or caval vein involvement should not be treated by laparoscopy. Here, experienced centers are currently investigating the feasibility of the laparoscopic approach. It is important to identify the layer between mesocolon and kidney by pulling the colon median with a grasper.

Background/Aims/Objectives: To evaluate the influence of body mass index (BMI) on complications and oncological outcomes in patients undergoing radical cystectomy (RC). Methods: Clinical and histopathological parameters of patients have been prospectively collected within the “PROspective MulticEnTer RadIcal Cystectomy Series 2011”. BMI was categorized as normal weight (<25 kg/m2), overweight (≥25–29.9 kg/m2) and obesity (≥30 kg/m2). The association between BMI and clinical and histopathological endpoints was examined. Ordinal logistic regression models were applied to assess the influence of BMI on complication rate and survival. Results: Data of 671 patients were eligible for final analysis. Of these patients, 26% (n = 175) showed obesity. No significant association of obesity on tumour stage, grade, lymph node metastasis, blood loss, type of urinary diversion and 90-day mortality rate was found. According to the ­American Society of Anesthesiologists score, local lymph node (NT) stage and operative case load patients with higher BMI had significantly higher probabilities of severe complications 30 days after RC (p = 0.037). The overall survival rate of obese patients was superior to normal weight patients (p = 0.019). Conclusions: There is no evidence of correlation between obesity and worse oncological outcomes after RC. While obesity should not be a parameter to exclude patients from cystectomy, surgical settings need to be aware of higher short-term complication risks and obese patients should be counselled ­accordingly.

Introduction: The aim of the present study was to compare long-term donor outcomes after open and laparoscopic living donor nephrectomy. The focus was on pregnancy rates, hypertension and quality of life parameters. Materials and Methods: Data were retrospectively collected using our institution's electronic database and a structured questionnaire. The study included 30 donors after open donor nephrectomy (ODN) and 131 donors after laparoscopic donor nephrectomy (LDN). Results: Demographic data did not differ between groups. When asked for their preference, significantly more donors in the LDN group would choose the same surgical approach again. The overall frequency of postoperative complications was significantly lower in the LDN group. The incidence of grade III complications was 2% after LDN and 10% after ODN (p = 0.79). Only 2 out of 15 female donors aged between 18 and 45 years delivered a healthy child after DN. On interview, only 4 out of 15 female donors declared the desire to have children after DN. Conclusions: From the donor perspective, long-term outcomes after LDN are more favorable than after ODN. To ensure favorable functional outcomes, strict preoperative donor selection and diligent long-term donor follow-up are required.

PURPOSE:To evaluate the prognostic relevance of different prostatic invasion patterns in pT4a urothelial carcinoma of the bladder (UCB) after radical cystectomy. MATERIALS AND METHODS:Our study comprised a total of 358 men with pT4a UCB. Patients were divided in 2 groups-group A with stromal infiltration of the prostate via the prostatic urethra with additional muscle-invasive UCB (n = 121, 33.8%) and group B with continuous infiltration of the prostate through the entire bladder wall (n = 237, 66.2%). The effect of age, tumor grade, carcinoma in situ, lymphovascular invasion, soft tissue surgical margin, lymph node metastases, administration of adjuvant chemotherapy, and prostatic invasion patterns on cancer-specific mortality (CSM) was evaluated using competing-risk regression analysis. Decision curve analysis was used to evaluate the net benefit of including the variable invasion pattern within our model. RESULTS:The estimated 5-year CSM-rates for group A and B were 50.1% and 66.0%, respectively. In multivariable competing-risk analysis, lymph node metastases (hazard ratio [HR] = 1.73, P<0.001), lymphovascular invasion (HR = 1.62, P = 0.0023), soft tissue surgical margin (HR = 1.49, P = 0.026), absence of adjuvant chemotherapy (HR = 2.11, P<0.001), and tumor infiltration of the prostate by continuous infiltration of the entire bladder wall (HR = 1.37, P = 0.044) were significantly associated with a higher risk for CSM. Decision curve analysis showed a net benefit of our model including the variable invasion pattern. CONCLUSIONS:Continuous infiltration of the prostate through the entire bladder wall showed an adverse effect on CSM. Besides including these patients into clinical trials for an adjuvant therapy, we recommend including prostatic invasion patterns in predictive models in pT4a UCB in men.

Neoadjuvant chemotherapy before radical cystectomy is recommended in patients with bladder cancer in clinical stages T2-T4a, cN0M0. We analyzed the frequency and current practice of neoadjuvant chemotherapy in 679 patients using uni- and multivariable regression analyses and using a questionnaire. We found a great discrepancy between guideline recommendations and practice patterns, despite medical indication and interdisciplinary tumor board discussion.Introduction: Guidelines recommend neoadjuvant chemotherapy (NAC) before radical cystectomy (RC) in patients with urothelial carcinoma of the bladder in clinical stages T2-T4a, cN0M0. We examined the frequency and current practice of NAC and sought to identify predictors for the use of NAC in a prospective contemporary cohort. Materials and Methods: We analyzed prospective data from 679 patients in the PROMETRICS (PROspective MulticEnTer Radical Cystectomy Series 2011) database. All patients underwent RC in 2011. Uni- and multivariable regression analyses identified predictors of NAC application. Furthermore, a questionnaire was used to evaluate the practice patterns of NAC at the PROMETRICS centers. Results: A total of 235 patients (35%) were included in the analysis. Only 15 patients (2.2%) received NAC before RC. Younger age (< 70 years; P = .035), lower case volume of the center (< 30 RC/year; P < .001), and advanced tumor stage (>= cT3; P = .038) were identified as predictors for NAC. Of the 200 urologists who replied to the questionnaire, 69% (n = 125) declared tumor stage cT3-4 a/o N1M0 to be the best indication for NAC application, although 45% of the urologists stated that they would not perform NAC despite recommendations. The decision for NAC was made by the individual urologist in 69% of cases, and only 29% reported that all cases were discussed in an interdisciplinary tumor board. Conclusion: NAC was rarely applied in the present cohort. We observed a discrepancy between guideline recommendations and practice patterns, despite medical indication and pre-therapeutic interdisciplinary discussion. The potential benefit of NAC within a multimodal approach seems to be neglected by many urologists. (C) 2016 Elsevier Inc. All rights reserved.

Objective To externally validate the pT4a‐specific risk model for cancer‐specific survival (CSS) proposed by May et al. (Urol Oncol 2013; 31: 1141–1147) and to develop a new pT4a‐specific nomogram predicting CSS in an international multicentre cohort of patients undergoing radical cystectomy (RC) for urothelial carcinoma of the bladder (UCB) Patients and Methods Data from 856 patients with pT4a UCB treated with RC at 21 centres in Europe and North‐America were assessed. The risk model proposed by May et al., which includes female gender, presence of positive lymphovascular invasion (LVI) and lack of adjuvant chemotherapy administration as adverse predictors for CSS, was applied to our cohort. For the purpose of external validation, model discrimination was measured using the receiver‐operating characteristic‐derived area under the curve. A nomogram for predicting CSS in pT4a UCB after RC was developed after internal validation based on multivariable Cox proportional hazards regression analysis evaluating the impact of clinicopathological variables on CSS. Decision‐curve analyses were applied to determine the net benefit derived from the two models. Results The estimated 5‐year‐CSS after RC was 34% in our cohort. The risk model devised by May et al. predicted individual 5‐year‐CSS with an accuracy of 60.1%. In multivariable Cox proportional hazards regression analysis, female gender (hazard ratio [HR] 1.45), LVI (HR 1.37), lymph node metastases (HR 2.54), positive soft tissue surgical margins (HR 1.39), neoadjuvant (HR 2.24) and lack of adjuvant chemotherapy (HR 1.67, all P < 0.05) were independent predictors of an adverse CSS rate and formed the features of our nomogram with a predictive accuracy of 67.1%. Decision‐curve analyses showed higher net benefits for the use of the newly developed nomogram in our cohort over all thresholds. Conclusions The risk model devised by May et al. was validated with moderate discrimination and was outperformed by our newly developed pT4a‐specific nomogram in the present study population. Our nomogram might be particularly suitable for postoperative patient counselling in the heterogeneous cohort of patients with pT4a UCB.

PURPOSE:The aim of this study was to examine preoperative patients' characteristics associated with the urinary diversion (UD) type (continent vs. incontinent) after radical cystectomy (RC) and UD-associated postoperative complications.MATERIALS:In 2011, 679 bladder cancer patients underwent RC at 18 European tertiary care centers. Data were prospectively collected within the 'PROspective MulticEnTer RadIcal Cystectomy Series 2011' (PROMETRICS 2011). Logistic regression models assessed the impact of preoperative characteristics on UD type and evaluated diversion-related complication rates.RESULTS:Of 570 eligible patients, 28.8, 2.6, 59.3, and 9.3% received orthotopic neobladders, continent cutaneous pouches, ileal conduits, and ureterocutaneostomies, respectively. In multivariable analyses, female sex (odds ratio [OR] 3.9; p = 0.002), American Society of Anesthesiologists score ≥3 (OR 2.3; p = 0.02), an age-adjusted Charlson Comorbidity Index ≥3 (OR 4.1; p < 0.001), and a positive biopsy of the prostatic urethra in the last transurethral resection of the bladder prior to RC (OR 4.9; p = 0.03) were independently associated with incontinent UD. There were no significant differences in 30- and/or 90-day complication rates between the UD types. Perioperative transfusion rates and 90-day mortality were significantly associated with incontinent UD (p < 0.001, respectively). Limitations included the small sample size and a certain level of heterogeneity in the application of clinical pathways between the different participating centers.CONCLUSIONS:Within this prospective contemporary cohort of European RC patients treated at tertiary care centers, the majority of patients received an incontinent UD. Female sex and pre-existing comorbidities were associated with receiving an incontinent UD. The risk of overall complications did not vary according to UD type.

To evaluate for the first time the prognostic significance of female invasive patterns in stage pT4a urothelial carcinoma of the bladder in a large series of women undergoing anterior pelvic exenteration.

INTRODUCTION:We aimed at developing and validating a pre-cystectomy nomogram for the prediction of locally advanced urothelial carcinoma of the bladder (UCB) using clinicopathological parameters.MATERIALS AND METHODS:Multicenter data from 337 patients who underwent radical cystectomy (RC) for UCB were prospectively collected and eligible for final analysis. Univariate and multivariate logistic regression models were applied to identify significant predictors of locally advanced tumor stage (pT3/4 and/or pN+) at RC. Internal validation was performed by bootstrapping. The decision curve analysis (DCA) was done to evaluate the clinical value.RESULTS:The distribution of tumor stages pT3/4, pN+ and pT3/4 and/or pN+ at RC was 44.2, 27.6 and 50.4%, respectively. Age (odds ratio (OR) 0.980; p < 0.001), advanced clinical tumor stage (cT3 vs. cTa, cTis, cT1; OR 3.367; p < 0.001), presence of hydronephrosis (OR 1.844; p = 0.043) and advanced tumor stage T3 and/or N+ at CT imaging (OR 4.378; p < 0.001) were independent predictors for pT3/4 and/or pN+ tumor stage. The predictive accuracy of our nomogram for pT3/4 and/or pN+ at RC was 77.5%. DCA for predicting pT3/4 and/or pN+ at RC showed a clinical net benefit across all probability thresholds.CONCLUSION:We developed a nomogram for the prediction of locally advanced tumor stage pT3/4 and/or pN+ before RC using established clinicopathological parameters.

You have accessJournal of UrologyBladder Cancer: Invasive II1 Apr 2015MP58-16 PREDICTION OF CANCER-SPECIFIC SURVIVAL IN PATIENTS WITH RADICAL CYSTECTOMY FOR BLADDER CANCER USING ARTIFICIAL NEURAL NETWORKS Philipp Nuhn, Atiqullah Aziz, Matthias May, Michael Staehler, Michael Gierth, Jörg Ellinger, Stefan C. Müller, Florian Wagenlehner, Wolfgang Weidner, Rudolf Moritz, Edwin Herrmann, Florian Hartmann, Marc-Oliver Grimm, Chris Protzel, Oliver Hakenberg, Lukas Lusuardi, Günter Janetschek, Murat Gördük, Jan Roigas, Maximilian Burger, Margit Fisch, Christian G. Stief, Patrick Bastian, Tobias Grimm, and Alexander Buchner Philipp NuhnPhilipp Nuhn More articles by this author , Atiqullah AzizAtiqullah Aziz More articles by this author , Matthias MayMatthias May More articles by this author , Michael StaehlerMichael Staehler More articles by this author , Michael GierthMichael Gierth More articles by this author , Jörg EllingerJörg Ellinger More articles by this author , Stefan C. MüllerStefan C. Müller More articles by this author , Florian WagenlehnerFlorian Wagenlehner More articles by this author , Wolfgang WeidnerWolfgang Weidner More articles by this author , Rudolf MoritzRudolf Moritz More articles by this author , Edwin HerrmannEdwin Herrmann More articles by this author , Florian HartmannFlorian Hartmann More articles by this author , Marc-Oliver GrimmMarc-Oliver Grimm More articles by this author , Chris ProtzelChris Protzel More articles by this author , Oliver HakenbergOliver Hakenberg More articles by this author , Lukas LusuardiLukas Lusuardi More articles by this author , Günter JanetschekGünter Janetschek More articles by this author , Murat GördükMurat Gördük More articles by this author , Jan RoigasJan Roigas More articles by this author , Maximilian BurgerMaximilian Burger More articles by this author , Margit FischMargit Fisch More articles by this author , Christian G. StiefChristian G. Stief More articles by this author , Patrick BastianPatrick Bastian More articles by this author , Tobias GrimmTobias Grimm More articles by this author , and Alexander BuchnerAlexander Buchner More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.02.2155AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES The outcome of patients after radical cystectomy (RC) shows substantial variability, and there is still an ongoing search for prognostic parameters. Artificial neural networks (ANN) can be trained to learn and recognize complex patterns of input data. In recent years, ANN have been increasingly used in medical studies, e.g. for the identification of certain patient subgroups. In this study, we utilized ANN for risk stratification of patients after RC. METHODS The Prospective Multicenter Radical Cystectomy Series 2011 (PROMETRICS 2011) database with 679 consecutive RC patients from 18 European centers was used for this study. The median follow-up time was 21 months, maximum 41 months. Age, body mass index, pack years of smoking, ASA score, TNMG classification, status of the surgical margin, lymphovascular invasion, presence of carcinoma in situ, focality and size of the tumor were used as input data for the ANN (StatSoft, Tulsa, OK, USA). At the time of analysis, 433 complete datasets with all of these data were available. Seventy percent of the cases were selected randomly and used for the training process, and the remaining cases served as two independent validation data sets. Target variable was cancer-specific survival after two years. ANN performance was judged by accuracy and ROC analysis, and the ANN results were compared with regression models. RESULTS Cancer-specific death occurred in 25% (109/433) of the patients within two years after RC. After network training had been completed, the ANN correctly assigned the survival status to 82% of patients in the training data set and to 81% and 83% in the two validation data sets, respectively. In ROC analysis, the area under curve (AUC) was 0.825 for the whole study cohort. A logistic regression model was built with the same variables that were used for the neural network. The predictive accuracy of the regression model was 78%. CONCLUSIONS The survival status two years after RC was accurately predicted by ANN, based on clinical and histopathological routine parameters; ANN outperformed the corresponding regression model. Neural networks are a promising approach for risk stratification after RC and may help to optimize the therapeutic strategy. © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 193Issue 4SApril 2015Page: e727 Peer Review Report Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.MetricsAuthor Information Philipp Nuhn More articles by this author Atiqullah Aziz More articles by this author Matthias May More articles by this author Michael Staehler More articles by this author Michael Gierth More articles by this author Jörg Ellinger More articles by this author Stefan C. Müller More articles by this author Florian Wagenlehner More articles by this author Wolfgang Weidner More articles by this author Rudolf Moritz More articles by this author Edwin Herrmann More articles by this author Florian Hartmann More articles by this author Marc-Oliver Grimm More articles by this author Chris Protzel More articles by this author Oliver Hakenberg More articles by this author Lukas Lusuardi More articles by this author Günter Janetschek More articles by this author Murat Gördük More articles by this author Jan Roigas More articles by this author Maximilian Burger More articles by this author Margit Fisch More articles by this author Christian G. Stief More articles by this author Patrick Bastian More articles by this author Tobias Grimm More articles by this author Alexander Buchner More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

To evaluate the prognostic value of concomitant seminal vesicle invasion (cSVI) in patients with urothelial carcinoma of the bladder (UCB) and contiguous prostatic stromal infiltration in a large cystectomy series.

Of 521 patients with clinical muscle-invasive bladder cancer (MIBC), 77% had primary MIBC and 23% had secondary MIBC. Patients with secondary MIBC were stratified into risk groups according to the results of first and last transurethral resection of bladder tumor (TURBT) in non-MIBC using the European Organisation for Research and Treatment of Cancer (EORTC) progression score. Patients with secondary MIBC and the highest risk of tumor stage progression at time of first and last TURBT in non-MIBC showed a significantly higher cancer-specific mortality (CSM) after radical cystectomy (RC) compared with patients with low to intermediate risk and patients with primary MIBC.Background: The aim of this study was to develop a risk stratification of patients with muscle-invasive bladder cancer (MIBC) after radical cystectomy (RC). For this purpose, we compared the cancer-specific mortality (CSM) of patients with primary MIBC and patients with secondary MIBC in different risk groups according to the European Organisation for Research and Treatment of Cancer (EORTC) progression score. Patients and Methods: The records of 521 consecutive patients treated with RC for clinical MIBC according to transurethral resection of bladder cancer (TURBT) diagnosis were reviewed. Of the 521 patients, 399 (76.6%) had primary MIBC (study group 1 [SG1]) and 122 (23.4%) had secondary MIBC (study group 2 [SG2]). Patients in SG2 were stratified into risk groups according to the results of the first and last TURBT in non-MIBC using the EORTC progression score. Results: CSM for patients with primary and secondary MIBC did not differ significantly. Patients in SG2 with the highest risk for tumor stage progression at time of the first and last TURBT in non-MIBC showed a significantly higher CSM after RC compared with patients with low-to-intermediate risk and compared with patients in SG1. In multivariable analyses, stage pT 3/4 (hazard ratio [HR], 2.12; P < .001), lymphovascular invasion (LVI) (HR, 3.47; P < .001), female sex (HR, 1.35; P = .048), and time from diagnosis of MIBC to RC > 90 days (HR, 2.07; P < .001) were significantly associated with higher CSM. Conclusion: Risk stratification by the EORTC progression score can help to identify those patients with the highest risk of CSM after progression to MIBC and thus enable us to offer these patients a multimodal treatment. Our results need to be verified in large prospective studies. (C) 2014 Elsevier Inc. All rights reserved.

Objective To evaluate the efficacy and safety of gemcitabine and cisplatin in combination with sorafenib, a tyrosine‐kinase inhibitor, compared with chemotherapy alone as first‐line treatment in advanced urothelial cancer. Patients and Methods The study was a randomized phase II trial. Its primary aim was to show an improvement in progression‐free survival (PFS) of 4.5 months by adding sorafenib to conventional chemotherapy. Secondary objectives were objective response rate (ORR), overall survival (OS) and toxicity. The patients included in the trial had histologically confirmed locally advanced and/or metastatic urothelial cancer of the bladder or upper urinary tract. Chemotherapy with gemcitabine (1250 mg/qm on days 1 and 8) and cisplatin (70 mg/qm on day 1) repeated every 21 days, was administered to all patients in a double‐blind randomization of additional sorafenib (400 mg twice daily) vs placebo (two tablets twice daily) on days 3–21. Treatment continued until progression or unacceptable toxicity, the maximum number of cycles was limited to eight. The response assessment was repeated after every two cycles. Results Between October 2006 and October 2010, 98 of 132 planned patients were recruited. Nine patients were ineligible. The final analysis included 40 patients in the sorafenib and 49 patients in the placebo arm. There were no significant differences between the two arms concerning ORR (sorafenib: complete response [CR] 12.5%, partial response [PR] 40%; placebo: CR 12%, PR 35%), median PFS (sorafenib: 6.3 months, placebo: 6.1 months) or OS (sorafenib: 11.3 months, placebo: 10.6 months). Toxicity was moderately higher in the sorafenib arm. Diarrrhoea occurred significantly more often in the sorafenib arm and hand‐foot syndrome occurred only in the sorafenib arm. The study was closed prematurely because of slow recruitment. Conclusion Although the addition of sorafenib to standard chemotherapy showed acceptable toxicity, the trial failed to show a 4.5 months improvement in PFS.

You have accessJournal of UrologyBladder Cancer: Basic Research (II)1 Apr 2013923 CLINICAL AND PATHOLOGICAL NODAL STAGING SCORE FOR UROTHELIAL CARCINOMA OF THE BLADDER ARE VALID DECISION TOOLS FOR RISK ASSESSMENT AND CLINICAL DECISION-MAKING: AN EXTERNAL VALIDATION Michael Gierth, Hans Martin Fritsche, Hannes Buchner, Matthias May, Attiqullah Aziz, Wolfgang Otto, Christian Bolenz, Lutz Trojan, Edwin Hermann, Arne Tiemann, Stefan C Müller, Jörg Ellinger, Sabine Brookmann-May, Christian G Stief, Derya Tilki, Philipp Nuhn, Thomas Höfner, Markus Hohenfellner, Axel Haferkamp, Jan Roigas, Mario Zacharias, Wolf F Wieland, Hubertus Riedmiller, Stefan Denzinger, Patrick J Bastian, and Maximilian Burger Michael GierthMichael Gierth Regensburg, Germany More articles by this author , Hans Martin FritscheHans Martin Fritsche Regensburg, Germany More articles by this author , Hannes BuchnerHannes Buchner Munich, Germany More articles by this author , Matthias MayMatthias May Straubing, Germany More articles by this author , Attiqullah AzizAttiqullah Aziz Regensburg, Germany More articles by this author , Wolfgang OttoWolfgang Otto Regensburg, Germany More articles by this author , Christian BolenzChristian Bolenz Mannheim, Germany More articles by this author , Lutz TrojanLutz Trojan Göttingen, Germany More articles by this author , Edwin HermannEdwin Hermann Münster, Germany More articles by this author , Arne TiemannArne Tiemann Münster, Germany More articles by this author , Stefan C MüllerStefan C Müller Bonn, Germany More articles by this author , Jörg EllingerJörg Ellinger Bonn, Germany More articles by this author , Sabine Brookmann-MaySabine Brookmann-May Munich, Germany More articles by this author , Christian G StiefChristian G Stief Munich, Germany More articles by this author , Derya TilkiDerya Tilki Munich, Germany More articles by this author , Philipp NuhnPhilipp Nuhn Munich, Germany More articles by this author , Thomas HöfnerThomas Höfner Heidelberg, Germany More articles by this author , Markus HohenfellnerMarkus Hohenfellner Heidelberg, Germany More articles by this author , Axel HaferkampAxel Haferkamp Frankfurt, Germany More articles by this author , Jan RoigasJan Roigas Berlin, Germany More articles by this author , Mario ZachariasMario Zacharias Berlin, Germany More articles by this author , Wolf F WielandWolf F Wieland Regensburg, Germany More articles by this author , Hubertus RiedmillerHubertus Riedmiller Würzburg, Germany More articles by this author , Stefan DenzingerStefan Denzinger Regensburg, Germany More articles by this author , Patrick J BastianPatrick J Bastian Munich, Germany More articles by this author , and Maximilian BurgerMaximilian Burger Würzburg, Germany More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2013.02.500AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Radical Cystectomy (RC) and pelvic lymph node dissection (LND) are standard treatments for muscle-invasive urothelial carcinoma of the bladder (UCB). Accurate lymph node staging is a prerequisite for clinical decision-making regarding adjuvant chemotherapy and follow-up regimens. Recently, the Clinical and Pathological Nodal Staging Scores (cNSS, pNSS) were developed. Prior to RC and LND, the cNSS determines the minimum number of lymph nodes required to be dissected; following RC and LND, the pNSS quantifies the accuracy of negative nodal staging based on pT-stage and dissected lymph nodes. To date, cNSS and pNSS have not been externally validated and their relevance for prediction of cancer-specific mortality (CSM) has not been assessed. We externally validated cNSS and pNSS in a large retrospective multicentre series of patients undergoing RC and LND and to determine their relevance for prediction of CSM. METHODS This retrospective multicentre study included 2483 patients from one of eight German centres undergoing RC and LND between 1989 and 2009. cNSS and pNSS sensitivity were evaluated using the original beta-binominal models. Additionally, the staging scores were adjusted with the falsely negative patients by an iterative algorithm. Cox regression models were calculated for pN0 patients to assess the predictive value of cNSS and pNSS for CSM. RESULTS cNSS and pNSS both pass external validation. Together with other clinical parameters, cNSS can predict patients' outcome after RC. It could be a useful tool for planning the extent of LND. pNSS has no independent impact on prediction of CSM. The study is limited due to its retrospective design and a lack of preoperative staging parameters. CONCLUSIONS In the present external validation we confirm the validity of both cNSS and pNSS. cNSS is an independent predictor of CSM, thus rendering it useful as a tool in therapy planning. © 2013 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 189Issue 4SApril 2013Page: e379 Advertisement Copyright & Permissions© 2013 by American Urological Association Education and Research, Inc.MetricsAuthor Information Michael Gierth Regensburg, Germany More articles by this author Hans Martin Fritsche Regensburg, Germany More articles by this author Hannes Buchner Munich, Germany More articles by this author Matthias May Straubing, Germany More articles by this author Attiqullah Aziz Regensburg, Germany More articles by this author Wolfgang Otto Regensburg, Germany More articles by this author Christian Bolenz Mannheim, Germany More articles by this author Lutz Trojan Göttingen, Germany More articles by this author Edwin Hermann Münster, Germany More articles by this author Arne Tiemann Münster, Germany More articles by this author Stefan C Müller Bonn, Germany More articles by this author Jörg Ellinger Bonn, Germany More articles by this author Sabine Brookmann-May Munich, Germany More articles by this author Christian G Stief Munich, Germany More articles by this author Derya Tilki Munich, Germany More articles by this author Philipp Nuhn Munich, Germany More articles by this author Thomas Höfner Heidelberg, Germany More articles by this author Markus Hohenfellner Heidelberg, Germany More articles by this author Axel Haferkamp Frankfurt, Germany More articles by this author Jan Roigas Berlin, Germany More articles by this author Mario Zacharias Berlin, Germany More articles by this author Wolf F Wieland Regensburg, Germany More articles by this author Hubertus Riedmiller Würzburg, Germany More articles by this author Stefan Denzinger Regensburg, Germany More articles by this author Patrick J Bastian Munich, Germany More articles by this author Maximilian Burger Würzburg, Germany More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

BACKGROUND:Temsirolimus (TEMSR) was approved for treating advanced renal cell carcinoma (RCC) in 2007. Based on the data from a single phase 3 trial, it is recommended explicitly as first-line therapy for patients with a poor clinical prognosis. OBJECTIVE:The aim of this prospective multicentre trial (STARTOR) was to examine the effectiveness of TEMSR in daily clinical practice with a broader indication in the treatment of metastatic RCC. DESIGN, SETTING, AND PARTICIPANTS:Metastatic RCC patients treated with 25mg of TEMSR weekly were submitted to a prospective systematic evaluation and follow-up in 87 German centres between January 2008 and October 2011 using standardised procedures. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS:All data were centrally analysed by an independent clinical research organisation. RESULTS AND LIMITATIONS:This interim analysis of the STARTOR study included 386 patients. The observed toxicity was tolerable, the median dose intensity was 91% (interquartile range: 79-100%), and the median treatment duration was 20.1 wk (95% confidence interval [CI], 17.0-23.3 wk). Clinical benefit was seen in 157 patients (40.7%); the median progression-free and overall survival were 4.9 mo (95% CI, 4.2-5.6) and 11.6 mo (95% CI, 9.3-13.9), respectively. The effectiveness of TEMSR did not differ significantly in relation to the patient's age, histologic RCC subtype, or line of treatment. The major limitations were the noninterventional study design, limited information about Memorial Sloan-Kettering Cancer Center risk factors and detailed toxicity, and the lack of central radiologic review. CONCLUSIONS:TEMSR is an effective and largely well-tolerated treatment alternative for metastatic RCC patients in daily clinical practice, irrespective of the patient's age, histologic RCC subtype, or line of treatment.

Background: Outcome of patients with urothelial carcinoma of the bladder (UCB) varies between sexes. Although overall incidence is higher in men, cancer-specific survival (CSS) has been suggested to be lower in women. Although the former effect is attributed to greater exposure to carcinogens in men, the latter has not been elucidated.Objectives: The aim of the study was to identify sex-specific outcomes based on one of the largest databases of patients with UCB who underwent radical cystectomy (RC).Methods: This retrospective multicenter series comprised 2483 patients in Stage M0 who underwent RC for UCB from 1989 to 2008; 20.4% of patients were women. The impact of sex on CSS in the entire study group and in specific subgroups was analyzed. The median follow-up time was 42 months (interquartile range, 21-79).Results: Histopathologic criteria of pathologic tumor (pT), pathologic nodal (pN), grade, lymphovascular invasion (LVI), and associated carcinoma in situ (CIS) of the study did not differ between sexes. The percentage of female patients increased over time. Five-year CSS in female patients was significantly lower than in male patients (60% vs 66%; P = 0.005). In multivariate analysis adjusted to other covariates, tumor stage >= pT3 (hazard ratio [HR] = 2.44; P < 0.001), positive pN status (HR = 1.91; P < 0.001), LVI (HR = 1.48; P < 0.001), lower count of lymph nodes removed (HR = 0.98; P = 0.002), older age (HR = 1.01; P < 0.001), female gender (HR = 1.26; P = 0.011) had an independent impact on CSS. Deterioration of CSS in female patients was pronounced when LVI was present (HR = 1.57; P < 0.001) and when RC was performed in the earlier time period (HR = 2.44; P < 0.001). However, women showed significantly lower perioperative mortality (within 90 days after RC) compared with men.Conclusions: After RC for UCB, cancer-specific mortality was higher in female patients; this disadvantage was more pronounced in earlier time periods. In addition, worse outcome of women with verified LVI was shown to be comparable with men. These findings were suggestive of different tumor biology and potentially unequal access to timely RC in earlier time periods because of reduced awareness of UCB in women. Further studies are required to improve UCB outcome in both sexes, notably in female patients. (Gend Med. 2012;9:481-489) (c) 2012 Elsevier HS Journals, Inc. All rights reserved.

The present study analysed the loss of prognostic information related to the abandonment of Gleason score (GS) 2–4 by the International Society of Urological Pathology (ISUP-2005).

PURPOSE:Patients with stage pT3N0 urothelial bladder cancer vary in outcome after radical cystectomy. To improve prognosis estimation a model was recently developed that defines 3 risk groups for recurrence-free survival based on pT substaging, lymphovascular invasion and positive surgical margin. We present what is to our knowledge the first external validation of this risk model.MATERIALS AND METHODS:Analogous to the risk model derivation cohort our study group comprised 472 patients with stage pT3, pN0, cM0 disease without perioperative chemotherapy and with a median followup of 42 months (IQR 20-75). The primary end point was recurrence-free survival. The effect of variables was determined by univariate and multivariate Cox regression analysis, and predictive accuracy was determined by ROC analysis.RESULTS:Stage pT3aN0 and pT3bN0 cases showed significantly different recurrence-free survival after 5 years (51% vs 29%, p<0.001). In the multivariate Cox model pT3 substage (HR 1.86, p<0.001), lymphovascular invasion (HR 1.48, p=0.002), positive surgical margins (HR 1.90, p=0.030) and patient age with a dichotomy at 70 years (HR 1.51, p=0.001) had an independent effect on recurrence-free survival. In the low (221 patients or 47%), intermediate (184 or 39%) and high (67 or 14%) risk groups the 5-year recurrence-free survival rate was 55%, 45% and 13%, respectively (p<0.001). The concordance index of the risk model to predict recurrence-free survival was 0.64 (95% CI 0.59-0.69).CONCLUSIONS:This user friendly risk model can be recommended to estimate prognosis in patients with stage pT3N0 after radical cystectomy. Patients at high risk showed clearly compromised recurrence-free survival and should be included in adjuvant therapy studies.