Soft Tissue Surgical Margins Research Articles

MP58-01 INCOMPLETENESS OF THE TRANSURETHRAL RESECTION AS A PREDICTOR OF ADVERSE PATHOLOGICAL FEATURES AT THE TIME OF RADICAL CYSTECTOMY: IMPLICATIONS FOR NEOADJUVANT CHEMOTHERAPY SELECTION

You have accessJournal of UrologyBladder Cancer: Invasive V1 Apr 2017MP58-01 INCOMPLETENESS OF THE TRANSURETHRAL RESECTION AS A PREDICTOR OF ADVERSE PATHOLOGICAL FEATURES AT THE TIME OF RADICAL CYSTECTOMY: IMPLICATIONS FOR NEOADJUVANT CHEMOTHERAPY SELECTION Marco Moschini, Marco Bandini, Giusy Burgio, Giovanni La Croce, Emanuele Zaffuto, Andrea Gallina, Agostino Mattei, Rocco Damiano, Vincenzo Mirone, Shahrokh Shariat, Alberto Briganti, Francesco Montorsi, and Renzo Colombo Marco MoschiniMarco Moschini More articles by this author , Marco BandiniMarco Bandini More articles by this author , Giusy BurgioGiusy Burgio More articles by this author , Giovanni La CroceGiovanni La Croce More articles by this author , Emanuele ZaffutoEmanuele Zaffuto More articles by this author , Andrea GallinaAndrea Gallina More articles by this author , Agostino MatteiAgostino Mattei More articles by this author , Rocco DamianoRocco Damiano More articles by this author , Vincenzo MironeVincenzo Mirone More articles by this author , Shahrokh ShariatShahrokh Shariat More articles by this author , Alberto BrigantiAlberto Briganti More articles by this author , Francesco MontorsiFrancesco Montorsi More articles by this author , and Renzo ColomboRenzo Colombo More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.02.1796AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Neoadjuvant chemotherapy (NAC) before radical cystectomy improves survival expectations in cT2-T4a bladder cancer (BCa) patients. However, this effect is more evident in patients with cT3 or higher disease. Several studies evaluated factors associated with might help in selecting patients who might benefit more from NAC before RC. However, none of them investigated the role of the completeness of transurethral resection (TUR) before RC which may represents a useful proxy of tumor extension in RC candidates. We therefore evaluated a cohort of patients treated with RC due to BCa stratifying according the completeness of TUR before RC. METHODS We retrospectively analyzed data of 481 patients treated with RC and bilateral PLND without NAC due to nonmetastatic BCa between 1990 and 2013 and complete data regarding the completeness of pre-cystectomy TUR. TUR were completed when possible, when not feasible physicians reported this aspect in a prospective maintained database. Demographics and preoperative RC data were available for all patients. Univariable and multivariable logistic regression were built predicting the impact of completeness of TUR and adverse pathologic T stage (defined as T3-T4), lymph node invasion (LNI) and positive soft tissue surgical margin (STSM) status. Multivariable models were adjusted for clinical T stage, presence of CIS or lymphovascular invasion at TUR, histology at TUR, age and preoperative idronephrosis. Area under curve (AUC) was calculated predicting adverse pathologic features with and without the completeness of TUR. RESULTS Overall, TUR has been completed in 326 (67.8%) patients submitted to RC. Patients where the TUR was not completed had higher cT3-4 disease, higher LVI, higher CIS and higher cN+ diseases. At univariable analyses, incompleteness of TUR was a predictor of LNI (odds ratio [OR]: 1.66, confidence interval [CI]: 1.08-2.55, p=0.02), adverse pathologic stage (OR: 1.78, CI: 1.21-2.62, p=0.003), positive STSM (OR: 2.15, CI: 1.13-4.10, p=0.02). At multivariable analyses, completeness of TUR was a predictor of positive STSM (OR: 2.18, CI: 1.12-4.25, p=0.02) and adverse pathologic T stage (OR: 1.57, CI: 1.03-2.40, p=0.03) but not in the prediction of LNI (p=0.06). The inclusion of completeness of TUR in our preoperative model increases of 3.5% its accuracy (AUC: 76.2 vs. 72.7 with or without completeness of TUR, respectively). CONCLUSIONS Incompleteness of the TUR before RC represents a predictor of adverse pathologic features at RC. Physicians should consider this aspect in predicting RC patients' survival and eventually the necessity of neoadjuvant chemotherapy. © 2017FiguresReferencesRelatedDetails Volume 197Issue 4SApril 2017Page: e772 Advertisement Copyright & Permissions© 2017MetricsAuthor Information Marco Moschini More articles by this author Marco Bandini More articles by this author Giusy Burgio More articles by this author Giovanni La Croce More articles by this author Emanuele Zaffuto More articles by this author Andrea Gallina More articles by this author Agostino Mattei More articles by this author Rocco Damiano More articles by this author Vincenzo Mirone More articles by this author Shahrokh Shariat More articles by this author Alberto Briganti More articles by this author Francesco Montorsi More articles by this author Renzo Colombo More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

MP21-13 DOES QUALITY OF CARE IMPACT OUTCOMES IN PATIENTS WITH LOCALLY ADVANCED BLADDER CANCER AFTER ROBOT-ASSISTED RADICAL CYSTECTOMY?

You have accessJournal of UrologyBladder Cancer: Invasive I1 Apr 2017MP21-13 DOES QUALITY OF CARE IMPACT OUTCOMES IN PATIENTS WITH LOCALLY ADVANCED BLADDER CANCER AFTER ROBOT-ASSISTED RADICAL CYSTECTOMY? Youssef Ahmed, Ahmed Hussein, Paul May, Basel Ahmed, Amir Khan, John Binkowski, Justen Kozlowski, and Khurshid Guru Youssef AhmedYoussef Ahmed More articles by this author , Ahmed HusseinAhmed Hussein More articles by this author , Paul MayPaul May More articles by this author , Basel AhmedBasel Ahmed More articles by this author , Amir KhanAmir Khan More articles by this author , John BinkowskiJohn Binkowski More articles by this author , Justen KozlowskiJusten Kozlowski More articles by this author , and Khurshid GuruKhurshid Guru More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.02.3275AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Lack of tactile feedback and potential higher risk of positive margins may advocate against the use of Robot-assisted Radical Cystectomy (RARC) for Locally advanced disease (LAD). We evaluated the quality of RARC in patients with LAD and compared it to organ-confined disease (OCD) METHODS Retrospective review of 421 consecutive RARCs between 2005 and 2015 was performed. Patients with LAD (>=pT3 and/or N+) were compared with OCD (<=pT2/N0). Validated Quality Cystectomy Score (QCS) based on 4 sets of quality metrics was used to compare surgical performance in both groups: [I- Preoperative (Administration of Neoadjuvant Chemotherapy); II- Operative (Overall operative time (< 6.5 hours) and estimated blood loss less <500 ml); III- Pathologic (Negative Soft Tissue Surgical Margins and Lymph Node Yield>20); and IV- Peri-operative (No high grade complications, Readmission or Mortality within 30-d)]. Star Scores were assigned according to the number of criteria achieved. Kaplan Meier method was used to compute recurrence free (RFS), cancer-specific (CSS) and overall survival (OS) rates. Cox proportional hazards model were fit to evaluate predictors of survival. RESULTS 52% had LAD. They had fewer neobladders (3% vs 12%, p<0.001), received adjuvant chemotherapy more frequently (34% vs 4%, p<0.001), and experienced higher mortality within 90 d of RARC (8% vs 1%, p=0.001). LAD patients showed more positive surgical margins (18% vs 2%, p<0.001) and developed recurrences more frequently (41% vs 13%, p<0.001). There was no significant difference in complications or readmissions. Patients with OCD exhibited better 3-year RFS, DSS and OS (85% vs 47%, 96% vs 65% and 81% vs 28%, respectively) (Figure 1). 91% of OCD patients achieved >=3 stars in comparison to 81% in LAD (Table 1). For OCD, patients who achieved star score of 3 or 4 remained stable (approximately 90%), while for LAD, it improved from 72% to 93% between 2005 and 2015. CONCLUSIONS Despite receiving comparable quality of surgical care, patients with LAD exhibited worse RFS, DSS and OS. © 2017FiguresReferencesRelatedDetailsCited byHautmann R (2018) Declining Use of Orthotopic Reconstruction Worldwide—What Went Wrong?Journal of Urology, VOL. 199, NO. 4, (900-903), Online publication date: 1-Apr-2018. Volume 197Issue 4SApril 2017Page: e252 Advertisement Copyright & Permissions© 2017MetricsAuthor Information Youssef Ahmed More articles by this author Ahmed Hussein More articles by this author Paul May More articles by this author Basel Ahmed More articles by this author Amir Khan More articles by this author John Binkowski More articles by this author Justen Kozlowski More articles by this author Khurshid Guru More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Surgical control and margin status after robotic and open cystectomy in high-risk cases: Caution or equivalence?

The benefits of robotic-assisted radical cystectomy (RARC) are unclear, especially in patients with high-risk disease (pT3/T4). We evaluated pathological and postoperative outcomes of RARC versus open radical cystectomy (ORC) in these patients. We identified bladder cancer patients treated with RARC or ORC from January 2010-August 2014. Clinicodemographic factors were examined for potential confounding. Our primary outcome of interest was positive soft-tissue surgical margins (STSMs). Secondary outcomes included post-operative complications and length of stay (LOS). We used logistic regression to define the association between clinical factors with outcomes of interest, focusing on patients with locally advanced disease. We identified 472 patients treated with ORC (407, 86.2%) or RARC (65, 13.8%) of which 215 (45.6%) were high-risk cases based on advanced pathologic stage (pT3/4). RARC patients were more commonly men (96.9 vs. 73.2%, p<0.01), had better performance status (ECOG0, 78.5 vs. 59.7%, p=0.031), and received less neoadjuvant chemotherapy (21.5 vs. 39.3%, p=0.006). Total (52.3 vs. 59.7%, p=0.26) and high-grade complication rates (13.8 vs. 19.7%, p=0.27) were similar, but median LOS was shorter after RARC (6 vs. 7days, p<0.01). On multivariate analysis, prior pelvic radiation (OR: 4.78, 95% CI: 2.16-10.57), and advanced tumor stage (OR: 3.06, 95% CI: 1.56-6.03) were independently associated with positive STSMs in high-risk patients but robotic surgical approach was not (OR: 0.81, 95% CI: 0.29-2.30; p=0.69). RARC had similar short-term postoperative outcomes compared to ORC and did not compromise oncological control in patients with extravesical disease.

Development and Validation of a Quality Assurance Score for Robot-assisted Radical Cystectomy: A 10-year Analysis

To develop quality assessment tool to evaluate surgical performance for robot-assisted radical cystectomy program. A prospectively maintained quality assurance database of 425 consecutive robot-assisted radical cystectomies performed by a single surgeon between 2005 and 2015 was retrospectively reviewed. Potentially modifiable factors, related to the management and perioperative care of patients, were used to evaluate patient care. Criteria included the following: preoperative (administration of neoadjuvant chemotherapy); operative (operative time <6.5 hours and estimated blood loss <500 cc); pathologic (negative soft tissue surgical margins and lymph node yield ≥20); and postoperative (no high-grade complications, readmission, or noncancer-related mortality within 30 days).The Quality Cystectomy Score (QCS) was developed (1 star: achieving ≤2 criteria or mortality within 30 days; 2 stars: 3 or 4 criteria met; 3 stars: 5 or 6 criteria met; and 4 stars: 7 or all criteria met). Univariate and multivariate Cox proportional hazard regression models were fitted to test for the association between QCS and survival outcomes. Most patients (85%) achieved at least 3 stars, and more patients achieved 4 stars with time. High QCS was associated with better recurrence-free, cancer-specific, and overall survival (P values <.05). None of the patients with 1-star were alive at 1 year. Patients with 4 stars achieved the best survival rates (recurrence-free survival [62%], cancer-specific survival [70%], and overall survival [53%] at 5 years) (log rank P < .0001). Continuous assessment for quality improvement facilitated implementation and maintenance of robot-assisted program for bladder cancer.

Comparative analysis of the effect of prostatic invasion patterns on cancer-specific mortality after radical cystectomy in pT4a urothelial carcinoma of the bladder

PurposeTo evaluate the prognostic relevance of different prostatic invasion patterns in pT4a urothelial carcinoma of the bladder (UCB) after radical cystectomy. Materials and methodsOur 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. ResultsThe 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. ConclusionsContinuous 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.

MP49-07 THE RISK OF POSTOPERATIVE VENOUS THROMBOEMBOLISM ACCORDING TO THE CIRCULATING TUMOR CELL STATUS IN PATIENTS WITH UROTHELIAL CARCINOMA OF THE BLADDER TREATED WITH RADICAL CYSTECTOMY

You have accessJournal of UrologyBladder Cancer: Invasive III1 Apr 2016MP49-07 THE RISK OF POSTOPERATIVE VENOUS THROMBOEMBOLISM ACCORDING TO THE CIRCULATING TUMOR CELL STATUS IN PATIENTS WITH UROTHELIAL CARCINOMA OF THE BLADDER TREATED WITH RADICAL CYSTECTOMY Armin Soave, Sabine Riethdorf, Roland Dahlem, Lars Weisbach, Valentin Maurer, Oliver Engel, Sarah Minner, Klaus Pantel, Margit Fisch, and Michael Rink Armin SoaveArmin Soave More articles by this author , Sabine RiethdorfSabine Riethdorf More articles by this author , Roland DahlemRoland Dahlem More articles by this author , Lars WeisbachLars Weisbach More articles by this author , Valentin MaurerValentin Maurer More articles by this author , Oliver EngelOliver Engel More articles by this author , Sarah MinnerSarah Minner More articles by this author , Klaus PantelKlaus Pantel More articles by this author , Margit FischMargit Fisch More articles by this author , and Michael RinkMichael Rink More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2016.02.420AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Urothelial carcinoma of the bladder (UCB) patients are at a relevant risk for venous thromboembolism (VTE) following radical cystectomy (RC). In other cancer entities, circulating tumor cells (CTC) are associated with an increased risk of VTE. To evaluate whether the presence of CTC is associated with an increased postoperative risk of VTE and surgical complications in UCB patients treated with RC. METHODS We included 201 UCB patients treated with RC with bilateral pelvic lymphadenectomy without neoadjuvant chemotherapy at an academic center between 2007 and 2014. Preoperatively collected blood samples (7.5 ml) were analyzed for CTC using the CellSearch® system (Janssen, USA). Postoperative VTE was defined as clinically apparent venous thrombosis and/or pulmonary embolism following RC, and was confirmed by diagnostic imaging studies. Data on postoperative VTE and complications were collected retrospectively by patients' chart review. Postoperative complications were classified according to the Clavien-Dindo classification of surgical complications. Clinico-pathologic features were correlated with the VTE status and the CTC status. RESULTS Prior to RC, 54 patients (26.9%) had presence of CTC (mean CTC number: 4.9±31.3 (standard deviation (SD); median: 0; range: 0-372). Within 30 days postoperatively, 6 patients (3.0%) had VTE, and 136 patients (67.7%) had any surgical complication. The most frequent complications were Clavien-Dindo grade 1 and 2 complications in 95 patients (47.3%), followed by grade 3 complications in 25 patients (12.4%) and grade 4 complications in 15 patients (7.5%), respectively. The presence of VTE was not associated with the CTC status or any other clinico-pathologic characteristics. There was no difference in the number of CTC in patients with VTE (mean CTC number: 1.0±1.5 SD) and without VTE (mean CTC number: 5.0±31.7 SD), respectively. The VTE status and the CTC status were not associated with surgical complications. The presence of CTC was associated with a positive soft tissue surgical margin, the presence of lymphovascular and micro-vessel invasion, and the administration of adjuvant chemotherapy (all p-values≤0.045). CONCLUSIONS While complications occur frequently within 30 days after RC, VTE are relatively rare events. Following RC, UCB patients with presence of CTC do not seem to be at an increased risk of VTE. In addition, the presence of CTC is not associated with surgical complications. However, a longer follow-up is urgently warranted. © 2016FiguresReferencesRelatedDetails Volume 195Issue 4SApril 2016Page: e666-e667 Advertisement Copyright & Permissions© 2016MetricsAuthor Information Armin Soave More articles by this author Sabine Riethdorf More articles by this author Roland Dahlem More articles by this author Lars Weisbach More articles by this author Valentin Maurer More articles by this author Oliver Engel More articles by this author Sarah Minner More articles by this author Klaus Pantel More articles by this author Margit Fisch More articles by this author Michael Rink More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

MP38-05 TUMOR DISSEMINATION DURING ROBOT-ASSISTED RADICAL CYSTECTOMY: DOES THE EMPEROR HAVE NO CLOTHES?

You have accessJournal of UrologyBladder Cancer: Invasive I1 Apr 2016MP38-05 TUMOR DISSEMINATION DURING ROBOT-ASSISTED RADICAL CYSTECTOMY: DOES THE EMPEROR HAVE NO CLOTHES? Ahmed Hussein, Yingyu Ma, Gissou Azabdaftari, Nobuyuki Hinata, Wei Luo, Victoria Cranwell, Brittany Bunch, Justen Kozlowski, Sean Glenn, Song Liu, Candace Johnson, and Khurshid Guru Ahmed HusseinAhmed Hussein More articles by this author , Yingyu MaYingyu Ma More articles by this author , Gissou AzabdaftariGissou Azabdaftari More articles by this author , Nobuyuki HinataNobuyuki Hinata More articles by this author , Wei LuoWei Luo More articles by this author , Victoria CranwellVictoria Cranwell More articles by this author , Brittany BunchBrittany Bunch More articles by this author , Justen KozlowskiJusten Kozlowski More articles by this author , Sean GlennSean Glenn More articles by this author , Song LiuSong Liu More articles by this author , Candace JohnsonCandace Johnson More articles by this author , and Khurshid GuruKhurshid Guru More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2016.02.109AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Local recurrence remains a major cause of cancer-specific mortality following radical cystectomy. We sought to investigate tumor dissemination in the operative field and contribution of pneumoperitoneum during robot-assisted radical cystectomy (RARC). METHODS Six RARCs were included. Four pelvic irrigations with 0.9% normal saline were performed; Sample I: before RARC; Sample II: after RARC; Sample III: after pelvic lymph node dissection [PLND], and leftover irrigation fluid at end of procedure (Sample IV). CO2 used for pneumoperitoneum was filtered using surgical smoke plume evacuation device. Filter was then removed, washed with 0.9% saline, centrifuged and sediment was analyzed. Intra-vesical bladder irrigations were performed for 3 patients. Methodology: pelvic irrigations (SI-IV) were examined for cytology using thin preparation and cell block by a Genito-Urinary Pathologist/Cytopathologist. Meanwhile, intra-vesical wash, pelvic irrigation, and filter sediment were analyzed for mRNA expression of bladder cancer related genes. mRNA expression was examined by qRT-PCR, with human bladder cancer cell line 253J and GAPDH (controls). Epithelial cell markers EpCAM, cytokeratins 8, 18 and 19 were also assessed. Bladder cancer gene panels used in the Cxbladder Detect urinary test were also examined (CDK1, MDK, IGFBP5, HOXA13 and CXCR2). RESULTS Four patients received neoadjuvant chemotherapy. The mean operative time was 300 minutes. Four patients had pT1 disease, 2 had pT2 disease. All patients had negative soft tissue surgical margins and mean LNY was 31. One patient had positive lymph nodes. No spillage of tumor cells or inadvertent entry into the bladder was observed. All lymph nodes were removed in specimen bags. Cytology: Pelvic Irrigation showed mostly blood, inflammatory, mesothelial cells and macrophages. All specimens were negative for malignant cells. mRNA expression: Bladder cancer related mRNA was detected in the intra-vesical wash and 253J bladder cancer cells (control). In contrast, all pelvic irrigations and filter sediment had very low or undetectable mRNA levels. However, in patient with node positive disease, SI irrigation showed many epithelial markers (KRT8, 18, 19, IGFBP5). CONCLUSIONS Our preliminary analysis showed that bladder cancer cells, bladder cancer related genes and epithelial markers were not present in pelvic irrigation but in intra-vesical wash. These cells were detected in the pelvis in 1 patient with advanced disease. Active enrollment in this study continues which will allow better understanding of local spread of bladder cancer. © 2016FiguresReferencesRelatedDetailsCited byHussein A, Saar M, May P, Wijburg C, Richstone L, Wagner A, Wilson T, Yuh B, Redorta J, Dasgupta P, Khan M, Menon M, Peabody J, Hosseini A, Gaboardi F, Mottrie A, Rha K, Hemal A, Stockle M, Kelly J, Maatman T, Canda A, Wiklund P and Guru K (2016) Early Oncologic Failure after Robot-Assisted Radical Cystectomy: Results from the International Robotic Cystectomy ConsortiumJournal of Urology, VOL. 197, NO. 6, (1427-1436), Online publication date: 1-Jun-2017. Volume 195Issue 4SApril 2016Page: e534-e535 Advertisement Copyright & Permissions© 2016MetricsAuthor Information Ahmed Hussein More articles by this author Yingyu Ma More articles by this author Gissou Azabdaftari More articles by this author Nobuyuki Hinata More articles by this author Wei Luo More articles by this author Victoria Cranwell More articles by this author Brittany Bunch More articles by this author Justen Kozlowski More articles by this author Sean Glenn More articles by this author Song Liu More articles by this author Candace Johnson More articles by this author Khurshid Guru More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

The prognostic role of pre-cystectomy hemoglobin levels in patients with invasive bladder cancer.

To determine whether pre-treatment hemoglobin (Hb) levels in patients with bladder cancer impact on oncological outcomes after radical cystectomy (RC). A consecutive, contemporary series of 246 patients undergoing RC and pelvic lymph node dissection for bladder cancer. Decreased Hb level was defined as ≤12g/dL. The Kaplan-Meier method was used to estimate recurrence-free (RFS), cancer-specific (CSS) and overall survival (OS). The Fisher exact/Chi-square test was used to investigate differences between both groups. Uni- and multivariable Cox regression analysis addressed risk factors for recurrence, cancer-specific death and overall death. The median follow-up was 30months (2-116). Of the 246 patients, 182 (74%) had normal (>12g/dL) and 64 decreased (≤12g/dL) preoperative Hb (26%). In univariable analysis, decreased Hb was associated with increased age, extravesical disease, hydronephrosis (all p<0.001), node-positive disease and positive resection margins (both p=0.01). Subanalyzed for patients with organ-confined disease (defined as ≤pT2bN0R0; N=109), the 3-year RFS, CSS and OS was significantly lower in patients with decreased (34.9, 35.5 and 19.8%) compared to normal Hb level (69.7, 86.3 and 77.6%; p=0.01/p=0.002/p<0.001). In multivariable analysis, RFS, CSS and OS were significantly lower in patients with decreased Hb (p=0.007, p=0.001 and p=0.002), pathologically locally advanced tumor (≥pT3a; p=0.023, p=0.036 and p=0.065) and nodal stage (p<0.001, p=0.006 and p=0.001) and positive soft tissue surgical margins (p=0.040, p=0.004 and 0.012). Pre-cystectomy Hb levels are associated with adverse histopathologic characteristics and provide additional prognostic information especially for patients with pathologically localized bladder cancer.

Preoperative Patient Reported Mental Health is Associated with High Grade Complications after Radical Cystectomy

Psychological distress has been associated with an impaired immune response and poor wound healing. We hypothesized that preoperative patient reported mental health would be associated with high grade 30-day complications after radical cystectomy. We retrospectively identified patients who underwent radical cystectomy for bladder cancer who completed Short Form 12 (SF-12) surveys for self-assessment of health status less than 6 months before surgery. Median physical and mental composite scores were calculated. An expert model including known predictors of postoperative high grade complications was developed, and SF-12 physical composite score and mental composite score were added to determine their association with this end point. From January 2010 to August 2014, 472 patients underwent radical cystectomy for bladder cancer, of whom 274 (58.1%) completed preoperative SF-12 questionnaires. Responders were more likely to be white (p=0.024), have higher preoperative albumin (p=0.037), receive neoadjuvant chemotherapy (p=0.002), have pT3/T4 disease (p=0.044) and have positive soft tissue surgical margins (p=0.006). Median SF-12 physical composite score was 43.1 (IQR 33.0-51.5) and mental composite score was 48.5 (IQR 39.5-54.7) in responders. Overall 46 (16.8%) responders experienced a high grade 30-day complication. Patients with a high grade complication had a lower preoperative median SF-12 mental composite score (44.8 vs 49.8, p=0.004) but no difference in physical composite score (39.2 vs 43.8, p=0.06). SF-12 mental composite score was also a significant predictive variable when added to our expert model (p=0.01). Preoperative patient reported mental health was independently associated with high grade complications after radical cystectomy. Therefore, patient self-assessment of health status before surgery through validated questionnaires may provide additional information useful in predicting short-term postoperative outcomes.

Implications of Definitive Prostate Cancer Therapy on Soft Tissue Margins and Survival in Patients Undergoing Radical Cystectomy for Bladder Urothelial Cancer

We evaluated the possibility of an existing link between definitive prostate cancer treatment and its effect on positive soft tissue surgical margins at radical cystectomy. A secondary objective was to determine whether definitive prostate cancer treatment was associated with bladder cancer survival end points. There were 749 patients who underwent radical cystectomy between 2000 and 2013. After excluding females and patients with nonurothelial histologies 561 men were identified, of whom 69 (12.3%) received single or multimodal definitive prostate cancer treatment. Univariate and multivariable logistic regression was used to determine an association between clinical and pathological features such as definitive prostate cancer treatment and positive soft tissue surgical margins. Cox regression models and competing risk regression were used to investigate the impact of definitive prostate cancer treatment and positive surgical margins on survival. The median age of the male population was 70.0 years. There were 57cases of positive soft tissue surgical margins in our cohort of 561 men (10.2%). Of men who underwent previous definitive prostate cancer treatment 20 of 69(29.0%) had positive surgical margins compared to 37 of 492 (7.5%) who never received definitive prostate cancer treatment (p <0.0001). Brachytherapy, radiotherapy, hormonal therapy and radical prostatectomy significantly increased the rate of positive margins. Brachytherapy (OR 5.8), radiotherapy (OR 2.7) and hormonal therapy (OR 5.1) remained independent predictors of positive margins on multivariate analysis. Positive margins were associated with negative effects on recurrence-free (HR 3.1), cancer specific (HR 4.1) and overall survival (HR 2.8). Patients with a history of definitive prostate cancer treatment are at increased risk for positive soft tissue surgical margins. Positive margins significantly impact bladder cancer recurrence-free, cancer specific and overall survival following radical cystectomy. Careful patient counseling and surgical planning are crucial when treating patients undergoing radical cystectomy who have ahistory of definitive prostate cancer treatment.

Prediction of cancer-specific survival after radical cystectomy in pT4a urothelial carcinoma of the bladder: development of a tool for clinical decision-making.

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. 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. 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.

Long-term Oncologic Outcomes Following Robot-assisted Radical Cystectomy: Results from the International Robotic Cystectomy Consortium

BackgroundLong-term oncologic data on patients undergoing robot-assisted radical cystectomy (RARC) are limited and based largely on single-institution series. ObjectiveReport survival outcomes of patients who underwent RARC ≥5 yr ago. Design, setting, and participantsRetrospective review of the prospectively populated International Robotic Cystectomy Consortium multi-institutional database identified 743 patients with RARC performed ≥5 yr ago. Clinical, pathologic, and survival data at the latest follow-up were collected. Patients with palliative RARC were excluded. Final analysis was performed on 702 patients from 11 institutions in 6 countries. InterventionRARC. Outcome measurements and statistical analysisOutcomes of interest, recurrence-free survival (RFS), cancer-specific survival (CSS), and overall survival (OS) were plotted using Kaplan-Meier survival curves. A Cox proportional hazards model was used to identify factors that predicted outcomes. Results and limitationsPathologic organ-confined (OC) disease was found in 62% of patients. Soft tissue surgical margins (SMs) were positive in 8%. Median lymph node (LN) yield was 16, and 21% of patients had positive LNs. Median follow-up was 67 mo (interquartile range: 18–84 mo). Five-year RFS, CSS, and OS were 67%, 75%, and 50%, respectively. Non-OC disease and SMs were associated with poorer RFS, CSS, and OS on multivariable analysis. Age predicted poorer CSS and OS. Adjuvant chemotherapy and positive SMs were predictors of RFS (hazard ratio: 3.20 and 2.16; p<0.001 and p<0.005, respectively). Stratified survival curves demonstrated poorer outcomes for positive SM, LN, and non-OC disease. Retrospective interrogation and lack of contemporaneous comparison groups that underwent open radical cystectomy were major limitations. ConclusionsThe largest multi-institutional series to date reported long-term survival outcomes after RARC. Patient summaryPatients who underwent robot-assisted radical cystectomy for bladder cancer have acceptable long-term survival.

Optimizing outcome reporting after radical cystectomy for organ-confined urothelial carcinoma of the bladder using oncological trifecta and pentafecta.

Radical cystectomy (RC) for urothelial carcinoma of the bladder (UCB) is associated with heterogeneous functional and oncological outcomes. The aim of this study was to generate trifecta and pentafecta criteria to optimize outcome reporting after RC. We interviewed 50 experts to consider a virtual group of patients (age ≤ 75 years, ASA score ≤ 3) undergoing RC for a cT2 UCB and a final histology of ≤pT3pN0M0. A ranking was generated for the three and five criteria with the highest sum score. The criteria were applied to the Prospective Multicenter Radical Cystectomy Series 2011. Multivariable binary logistic regression analyses were used to evaluate the impact of clinical and histopathological parameters on meeting the top selected criteria. The criteria with the highest sum score were negative soft tissue surgical margin, lymph node (LN) dissection of at least 16 LNs, no complications according to Clavien-Dindo grade 3-5 within 90 days after RC, treatment-free time between TUR-BT with detection of muscle-invasive UCB and RC <3 months and the absence of local UCB-recurrence in the pelvis ≤12 months. The first three criteria formed trifecta, and all five criteria pentafecta. A total of 334 patients qualified for final analysis, whereas 35.3 and 29 % met trifecta and pentafecta criteria, respectively. Multivariable analyses showed that the relative probability of meeting trifecta and pentafecta decreases with higher age (3.2 %, p = 0.043 and 3.3 %, p = 0.042) per year, respectively. Trifecta and pentafecta incorporate essential criteria in terms of outcome reporting and might be considered for the improvement of standardized quality assessment after RC for UCB.

MP58-20 PREDICTION OF LOCOREGIONAL RECURRENCE AFTER RADICAL CYSTECTOMY FOR UROTHELIAL CARCINOMA OF THE BLADDER

INTRODUCTION AND OBJECTIVES: Data on locoregional recurrence (LR) after radical cystectomy (RC) for urothelial carcinoma of the bladder (UCB) is scarce. An accurate stratification of patients potentially experiencing LR could help in patient counseling regarding adjuvant therapy and in clinical trial design-setting. We therefore externally validated Christodouleas’ risk-model (RM) incorporating pathological tumor stage, lymph node count and soft-tissue surgical margin and stratifying patients who develop LR after RC for UCB. In addition, we generated a new model including established clinicopathological features that were absent in Christodouleas’ RM based on the data of the Prospective Multicenter Radical Cystectomy Series 2011 (PROMETRICS 2011). METHODS: Prospectively assessed multicenter data from 565 patients undergoing RC in 2011 qualified for final analysis. For the purpose of external validation, risk-group stratification according to Christodouleas was performed. Competing-risk models were calculated to compare the cumulative incidences of LR after RC. RESULTS: After a median follow-up of 25 months, the LR rate was in 11.5%. Christodouleas’ RM showed a predictive accuracy of 83.2% in our cohort. In multivariable competing-risks analysis, tumor stage pT3 (HR4.32, p<0.001), positive soft-tissue surgical margin (HR2.93, p1⁄40.005), the presence of lymphovascular invasion (HR3.41, p<0.001), the number of removed lymph nodes <10 (HR2.62, p<0.001) and the administration of adjuvant chemotherapy (HR0.40, p1⁄40.008) independently predicted the LR rate. The resulting risk-groups revealed significant differences in LR rates after 24 months with 4.8% for low-risk patients, 14.7% for intermediate-risk patients and 38.9% for high-risk patients (p<0.001 for all), respectively, with a predictive accuracy of 85.6%. CONCLUSIONS: Christodouleas’ RM for prediction of LR after RC for UCB could be externally validated with a good discrimination within our cohort. In contrast, we incorporated besides the established clinico-pathological features pathological tumor stage, lymph node count, soft tissue surgical margin also lymphovascular invasion and adjuvant chemotherapy which have been missed to include in Christodouleas’ RM. Furthermore, our bely developed RM allows stratifying patients individually for their risk of LR with a good predictive accuracy and can serve as a tool for identifying eligible patients who can be administered adjuvant chemotherapy and included in clinical trials setting.

MP59-01 IMPACT OF BLOOD TRANSFUSIONS ON ONCOLOGICAL OUTCOMES OF SURGICALLY TREATED LOCALIZED RENAL CELL CARCINOMA

INTRODUCTION AND OBJECTIVES: Data on locoregional recurrence (LR) after radical cystectomy (RC) for urothelial carcinoma of the bladder (UCB) is scarce. An accurate stratification of patients potentially experiencing LR could help in patient counseling regarding adjuvant therapy and in clinical trial design-setting. We therefore externally validated Christodouleas’ risk-model (RM) incorporating pathological tumor stage, lymph node count and soft-tissue surgical margin and stratifying patients who develop LR after RC for UCB. In addition, we generated a new model including established clinicopathological features that were absent in Christodouleas’ RM based on the data of the Prospective Multicenter Radical Cystectomy Series 2011 (PROMETRICS 2011). METHODS: Prospectively assessed multicenter data from 565 patients undergoing RC in 2011 qualified for final analysis. For the purpose of external validation, risk-group stratification according to Christodouleas was performed. Competing-risk models were calculated to compare the cumulative incidences of LR after RC. RESULTS: After a median follow-up of 25 months, the LR rate was in 11.5%. Christodouleas’ RM showed a predictive accuracy of 83.2% in our cohort. In multivariable competing-risks analysis, tumor stage pT3 (HR4.32, p<0.001), positive soft-tissue surgical margin (HR2.93, p1⁄40.005), the presence of lymphovascular invasion (HR3.41, p<0.001), the number of removed lymph nodes <10 (HR2.62, p<0.001) and the administration of adjuvant chemotherapy (HR0.40, p1⁄40.008) independently predicted the LR rate. The resulting risk-groups revealed significant differences in LR rates after 24 months with 4.8% for low-risk patients, 14.7% for intermediate-risk patients and 38.9% for high-risk patients (p<0.001 for all), respectively, with a predictive accuracy of 85.6%. CONCLUSIONS: Christodouleas’ RM for prediction of LR after RC for UCB could be externally validated with a good discrimination within our cohort. In contrast, we incorporated besides the established clinico-pathological features pathological tumor stage, lymph node count, soft tissue surgical margin also lymphovascular invasion and adjuvant chemotherapy which have been missed to include in Christodouleas’ RM. Furthermore, our bely developed RM allows stratifying patients individually for their risk of LR with a good predictive accuracy and can serve as a tool for identifying eligible patients who can be administered adjuvant chemotherapy and included in clinical trials setting.

Risk stratification for locoregional recurrence after radical cystectomy for urothelial carcinoma of the bladder.

To externally validate the Christodouleas risk model incorporating pathological tumor stage, lymph node (LN) count and soft tissue surgical margin (STSM) and stratifying patients who develop locoregional recurrence (LR) after radical cystectomy (RC) for urothelial carcinoma of the bladder (UCB). In addition, we aimed to generate a new model including established clinicopathological features that were absent in the Christodouleas risk model. Prospectively assessed multicenter data from 565 patients undergoing RC for UCB in 2011 qualified for final analysis. For the purpose of external validation, risk group stratification according to Christodouleas was performed. Competing-risk models were calculated to compare the cumulative incidences of LR after RC. After a median follow-up of 25 months (interquartile range 19-29), the LR-rate was 11.5 %. The Christodouleas model showed a predictive accuracy of 83.2 % in our cohort. In multivariable competing-risk analysis, tumor stage ≥pT3 (HR 4.32, p < 0.001), positive STSM (HR 2.93, p = 0.005), lymphovascular invasion (HR 3.41, p < 0.001), the number of removed LNs <10 (HR 2.62, p < 0.001) and the administration of adjuvant chemotherapy (HR 0.40, p = 0.008) independently predicted the LR-rate. The resulting risk groups revealed significant differences in LR-rates after 24 months with 4.8 % for low-risk patients, 14.7 % for intermediate-risk patients and 38.9 % for high-risk patients (p < 0.001 for all), with a predictive accuracy of 85.6 %, respectively. The Christodouleas risk model has been successfully externally validated in the present prospective series. However, this analysis finds that overall model performance may be improved by incorporating lymphovascular invasion. After external validation of the newly proposed risk model, it may be used to identify patients who benefit from an adjuvant therapy and suit for inclusion in clinical trials.

Fluorescence-guided bladder tumour resection: impact on survival after radical cystectomy.

To investigate whether photodynamic diagnosis (PDD)-guided bladder tumour resection (TUR-BT) is of prognostic value in patients undergoing subsequent radical cystectomy (RC) for bladder cancer (BC). In 224 consecutive patients who underwent RC and bilateral pelvic lymphadenectomy for BC between 2002 and 2010 (median follow-up 29 months [IQR 8-59]), we retrospectively investigated whether patients had previously undergone PDD-guided (hexaminolevulinate [HAL] vs. 5-aminolevulinate [ALA]) versus white light (WL)-TUR-BT. Kaplan-Meier analysis was used to estimate recurrence-free survival (RFS), cancer-specific survival (CSS) and overall survival (OS) using log-rank and Cox regression model for uni- and multivariable analysis. Of the 224 patients, 66 (29.5 %) underwent HAL-, 23 (10.3 %) ALA- and 135 (60.2 %) WL-TUR-BT before RC. The 3-year RFS/CSS/OS was 77.8/83.9/74.0 % for HAL-, 53.6/74.5/60.9 % for ALA- and 52.4/59.7/56.5 % for WL-TUR-BT (p = 0.002/0.023/0.037 for HAL vs. WL/ALA). PDD-TUR-BT was associated with a higher number of TUR-BTs before RC (p < 0.001) and re-resections (p = 0.015), a longer time between the first TUR-BT and RC (p = 0.044) and a lower rate of post-operative systemic chemotherapy (p = 0.001). In multivariable analysis, performance of HAL-TUR-BT, pathologic tumour and nodal stage as well as soft tissue surgical margin status were independent predictors for RFS, CSS and OS. This series indicates for the first time that HAL-guided TUR-BT is an independent predictor for improved survival after RC.

Immediate Radical Cystectomy for Massive Bleeding of Bladder Cancer.

Objective. To investigate feasibility and safety of our surgical strategy and clinical and oncological efficacy. Materials and Methods. In a high volume tertiary institution 225 radical cystectomies were performed from January 2012 to December 2014. We prospectively collected data of a cohort of 12 patients who underwent immediate open radical cystectomy for bladder cancer causing massive haematuria, acute anemia, and impossibility of postponing surgery. A retrospective study was carried out to evaluate operative data, intra- and postoperative complications, and oncologic outcomes. The Clavien-Dindo Classification was used to grade complications. The oncologic outcome was evaluated in terms of positive overall and soft tissue surgical margins and cancer specific survival at a median follow-up of 26 months. Results. Mean preoperative haemoglobin was 6.8 mg/dL. Mean operative time was 278 minutes. Mean blood loss was 633 mL. The overall transfusion rate was 100% with a mean of 3.6 blood units per patient before surgery and 1.8 units postoperatively. No intraoperative complications occurred. Major complications (defined as grades III, IV, and V according to Clavien-Dindo Classification) were 18,5%. In fact grade III complications were 14.8% and grade IV complications were 3.7%. Grade V did not occur. The positive surgical margin rate was 33.3% and cancer specific survival was 58,3% at median follow-up of 26 months. Conclusions. Immediate surgical management seems feasible, safe, and efficacious.

Commentary on “Impact of statin use on oncologic outcomes in patients with urothelial carcinoma ofthe bladder treated with radical cystectomy.” da Silva RD, Xylinas E, Kluth L, Crivelli JJ, Chrystal J, Chade D, Guglielmetti GB, Pycha A, Lotan Y, Karakiewicz PI, Sun M, Fajkovic H, Zerbib M, Scherr DS, Shariat SF, Department of Urology and Division of Medical Oncology, Weill

PurposeStatins are cholesterol lowering agents used to prevent cardiovascular disease. Evidence suggests a dichotomous effect of statins with cancer inhibiting and promoting properties. To our knowledge the effect of statins on the prognosis of muscle invasive urothelial carcinoma of the bladder remains uninvestigated to date. We tested the hypothesis that statin use impacts oncological outcomes in patients treated with radical cystectomy for urothelial carcinoma of the bladder. Materials and methodsWe retrospectively evaluated the records of 1,502 patients treated with radical cystectomy and pelvic lymphadenectomy without neoadjuvant therapy at a total of 4 institutions. Cox regression models were used to determine the association of statins with disease recurrence and cancer specific mortality. ResultsA total of 642 patients (42.7%) were on statins. At a median followup of 34 months 509 patients (33.9%) experienced disease recurrence and 402 (26.8%) had died of urothelial carcinoma of the bladder. Statin users were older (p = 0.003), had a higher body mass index (median 32 vs 28 kg/m(2), p <0.001) and were more likely to have positive soft tissue surgical margins (9% vs 4%, p<0.001). On univariable Cox regression analysis statins, female gender, advanced age, higher body mass index, smoking status, tumor stage, tumor grade, soft tissue surgical margin status, lymphovascular invasion, lymph node metastasis and adjuvant chemotherapy were associated with disease recurrence (p≤0.05) and cancer specific mortality (p≤0.02). On multivariable Cox regression analysis statin use was not associated with either outcome. ConclusionsStatin users were at higher risk for disease recurrence and cancer specific mortality on univariable but not multivariable analysis. These data do not support modification of statin use in patients with high risk urothelial carcinoma of the bladder who will be treated with radical cystectomy.

Concomitant Seminal Vesicle Invasion in pT4a Urothelial Carcinoma of the Bladder with Contiguous Prostatic Infiltration is an Adverse Prognosticator for Cancer-Specific Survival after Radical Cystectomy

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. A total of 385 patients with UCB and contiguous prostatic infiltration comprised our study. Patients were divided in two groups according to cSVI. Median follow-up was 36months (interquartile range 11-74); the primary end point was cancer-specific mortality. The prognostic impact of cSVI was evaluated using multivariable Cox regression analysis. The predictive accuracy was assessed by a receiver operating characteristic analysis. A total of 229 patients (59.5 %) without cSVI comprised group A, and 156 patients (40.5 %) with cSVI comprised group B. Positive lymph nodes (63 vs. 44 %, p<0.001) and positive surgical margins (34 % vs. 14 %, p<0.001) were more common in patients with cSVI. The 5- and 10-year cancer-specific survival rates were 41 % and 32 % (group A) and 21 and 17 % (group B) (p<0.001). In multivariable analysis, pathological nodal stage (hazard ratio [HR] 2.19, p<0.001), soft tissue surgical margin (HR 1.57, p=0.010), clinical tumor stage (HR 1.46, p=0.010), adjuvant chemotherapy (HR 0.40, p<0.001), and cSVI (HR 1.69, p<0.001) independently impacted cancer-specific mortality. The c-indices of the multivariable models with and without inclusion of cSVI were 0.658 (95 % confidence interval 0.60-0.71) and 0.635 (95 % confidence interval 0.58-0.69), respectively, resulting in a predictive accuracy gain of 2.3 % (p=0.002). In patients with UCB and prostatic stromal invasion, cSVI adversely affected cancer-specific survival compared to patients without cSVI. The inclusion of cSVI significantly improved the predictive accuracy of our multivariable model regarding survival.