Minimally invasive cytoreductive radical prostatectomy, exploring the safety and feasibility of a single-port or multi-port robotic platform.

BACKGROUND: Consolidative resection or cytoreductive radical prostatectomy (CRP) may benefit men with non-organ confined prostate cancer. We report the safety, feasibility, and outcomes of robot-assisted laparoscopic CRP using a single-port (SP) or multi-port (MP) platform. METHODS: We reviewed consecutive men with clinical node positive or metastatic castrate-sensitive prostate cancer who underwent IRB-approved CRP and extended pelvic lymph node dissection using the da Vinci SP or MP Surgical Systems (Intuitive Surgical, Sunnyvale, CA) from 2015-2022. Perioperative data and Clavien-Dindo 90-day complications were recorded. RESULTS: Twenty-four men with a median age of 61 (IQR 56-69) years and prostate-specific antigen of 32.1 (IQR 21.9-62.3) ng/mL were included. Clinical N1, M1, or N1 + M1 disease were detected in 8 (33%), 9 (38%), 7 (29%) patients, respectively. There was no difference in positive margins, 41% vs. 29% (P = 0.67), lymph node yield, 21 (IQR 14-28) vs. 20 (IQR 13.5-21) nodes (P = 0.31), or estimated blood loss, 150 mL (IQR 100-200) vs. 50 mL (IQR 50-125) (P = 0.06), between the MP and SP cohorts, respectively. Hospital length of stay was significantly shorter for the SP group, same-day discharge (IQR 0-0), compared to MP, 1-day (IQR 1-1), P < 0.001. One grade III bowel obstruction and lymphocele occurred in the MP cohort. No major complications occurred in the SP cohort. CONCLUSION: Robot-assisted laparoscopic CRP is safe and feasible for select men with advanced castrate-sensitive prostate cancer.

Ureteroenteric anastomotic revision as initial management of stricture after urinary diversion.

OBJECTIVE: To report our experience with ureteroenteric anastomotic revision as initial treatment of stricture after urinary diversion. METHODS: An institutional review board-approved retrospective study was carried out. A total of 41 patients who underwent primary ureteroenteric anastamotic revision were identified between 2007 and 2015. Data analyzed included patient characteristics, type of diversion, estimated blood loss, operative time, change in renal function, length of stay, postoperative complications and time with nephrostomy/stent. Success of revision was defined as an improvement in hydronephrosis on radiographic imaging and/or reflux during pouchogram. Predictors of length of stay and complications were analyzed using analysis of covariance. RESULTS: A total of 50 renal units were revised with a success rate of 100%. The median length of stay was 6 days (2-16 days). There were a total of 15 complications (one major, 14 minor) in 14 patients (33% 30-day complication rate). The most common were wound infection (n = 4) and arrhythmia (n = 4). Robotic revision (n = 5) had a median length of stay of 3 days (2-4) with no complications. CONCLUSIONS: Primary ureteroenteric anastomotic revisions have an excellent success rate at an experienced center and might obviate the need for multiple interventions. Open revision is associated with mostly minor complications. Robotic revision might reduce the morbidity of open revision in select cases.

Long-term Outcomes and Patient Satisfaction Following Salvage Robot-assisted Radical Prostatectomy: A Modern Perspective.

Background and objective: Approximately two-thirds of men who undergo primary treatment for prostate cancer (PC) will experience biochemical recurrence (BCR). Salvage robot-assisted radical prostatectomy (sRARP) offers curative treatment in this disease setting and men who choose this option may avoid palliative androgen deprivation therapy (ADT). The purpose of this study was to describe long-term outcomes and patient feedback following sRARP. Methods: We reviewed data for consecutive men with biopsy-proven localized BCR who underwent sRARP and pelvic lymph node dissection at a single tertiary referral center between 2004 and 2021. Perioperative data, Clavien-Dindo complications, and functional outcomes were recorded. The Kaplan-Meier method was used to estimate prostate-specific antigen-free (≥0.2 ng/ml) survival (PSAFS) and metastasis-free survival (MFS). Three Likert-type items (score 1-5) from the validated Surgical Satisfaction Questionnaire-8 were distributed to patients postoperatively. Key findings and limitations: We included 78 men, of whom 72 (92%) had undergone primary radiotherapy and six (8%) had received primary prostate ablation. Median follow-up was 10.1 yr (interquartile range 5.8-12.4). Final pathology identified ≥pT3N0M0 in 35 patients (45%) and positive margins in 23 (29%). The overall complication rate was 50%. Of the 26 (33%) major (grade ≥III) complications, anastomotic stricture (32%) was most common. The estimated 3-, 5-, and 10-yr survival rates were 85.6% and 80.2%, 83.5% for PSAFS (n = 11), and 74.1%, 83.5%, and 70.5% for MFS (n = 23), respectively. At last follow-up, postoperative ADT had been administered to 17 patients (22%), and 39 men (50%) remained alive a decade after sRARP. Continence and potency were maintained in 33/62 (53%) and 1/16 (6%) patients, respectively. Thirty-five respondents (45%) reported median questionnaire scores (≥4) in favor of sRARP. Limitations include the small single-center series and a single query point for patient feedback. Conclusions and clinical implications: Long-term outcomes of sRARP suggest that the technical challenges and morbidity of the procedure are qualified by patient feedback and the opportunity to evade the morbidity and mortality of biochemically recurrent PC. Patient summary: We reviewed the cancer outcomes and side effects of robot-assisted surgical removal of the prostate after treatment failure with radiation or ablation for prostate cancer. We found that this type of treatment has substantial risks and long-term side effects, but the surgery provides an opportunity to cure prostate cancer and/or avoid the consequences of indefinite hormonal treatment. Overall, most men who underwent this surgery were not disappointed with their decision despite the higher risks and consequences.

Indiana Pouch Continent Cutaneous Urinary Diversion After Robotic-assisted Radical Cystectomy: A 16-Year Experience.

BACKGROUND: Population-based practice patterns in the United States reveal continent diversions are only performed in 8%-10.4% of patients.1-4 Ideally, for patients undergoing radical cystectomy the choice of urinary diversion should be influenced by clinical factors and patient preference, with discussions surrounding quality of life. Unfortunately, receipt of continent diversion has been shown to be influenced by a plethora of other factors such as surgeon preference/training, geography, socioeconomic status, gender, and hospital volume.1-3 Thus, by providing detailed instruction and long-term follow-up, we hope to mitigate some of these disparities by changing the perceptions regarding feasibility and complications of continent diversions. OBJECTIVE: To provide step-by-step instruction and to report long-term clinical outcomes in bladder cancer patients receiving an Indiana pouch continent cutaneous urinary diversion (CCUD) after robot-assisted radical cystectomy. DESIGN, SETTING, AND PARTICIPANTS: After Institutional Review Board approval, a prospectively maintained bladder cancer database was queried for patients with T1-T4, N0-N1, M0 bladder cancer undergoing radical cystectomy with CCUD at a tertiary referral center from 2004 to 2020. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Complications at 30- and 90-day were recorded according to the Clavien-Dindo classification. Continence rates were recorded by chart review. RESULTS AND LIMITATIONS: A total of 97 patients were included with a median follow-up of 93months. Clinically, 91.8% had ≤T2 disease and 29.9% received neoadjuvant chemotherapy. The median length of surgery was 8.0 hours, length of hospital stay was 8.3days, and urinary continence rate was 99.0%. The overall complication rate was 73.2% and 76.5% at 30- and 90-day, respectively. The major complication rate (Clavien III-V) was 17.5% at 30-day and 22.7% at 90-day. The most common major complications were abdominal infection and uretero-colonic stricture. The readmission rate was 21.4% and median overall survival was 108months. CONCLUSION: CCUD provides exceptional functional outcomes with acceptable complication rates compared to other diversion types. CCUD is a reliable reconstructive option and with this step-by-step video as a reference, we hope it will be offered to more patients.

Pooled analysis of clinical outcomes with neoadjuvant cisplatin and gemcitabine chemotherapy for muscle invasive bladder cancer.

PURPOSE: Neoadjuvant chemotherapy for muscle invasive bladder cancer has been shown to confer a survival advantage in phase III studies. Although cisplatin and gemcitabine are often used in this setting, a comprehensive evaluation of this regimen is lacking. In this review we summarize the efficacy of neoadjuvant cisplatin and gemcitabine chemotherapy for muscle invasive bladder cancer based on currently published studies. MATERIALS AND METHODS: A systematic literature review was conducted in April 2012 searching MEDLINE® databases. Articles were selected if they included patients with muscle invasive bladder cancer, evaluated the combination of cisplatin and gemcitabine as neoadjuvant treatment, and reported pathological data after cystectomy. Cisplatin and gemcitabine dosing regimens and clinical data were further summarized using weighted averages. RESULTS: Seven studies encompassing 164 patients were published between 2007 and 2012. The majority of patients (79%) received cisplatin and gemcitabine on a 21-day cycle. A weighted average of 19.2 lymph nodes was obtained at cystectomy, and 29.7% of patients were found to have pN1 disease. Pathological down staging to pT0 and less than pT2 occurred in 42 (25.6%) and 67 (46.5%) patients, respectively. CONCLUSIONS: Neoadjuvant cisplatin and gemcitabine yield appreciable pathological response rates in patients with muscle invasive bladder cancer. Since pathological response has been implicated as a potential surrogate for survival in muscle invasive bladder cancer, these data suggest that neoadjuvant cisplatin and gemcitabine may warrant further prospective assessment.

Standardized comparison of robot-assisted limited and extended pelvic lymphadenectomy for prostate cancer.

UNLABELLED: WHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: Extended pelvic lymphadenectomy is the present standard of care according to European Association of Urology guidelines. Extended dissection improves staging, removes more metastatic lymph nodes, and potentially has therapeutic benefits. Previous reports have examined the morbidity of extended dissection compared with a more limited dissection in the open and laparoscopic setting. While some have suggested an increased complication rate with extended node dissection, others have not. This represents the first study focused on comparing the complications associated with the extent of node dissection using the modified Clavien system and Martin criteria in the literature on robot-assisted surgery. In a single surgeon series, we found no statistically significant differences in complications. With careful anatomic dissection, robot-assisted extended lymph node dissection can be performed safely and effectively, although operating time and length of hospital of stay are slightly increased. OBJECTIVES: To compare the perioperative course of patients undergoing robot-assisted limited lymph node dissection (LLND) or extended lymph node dissection (ELND) for prostate cancer. To examine the differential lymph node counts and rates of detection of lymph node metastases. PATIENTS AND METHODS: Between 2008 and 2012, 406 consecutive patients with D'Amico intermediate- or high-risk prostate cancer underwent either bilateral LLND (n = 204) or ELND (n = 202) and robot-assisted laparoscopic radical prostatectomy by a single surgeon. The region of dissection was the obturator fossa for LLND, while ELND included, in addition, the common iliac, external iliac and internal iliac lymph nodes. All complications within 90 days of surgery were recorded according to a modified Clavien system. Clinical variables were summarized and compared. Logistic regression was used to identify predictors of complications. RESULTS: There were no differences in demographics when comparing patients who underwent ELND with those who underwent LLND. The median operating time was 3.0 h for the ELND cohort and 2.8 h in the LLND cohort (P < 0.001). Intraoperative blood loss was 200 mL in both cohorts. Hospital stay was longer for a small percentage of patients in the ELND cohort, with 75% of ELND patients and 85% of LLND patients staying 1 day (P = 0.004). No significant difference was found in the overall or major complication rates between LLND (21.6% overall; 6.9% major) and ELND (22.8% overall; 4.5% major). No difference was seen in the symptomatic lymphocele rate between LLND and ELND, 2.9 vs 2.5%, respectively. Overall, the lymph-node-positive rate was 12% compared with 4% for the ELND and LLND groups, respectively (P = 0.002). A higher Charlson comorbidity index score was associated with the development of major complications. CONCLUSIONS: ELND at the time of robot-assisted radical prostatectomy can be performed safely with minimal additional morbidity. Long-term oncological and functional outcomes require further study.

Novel Antibiotic-Irrigating Wound Protector Reduces Infectious Complications in Robot-Assisted Radical Cystectomy with Extracorporeal Urinary Diversion.

OBJECTIVE: To determine whether use of an antibiotic-irrigating wound protector (AWP) reduces infectious complications after robotic radical cystectomy with extracorporeal urinary diversion (RCUD). METHODS: A prospectively maintained bladder cancer database was queried for patients undergoing robotic RCUD at a tertiary referral center one year prior to implementing an AWP and one year after (2018-2020). All diversions were performed extra-corporally. 92 patients total. 46 consecutive patients using a traditional wound protector (TWP) and 46 consecutive with an AWP. Infections were classified as symptomatic urinary tract infection, blood stream infection, and surgical site infection. The incidence of infectious complications at 30- and 90-days were compared. RESULTS: Baseline patient characteristics between the 2 groups showed no statistically significant differences. The overall complication rate was 65.2% in the TWP group and 26.1% in the AWP group at 30-days, and 67.4% vs 30.4% at 90-days. Focusing on infections, the 30-day complication rate was 30.4% in the TWP group compared to 6.5% in the AWP group (P =.003). This pattern persisted at 90-days with 37.0% in the TWP group compared to 6.5% in the AWP group (P =.004). Most complications were symptomatic UTI and blood stream infections, 14/24 (58%), requiring parenteral antibiotic treatment. CONCLUSION: We provide preliminary data showing use of an AWP can reduce infectious complications after RCUD. While larger prospective studies are warranted, our findings are a significant step towards decreasing morbidity of an already highly morbid procedure.

Impact of previous abdominal surgery on robot-assisted radical cystectomy.

OBJECTIVE: We analyzed the effect of previous abdominal surgery (PAS) on consecutive patients who underwent robot-assisted radical cystectomy (RARC). MATERIALS AND METHODS: From 2005 to 2008, 73 patients at a single institution underwent RARC with bilateral extended pelvic lymph node dissection and urinary diversion. Lysis of adhesions was performed robotically and laparoscopically. Records were reviewed to assess the impact of PAS on operative outcomes and complications up to 3 months after surgery. RESULTS: Of the 73 patients, 37 (51%) had undergone PAS. Of these 37, 6 (16%) had PAS above the umbilicus, and 31 (84%) had surgery either above and below or strictly below the umbilicus. Patients with PAS were significantly older than those without (P<0.01). No statistically significant difference was seen with respect to blood loss, transfusion requirement, operative time, lysis of adhesion time, length of ICU stay, overall hospital stay, or the need for reoperation between patients with PAS and those without PAS. The overall postoperative complication rate was higher in the group with PAS (P=0.04). Lymph node yield was higher in patients without PAS (P<0.01). Patients with PAS below the umbilicus had a significantly longer hospital stay than patients with surgery strictly above the umbilicus had (P=0.01). Whether individuals had previously undergone single or multiple surgeries had no significance. CONCLUSION: Robot-assisted radical cystectomy in patients with a history of previous surgery may carry a higher risk for postoperative complications. However, previous operations do not appear to affect the likelihood of a safely completed robotic operation. Patients should be counseled about their risk of obstacles after surgery.

A delay ≥8 weeks to neoadjuvant chemotherapy before radical cystectomy increases the risk of upstaging.

OBJECTIVES: To investigate delays to neoadjuvant chemotherapy (NAC) and radical cystectomy (RC) and their effect on outcomes in a large national registry of patients with localized muscle invasive bladder cancer. PATIENTS AND METHODS: Within the National Cancer Database (2004-2014), we identified 2,227 patients who underwent NAC and RC for cT2-T4aN0M0 urothelial carcinoma of the bladder. Times from diagnosis to treatments were tested for association with overall survival and pathologic outcomes, using Cox models, and restricted cubic splines regression. RESULTS: Median times from diagnosis to NAC and RC were 39 days (interquartile range: 26-56) and 155 days (interquartile range: 131-185), respectively. Time to NAC and time to RC were not associated with overall survival in the complete cohort, as well as in subgroups of responders and nonresponders to NAC. Overall, 916 patients (41%) were upstaged after RC, including 485 patients (22%) with positive lymph nodes. We identified delay to NAC ≥8 weeks as a significant cut-off point to predict the risk of upstaging in multivariable analysis (odds ratio: 1.27; 95% confidence interval: 1.02-1.59; P = 0.031). Black race, Medicaid insurance, and academic facilities were associated with a higher risk of delayed treatment. CONCLUSION: After diagnosis of muscle invasive bladder cancer, NAC should be initiated as soon as possible and no more than 8 weeks to prevent upstaging. There is no evidence to support avoiding NAC due to concerns of delayed RC that was generated from surgery alone studies, as long as RC is performed within 7 months from initial diagnosis.

Real-time indocyanine green angiography with the SPY fluorescence imaging platform decreases benign ureteroenteric strictures in urinary diversions performed during radical cystectomy.

BACKGROUND: Ischemia is thought to contribute to benign ureteroenteric stricture (UES) after radical cystectomy with urinary diversion (RCUD). Our institution adopted the use of ureteral perfusion assessment during all RCUDs using real-time indocyanine green angiography using the SPY fluorescence imaging platform (Stryker Corp., Kalamazoo, MI, USA). This guides the location of ureteral transection prior to ureteroenteric anastomosis. We sought to compare UES rates before and after adoption of SPY. METHODS: A retrospective chart review was undertaken for the first 47 consecutive cases of RCUD using SPY as well as the previous 47 consecutive cases, which were performed without SPY. Fisher's exact and Wilcoxon rank-sum tests were used to compare benign UES rates and the length of ureter excised during anastomosis. A p < 0.05 indicated statistical significance. RESULTS: Median follow up was 12.0 months for SPY cases and 24.3 months for non-SPY cases. The UES rate for SPY RCUDs was 0% (0/93 ureters) compared with 7.5% (7/93 ureters) for non-SPY RCUDs (p = 0.01). Amongst SPY RCUDs, 86 ureters had no hydronephrosis and 7 had mild hydronephrosis with reflux on loopogram. A total of 34.4% of ureters (32/93) had poor distal perfusion, requiring a more proximal anastomosis. The median length excised for ureters with poor distal perfusion was 3.8 cm, compared with 2.2 cm for ureters with good distal perfusion (p < 0.0001). No complications attributable to the use of SPY were noted. CONCLUSION: Use of SPY to assess ureteral perfusion was associated with a decrease in the UES rate after RCUD. A total of 34.4% of ureters demonstrated poor distal perfusion, requiring a significantly more proximal ureteroenteric anastomosis.

Results of Phase 1 study on cytoreductive radical prostatectomy in men with newly diagnosed metastatic prostate cancer.

BACKGROUND: Preclinical and retrospective data suggest that cytoreductive radical prostatectomy may benefit a subset of men who present with metastatic prostate cancer (mPCa). Herein, we report the results of the first planned Phase 1 study on cytoreductive surgery. METHODS: From four institutions, 36 patients consented to the study. However, four did not complete surgery because of rapid disease progression (n = 3) and another because of an intraoperatively discovered pericolonic abscess. Men with newly diagnosed clinical mPCa to lymph nodes or bones were eligible. The primary endpoint was the rate of major perioperative complications (Clavien-Dindo Grade 3 or higher) occurring within 90 days of surgery. RESULTS: The mean age at surgery was 64.0 years. The 90-day overall complication rate was 31.2% (n = 10), of which two (6.25%) were considered major complications: one acute tubular necrosis requiring temporary dialysis and one death. In men with more than 6 months of follow-up, 67.9% had prostate specific antigen nadir ≤0.2 ng/mL, while one patient experienced a rapid rise in prostate specific antigen and another a widely disseminated disease that resulted in death 5 months after surgery. Altogether, these results demonstrate that cytoreductive radical prostatectomy is safe and surgically feasible in selected patients who present with mPCa . Yet, there may be a small subset of patients in whom surgery may cause a significant harm. CONCLUSION: Therefore, cytoreductive surgery in men with mPCa should be limited to clinical trials until robust data are available.

Lymph Node Fluorescence During Robot-Assisted Radical Prostatectomy With Indocyanine Green: Prospective Dosing Analysis.

OBJECTIVE: To prospectively assess the ideal dosing and the value of fluorescent sentinel lymph node (LN) detection with indocyanine green (ICG) for the detection of LN metastases in intermediate- and high-risk patients undergoing robot-assisted prostatectomy and extended pelvic LN dissection (ePLND). PATIENTS AND METHODS: Twenty patients received transperineal prostatic injections of ICG. Patients were cycled through 5 doses (1.25, 2.5, 3.75, 5, and 7.5 mg) so optimal ICG dosing could be discovered early. RESULTS: ICG injection was able to identify fluorescent LN (FLN) packets in all 20 patients. Compared to the higher ICG doses, the 1.25 and 2.5 mg doses had fewer FLN packets and were abandoned after 1 dose each. The median number of FLN packets was 4.0, 6.0, and 4.5 for the respective doses of 3.75, 5.0, and 7.5 mg. The external iliac group was the most common site of fluorescence in 27.2% of patients, followed by the common iliac (21.3%), obturator (20.3%), internal iliac (18.5%), and node of Cloquet (7.7%). Seven (35%) of 20 patients had node-positive disease. Of the 5 patients that had fluorescent tissue outside of our ePLND template, 1 had a positive node present in the anterior bladder neck fat. Across all patients, ICG had 62% sensitivity, 50% specificity, 8% positive predictive value, and 95% negative predictive value in detecting LN metastases. CONCLUSION: The low sensitivity of ICG for the detection of LN metastases highlights why FLN dissection with ICG does not represent an alternative to ePLND.

Utilization of perioperative systemic chemotherapy in upper tract urothelial carcinoma.

INTRODUCTION: Evidence for the use of perioperative chemotherapy (PC) in upper tract urothelial carcinoma (UTUC) is largely derived from level I evidence for invasive urothelial carcinoma of the bladder (UCB). There has been an increase in PC for urothelial carcinoma of the bladder, as it has disseminated into clinical practice. Therefore, we sought to not only analyze trends in the utilization of PC in UTUC, but also assess factors associated with its use in a large cancer registry database. METHODS: The National Cancer Database was queried for patients with UTUC who underwent extirpative surgery from 2004 to 2013. Predictors of receiving PC were identified using univariate and multivariate logistic regression. Temporal trends in the utilization of PC were also analyzed using a general analysis of variance linear model. RESULTS: From 2004 to 2013, there was significant increase in PC for UTUC from 9.6% to 13.8% (P = 0.0003). Neoadjuvant chemotherapy increased from 0.7% to 2.1% (P = 0.0018), whereas adjuvant chemotherapy remained relatively stable at 11.3%. Significant predictors of receiving PC on multivariate analysis were private insurance, ureter as the primary site, poorly differentiated and undifferentiated grade, lymphovascular invasion, positive margins, clinical T3 or T4 disease, nodal metastasis, and reporting from an academic research program. Patients who were≥70 years old,>50 miles to treatment center, had tumor in the kidney, or had an increased Charlson-Deyo Score were significantly less likely to receive PC. CONCLUSIONS: Over the time period studied, there has been an increase in the use of PC, primarily from increased administration of neoadjuvant chemotherapy. Its use is mostly associated with advanced pathologic characteristics. The study also highlights key demographic and socioeconomic differences that can help identify barriers to receiving PC and aid in making improvements in delivery of health care to patients with UTUC.

Prognostic Significance of Neutrophilic Infiltration in Benign Lymph Nodes in Patients with Muscle-invasive Bladder Cancer.

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

CKD-EPI and cockcroft-gault equations identify similar candidates for neoadjuvant chemotherapy in muscle-invasive bladder cancer.

Clinical guidelines suggest neoadjuvant cisplatin-based chemotherapy prior to cystectomy in the setting of muscle-invasive bladder cancer (MIBC). A creatinine clearance (CrCl) >60 mL/min is frequently used to characterize cisplatin-eligible patients, and use of the CKD-EPI equation to estimate CrCl has been advocated. From a prospectively maintained institutional database, patients with MIBC who received cystectomy were identified and clinicopathologic information was ascertained. CrCl prior to surgery was computed using three equations: (1) Cockcroft-Gault (CG), (2) CKD-EPI, and (3) MDRD. The primary objective was to determine if the CG and CKD-EPI equations identified a different proportion of patients who were cisplatin-eligible, based on an estimated CrCl of >60 mL/min. Cisplatin-eligibility was also assessed in subsets based on age, CCI score and race. Actuarial rates of neoadjuvant cisplatin-based chemotherapy use were also reported. Of 126 patients, 70% and 71% of patients were found to be cisplatin-eligible by the CKD-EPI and CG equations, respectively (P = 0.9). The MDRD did not result in significantly different characterization of cisplatin-eligibility as compared to the CKD-EPI and CG equations. In the subset of patients age >80, the CKD-EPI equation identified a much smaller proportion of cisplatin-eligible patients (25%) as compared to the CG equation (50%) or the MDRD equation (63%). Only 34 patients (27%) received neoadjuvant cisplatin-based chemotherapy. Of the 92 patients who did not receive neoadjuvant chemotherapy, 64% had a CrCl >60 mL/min by CG. In contrast to previous reports, the CKD-EPI equation does not appear to characterize a broader span of patients as cisplatin-eligible. Older patients (age >80) may less frequently be characterized as cisplatin-eligible by CKD-EPI. The discordance between actual rates of neoadjuvant chemotherapy use and rates of cisplatin eligibility suggest that other factors (e.g., patient and physician preference) may guide clinical decision-making.

Quality of life in patients with metastatic renal cell carcinoma: assessment of long-term survivors.

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

Preoperative therapy for localized prostate cancer: a comprehensive overview.

At the 2012 American Society of Clinical Oncology (ASCO) Annual Meeting, two studies of preoperative systemic therapy for localized prostate cancer garnered significant attention. In the first, investigators evaluated various permutations of conventional hormonal therapies prior to prostatectomy, with detailed biomarker studies focused on tissue androgens. In the second, investigators assessed the novel CYP17 lyase inhibitor abiraterone prior to prostatectomy. Both studies provide a wealth of biological information, but the question remains - will preoperative systemic therapy ultimately be incorporated into clinical algorithms for prostate cancer? Herein, the existing literature for both preoperative hormonal and chemotherapeutic approaches is reviewed. We performed a MEDLINE search of published prospective and retrospective clinical studies assessing preoperative systemic therapy for prostate cancer from 1982 onwards, revealing a total of 75 publications meeting these criteria. Of these, 55 possessed a number of patients (i.e., greater than 10) deemed worth of the current analysis. Beyond outlining these datasets, we discuss the relevance of clinical and pathologic endpoints in assessing preoperative therapy.

Retrospective analysis of clinical outcomes with neoadjuvant cisplatin-based regimens for muscle-invasive bladder cancer.

BACKGROUND: The benefit of neoadjuvant methotrexate, vinblastine, doxorubicin (Adriamycin), and cisplatin (MVAC) for muscle-invasive bladder cancer (MIBC) has been prospectively demonstrated in a phase III study. Extrapolating from comparative data in the metastatic setting, platinum doublets such as cisplatin-gemcitabine (CG) have been adopted. We sought to compare clinical outcomes in patients treated for MIBC with neoadjuvant CG and MVAC at our institution. PATIENTS AND METHODS: Patients with MIBC were identified from a prospectively maintained registry. Clinicopathologic information and clinical outcome data were obtained directly from the registry. When available, pharmacy records were reviewed to ascertain the use of growth factors and chemotherapy dose intensity (DI). Survival was compared in subgroups divided by the regimen of chemotherapy rendered (ie, CG vs. MVAC) using the Kaplan-Meier method. RESULTS: Median overall survival (OS) in the overall cohort (N = 61) was 23 months. OS was improved in patients receiving either MVAC or CG chemotherapy compared with patients receiving "other" chemotherapy (35.3 vs. 16.3 months; P = .055). Although the median OS associated with neoadjuvant CG numerically exceeded the survival associated with neoadjuvant MVAC (104.3 and 21.8 months, respectively), this was not statistically significant (P = .73). Pathologic downstaging predicted improved OS with both neoadjuvant CG and MVAC, and the rates of downstaging were similar with both regimens. CONCLUSIONS: Although warranting prospective validation, our data suggest that CG is a possible alternative neoadjuvant approach to traditional regimens such as MVAC for patients with MIBC.

Robotic extended pelvic lymphadenectomy for intermediate- and high-risk prostate cancer.

BACKGROUND: Accurate staging of prostate cancer is enhanced by a thorough evaluation of the pelvic lymph nodes. Limited data are available regarding robotic extended pelvic lymphadenectomy (PLA) in this setting. OBJECTIVE: Analyze our experience performing robotic extended PLA. DESIGN, SETTING, AND PARTICIPANTS: A total of 143 consecutive men with intermediate- or high-risk clinically localized adenocarcinoma of the prostate underwent robotic extended PLA and radical prostatectomy between September 2010 and November 2011 by a single surgeon. SURGICAL PROCEDURE: Lymph node packets were sent separately from bilateral common, external, and internal iliacs, obturators, node of Cloquet, and anterior prostatic fat. MEASUREMENTS: Descriptive statistics were used to summarize lymph node yields and positive nodes. Clinical variables were examined in logistic regression models to predict lymph node positivity. RESULTS AND LIMITATIONS: Median lymph node yield was 20 (range: 9-65, interquartile range: 15-25). Eighteen patients (13%) were found to have metastatic prostate cancer in the lymph nodes. The mean number of positive nodes found was 2.9 (range: 1-11). In 14 of 18 node-positive patients (78%), the extent of nodal invasion was outside the boundaries of a limited PLA. For four patients with positive nodes (22%), prostate biopsy predicted unilateral disease but PLA revealed contralateral positive lymph nodes. A total of 82% of patients experienced no complications, and most Clavien grade 1-2 complications consisted of anastomotic leakage, urinary retention, ileus, and lymphocele. Only 4% of patients experienced a grade 3 complication. Under multivariate regression analysis, prostate-specific antigen (PSA), clinical stage, and maximum biopsy core tumor volume were identified as significant predictors of finding positive pelvic lymph nodes (area under the curve: 91%). The main limitations include short follow-up and lack of randomization. CONCLUSIONS: Robotic extended bilateral PLA for prostate cancer up to the common iliac bifurcation increases nodal yield and positive nodal rate and can be performed safely. PSA, clinical stage, and maximum biopsy core volume are predictors for lymph node invasion. Long-term follow-up is needed to evaluate for therapeutic benefit.

Standardized analysis of frequency and severity of complications after robot-assisted radical cystectomy.

BACKGROUND: Comprehensive and standardized reporting of adverse events after robot-assisted radical cystectomy (RARC) and urinary diversion for bladder cancer is necessary to evaluate the magnitude of morbidity for this complex operation. OBJECTIVE: To accurately identify and assess postoperative morbidity after RARC using a standardized reporting system. DESIGN, SETTING, AND PARTICIPANTS: A total of 241 consecutive patients underwent RARC, extended pelvic lymph node dissection, and urinary diversion between 2003 and 2011. In all, 196 patients consented to a prospective database, and they are the subject of this report. Continent diversions were performed in 68% of cases. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: All complications within 90 d of surgery were defined and categorized by a five-grade and 10-domain modification of the Clavien system. Univariable and multivariable logistic regression analyses were used to identify predictors of complications. Grade 1-2 complications were categorized as minor, and grade 3-5 complications were categorized as major. All blood transfusions were recorded as grade ≥2. RESULTS AND LIMITATIONS: Eighty percent of patients (156 of 196 patients) experienced a complication of any grade ≤90 d after surgery. A total of 475 adverse events (113 major) were recorded, with 365 adverse events (77%) occurring ≤30 d after surgery. Sixty-eight patients (35%) experienced a major complication within the first 90 d. Other than blood transfusions given (86 patients [43.9%]), infectious, gastrointestinal, and procedural complications were the most common, at 16.2%, 14.1%, and 10.3%, respectively. Age, comorbidity, preoperative hematocrit, estimated blood loss, and length of surgery were predictive of a complication of any grade, while comorbidity, preoperative hematocrit, and orthotopic diversion were predictive of major complications. The 90-d mortality rate was 4.1%. The main limitation is lack of a control group. CONCLUSIONS: Analysis of postoperative morbidity following RARC demonstrates a considerable complication rate, though the rate is comparable to contemporary open series that followed similar reporting guidelines. This finding reinforces the need for complete and standardized reporting when evaluating surgical techniques and comparing published series.