Demonstrating the effectiveness of the fundamentals of robotic surgery (FRS) curriculum on the RobotiX Mentor Virtual Reality Simulation Platform.

Fundamentals of robotic surgery (FRS) is a proficiency-based progression curriculum developed by robotic surgery experts from multiple specialty areas to address gaps in existing robotic surgery training curricula. The RobotiX Mentor is a virtual reality training platform for robotic surgery. Our aims were to determine if robotic surgery novices would demonstrate improved technical skills after completing FRS training on the RobotiX Mentor, and to compare the effectiveness of FRS across training platforms. An observational, pre-post design, multi-institutional rater-blinded trial was conducted at two American College of Surgeons Accredited Education Institutes-certified simulation centers. Robotic surgery novices (n = 20) were enrolled and trained to expert-derived benchmarks using FRS on the RobotiX Mentor. Participants' baseline skill was assessed before (pre-test) and after (post-test) training on an avian tissue model. Tests were video recorded and graded by blinded raters using the Global Evaluative Assessment of Robotic Skills (GEARS) and a 32-criteria psychomotor checklist. Post hoc comparisons were conducted against previously published comparator groups. On paired-samples T tests, participants demonstrated improved performance across all GEARS domains (p < 0.001 to p = 0.01) and for time (p < 0.001) and errors (p = 0.003) as measured by psychometric checklist. By ANOVA, improvement in novices' skill after FRS training on the RobotiX Mentor was not inferior to improvement reported after FRS training on previously published platforms. Completion of FRS on the RobotiX Mentor resulted in improved robotic surgery skills among novices, proving effectiveness of training. These data provide additional validity evidence for FRS and support use of the RobotiX Mentor for robotic surgery skill acquisition.

Proving the Effectiveness of the Fundamentals of Robotic Surgery (FRS) Skills Curriculum: A Single-blinded, Multispecialty, Multi-institutional Randomized Control Trial.

OBJECTIVE: To demonstrate the noninferiority of the fundamentals of robotic surgery (FRS) skills curriculum over current training paradigms and identify an ideal training platform. SUMMARY BACKGROUND DATA: There is currently no validated, uniformly accepted curriculum for training in robotic surgery skills. METHODS: Single-blinded parallel-group randomized trial at 12 international American College of Surgeons (ACS) Accredited Education Institutes (AEI). Thirty-three robotic surgery experts and 123 inexperienced surgical trainees were enrolled between April 2015 and November 2016. Benchmarks (proficiency levels) on the 7 FRS Dome tasks were established based on expert performance. Participants were then randomly assigned to 4 training groups: Dome (n = 29), dV-Trainer (n = 30), and DVSS (n = 32) that trained to benchmarks and control (n = 32) that trained using locally available robotic skills curricula. The primary outcome was participant performance after training based on task errors and duration on 5 basic robotic tasks (knot tying, continuous suturing, cutting, dissection, and vessel coagulation) using an avian tissue model (transfer-test). Secondary outcomes included cognitive test scores, GEARS ratings, and robot familiarity checklist scores. RESULTS: All groups demonstrated significant performance improvement after skills training (P < 0.01). Participating residents and fellows performed tasks faster (DOME and DVSS groups) and with fewer errors than controls (DOME group; P < 0.01). Inter-rater reliability was high for the checklist scores (0.82-0.97) but moderate for GEARS ratings (0.40-0.67). CONCLUSIONS: We provide evidence of effectiveness for the FRS curriculum by demonstrating better performance of those trained following FRS compared with controls on a transfer test. We therefore argue for its implementation across training programs before surgeons apply these skills clinically.

Urinary Bother as a Predictor of Postsurgical Changes in Urinary Function After Robotic Radical Prostatectomy.

OBJECTIVE: To characterize changes in indices of urinary function in prostatectomy patients with presurgical voiding symptoms. METHODS: A retrospective analysis of our prostate cancer database identified robot-assisted radical prostatectomy patients between April 2007 and December 2011 who completed pre- and postsurgical (24 months) Expanded Prostate Cancer Index Composite-26 surveys. Gleason score, margins, D'Amico risk, prostate-specific antigen, radiotherapy, and nerve-sparing status were tabulated. Survey questions addressed urinary irritation/obstruction, incontinence, and overall bother. Responses were averaged to calculate a urinary sum (US) score. Patients were stratified according to the severity of their baseline urinary bother (UB), and changes in urinary indices determined at 24 months. RESULTS: A total of 737 patients were included. Postsurgical improvement in urinary obstruction, bother, and sum score was related to baseline UB (P <.001). Men with severe baseline bother had the greatest improvement in US (+9.3), whereas those with asymptomatic baseline UB experienced a decline in US (-2.8). All patients experienced a decline in urinary incontinence of 6.3-8.3 that was independent of baseline bother (P = .507). Patients with severe UB experienced positive outcomes, whereas those at asymptomatic baseline experienced negative US outcomes. Negative urinary incontinence outcomes were unrelated to baseline UB. Age, radiotherapy, and nerve-sparing status were not associated with improved UB (P = .029). However, baseline UB was significantly associated with improvement in postsurgical UB (P = .001). CONCLUSION: Baseline UB is a predictor of postsurgical improvement in urinary function. These data are helpful when counseling a subset of robot-assisted laparoscopic radical prostatectomy patients with severe preoperative urinary symptoms.

Construction of a Urologic Robotic Surgery Training Curriculum: How Many Simulator Sessions Are Required for Residents to Achieve Proficiency?

PURPOSE: To define the time needed by urology residents to attain proficiency in computer-aided robotic surgery to aid in the refinement of a robotic surgery simulation curriculum. METHODS: We undertook a retrospective review of robotic skills training data acquired during January 2012 to December 2014 from junior (postgraduate year [PGY] 2-3) and senior (PGY4-5) urology residents using the da Vinci Skills Simulator. We determined the number of training sessions attended and the level of proficiency achieved by junior and senior residents in attempting 11 basic or 6 advanced tasks, respectively. RESULTS: Junior residents successfully completed 9.9 ± 1.8 tasks, with 62.5% completing all 11 basic tasks. The maximal cumulative success rate of junior residents completing basic tasks was 89.8%, which was achieved within 7.0 ± 1.5 hours of training. Of senior residents, 75% successfully completed all six advanced tasks. Senior residents attended 6.3 ± 3.5 hours of training during which 5.1 ± 1.6 tasks were completed. The maximal cumulative success rate of senior residents completing advanced tasks was 85.4%. CONCLUSION: When designing and implementing an effective robotic surgical training curriculum, an allocation of 10 hours of training may be optimal to allow junior and senior residents to achieve an acceptable level of surgical proficiency in basic and advanced robotic surgical skills, respectively. These data help guide the design and scheduling of a residents training curriculum within the time constraints of a resident's workload.

Surgical complications associated with robotic urologic procedures in elderly patients.

INTRODUCTION: Urologic malignancies are often diagnosed at an older age, and are increasingly managed utilizing robotic-assisted surgical techniques. As such, we assessed and compared peri-postoperative complication rates following robotic urologic surgery in elderly and younger patients. MATERIALS AND METHODS: A retrospective analysis of IRB-approved databases and electronic medical records identified patients who underwent robotic-assisted urologic surgery between December 2003-September 2013. Patients were grouped according to surgical procedure (partial nephrectomy, radical cystectomy, radical prostatectomy) and age at surgery (≤ 74 or ≥ 75 years old). Associations between age, comorbidities, Charlson comorbidity index (CCI), and patient outcomes were evaluated within each surgery type. RESULTS: 97.5% and 2.5% of patients were ≤ 74 or ≥ 75 years old, respectively. Cystectomies, partial nephrectomies and prostatectomies accounted for 3.5%, 9.5% and 87.1% of surgeries, respectively. Within cystectomy, nephrectomy and prostatectomy groups, 24.4%, 12.5% and 0.6% patients were ≥ 75 years old. Within each surgical type, elderly patients had significantly elevated CCI scores. Length of stay was significantly prolonged in elderly patients undergoing partial nephrectomy or prostatectomy. In elderly cystectomy, partial nephrectomy and prostatectomy patients, 36.7%, 14.3% and 5.9% suffered ≥ 1 Clavien grade 3-5 complication, respectively. Major complications were not significantly different between age groups. A qualitatively similar pattern was observed regarding Clavien grade 1-2 complications. CONCLUSIONS: The risks of robotic-assisted urologic surgery in elderly patients are not significantly elevated compared to younger patients.

Prostate atypia: does repeat biopsy detect clinically significant prostate cancer?

BACKGROUND: While the treatment pathway in response to benign or malignant prostate biopsies is well established, there is uncertainty regarding the risk of subsequently diagnosing prostate cancer when an initial diagnosis of prostate atypia is made. As such, we investigated the likelihood of a repeat biopsy diagnosing prostate cancer (PCa) in patients in which an initial biopsy diagnosed prostate atypia. METHODS: We reviewed our prospectively maintained prostate biopsy database to identify patients who underwent a repeat prostate biopsy within one year of atypia (atypical small acinar proliferation; ASAP) diagnosis between November 1987 and March 2011. Patients with a history of PCa were excluded. Chart review identified patients who underwent radical prostatectomy (RP), radiotherapy (RT), or active surveillance (AS). For some analyses, patients were divided into two subgroups based on their date of service. RESULTS: Ten thousand seven hundred and twenty patients underwent 13,595 biopsies during November 1987-March 2011. Five hundred and sixty seven patients (5.3%) had ASAP on initial biopsy, and 287 (50.1%) of these patients underwent a repeat biopsy within one year. Of these, 122 (42.5%) were negative, 44 (15.3%) had atypia, 19 (6.6%) had prostatic intraepithelial neoplasia, and 102 (35.6%) contained PCa. Using modified Epstein's criteria, 27/53 (51%) patients with PCa on repeat biopsy were determined to have clinically significant tumors. 37 (36.3%) proceeded to RP, 25 (24.5%) underwent RT, and 40 (39.2%) received no immediate treatment. In patients who underwent surgery, Gleason grade on final pathology was upgraded in 11 (35.5%), and downgraded 1 (3.2%) patient. CONCLUSIONS: ASAP on initial biopsy was associated with a significant risk of PCa on repeat biopsy in patients who subsequently underwent definitive local therapy. Patients with ASAP should be counseled on the probability of harboring both clinically significant and insignificant prostate cancer.

Active surveillance of renal masses: an analysis of growth kinetics and clinical outcomes stratified by radiological characteristics at diagnosis.

AIMS: To determine the growth rate of renal masses (RMs) under active surveillance (AS), and to describe the clinical outcome of AS patients. MATERIALS AND METHODS: We conducted a retrospective review of an AS database to obtain demographics, radiological and pathologic characteristics and RM size of patients. RMs were followed at 6-12 month intervals for ≥1 year with computed tomography (CT), magnetic resonance imaging (MRI), or renal ultrasound. Kaplan-Meier analysis determined the annual likelihood of intervention. RMs were divided into 3 radiographic subcategories (solid, cystic, and angiomyolipoma). A linear regression model determined RM growth rates. RESULTS: 131 RMs in 114 patients were included. Median age, Charlson Comorbidity Index score and mean follow-up were 69.1 years, 4.0 and 4.2±2.6 years, respectively. Maximal tumor diameter (MTD) at diagnosis was 2.1 ± 1.3 cm. 49 RMs exhibited negative or zero net growth. Mean MTD growth rate for all RMs was 0.72±3.2 (95% CI: 0.16-1.28) mm/year. When stratified by MTD at diagnosis, mean RM growth rates were 0.84, 0.84, 0.44, 0.74 and 0.71 mm/year for RMs ≤1 cm, 1-≤2cm, 2-≤ 3cm, 3-≤ 4cm and ≥4cm, respectively (p≤0.01). The 5 and 10-year freedom from intervention rates were 93.1% and 88.5%, respectively. There was a single case of suspected metastases, but no deaths related to kidney cancer. CONCLUSIONS: RMs under AS grew slowly, and had a low incidence of requiring surgical intervention and progression. Solid enhancing masses grew slowly, and were more likely to trigger intervention. AS should be considered for selected patients with small RMs.

Active surveillance of renal masses: an analysis of growth kinetics and clinical outcomes stratified by radiological characteristics at diagnosis

AIMS To determine the growth rate of renal masses (RMs) under active surveillance (AS), and to describe the clinical outcome of AS patients. Materials and Methods We conducted a retrospective review of an AS database to obtain demographics, radiological and pathologic characteristics and RM size of patients. RMs were followed at 6-12 month intervals for ≥1 year with computed tomography (CT), magnetic resonance imaging (MRI), or renal ultrasound. Kaplan-Meier analysis determined the annual likelihood of intervention. RMs were divided into 3 radiographic subcategories (solid, cystic, and angiomyolipoma). A linear regression model determined RM growth rates. Results 131 RMs in 114 patients were included. Median age, Charlson Comorbidity Index score and mean follow-up were 69.1 years, 4.0 and 4.2±2.6 years, respectively. Maximal tumor diameter (MTD) at diagnosis was 2.1±1.3 cm. 49 RMs exhibited negative or zero net growth. Mean MTD growth rate for all RMs was 0.72±3.2 (95% CI: 0.16-1.28) mm/year. When stratified by MTD at diagnosis, mean RM growth rates were 0.84, 0.84, 0.44, 0.74 and 0.71 mm/year for RMs <1 cm, 1-<2cm, 2-<3cm, 3-<4cm and ≥4cm, respectively (p<0.01). The 5 and 10-year freedom from intervention rates were 93.1% and 88.5%, respectively. There was a single case of suspected metastases, but no deaths related to kidney cancer. Conclusions RMs under AS grew slowly, and had a low incidence of requiring surgical intervention and progression. Solid enhancing masses grew slowly, and were more likely to trigger intervention. AS should be considered for selected patients with small RMs. .

Prognostic indices of perioperative outcome following transperitoneal laparoscopic adrenalectomy.

OBJECTIVES: We sought to identify preoperative patient and tumor characteristics that may be useful prognostic indicators of postsurgical outcome in patients undergoing laparoscopic adrenalectomy (LA). SUBJECTS AND METHODS: Data from 92 patients who underwent 93 transabdominal LA procedures between 2006-2012 were retrieved. Patients were stratified based on estimated blood loss (EBL), length of stay (LOS), and perioperative complications. Interdependencies between surgical outcome and patient demographics, tumor characteristics, comorbidities, and Charlson Comorbidity Index (CCI) were statistically analyzed. The predictive capacity of each index was assessed using receiver operating characteristic curves. RESULTS: Neither age, gender, tumor laterality, body mass index, American Society of Anesthesiologists (ASA) score, nor CCI predicted the occurrence of perioperative complications. EBL was significantly associated with increased age, tumor size, ASA score, and CCI, whereas prolonged LOS was associated with higher ASA score. Tumor size was related, although not significantly, to LOS and perioperative complications. Tumors ≥7.5 cm in diameter were significantly associated with worse perioperative outcomes. CONCLUSIONS: LA for adrenal lesions demonstrated reasonable complication rates and perioperative outcomes. Tumor size, CCI, and ASA score are predictive of increased EBL and LOS.

Predictors of postoperative decline in estimated glomerular filtration rate in patients undergoing robotic partial nephrectomy.

PURPOSE: To identify prognostic indicators of estimated glomerular filtration rate (eGFR) following robotic partial nephrectomy (RPN). MATERIALS AND METHODS: In a retrospective study of RPN patients, we examined data describing age, gender, eGFR, body mass index (BMI), tumor size (TS), length of stay, and estimated blood loss (EBL). Changes in eGFR (i.e., renal function trajectory [RFT]) and chronic kidney disease (CKD) stage shift were analyzed with mixed model linear and logistic regression analyses, Chi-squared, and t-tests. RESULTS: Changes in eGFR (RFT) were determined in 122 patients at baseline and at 6- and 12-month follow-up visits. Mean age, TS, and Charlson comorbidity index (CCI) were 62±11 years, 3±1.2 cm, and 4.8±1.8, respectively. The pre- and postoperative eGFR was lower in patients >60 years. Preoperative eGFR was unrelated to gender, BMI>30 kg/m(2), histopathology, nuclear grade, and TS. Univariate analyses determined that age, BMI>30, EBL>200 mL, CCI>5, and TS were associated with greater declines in eGFR. Reduced eGFR was also associated with warm ischemia time ≥22 minutes, while age was associated with a ≥1 worsening of British CKD classification. Using multivariate analysis, only age was significantly associated with a decline in eGFR, which was greater in patients with a normal preoperative eGFR. CONCLUSIONS: Patient age, BMI>30, EBL>200 mL, CCI>5, and TS were predictors of greater postoperative declines in eGFR. Although a decline in eGFR was proportionally greater in low stage CKD, postoperative changes are associated with advancing age.

Incidence and location of lymph node metastases in patients undergoing radical cystectomy for clinical non-muscle invasive bladder cancer: results from a prospective lymph node mapping study.

OBJECTIVES: The objective of this study is to investigate the incidence and location of lymph node metastases (LNMs) in patients undergoing radical cystectomy (RC) and lymph node dissection (LND) for clinical non-muscle invasive bladder cancer (NMIBC). METHODS AND MATERIALS: Prospectively collected data of 637 patients who underwent RC and 'superextended' LND with intent-to-cure for urothelial carcinoma of the bladder between 2002 and 2008 were examined. Inclusion criteria were (a) clinical stage Ta, Tis-only, or T1, (b) muscle presence at diagnostic transurethral resection in clinical T1 patients, (c) no prior diagnosis of ≥ T2 disease, (d) no neoadjuvant therapy, and (e) lymphatic tissue sample submitted from all 13 predesignated locations. Lymph node mapping was performed in all patients to determine the location of metastatic lymph nodes. Median follow-up time was 4.7 years. Recurrence-free survival and overall survival were reported. RESULTS: A total of 114 patients were included of whom 9 patients (7.9%) had LNM. Stratified by clinical stage, LNM was present in 6/67 (9.0%) patients with cT1, 3/25 (12.0%) patients with cTis-only, and none of the 22 patients with cTa. Of the 9 node-positive patients (33.3%), 3 had LNM proximal to the aortic bifurcation. No skip metastases were found. After RC, 27 patients (23.7%) were upstaged to muscle invasive disease; of whom 16.7% had cT1, 2.6% had cTa, and 4.4% had cTis-only. Of the remaining 87 patients with pathologic NMIBC, 1 patient (1.1%) had LNM, limited to the true pelvis. Five-year RFS was 82.3%, 81.5%, and 62.0% in patients with pathologic NMIBC, clinical NMIBC, and pathologic muscle invasive bladder cancer, respectively. CONCLUSIONS: Routine LND is important in patients with cT1 and cTis-only bladder cancer, but may have limited value in patients with cTa. LNM beyond the boundaries of a standard LND occurred in up to one-third of node-positive patients. In the absence of skip metastases, however, performing a standard LND would correctly identify all node-positive patients. Whether removal of LNM proximal to the common iliac vessels provides a survival benefit remains to be evaluated in future prospective studies.

Was a Change to a Urologist Owned Pathology Laboratory Associated with a Change in Prostate Biopsy Use?

INTRODUCTION: We assessed the impact of self-referral to urologist owned pathology facilities on prostate biopsy practice patterns, clinical decision making and pathology service use. METHODS: We reviewed a transrectal ultrasound guided prostate biopsy database during 2 periods, including 1) August 5, 2008 to April 10, 2010 (613 days) when pathology samples were sent to an independent service laboratory, and 2) June 11, 2010 to February 13, 2012 (613 days) when samples were assessed at a urologist owned pathology laboratory. We also examined data on 3 additional preceding equal length periods before urologist ownership to determine baseline biopsy rates. Billing databases were used to identify the number of new patient visits for increased prostate specific antigen and/or abnormal digital rectal examination. The Student t-test, and Wilcoxon rank sum and chi-square tests were used for statistical comparisons. RESULTS: All biopsies were obtained using a standard transrectal ultrasound guided prostate biopsy protocol. The biopsy rate in patients with increased or abnormal digital rectal examination was 39% during the urologist owned pathology laboratory era, and 35%, 40%, 35% and 40% during the 4 preceding independent service laboratory periods of equal length. There was no statistically significant difference in patient age, rate of abnormal digital rectal examination or indications for repeat transrectal ultrasound guided prostate biopsy among the periods. The prostate cancer detection rate was 45% in the independent service laboratory era and 46% in the urologist owned pathology laboratory era. CONCLUSIONS: Self-referral of transrectal ultrasound guided prostate biopsy specimens to urologist owned pathology facilities was not associated with a significant variation in the biopsy rate, the repeat biopsy rate, indications triggering repeat biopsy or the cancer detection rate.

Unaltered oncological outcomes of radical cystectomy with extended lymphadenectomy over three decades.

OBJECTIVE: To evaluate oncological outcome trends over the last three decades in patients after radical cystectomy (RC) and extended pelvic lymph node (LN) dissection. PATIENTS AND METHODS: Retrospective analysis of the University of Southern California (USC) RC cohort of patients (1488 patients) operated with intent to cure from 1980 to 2005 for biopsy confirmed muscle-invasive urothelial bladder cancer. To focus on outcomes of unexpected (cN0M0) LN-positive patients, the USC subset was extended with unexpected LN-positive patients from the University of Berne (UB) (combined subgroup 521 patients). Patients were grouped and compared according to decade of surgery (1980-1989/1990-1999/≥2000). Survival probabilities were calculated with Kaplan-Meier plots, log-rank tests compared outcomes according to decade of surgery, followed by multivariable verification. RESULTS: The 10-year recurrence-free survival was 78-80% in patients with organ-confined, LN-negative disease, 53-60% in patients with extravesical, yet LN-negative disease and ≈30% in LN-positive patients. Although the number of patients receiving systemic chemotherapy increased, no survival improvement was noted in either the entire USC cohort, or in the combined LN-positive USC-UB cohort. In contrast, patient age at surgery increased progressively, suggesting a relative survival benefit. CONCLUSIONS: Radical surgery remains the mainstay of therapy for muscle-invasive bladder cancer. Yet, our study reveals predictable outcomes but no survival improvement in patients undergoing RC over the last three decades. Any future survival improvements are likely to result from more effective systemic treatments and/or earlier detection of the disease.

The impact of body mass index on perioperative outcomes in robot-assisted laparoscopic partial nephrectomy.

BACKGROUND AND PURPOSE: Obese patients undergoing surgical procedures are at increased risk for perioperative morbidity. The purpose of this study is to determine whether there is an association with body mass index (BMI), clinicopathologic features, and perioperative outcomes and complications in patients undergoing robot-assisted laparoscopic partial nephrectomy (RPN). PATIENTS AND METHODS: Medical records of 283 patients who underwent RPN between 2007 and 2012 were reviewed from an Institutional Review Board approved database. We analyzed the association of perioperative outcomes and complications of the surgery with BMI and clinicopathologic features using analysis of variance, Kruskal-Wallis test, t test and chi-square-test. Eventually, independent factors associated with perioperative outcomes and complications were studied using univariate and multivariate regression analysis. RESULTS: Perioperative outcomes including estimated blood loss (EBL), length of hospital stay (LOS) and operative time (OT) were significantly associated with BMI (P=0.002, P=0.009 and P=0.002, respectively). Warm ischemia time (WIT), perioperative complications, and change in glomerular filtration rate (GFR) before and after surgery were not associated with BMI (P=0.459, P=0.86 and P=0.773). In multivariate analysis, BMI, tumor size≥4 cm, and collecting system invasion were independently associated with EBL and OT. Increased LOS was independently associated with BMI and tumor size ≥4 cm. CONCLUSIONS: Increasing BMI was not associated with a significant increase in perioperative complications, WIT, or change in GFR in patients undergoing RPN at a high-volume tertiary medical center. Collecting system invasion or tumor size ≥4 cm and BMI were independently associated with higher EBL, LOS, and OT, however.

Outcomes after radical prostatectomy for patients with clinical stages T1-T2 prostate cancer with pathologically positive lymph nodes in the prostate-specific antigen era.

OBJECTIVES: To evaluate the outcomes of radical prostatectomy (RP) and pelvic lymph node dissection (PLND) for clinically organ confined prostate cancer (CaP) with regional lymph node metastases (pN1) treated in the era of prostate-specific antigen (PSA) screening. MATERIALS AND METHODS: A single institution cohort of 2,487 men with cT1-T2 CaP treated with open radical prostatectomy and pelvic lymph node dissection between 1988 and 2008 were analyzed. Kaplan-Meier and Cox proportional regression models were used to analyze overall survival (OS), clinical recurrence-free survival (cRFS), and biochemical recurrence-free survival (bRFS). RESULTS: Overall, 150 out of 2,487 patients (6%) had pN1 disease, with a median follow-up of 10.4 years. The predicted 10-year OS, cRFS, and bRFS rates for patients with pN0 and pN1 were 86% and 74% (Log rank P < 0.001), 97% and 84% (Log rank P < 0.001), and 88% and 57% (Log rank P < 0.001), respectively. In the subset of pN1 patients treated with surgery only (n = 49), the predicted 10-year OS, cRFS, and bRFS rates were 81%, 80%, and 59%, respectively. Exploratory univariate regression analysis showed that age (P = 0.003), total number of lymph nodes identified (P = 0.040), and total number of positive lymph nodes identified (P = 0.004) were associated with OS. Total number of positive lymph nodes (LNs) identified was also significantly associated with cRFS (P = 0.05). CONCLUSIONS: The incidence of pN1 in patients with cT1-T2 CaP treated with surgery in the era of PSA screening was low. RP and PLND demonstrated therapeutic efficacy in a subset of pN1 patients treated with surgery alone.

Neoadjuvant chemotherapy with gemcitabine/cisplatin vs. methotrexate/vinblastine/doxorubicin/cisplatin for muscle-invasive urothelial carcinoma of the bladder: a retrospective analysis from the University of Southern California.

OBJECTIVES: We evaluated pathologic and survival outcomes of GC (gemcitabine/cisplatin) and methotrexate/vinblastine/doxorubicin/cisplatin (M-VAC) neoadjuvant chemotherapy (NAC) in patients with muscle-invasive bladder cancer (MIBC). MATERIALS AND METHODS: A retrospective analysis of prospectively collected data on 116 patients who received NAC (GC: n = 58; M-VAC: n = 58) before radical cystectomy and superextended pelvic lymph node dissection for clinical stage T2-4N0M0 bladder cancer was performed. The outcomes were complete response rate (CRR; pT0N0), partial response rate (PRR; pT0N0, pTaN0, pT1N0, or pTisN0), overall mortality (OM), and recurrence. The Kaplan-Meier method and multivariable Cox regression analysis were used to analyze OM. The cumulative incidence method and Fine and Gray's competing risk regression analysis were used to analyze recurrence. RESULTS: The median follow-up duration was 2.1 years for the GC group and 7.4 years for the M-VAC group (P < 0.001). There were no statistically significant differences between the GC and M-VAC groups with regard to CRR (27.3% vs. 17.1%, P = 0.419) or PRR (45.5% vs. 37.1%, P = 0.498). The predicted 5-year freedom from OM rate (P = 0.634) and cumulative incidence of recurrence rate (P = 0.891) did not differ between the GC and M-VAC groups. Multivariable analysis showed that there was no independent association between type of NAC and OM (P = 0.721) or recurrence (P = 0.065). CONCLUSIONS: Pathologic and survival outcomes did not differ in patients who received GC and M-VAC NAC. These data support the use of the GC regimen in the neoadjuvant setting.

Critical evaluation of the American Joint Committee on Cancer TNM nodal staging system in patients with lymph node-positive disease after radical cystectomy.

BACKGROUND: The current 7th edition of the American Joint Committee on Cancer TNM staging system for bladder cancer stages lymph node (LN)-positive disease based on LN location rather than LN size. In addition, common iliac LNs are now considered regional LNs. Whether these changes improve prognostication for node-positive patients, however, remains unclear. OBJECTIVE: To investigate whether the 7th edition of the TNM nodal staging system provides superior prognostication compared with the 6th edition. DESIGN, SETTING, AND PARTICIPANTS: Patients between 2002 and 2008 with LN metastases after radical cystectomy combined with extended or superextended LN dissection were included. Patients were staged using both TNM staging systems. Median follow-up was 54 mo. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Kaplan-Meier curves were used to estimate overall survival (OS) and recurrence-free survival (RFS). Log-rank tests and Cox proportional hazard regression models were used to test associations of pathologic variables with OS and RFS. RESULTS AND LIMITATIONS: Included were 146 patients with LN metastases of whom 131 patients underwent superextended LN dissection and 15 patients underwent extended LN dissection. Although in the 7th TNM edition many patients moved from the N2 category to the N3 category, RFS did not significantly differ within the nodal subgroups in either editions. LN metastases at or above the aortic bifurcation were not associated with decreased RFS (p=0.67). On multivariable analysis, the presence of extravesical disease (hazard ratio [HR]: 2.84; p=0.002), absence of adjuvant chemotherapy (HR: 0.32; p<0.0001), and more than six positive LNs (HR: 2.72; p=0.007) were associated with decreased RFS. This was a retrospective study with inherent limitations. CONCLUSIONS: LNs at or above the aortic bifurcation should be considered regional LNs. Neither the 6th nor the 7th TNM staging system performed well as a prognostic tool. A better staging system for LN-positive bladder cancer needs to be developed.

Long-term outcomes of open radical retropubic prostatectomy for clinically localized prostate cancer in the prostate-specific antigen era.

OBJECTIVE: To determine long-term oncological outcomes and complication rates for patients with clinically organ confined prostate adenocarcinoma (PCa) treated with open radical retropubic prostatectomy and pelvic lymph node dissection (RRP/PLND) in the prostate-specific antigen (PSA) era. METHODS: Outcomes data were obtained from a prospectively maintained prostate cancer database. Patients with cT1/cT2 PCa undergoing RRP/PLND without neoadjuvant therapy between July 1988 and June 2008 were included. Kaplan-Meier and Cox proportional regression models were used to evaluate factors influencing biochemical recurrence, clinical recurrence, and overall survival (OS). RESULTS: A total of 2487 patients met inclusion criteria, and median follow-up was 7.2 years (range 1-21 years). Of the patients, 49.7% were low risk, 33.2% intermediate risk, and 16.1% high risk by D'Amico criteria, and 6% were LN+. The 10-year biochemical recurrence-free survival (BCRFS) for low-, intermediate-, and high-risk patients was 92%, 83%, and 76%, respectively (P < .001), and 10 year OS was 91%, 83%, and 74%, respectively (P < .001). BCRFS at 10 years was 76% and 88% for patients with positive and negative margins, respectively (P < .001). Of the 2487 patients, 11% developed BCR, and 3.7% experienced CR, with 9 local recurrences. The overall complication rate was 2.3%, and the cancer specific mortality rate was 2%. CONCLUSION: D'Amico risk group, margin status, and LN status are significantly correlated with outcomes in patients undergoing RRP/PLND for clinically localized PCa. Local recurrence and death from prostate cancer are rare in patients undergoing open RRP/PLND for clinically organ confined disease in the PSA era.