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.

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.

Survival effect of perioperative systemic chemotherapy on overall mortality in locally advanced and/or positive regional lymph node non-metastatic urothelial carcinoma of the upper urinary tract.

OBJECTIVES: To analyze the potential survival benefit of perioperative chemotherapy (CHT) in patients treated with nephroureterectomy (NU) for non-metastatic locally advanced upper tract urothelial carcinoma. METHODS: Within the Surveillance, Epidemiology, and End Results database (2004-2014), we identified 1286 patients with T3 or T4, N 0-3 M0 UTUC. Kaplan-Meier plots, as well as multivariable Cox regression models (MCRMs) relying on inverse probability after treatment weighting (IPTW) and landmark analyses, were used to test the effect of CHT vs no CHT on overall mortality (OM) in the overall population (n =1286), as well as after stratification according to lymph node invasion (LNI). RESULTS: Overall, 37.4% patients received CHT. The CHT rate was higher with LNI (62.2% vs 35.2%, p < 0.001). In MCRMs, testing for OM in the overall population, CHT was associated with lower rates of OM (HR 0.71, CI 0.58-0.87; p = 0.001). Similarly, in MCRMs testing for OM in patients with LNI, CHT achieved independent predictor status for lower OM (HR 0.61, CI 0.48-0.78; p < 0.001). Conversely, in MCRMs testing for OM in patients without LNI, no CHT effect was recorded (HR 0.72, CI 0.52-1.01; p = 0.05). All results were confirmed after IPTW adjustment and in landmark analyses. CONCLUSIONS: Our results represent a contemporary North American report indicating lower OM after CHT for patients with locally advanced non-metastatic upper tract urothelial carcinoma, specifically in patients with T3-T4, N1-N3, M0 disease. Validation of the current and of the previous study is required within a randomized prospective design.

Regional differences in total hospital charges between open and robotically assisted radical prostatectomy in the United States.

BACKGROUND: Robotically assisted radical prostatectomy (RARP) has become the most frequently used surgical approach for patients treated with radical prostatectomy (RP) for localized prostate cancer (PCa). Previous studies reported higher total hospital charges (THCs) for RARP than open RP (ORP). We hypothesized that based on increasing RARP surgical expertise, differences in THCs between RARP and ORP should have decreased or even disappeared in the United States in most contemporary years. PATIENTS AND METHODS: Within the National Inpatient Sample database (2008-2015), we identified patients who underwent RARP or ORP. Multivariable linear regression models with adjustment for clustering were used to test for differences in THCs. Subgroup analyses focused on geographical regions, defined as West, Midwest, South and Northeast. RESULTS: Of 83,693 RP patients, 51,363 (61.4%) underwent RARP. RARP rates increased from 13.1 to 81.5% (p = 0.04). Overall, median THCs were $11,898 vs. $10,162 (p < 0.001) for RARP vs. ORP, respectively. After adjustment for complications, length of stay and clustering, RARP was associated with higher THCs ($3124 more for each RARP, p < 0.001). Additional charges for RARP did not change over time (p = 0.3). However, additional charges for RARP were highest in the West ($4610, p < 0.001), followed by the Midwest ($3278, p < 0.001), the South ($2906, p < 0.001) and the Northeast ($2216, p < 0.001). CONCLUSION: RARP rates have increased exponentially from 13.1 to over 80%. Similar rates were identified across all four geographical regions. RARP THCs exceeded those of ORP. Finally, important regional differences in RARP THCs were identified and persisted even after most detailed adjustment for population differences.

Predictors of deviation in neurovascular bundle preservation during robotic prostatectomy.

INTRODUCTION: Neurovascular bundle (NVB) preservation during robot-assisted radical prostatectomy (RARP) directly affects patient functional outcomes. Despite careful surgical planning, many NVB preservation techniques are changed intraoperatively from their preoperative plan. Our objective was to identify risk factors predicting intraoperative change in NVB preservation technique during RARP. MATERIALS AND METHODS: Prospective data from 578 RARPs performed by a single surgeon between 2010 and 2017 at a tertiary care center. Side-specific NVB preservation technique was planned preoperatively. Surgical techniques were either complete nerve sparing (CNS), or incomplete nerve sparing (INS). Variables included age, tumor grade, prostate volume, number of lifetime biopsies, history of post-biopsy sepsis, and laterality. Variables were modeled in multivariable logistic regressions as potential predictors of deviation in surgical technique. Functional and oncological outcomes were also assessed. RESULTS: A total of 46.9% of cases underwent some intraoperative change in NVB preservation from their preoperative plan. A total of 37.7% of 880 prostate sides planned for CNS underwent unplanned INS. Older age, Gleason ≥ 3+4, post-biopsy sepsis, prostate volume, and left-sided dissections were significantly associated with unplanned INS. Number of lifetime biopsies was not a predictor of unplanned INS. Patients with an intraoperative change to INS had poorer potency and continence. Study limitations included the retrospective nature of analysis and lack of pathological assessment of NVB preservation. CONCLUSIONS: Age, Gleason ≥ 3+4, post-biopsy sepsis, prostate volume, and laterality were significant predictors of unplanned INS during RARP, which should guide patient counseling when discussing risks and functional outcomes. The number of lifetime biopsies did not predict unplanned INS, a valuable finding for patients on active surveillance. Our findings highlight the importance of careful preoperative planning and novel adjuncts such as multiparametric MRI.

Comparison of perioperative outcomes between open and minimally invasive nephroureterectomy: A population-based analysis.

OBJECTIVES: To examine intraoperative and postoperative morbidity and mortality, as well as the impact on length of stay and total hospital charges of minimally invasive nephroureterectomy compared with open nephroureterectomy in patients with upper tract urothelial carcinoma. METHODS: Within the National Inpatient Sample (2008-2013), we identified patients with non-metastatic upper tract urothelial carcinoma treated with either minimally invasive nephroureterectomy or open nephroureterectomy. We relied on inverse probability of treatment weighting to reduce the effect of inherent differences between open nephroureterectomy versus minimally invasive nephroureterectomy. Multivariable logistic regression, multivariable Poisson regression models and multivariable linear regression models were used. RESULTS: Between 2008 and 2013, we identified 3897 patients treated with either minimally invasive nephroureterectomy (1093 [28%]) or open nephroureterectomy (2804 [72%]). In multivariable logistic regression models, minimally invasive nephroureterectomy resulted in lower rates of overall (odds ratio 0.71, P < 0.001), wound (odds ratio 0.49, P = 0.01), intraoperative (odds ratio 0.55, P = 0.01), miscellaneous surgical (odds ratio 0.64, P = 0.008) and miscellaneous medical complications (odds ratio 0.77, P = 0.002). Furthermore, minimally invasive nephroureterectomy was associated with lower rates of transfusions (odds ratio 0.61, P < 0.001). In multivariable Poisson regression models, minimally invasive nephroureterectomy was associated with shorter length of stay (relative risk 0.88, P < 0.001). Finally, higher total hospital charges ($2500 more per patient) were recorded for minimally invasive nephroureterectomy. CONCLUSIONS: Intraoperative and postoperative morbidity, as well as length of stay, but not total hospital charges favor minimally invasive nephroureterectomy over open nephroureterectomy. These outcomes validate the safety and feasibility of minimally invasive nephroureterectomy in select upper tract urothelial carcinoma patients.

Extent of lymph node dissection improves survival in prostate cancer patients treated with radical prostatectomy without lymph node invasion.

PURPOSE: To assess the effect of pelvic lymph node dissection (PLND) extent on cancer-specific mortality (CSM) in prostate cancer (PCa) patients without lymph node invasion (LNI) treated with radical prostatectomy (RP). METHODS: Within the Surveillance, Epidemiology, and End results (SEER) database (2004-2014), we identified patients with D'Amico intermediate- or high-risk characteristics who underwent RP with PLND, without evidence of LNI. First, multivariable logistic regression models tested for predictors of more extensive PLND, defined as removed lymph node count (NRN) ≥75th percentile. Second, Kaplan-Meier analyses and multivariable Cox regression models tested the effect of NRN ≥75th percentile on CSM. Finally, survival analyses were repeated using continuously coded NRN. RESULTS: In 28 147 RP and PLND patients without LNI, 67.3% versus 32.7% exhibited D'Amico intermediate- or high-risk characteristics. The median NRN was 6 (IQR 3-10), the 75th percentile defined patients with NRN ≥11. Patients with NRN ≥11 had higher rate of cT2/3 stage (29.8 vs 26.1%), GS ≥8 (25.7 vs 22.4%), and respectively more frequently exhibited D'Amico high-risk characteristics (34.6 vs 32.1%). In multivariable logistic regression models predicting the probability of more extensive PLND (NRN ≥11), higher biopsy GS, higher cT stage, higher PSA, more recent year of diagnosis, and younger age at diagnosis represented independent predictors. At 72 months after RP, CSM-free rates were 99.5 versus 98.1% for NRN ≥11 and NRN ≤10, respectively and resulted in a HR of 0.50 (P = 0.01), after adjustment for all covariates. Similarly, continuously coded NRN achieved independent predictor status (HR: 0.955, P = 0.01), where each additional removed lymph node reduced CSM risk by 4.5%. CONCLUSION: More extensive PLND at RP provides improved staging information and consequently is associated with lower CSM in D'Amico intermediate- and high-risk PCa patients without evidence of LNI. Hence, more extensive PLND should be recommended in such individuals.

North American population-based validation of the National Comprehensive Cancer Network Practice Guideline Recommendations for locoregional lymph node and bone imaging in prostate cancer patients.

BACKGROUND: The National Comprehensive Cancer Network (NCCN) guidelines provide recommendations for staging of prostate cancer patients in the objective regarding presence of locoregional lymph node metastases (LNM) and bone metastases. We tested the performance characteristics of these recommendations in a community setting. METHODS: Within the Surveillance, Epidemiology, and End Results database (2004-2014), we identified patients with available Gleason, clinical stage and prostatic specific antigen. Performance characteristics endpoints consisted of sensitivity, specificity, positive predictive value (PPV), negative predictive value (NVP), overall accuracy and the number needed to image (NNI). RESULTS: Totally, 191,308 patients were assessable for the validation of the LNM staging recommendations. Sensitivity ranged from 80.6 to 86.3%, specificity from 74.7 to 79.3%, PPV from 7.8 to 8.0%, overall accuracy from 75.0 to 79.3% and NPV was 99.5%. The respective NNI values were 12.5 and 12.8. 197,408 patients were assessable for the validation of bone scan recommendations. These recommendations resulted in 90.8% sensitivity, 76.3% specificity, PPV of 5.7%, NPV of 99.8% and overall accuracy of 76.5%. The NNI was 17.5. CONCLUSION: The NCCN recommendations for locoregional LNM miss few patients with clinical LNM (0.3-0.4%) and provide a virtually perfect NPV of 99.5%. Also, the recommendations for bone scan miss a marginal number of patients with established bone metastases (0.14%) and yield a virtually perfect NPV of 99.8%.

Racial disparities in lymph node dissection at radical prostatectomy: A Surveillance, Epidemiology and End Results database analysis.

OBJECTIVES: To test for racial disparities in lymph node dissection rates, lymph node dissection extent, lymph node invasion rates and cancer-specific mortality in North American African Americans versus non-Hispanic whites, at radical prostatectomy for clinically localized prostate cancer. METHODS: Within the Surveillance, Epidemiology and End Results database (2010-2014), we identified 58 974 African Americans or non-Hispanic whites with prostate cancer, who underwent radical prostatectomy with available clinical stage, prostate-specific antigen and biopsy Gleason score. Annual trends were examined. Logistic regression models focused on lymph node dissection rates, lymph node dissection extent (number of removed lymph nodes) and lymph node invasion. Cox regression models tested for differences in cancer-specific mortality. Multivariable models were adjusted for D'Amico risk groups, age and year. Models predicting lymph node invasion and cancer-specific mortality were additionally adjusted for lymph node dissection extent. RESULTS: Among all patients, 14.5% were African Americans. Lymph node dissection was carried out in 60.0% of African Americans versus 59.5% of non-Hispanic whites (P = 0.4). The median number of removed lymph nodes was five in African Americans versus six in non-Hispanic whites (P < 0.001). Furthermore, 3.1% versus 3.3% of African Americans and non-Hispanic whites, respectively, harbored lymph node invasion (P = 0.3). In multivariable logistic regression models African American race did not affect lymph node dissection or lymph node invasion rates, but lymph node dissection extent was lower in African Americans (hazard ratio 0.9; P < 0.001). No statistical differences in cancer-specific mortality were identified according to race. CONCLUSIONS: Contemporary North American African American patients treated with radical prostatectomy have equal access to lymph node dissection, the same lymph node invasion rates and the same cancer-specific mortality rates as non-Hispanic whites. However, the extent of lymph node dissection is lower in African Americans. The results regarding lymph node dissection rates are encouraging. However, improvements are required regarding lymph node dissection extent in African Americans.

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.

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.

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.

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.

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.

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.

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.

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.