Surveillance or Dynamic Sentinel Lymph-Node Biopsy in Low-Risk Clinically N0 Penile Squamous Cell Carcinoma: Single-Institution Real World Data.

INTRODUCTION: Surveillance is the standard management in low-risk cN0 penile squamous cell carcinoma (peSCC) patients. However, no previous analysis focused on early and long-term outcomes of these patients. We report on main oncological outcomes of a large series of low-risk cN0 peSCC patients. PATIENTS AND METHODS: Between 1980 and 2017 included, 93 evaluable consecutive low-risk (ie, pT1a G1 cN0M0) peSCC patients underwent primary tumor surgery and either observation (74) or dynamic sentinel node biopsy (DSNB) (19) following a clinical diagnosis of T1 in 66 (71%), T2 in 15 (16.1%) and Tx in 12 (12.9%) patients, respectively. The statistical significance of differences in medians and proportions was tested with the Kruskal-Wallis and chi-square tests. Kaplan-Meier plots illustrated 5-year inguinal relapse (IR)-free survival rates. RESULTS: Median age was 60 years (IQR: 50-69 years). Median follow-up was 92 months (IQR 54-133 months). Surveillance was more frequently adopted in clinical (c)T1 than in cT2 tumors (79.7% vs. 36.8%). None of 19 patients who had DSNB had nodal metastasis. Overall, 7 (7.5%) out of 93 pT1aG1cN0 peSCC patients had IR after a median interval of 9 months. Of note, 1 patient only relapsed after 12 months of surveillance. After stratification according to IR, relapses occurred more frequently in younger patients (59 vs. 64 years, P < .001). The 5-year IR-free survival rates for the entire cohort was 92% (95% Confidence interval [CI] 87-98%). CONCLUSIONS: Observation is a safe and effective management for low-risk peSCC patients. Younger patients may be offered a mini-invasive staging as an alternative.

Risk Factors for Relapse in Nonseminomatous Testicular Cancer After Postchemotherapy Retroperitoneal Lymph Node Dissection With Viable Residual Cancer.

PURPOSE: No consensus exists on the management of men with nonseminoma and viable nonteratomatous germ cell tumor in the postchemotherapy retroperitoneal lymph node dissection (pcRPLND) specimen after first-line chemotherapy. We analyzed surveillance versus different adjuvant chemotherapy regimens and the influence of time to pcRPLND on oncologic outcomes. METHODS: Data on 117 men treated with cisplatin-based first-line chemotherapy between 1990 and 2018 were collected from 13 institutions. All patients had viable nonteratomatous germ cell tumor in the pcRPLND specimen. Surgery was performed after a median of 57 days, followed by either surveillance (n = 64) or adjuvant chemotherapy (n = 53). Primary end points were progression-free survival (PFS), cancer-specific survival (CSS), and overall survival (OS). RESULTS: After controlling for International Germ Cell Cancer Cooperative Group risk group and percent of viable malignant cells found at RPLND, no difference was observed between men managed with surveillance or adjuvant chemotherapy regarding PFS (hazard ratio [HR], 0.72 [95% CI, 0.32 to 1.6]; P = .4), CSS (HR, 0.69; 95% CI, 0.20 to 2.39; P = .6), and OS (HR, 0.78 [95% CI, 0.25 to 2.44]; P = .7). No statistically significant differences for PFS, CSS, or OS were observed on the basis of chemotherapy regimen or in men treated with pcRPLND ≤57 versus >57 days after first-line chemotherapy. Residual disease with <10% versus ≥10% viable cancer cells were associated with a longer PFS (HR, 3.22 [95% CI, 1.29 to 8]; P = .012). Relapse in the retroperitoneum was observed in 34 (29%) men. CONCLUSION: Men with a complete resection at pcRPLND and <10% viable cells have favorable outcomes without further treatment. Complete retroperitoneal resection seems more important than early pcRPLND.

Bilateral inguinal lymph-node dissection vs. unilateral inguinal lymph-node dissection and dynamic sentinel node biopsy in clinical N1 squamous cell carcinoma of the penis.

INTRODUCTION: To evaluate the role of unilateral inguinal lymph-node dissection (ILND) plus contralateral dynamic sentinel node biopsy (DSNB) vs. bilateral ILND in clinical N1 (cN1) penile squamous cell carcinoma (peSCC) patients. MATERIAL AND METHODS: Within our institutional database (1980-2020, included), we identified 61 consecutive cT1-4 cN1 cM0 patients with histological confirmed peSCC who underwent either unilateral ILND plus DSNB (26) or bilateral ILND (35). RESULTS: Median age was 54 years (Interquartile range [IQR]: 48-60 years). Median follow-up was 68 months (IQR 21-105 months). Most patients had pT1 (23 %) or pT2 (54.1%), as well as G2 (47.5%) or G3 (23%) tumors, while lymphovascular invasion (LVI) was present in 67.1% of cases. Considering a cN1 and a cN0 groin, overall 57 out of 61 patients (93.5%) had nodal disease in the cN1 groin. Conversely, only 14 out of 61 patients (22.9%) had nodal disease in the cN0 groin. 5-year IR-free survival was 91% (Confidence interval [CI] 80%-100%) for bilateral ILND group and 88% (CI 73%-100%) for the ipsilateral ILND plus DSNB group (P-value 0.8). Conversely, 5-year CSS was 76% (CI 62%-92%) for bilateral ILND group and 78% (CI 63%-97%) for the ipsilateral ILND plus contralateral DSNB group (P-value 0.9). CONCLUSIONS: In patients with cN1 peSCC the risk of occult contralateral nodal disease is comparable to cN0 high risk peSCC and the gold standard, namely bilateral ILND, may be replaced by unilateral ILND and contralateral DSNB without affecting positive node detection, IRRs and CSS.

Risk of residual cancer after complete response following first-line chemotherapy in men with metastatic non-seminomatous germ cell tumour and International Germ Cell Cancer Cooperative Group intermediate/poor prognosis: A multi-institutional retrospective cohort study.

INTRODUCTION: Current guidelines recommend surveillance in metastatic non-seminomatous germ cell tumour patients treated with first-line-chemotherapy and a complete clinical response (normalisation of serum tumour markers and residual masses <1 cm). However, this recommendation is based on a series including patients with good prognosis according to International Germ Cell Cancer Cooperative Group prognostic group (IGCCCG-PG). The aim of this study was to analyse the proportion of residual teratoma and survival among patients with intermediate/poor IGCCCG-PG and a complete clinical response after first-line-chemotherapy. MATERIAL & METHODS: This is a retrospective study of men with intermediate/poor IGCCCG-PG, who had a complete clinical response after first-line chemotherapy. Patients were either followed by surveillance or treated with post-chemotherapy retroperitoneal lymph node dissection (pcRPLND). RESULTS: Between 2009 and 2018, 143 men with intermediate (n = 83) or poor (n = 60) IGCCCG-PG were treated at 11 international centres. Among 33 patients treated with pcRPLND, the specimen showed teratoma and viable cancer in 16 (48%) and 4 (12%). During a median a 7-year follow-up, 20/110 (18%) patients managed with surveillance relapsed, of whom seven (6%) had a retroperitoneal-only relapse versus 2/33 patients managed with pcRPLND relapsed. No difference was observed regarding overall survival (OS) among men treated with pcRPLND or surveillance (5-year OS, 93% and 89%, p-value = 0.35). The median time-to-recurrence among men on surveillance was 1.3 years (range: 0.3-9.1), and the most common sites of relapses included retroperitoneum (11%), chest (5%), and bones (4%). CONCLUSIONS: While most men with intermediate/poor IGCCCG-PG harbour teratoma/cancer in the retroperitoneum despite a complete response to first-line-chemotherapy, only 6% managed with surveillance relapsed in the retroperitoneum. There was no significant difference in OS between the two groups.

Retroperitoneal lymph-node dissection (RPLND) as upfront management in stage II germ-cell tumours: Evaluation of safety and efficacy.

INTRODUCTION: Patients with stage II germ-cell tumours (GCT) usually undergo radiotherapy (seminoma only) or chemotherapy. Both strategies display a recognised risk of long-term side effects. We evaluated retroperitoneal lymph node dissection (RPLND) as exclusive treatment in stage II GCT. METHODS: Between 2008 and 2019 included, 66 selected stage II GCT patients underwent primary open (O-) or laparoscopic (L-)RPLND. Type of procedure and extent of dissection, operative time, node rescue, hospital stay, complications (according to Clavien-Dindo), administration of chemotherapy, relapse and site of relapse were evaluated. RESULTS: Five patients had pure testicular seminoma. Nineteen (28.8%) had raised markers prior to RPLND; 48 (72.7%), 16 (24.2%) and two (3.0%) were stage IIA, IIB and IIC, respectively. O-RPLND and unilateral L-RPLND were 36 and 30 respectively. Six stage II A patients (12.5%) had negative nodes. Four patients underwent immediate adjuvant chemotherapy. One patient was lost at follow-up. After a median follow-up of 29 months, 48 (77.4%) of the 62 patients undergoing RPLND alone remained recurrence-free; one patient had an in-field recurrence following a bilateral dissection. According to procedure, number of rescued nodes (O-RPLND: 25. IQR 21-31; L-RPLND: 20, IQR 15-26; p: 0.001), hospital stay (L-RPLND: 3 days, IQR 3-4; O-RPLND: 6 days, IQR 5-8; p: .001) and grade ≥2 complications (L-RPLND 7%, O-RPLND 22%; p: 0.1) were the only significant differences. CONCLUSION: Primary RPLND is safe in stage II GCT, including seminoma, and may warrant a cure rate greater than 70%. When feasible, L-RPLND may be as effective as O-RPLND with better tolerability.

Laparoscopic retroperitoneal lymph-node dissection in metastatic nonseminomatous germ-cell tumors.

OBJECTIVES: To support laparoscopic post-chemotherapy retroperitoneal lymph-node dissection (L-PC-RPLND) as a potential new standard, we report on a large dataset of patients systematically undergoing L-PC-RPLND. PATIENTS AND METHODS: Patients with unilateral residual mass (≥1 cm), normalized markers, limited encasement (<30%) of gross retroperitoneal vessels underwent unilateral L-PC-RPLND with no adjuvant chemotherapy. Surgical performances, histology, hospital stay, complications within 30 days and follow-up visits were recorded. Multivariable linear and logistic regression models were used. RESULTS: Between February 2011 and January 2021, 151 consecutive patients underwent L-PC-RPLND. Median size of the residual mass was 25 mm (interquartile range [IQR] 20-35 mm). Overall median operative time was 208 min (IQR 177-241) and was 51 min longer (p-value <0.001) for right L-PC-RPLNDs. Eleven procedures were converted to open surgery. Median number of removed and positive nodes was 11 (IQR 8-16) and 1 (IQR 1-2), respectively. Mean hospital stay was 2 days (IQR 2-3). Nine complications (6%) occurred: two were Clavien-Dindo grade III. Definitive pathology revealed post-pubertal teratoma in 65.6%, fibro-necrotic tissue in 23.8%, teratoma with malignant somatic component in 6.6% and viable tumour in 4.0% patients. In multivariable linear regression models, fibro-necrotic tissue (32 min, CI 8.5-55.5; p < 0.01) and residual volume (1.05 min, CI 0.24-1.85; p < 0.01) achieved independent predictor status for longer operative time. All patients, but one, are alive and disease-free after a median follow-up of 22 months (IQR 10, 48). CONCLUSION: L-PC-RPLND, when adequately planned, is safe and effective for most patients with low to medium volume residual masses.

Renal tumor biopsy in patients with cT1b-T4-M0 disease susceptible to radical nephrectomy: analysis of safety, accuracy and clinical impact on definitive management.

PURPOSE: Renal tumor biopsy was provided in patients candidate to radical nephrectomy for a renal mass ≥4 cm, to evaluate treatment deviation. METHODS: Between 2008 and 2017, 102 patients with a solid renal mass ≥4 cm with no distant metastases underwent preliminary renal tumor biopsy. We investigated the proportion of patients who proceeded with radical nephrectomy, variables predicting non-renal cell carcinoma (RCC) and concordance between biopsy findings and definitive pathology. RESULTS: Median tumor size was 70 mm (IQR 55-110). Clinical stage was cT1b in 41, cT2 in 33, cT3 in 25 and cT4 in three patients. A median of three (IQR 2-3) renal tumor biopsies were taken with 16/18 Gauge needles in 97% of cases. Clavien grade I complications occurred in five cases. Malignant tumors were documented in 84 patients: 78 RCCs and six non-RCCs. Fifteen biopsies documented oncocytoma and three were non-diagnostic. Grade was reported in 50 RCCs: 42 (84%) were low and eight (16%) high grade. Eighty-three patients proceeded with radical nephrectomy; six non-RCC malignant tumors underwent combined and/or intensified treatment; 13 of 15 patients with oncocytoma did not undergo radical nephrectomy (eight underwent observation). Definitive pathology confirmed diagnosis in all cases. Grade concordance was 84%, considering two tiers (high vs low grade). No preoperative clinical variable predicted definitive pathology. CONCLUSIONS: Renal tumor biopsy is a safe procedure that leads to radical nephrectomy in most tumors ≥4 cm. Nonetheless, 20% of patients exhibited non-RCC histology. Renal tumor biopsy should be considered in this setting.

Minimally invasive retroperitoneal lymph node dissection for men with testis cancer: a retrospective cohort study of safety and feasibility.

PURPOSE: To describe the perioperative safety, functional and immediate post-operative oncological outcomes of minimally invasive RPLND (miRPLND) for testis cancer. METHODS: We performed a retrospective multi-centre cohort study on testis cancer patients treated with miRPLND from 16 institutions in eight countries. We measured clinician-reported outcomes stratified by indication. We performed logistic regression to identify predictors for maintained postoperative ejaculatory function. RESULTS: Data for 457 men undergoing miRPLND were studied. miRPLND comprised laparoscopic (n = 56) or robotic (n = 401) miRPLND. Indications included pre-chemotherapy in 305 and post-chemotherapy in 152 men. The median retroperitoneal mass size was 32 mm and operative time 270 min. Intraoperative complications occurred in 20 (4%) and postoperative complications in 26 (6%). In multivariable regression, nerve sparing, and template resection improved ejaculatory function significantly (template vs bilateral resection [odds ratio (OR) 19.4, 95% confidence interval (CI) 6.5-75.6], nerve sparing vs non-nerve sparing [OR 5.9, 95% CI 2.3-16.1]). In 91 men treated with primary RPLND, nerve sparing and template resection, normal postoperative ejaculation was reported in 96%. During a median follow-up of 33 months, relapse was detected in 39 (9%) of which one with port site (< 1%), one with peritoneal recurrence and 10 (2%) with retroperitoneum recurrences. CONCLUSION: The low proportion of complications or peritoneal recurrences and high proportion of men with normal postoperative ejaculatory function supports further miRPLND studies.

Clinical Outcomes in Clinical N0 Squamous Cell Carcinoma of the Penis According to Nodal Management: Early, Delayed or Selective (following Dynamic Sentinel Node Biopsy) Inguinal Lymph-Node Dissection.

PURPOSE: We evaluated the oncologic efficacy of early inguinal lymph-node dissection, observation or dynamic sentinel node biopsy followed by delayed or selective inguinal lymph-node dissection in cN0 patients with penile squamous cell carcinoma. MATERIALS AND METHODS: Between 1980 and 2017 (inclusive), 296 evaluable consecutive cN0 penile squamous cell carcinoma patients underwent early inguinal lymph-node dissection (16), observation (114) or dynamic sentinel node biopsy (166). Median followup was 50 months. Tumor stage, grade, lympho-vascular invasion and age were considered. Kaplan-Meier plots illustrated 5-year inguinal relapse-free and cancer specific survival rates. Multivariable Cox regression models tested the treatment effect. Analyses were repeated after inverse probability of treatment weighting adjustment. RESULTS: The 5-year inguinal relapse-free survival and cancer specific survival rates following early, observation and dynamic sentinel node biopsy inguinal lymph-node dissection were 100%, 87%, 89%, and 84%, 81%, 85%, respectively. The 5-year crude inguinal relapse-free survival and cancer specific survival rates were 90% and 93% in low-risk patients undergoing observation. Clavien grade 3 complications were 0.6 vs 12.5% in the dynamic sentinel node biopsy and early inguinal lymph-node dissection group, respectively. After inverse probability after treatment weighting adjustment, 5-year inguinal relapse and cancer specific survival were 90% vs 73% and 90% vs 77% following dynamic sentinel node biopsy and observation, respectively. At multivariable Cox regression model, patients undergoing dynamic sentinel node biopsy had significantly lower inguinal relapse (HR 0.4, 95% CI 0.2-0.85, p 0.02) and cancer specific mortality (HR 0.29, 95% CI 0.11-0.77; p=0.01) compared to those under observation. The low number of patients undergoing early inguinal lymph-node dissection made a reliable comparison with this group impractical. CONCLUSIONS: Selective inguinal lymph-node dissection following dynamic sentinel node biopsy significantly improved inguinal relapse and cancer specific mortality when compared with observation, providing evidence of efficacy of dynamic sentinel node biopsy in clinical stage N0 squamous cell carcinoma of the penis.

Is partial nephrectomy safe and effective in the setting of frail comorbid patients affected by renal cell carcinoma? Insights from the RECORD 2 multicentre prospective study.

BACKGROUND: To investigate the perioperative and morbidity outcomes after partial nephrectomy (PN) in patients with short life expectancy (SLE) (≥95% 10-year expected mortality (10y-EM)), to assess the main predictors of outcomes in this population and to compare these results with those of a group at the opposite upper range with long LE (LLE, ≤5% 10y-EM) relying on a multicenter Italian prospective registry of kidney surgery (the RECORD 2 project). METHODS: Clinical data of 4,325 patients undergone kidney surgery were collected at 26 urological Italian Centers from 2013 to 2016. SLE was defined as a ≥95% 10y-EM (assessed using the age-adjusted Charlson comorbidity index [CCI]). A multivariable logistic regression for overall postoperative complications, acute kidney injury (AKI), positive surgical margins (SM) and ∆ estimated glomerular filtration rate (eGFR) ≥25% at 2 years from surgery was performed in patients with SLE including clinically relevant variables. Adjusted outcomes reported as mean (SD) of the 2 groups were generated using separate multivariable logistic regression models and compared. RESULTS: Overall, 559 patients with SLE were selected. Patients had an ASA score ≥3 in 58.4% of cases. A clinical T1a, T1b, and T2 stage was found in 412 (74.5%), 124 (22.4%), and 17 (3.1%) patients. The median PADUA score was 7 (6-8). Surgical and medical postoperative complication rates were registered in 14.8% and 6% cases. Postoperative AKI was reported in 27.3% cases, positive surgical margins (PSM) in 9.3% cases. In this subgroup of patients, ASA score, cerebrovascular disease, surgery in low volume centers, and open surgery were independent predictors of overall complications. ASA and PADUA scores, renal clamping, resection technique and lower eGFR at baseline were independent predictors of AKI. PADUA score, open approach and resection technique were independent predictors of PSM. Cardiovascular disease, hilar clamping, and resection technique were independent predictors of eGFR decrease >25% at 2 years from surgery. Patients with SLE were compared with those with LLE (n = 302). All analyzed parameters at baseline were significantly different among the groups with the exception of cancer laterality. After adjusting for several clinical variables, the SLE group had a significantly higher risk rate of adjusted overall postoperative complication rate compared to the LLE group (20.6% ± 0.36 vs. 9.9% ± 0.65, P < 0.0001), while the overall intraoperative complications (4.1% ±0.13 vs. 2.3% ± 0.23), overall postoperative major complications (3.8% ± 0.09 vs. 1.9% ± 0.14) adjusted AKI (24.2% ± 0.37 vs. 22.6% ± 0.92), positive surgical margins (8% ± 0.22 vs. 6.4% ± 0.49), and 2-year RF loss (13.4% ± 0.17 vs. 12.4% ± 0.74). CONCLUSION: In selected patients with SLE, PN is feasible with an acceptable safety profile that is overall comparable to patients with no LE limitations. While a robotic approach and surgery performed in high volume centers could reduce the risk of complications, an off-clamp approach and a SE surgical technique may decrease the risk of postoperative AKI and of longer term eGFR decrease.

Survival of Contemporary Patients With Non-metastatic Small-cell Carcinoma of Urinary Bladder, According to Alternative Treatment Modalities.

BACKGROUND: The objective of this study was to test the effect of chemotherapy and/or radical cystectomy (RC) and/or radiotherapy (RT) on survival of patients with non-metastatic small-cell carcinoma of the urinary bladder (SCCUB). MATERIALS AND METHODS: Within the Surveillance, Epidemiology, and End Results registry (2001-2016), we identified patients with non-metastatic (T1-4, N0, M0) SCCUB. Treatment was defined as: chemotherapy alone, chemotherapy + RC, and chemotherapy + RT. Temporal trends, cumulative incidence plots, and multivariable competing risks regression models were used. RESULTS: Of 595 patients with SCCUB, 230 (38.5%), 159 (27%), and 206 (34.5%) were treated with chemotherapy alone, chemotherapy + RC, and chemotherapy + RT, respectively. The rates of chemotherapy + RC increased (estimated annual percentage changes [EAPC], +5.9%; P = .002). Conversely, chemotherapy alone (EAPC, -1.7%; P = .1) and chemotherapy + RT rates decreased (EAPC: -2.2%; P = .08). Overall, 5-year cancer-specific mortality (CSM) rates were 44%, 29%, and 40% for patients treated with chemotherapy alone, chemotherapy + RC, and chemotherapy + RT, respectively (P = .004). Relative to chemotherapy alone, patients treated with chemotherapy + RC experienced lower CSM (hazard ratio, 0.5; P < .001). Conversely, patients treated with chemotherapy + RT did not exhibit any CSM benefit (hazard ratio, 0.8; P = .2), when compared with chemotherapy alone. CONCLUSION: In contemporary patients with SCCUB with non-metastatic disease, the rates of chemotherapy + RC are increasing. Conversely, the rates of combined chemotherapy with RT and chemotherapy alone are decreasing. These patterns of treatment are in agreement with better cancer control in patients with SCCUB. In consequence, until more robust data become available, the combination of chemotherapy and RC should represent the recommended treatment strategy.

Partial Cystectomy With Pelvic Lymph Node Dissection for Patients With Nonmetastatic Stage pT2-T3 Urothelial Carcinoma of Urinary Bladder: Temporal Trends and Survival Outcomes.

INTRODUCTION: We investigated the effect of partial cystectomy (PC) on cancer-specific mortality (CSM) and other-cause mortality (OCM) and the effect of pelvic lymph node dissection (PLND) during PC on CSM. MATERIALS AND METHODS: Within the Surveillance, Epidemiology, and End Results database (2004-2015), 11,429 cases of nonmetastatic stage pT2-T3 urothelial carcinoma of the urinary bladder treated with either PC or radical cystectomy (RC) were identified. All comparisons between PC and RC relied on propensity score (PS; ratio, 1:1) adjusted univariable and multivariable logistic and competing risks regression models. In contrast, all comparisons between PLND and no PLND at PC relied on inverse probability of treatment weighting-adjusted univariable and multivariable Cox regression models. RESULTS: Within the SEER database, PC had been performed in 979 patients (8.6%). The PC annual rates decreased from 11.0% to 6.8% during the study period (P < .001). In PS-adjusted multivariable analyses focusing on CSM and OCM, no statistically significant difference between the PC and RC groups (P = .2 and P = .3, respectively). The annual PLND rates with PC (50.3%) did not vary over time (P = .3). In the overall cohort and the PC subgroup, PLND was associated with a lower CSM rate (hazard ratio, 0.56; P < .001; and hazard ratio, 0.57; P < .001, respectively). CONCLUSIONS: A small proportion of patients with stage pT2-T3 urothelial carcinoma of the urinary bladder were candidates for PC. In the PS-adjusted multivariable analyses, no statistically significant differences were found in CSM or OCM between the PC and RC groups. Within the PC group, PLND had been omitted 50% of the time despite its association with lower CSM.

Racial and ethnic differences in survival in contemporary metastatic renal cell carcinoma patients, according to alternative treatment modalities.

PURPOSE: To test the association between African-American race and overall mortality (OM) rates in patients with metastatic renal cell carcinoma (mRCC). METHODS: Within the Surveillance, Epidemiology, and End Results registry (2006-2015), we identified patients with clear cell (ccmRCC) and non-clear cell mRCC (non-ccmRCC). African-Americans, Caucasians, and Hispanics were identified. Stratification was made according to histology and treatments: (1) no treatment, (2) systemic therapy (ST), (3) cytoreductive nephrectomy (CNT), (4) CNT + ST. Kaplan-Meier plots and multivariable Cox regression analyses were used. RESULTS: Of ccmRCC patients, 410 (7%), 4353 (75%), and 1005 (17%) were African-American, Caucasian, and Hispanic, respectively. Of non-ccmRCC patients, 183 (25%), 479 (65%), and 77 (10%) were African-American, Caucasian, and Hispanic, respectively. In ccmRCC, African-Americans were associated with higher OM rates (HR 1.20; 95% CI 1.05-1.37). Conversely, in non-ccmRCC, African-Americans were associated with lower OM rates (HR 0.75; 95% CI 0.59-0.97). CONCLUSION: African-American race is associated with prolonged survival in non-ccmRCC, but it is also associated with lower survival rates in ccmRCC. The exception to these observations consisted of patients treated with combination of CNT + ST for either ccmRCC or non-ccmRCC.

Impact of Age on Perioperative Outcomes at Radical Prostatectomy: A Population-Based Study.

BACKGROUND: Radical prostatectomy (RP) represents one standard of care for patients with localized prostate cancer and is associated with several established postoperative complications. OBJECTIVE: We tested the relationship between RP early postoperative outcomes and age within a population-based data repository. DESIGN, SETTING, AND PARTICIPANTS: Within the National Inpatient Sample database (2008-2013), we identified patients who underwent robotically assisted or open RP. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Multivariable logistic regression (MLR), multivariable Poisson regression (MPR), and linear regression models were used. Cubic spline graphically depicted the relationship between age and complications. RESULTS AND LIMITATIONS: Overall, 68780 patients underwent RP with a median age of 62 yr (interquartile range: 57-67 yr). In MLR models, patient age represented an independent predictor of overall [odds ratio (OR): 1.02, p<0.001], intraoperative (OR: 1.03, p<0.001), cardiac (OR: 1.03, p<0.001), miscellaneous medical (OR: 1.02, p<0.001), miscellaneous surgical (OR: 1.01, p=0.01), pulmonary (OR: 1.02, p<0.001), and vascular complications (OR: 1.05, p<0.001); blood transfusions (OR: 1.02, p<0.001); and bowel obstruction (OR: 1.02, p<0.001). In MPR models, patient age was associated with longer stay (OR: 1.001, p=0.02). Similar results were recorded after adjustment for clustering in stratified analyses (<70 vs ≥70 yr) and in the subgroup of patients that underwent robotically assisted RP. For nine out of twelve examined outcomes, a virtually direct relationship existed with increasing age, in cubic spline analyses. CONCLUSIONS: Virtually all early postoperative RP complications are directly related to age. In consequence, these observations should be considered from an individual patient perspective as well as from a health management perspective. PATIENT SUMMARY: RP is provided through a wide patient age spectrum. Virtually all early postoperative RP complications are directly related to age. Individual patient's age needs to be considered in treatment decision-making.

Development and Validation of a Lookup Table for the Prediction of Metastatic Prostate Cancer According to Prostatic-specific Antigen Value, Clinical Tumor Stage, and Gleason Grade Groups.

BACKGROUND: Prostate cancer (PCa) staging is crucial in clinical decision making and treatment assignment. OBJECTIVE: To develop a predictive tool that is capable of predicting the probability of metastases at initial PCa diagnosis. DESIGN, SETTING, AND PARTICIPANTS: Within the Surveillance, Epidemiology, and End Results database (2010-2014), we identified patients with newly diagnosed PCa and available clinical tumor stage, prostatic-specific antigen value (PSA), and Gleason grade group (GGG), and with or without metastases. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: We relied on PSA, clinical tumor stages, and GGG to discriminate between M1 and M0 patients. Patients were randomly divided according to the registry of origin between development (n=102469) and validation (n=98755) cohorts. Logistic regression modeling coefficients were used to devise a lookup table to discriminate between M0 and M1 stages. Receiver operating characteristic-derived area under the curve was tested for model accuracy, within the validation cohort. A total of 2000 bootstrap resamples were applied to 95% confidence intervals (CIs). Decision curve analysis (DCA) and calibration plots were used to test the performance of the lookup table. RESULTS AND LIMITATIONS: Of 201224 patients, 3.5% harbored metastatic PCa (mPCa). PSA >40ng/ml, GGG5, and GGG4, in that order, represented the strongest predictors of mPCa. Overall, PSA, clinical tumor stage, and GGG were 94.3% (95% CI: 94.2-94.3%) accurate in predicting the probability of mPCa, in the external validation cohort. Up to 39.4% probability of mPCa, the model demonstrated accurate predictions in the calibration plot. In DCA, a net benefit was recorded up to a threshold probability of approximately 54%. CONCLUSIONS: The proposed lookup table for the prediction of the probability of mPCa may represent a useful clinical tool based on its high accuracy, excellent calibration, and robust nature of predictions. PATIENT SUMMARY: Our study provides a highly accurate lookup table for the prediction of the probability of metastatic prostate cancer patients. This clinical tool can be useful in staging decisions.

Nephroureterectomy with or without Bladder Cuff Excision for Localized Urothelial Carcinoma of the Renal Pelvis.

BACKGROUND: Few studies examined the rates of guideline implementation and the survival effect of bladder cuff excision (BCE) at nephroureterectomy (NU). OBJECTIVE: To assess the rates of guideline implementation regarding NU with BCE relative to NU without BCE in patients with upper tract urothelial carcinoma (UTUC) and to test the effect of BCE on cancer-specific (CSM) and other-cause mortality (OCM). DESIGN, SETTING, AND PARTICIPANTS: We relied on Surveillance, Epidemiology, and End Results database (2004-2014) for UTUC of the renal pelvis patients (T1-T3, N0, M0) treated with NU with or without BCE. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Cumulative incidence plots relying on competing-risks methodology illustrated 5-yr CSM and OCM rates. Multivariable competing-risks regression (MCRR) models tested the effect of BCE versus no BCE at NU. RESULTS AND LIMITATIONS: Of 4266 assessable patients, 2913 (68.3%) underwent NU with BCE. Between 2004 and 2014, rates of BCE at NU increased from 63.0% to 74.5% (European Association for Palliative Care: 2%; p<0.001). At 60 mo, CSM rates were 19.7% versus 23.5% (p=0.005) in NU with BCE versus NU without BCE patients, respectively. In MCRR models, no difference in CSM was recorded according to BCE at NU (hazard ratio [HR]: 0.88, confidence interval [CI]: 0.75-1.03, p=0.1). Finally, OCM was unaffected by BCE at NU (HR: 0.94, CI: 0.77-1.15, p=0.5). This study is retrospective. CONCLUSIONS: According to guideline recommendation, the rates of NU with BCE increased over time. However, BCE status does not appear to affect CSM or OCM. Thus, our study was unable to examine the rates of urothelial cancer recurrence or metastatic progression according to BCE status. PATIENT SUMMARY: Rates of bladder cuff excision (BCE) at nephroureterectomy (NU) are increasing. This observation confirms improved adherence to guidelines over time. However, BCE status does not appear to affect survival after NU for upper tract urothelial carcinoma.

Effect of external beam radiotherapy on second primary cancer risk after radical prostatectomy.

INTRODUCTION: We aimed to investigate the effect of radiotherapy (RT) in contemporary patients treated with radical prostatectomy (RP) compared to RP alone for non-metastatic prostate cancer (PCa) on the incidence of second primary cancers (SPCs). METHODS: Within the Surveillance, Epidemiology, and End Results (SEER) database (2004-2015), we identified patients with PCa as the only or first primary cancer, who underwent RP and RT or RP alone. Cumulative incidence plots and multivariable Cox regression models tested for SPC rate differences according to treatment type: RP and RT vs. RP alone. Subgroup analyses focused on pelvic, primary pelvic, and non-pelvic SPCs, as well as on late SPCs (>5 years after PCa diagnosis). RESULTS: Of 152 161 patients, 7.1% (n=10 870) received RP and RT. Overall, 6.6 vs. 5.0% developed SPCs after RP and RT vs. RP alone, respectively (p<0.001). Cumulative incidence rates at 10 years after PCa diagnosis for RP and RT vs. RP were 12.0 vs. 8.7% (p<0.001), 2.0 vs. 1.2% (p<0.001), 2.1 vs. 1.3% (p<0.001), and 9.9 vs. 7.4% (p<0.001) for overall SPCs, primary pelvic SPCs, overall pelvic SPCs, and non-pelvic SPCs, respectively. Multivariable Cox regression models revealed an increased risk after RP and RT vs. RP alone for overall (hazard ratio [HR] 1.2; p<0.001), primary pelvic (HR 1.5; p<0.01), pelvic (HR1.4; p<0.001), non-pelvic (HR1.1; p<0.01), late overall (HR 1.2; p=0.01), and late non-pelvic SPCs (HR1.2; p=0.03). CONCLUSIONS: RP with RT was associated with moderately increased risk of SPCs compared to RP alone. This observation should be thoroughly discussed at informed consent and considered during followup.