T1 Renal Cell Carcinoma Research Articles

Comparison of Partial and Radical Laparascopic Nephrectomy: Perioperative and Oncologic Outcomes for Clinical T2 Renal Cell Carcinoma.

Nephron-sparing surgery has emerged as the treatment of choice for small renal masses. However, its role in larger tumors remains controversial. In this study, we compare the outcomes of laparoscopic partial nephrectomy (LPN) vs those of laparoscopic radical nephrectomy (LRN) for T2 renal tumors. Thirteen patients who had LPN and 16 patients who had LRN for T2 renal tumors were retrospectively analyzed for preoperative factors (age, gender, comorbidities, hemoglobin, and creatinine levels and estimated glomerular filtration rate [eGFR]), operative and perioperative characteristics (tumor characteristics, operative time [OT], warm ischemia time [WIT], estimated blood loss [EBL], length of stay [LOS], and postoperative complications), histopathologic results, and follow-up data (eGFR and recurrences). Tumor size was comparable between groups; however, tumors in the LRN group were more endophytic, central, and closer to the collecting system. There were no cases of positive surgical margins. Median OT was 160 minutes vs 230 minutes (p = 0.0029) and EBL was 25 mL vs 100 mL ([p = 0.0027], LRN vs LPN). Median WIT in the LPN group was 27 minutes, with three zero ischemias. Minor postoperative complications (≤Clavien-Dindo III) were noted in 6.25% and 23% (LRN vs LPN). Median LOS was 4.56 and 5.77 days (LRN vs LPN), respectively. Mean postsurgery eGFR was significantly lower for the LRN group (54.5 cc/[min ·1.73 m2] vs 76.3 cc/[min ·1.73 m2], p = 0.019). Within mean follow-up of 44.5 months, one tumor recurrence in the contra lateral kidney was observed in the LPN group and two cases of metastasis in the LRN group. We show that LPN is technically feasible for T2 tumors, with acceptable intra- and perioperative outcomes. Furthermore, our results show a significant advantage in preservation of renal function for LPN without compromising oncologic results. Taken together, we believe that LPN should be considered for larger tumors based on technical feasibility rather than only tumor size.

Image-guided Cryoablation for Sporadic Renal Cell Carcinoma: Three- and 5-year Outcomes in 220 Patients with Biopsy-proven Renal Cell Carcinoma.

Purpose To evaluate the long-term efficacy of image-guided cryoablation of sporadic clinical T1 (cT1) biopsy-proven renal cell carcinoma (RCC) and the technical success and safety of all cryoablation treatments. Materials and Methods For this retrospective single-institution study, 433 patients (median age, 68 years; range, 19-90 years), of whom 293 were men (median age, 69 years; range, 19-90 years) and 140 were women (median age, 68 years; range, 30-89 years), who had 484 cT1 renal masses (mean size, 33 mm) and who were treated between 2007 and 2016 were identified from a prospectively maintained tumor registry. Treatment efficacy for all treated lesions and complication rates of all procedures were computed. Oncologic outcomes for a subset of 220 patients with sporadic biopsy-proven RCC were analyzed. The Kaplan-Meier method was used to estimate local recurrence-free survival (LRFS), metastasis-free survival (MFS), and overall survival (OS) rates. Results Of the 484 treated cT1 renal masses, 474 were imaged subsequently, with a primary treatment efficacy of 96% (453 of 474), increasing to 98% (465 of 474) after secondary ablation, and a major complication rate (Clavien-Dindo grade ≥ III) of 4.9% (23 of 473 procedures). The estimated LRFS and MFS rates, respectively, for the 220 patients with biopsy-proven RCC were 97.2% (95% confidence interval [CI]: 92.6%, 99.0%) and 97.7% (95% CI: 93.3%, 99.1%) at 3 years and 93.9% (95% CI: 85.8%, 97.4%) and 94.4% (95% CI: 86.7%, 97.7%) at 5 years. The estimated OS of all 433 patients was 91.7% (95% CI: 87.5%, 94.5%) and 78.8% (95% CI: 71.1%, 84.6%) at 3 and 5 years, respectively. Conclusion Five-year oncologic outcomes after image-guided cryoablation for clinical T1 renal cell carcinoma are competitive with those of resection at a lower complication rate. © RSNA, 2018.

Comparison of Radical Nephrectomy and Partial Nephrectomy for T1 Renal Cell Carcinoma: A Meta-Analysis

Objective: To contrast the clinical effects and complications for the treatment of T1 renal carcinoma in partial nephrectomy (PN) and radical nephrectomy (RN). Methods: Multiple databases were adopted to search relevant studies, and articles that eventually satisfied the inclusion criteria were included. All meta-analyses were conducted with the Review Manager 5.0, and to estimate the quality of each article, risk of bias table was performed. Results: In the end, 13 studies including 13,269 patients were involved, which eventually satisfied the eligibility criteria. The number of samples in the PN group and the RN group were 6,145 and 7,124 respectively. The results of heterogeneity test suggested that the operating time (mean difference [MD] = –13.02, 95% CI [–14.15 to –11.89], p < 0.00001; p for heterogeneity < 0.00001, I² = 100%), glomerular filtration rate (GFR) at 24 h after surgery (MD = 11.28, 95% CI [10.71–11.85], p < 0.00001; p for heterogeneity < 0.000001, I²= 98%), and recurrence (OR 0.99, 95% CI [0.51–1.93], p = 0.97; p for Heterogeneity = 0.73, I² = 0%) were significantly different, while differences in GFR at 24 h before surgery (MD = 0.59, 95% CI [0.06–1.12], p = 0.03; p for heterogeneity < 0.000001, I² = 76%) between PN and RN were insignificant. Conclusion: This study demonstrated that clinical efficacy of RN was better than that of PN to some extent, but PN was a quicker recovery and less harmful therapy.

Renal Function after Nephrectomy Influences the Risk of Cardiovascular Events.

We retrospectively analyzed the factors related to postoperative cardiovascular (CV) events in patients undergoing partial nephrectomy (PN) or radical nephrectomy (RN) for clinical T1 renal cell carcinoma (RCC). We identified 570 patients who underwent PN or RN for T1 renal cell carcinoma between January 1998 and December 2009 at our institution and related hospitals. We determined the cumulative incidence rate of CV events and overall survival (OS) using Kaplan-Meier survival curves with a log-rank test, and we evaluated the risk for an increase in CV events and OS using Cox proportional hazard regression. Of the 570 patients, 171 underwent PN and 399 underwent RN. The type of surgery was not significantly related with CV events. The only factor that significantly increased the risk of CV events in both the univariate (HR 2.67, p=0.006) and multivariate analyses (HR 2.14, p=0.044) was a postoperative estimated glomerular filtration rate (eGFR) <45 ml/min/1.73 m2. Postoperative eGFR was also a significant risk factor for OS in the univariate analysis (HR 2.38, p=0.0104), but not in the multivariate model. Postoperative renal function was a significant independent predictor of the incidence of subsequent CV events.

Multi-institutional Survival Analysis of Incidental Pathologic T3a Upstaging in Clinical T1 Renal Cell Carcinoma Following Partial Nephrectomy

To evaluate whether incidental pathologic T3a (pT3a) upstaging after partial nephrectomy (PN) for clinical T1 disease results in inferior oncologic outcomes compared to pT1a-b disease. Retrospective chart review was completed at the University of Michigan and Moffitt Cancer Center to identify patients undergoing PN for clinical T1 masses between 1995 and 2015. A total of 1955 patients were identified, of which 95 had pT3a upstaging. Median follow-up was 38.2 months. Patients with pT3a disease were individually matched by clinicopathologic features with patients undergoing PN with pT1a-b disease in a 1:2 ratio. Kaplan-Meier analysis and univariate and multivariable Cox proportional hazards regression analysis were performed. Primary endpoint was recurrence-free survival (RFS). Secondary endpoints were all-cause mortality, cancer-specific survival (CSS), and rates of local and distant recurrence. Recurrence rates were significantly higher in pT3a disease compared to pT1a-b controls (P <.01). In those patients with pT3a upstaging, 3- and 5-year RFS were 81% and 58%, compared to 86% and 75% in pT1a-b controls (P = .01). CSS at 3 and 5 years were 91% and 90% in pT3a disease and 100% and 97% in pT1a-b controls (P <.01). All-cause mortality at 3 and 5 years were 82% and 71% in pT3a disease and 93% and 80% in pT1a-b controls (P = .04). Univariate and multivariable analysis of pT3a disease demonstrated no association between demographic or pathologic characteristics and RCC recurrence. Patients with pT3a upstaging following PN experience a significantly reduced RFS and CSS when compared to pT1 disease.

Outcomes of pathologic stage T3a renal cell carcinoma up-staged from small renal tumor: emphasis on partial nephrectomy

BackgroundThe prognosis of patients with pathologic stage T3a renal cell carcinoma (RCC) that is up-staged from a small renal tumor remains controversial. We evaluated the prognosis of patients with RCC who were up-staged from clinical stage T1 to pathologic stage T3a.MethodsWe retrospectively reviewed the data of 3431 patients who were surgically treated for clinical stage T1 RCC. The survival outcomes were compared using Kaplan-Meier and Cox proportional analyses.ResultsAmong the clinical stage T1 patients, 215 (6.3%) were finally up-staged to pathologic stage T3a. Patient age (HR 1.302, 95% CI 1.018–1.046, p < 0.001), tumor diameter (HR 1.686, 95% CI 1.551–1.834, p < 0.001), and hilar location (HR 1.765, 95% CI 1.147–2.715, p = 0.010) were significantly associated with upstaging. Kaplan-Meier analyses showed significantly shorter recurrence-free, cancer-specific and overall survivals (all p < 0.001) in patients who were up-staged. Multivariate Cox analyses revealed pathologic upstaging as an independent predictor of shorter recurrence-free (HR 2.195, 95% CI 1.459–3.300, p < 0.001), cancer-specific (HR 2.238, 95% CI 1.252–4.003, p = 0.007), and overall survivals (HR 1.632, 95% CI 1.029–2.588, p = 0.037). Subgroup analysis of pathologic stage T3a showed no significant difference in survival of the partial nephrectomy group when compared to the radical nephrectomy group (all p > 0.5).ConclusionsPatients up-staged from clinical stage T1 to pathologic stage T3a RCC showed shorter survival outcomes than those without upstaging. However, partial nephrectomy, compared with radical nephrectomy, showed comparable outcomes in patients who were up-staged.

The Overall Survival Benefit for Patients with T1 Renal Cell Carcinoma after Nephron-Sparing Surgery Depends on Gender and Age

Due to the recommendations in the urological guidelines to perform nephron-sparing surgery in patients with organ-confined renal cell carcinoma (RCC), the customary therapy regimen changed, but it is not well studied yet whether partial nephrectomy (PN) especially in the elderly is beneficial. From 2000 to 2015, 3,592 patients from 7 clinics undergoing surgery in RCC were identified; 2,323 had T1 tumours. We retrospectively compared the overall survival benefit of patients with T1 RCC who underwent either PN or radical nephrectomy (RN) and studied effects of age and gender. Results: In T1 RCC, PN was beneficial in male patients (p = 0.0006) independent of age, especially in those men ≤75 years of age (p = 0.0005); but PN was not beneficial for female patients (p = 0.0629) regardless of age and male patients older than 75 years (p = 0.736). The OS of female patients after RN and male patients after PN is the same, regardless of age. A life expectancy of more than 45 months at least is necessary to experience an overall survival benefit after PN. Conclusions: There should be harder proven indications for PN in female patients and especially in all patients older than 75 years, particularly with regard to perioperative risk factors.

649 - Risks of chronic kidney disease, cardiovascular events and mortality between partial and radical nephrectomy for T1 renal cell carcinoma

649 - Risks of chronic kidney disease, cardiovascular events and mortality between partial and radical nephrectomy for T1 renal cell carcinoma

Association of dividing pathologically upstaged T3a renal cell carcinoma with improved alignment of outcomes: A call for TMN revision.

642 Background: Incidental pathological upstaging to pT3a disease can occur after surgical treatment of clinical T1 and T2 Renal Cell Carcinoma (RCC), and upstaged pT3a disease is associated with worsened outcomes. Oncologic and survival outcomes within the pT3a category are heterogeneous. We investigated recurrence and survival outcomes in pT3a disease, and aimed to better categorize this cohort for improvement on current TMN staging. Methods: Multi-center retrospective analysis of patients with renal cell carcinoma (cT1-3aN0M0) from 1987-2016. After initial comparison of outcomes between pT1, pT2 and pT3a, patients were substratified within the pT3a category based on presenting clinical stage. Comparison was drawn between pT1, pT2 and the subdivided pT3a group (cT1 → pT3a, cT2 → pT3a, and cT3a → pT3a). Primary outcome was recurrence free survival (RFS). Secondary outcome was overall survival (OS). Kaplan−Meier (KM) analysis was utilized. Results: 2640 patients were analyzed (2125 cT1, 448 cT2, 67 cT3a, mean follow up 67.8 months). Rate of incidental T3a upstaging from cT1-2 was 14.7%. Compared to pT1-2 disease, patients with incidental pT3a upstaging had higher rate of recurrence (7.5% vs. 29.6%, p &lt; 0.001) and all-cause mortality at last follow up (15.9% vs. 25.4%, p &lt; 0.001). With regards to RFS, when pT3a was subdivided based on presenting clinical stage, significant differences in RFS emerged which aligned differently. Compared to 5 year RFS of pT1 (94.4%), cT1 → pT3a aligned with pT2 (76.6% and 81.2%, p = 0.346) while cT2 → pT3a aligned with cT3a → pT3a 47.4% and 44.0%, p = 0.815). With regards to OS, a similar alignment was noted for 5 year OS after subdivision, where pT1 was 89.9%, while cT1 → pT3a correlated with pT2 (79.8% and 83.1%, p = 0.640) and cT2 → pT3a correlated with cT3a → pT3a 67.0% and 64.2%; p = 0.893). Conclusions: Patients with cT1 → pT3a have outcomes more similar to pT2, than patients with cT2 → pT3a which align more closely to cT3a → pT3a. Future refinements of the TNM staging system for RCC should consider re-grouping cT1 → pT3a into the pT2 group. Further confirmation is requisite.

FACTORS AFFECTING SHORT-TERM RENAL FUNCTION AFTER PARTIAL NEPHRECTOMY

(Objectives) Recently, partial nephrectomy has been recommended for patients with T1 renal cell carcinoma to preserve renal function. In this study, we retrospectively investigated the factors that affect renal function after laparoscopic or robotic partial nephrectomy using cold or warm ischemia. (Patients and methods) We reviewed 105 patients who underwent laparoscopic or robotic partial nephrectomy between March 2006 and July 2016. Patients who had a single kidney were excluded. Thirty-nine patients were managed with cold ischemia, and 66 were managed with warm ischemia. Renal function was assessed using the estimated glomerular filtration rate (eGFR) and glomerular filtration rate (GFR) categories of the stage of chronic kidney disease (CKD). (Results) In the cold and warm ischemia groups, the duration of ischemia was significantly correlated with deterioration of the eGFR at 12 months postoperatively, but the duration of ischemia was not significantly correlated with exacerbation of the GFR categories for the stage of CKD in multivariate analyses. (Conclusions) These results suggest that the ischemia time may not have an impact on prognosis. However, due to the lack of deaths from renal carcinoma or cardiovascular events postoperatively in this study, the influence of each factor on overall survival or cardiovascular events could not be evaluated. More investigations are necessary to discern the acceptable level of deterioration and the corresponding clinical implications for postoperative eGFR.

Pathological upstaging of clinical T1 renal cell carcinoma: an analysis of 115,835 patients from National Cancer Data Base, 2004-2013.

Clinical staging is vital for treatment decision-making by renal cell carcinoma (RCC) patients. Some RCCs clinically appear T1 on CT, but are actually T3a due to extension into fat or renal vein, causing the tumor to be pathologically upstaged. The objective of this study to determine the rate, survival, and predictors of RCC upstaging, for patients with cT1 disease treated surgically. Using the National Cancer Data Base Participant User File for RCC from 2004 to 2013, we selected AJCC cT1 patients, who underwent surgical resection and whose AJCC pathological T stage (pT) was available. Upstaging was characterized dichotomously-overall (any pT>T1) and pT3a-specific upstaging. Patient and tumor characteristics of those upstaged and not were compared using Chi-squared analyses. Multivariable logistic regression was used to analyze predictors of upstaging, and Cox proportional hazards regression was used to estimate overall survival hazards ratios. Overall upstaging (pT>T1) was observed in 8252 (7.1%) patients, and T3a-specific upstaging was observed in 3380 (5.4%) patients. Patients who were older, male, and had comorbidities, and tumors that were cT1b, underwent RN, and had high Fuhrman grade were at a higher risk of pathological upstaging. Upstaging led to a 40% increased risk of death compared to patients who were not upstaged. The rate of upstaging is not negligible (5-7% of the time), negatively impacts survival, and various patient and tumor characteristics can be used to predict upstaging.

P108 - Impact of warm ischemia time on postoperative renal function after partial nephrectomy for clinical T1 renal cell carcinoma: a propensity score matched study

P108 - Impact of warm ischemia time on postoperative renal function after partial nephrectomy for clinical T1 renal cell carcinoma: a propensity score matched study

Relationship Between Preoperative C-Reactive Protein and Fuhrman Nuclear Grade in Stage T1 Renal Cell Carcinoma: A Short-Term Update

Relationship Between Preoperative C-Reactive Protein and Fuhrman Nuclear Grade in Stage T1 Renal Cell Carcinoma: A Short-Term Update

Percutaneous Cryoablation of Renal Tumors: Is It Time for a New Paradigm Shift?

PurposeTo retrospectively assess long-term outcomes of percutaneous renal cryoablation, including factors affecting complications and local recurrence rates. Materials and MethodsA total of 357 computed tomographic (CT) fluoroscopy–guided percutaneous cryoablation procedures were performed for 382 masses in 302 outpatients; 347 were biopsy-proven renal-cell carcinoma (RCC) or Bosniak category > III masses (n = 28). Benign pathologic conditions (n = 18) or metastatic non-RCC disease (n = 17) were included to analyze procedural complication rate, but recurrence rates, tumor staging, and nephrometry score were limited to RCCs. The average tumor diameter was 2.9 cm (range, 1–10.3 cm), and median nephrometry score for RCC was 8 (mean, 7.4). Protection of adjacent vital structures was performed in 34% of procedures (n = 121), and ureteral stent placement was performed for 9.2% (n = 33). All major complications were graded per surgical Clavien–Dindo criteria. ResultsThe average CT-visible cryoablation zone diameter was 5 cm (range, 2.5–10.5 cm). Grade ≥ 3 complications occurred in 2.8% of procedures (n = 10), and appeared related to only high nephrometry scores (P = .0086) and larger tumors (P = .0034). No significant changes in renal function before and after the procedure were noted (P = .18). At a mean follow-up of 31.8 months, the local tumor recurrence rate was 3.2% (11 of 347) for RCC, and no significant difference was noted between tumors larger or smaller than 3 cm (P = .15). The difference reached significance only among the small number of stage ≥ T2 RCC tumors (P = .0039). ConclusionsLong-term follow-up of percutaneous renal cryoablation demonstrates low recurrence rates with preserved renal function, even for patients with high nephrometry scores and body mass index, assuming thorough cytotoxic technique and protection measures.

Renal Cell Carcinoma: Alternative Nephron-Sparing Treatment Options for Small Renal Masses, a Systematic Review.

The standard treatment of T1 renal cell carcinoma (RCC) is (partial) nephrectomy. For patients where surgery is not the treatment of choice, for example in the elderly, in case of severe comorbidity, inoperability, or refusal of surgery, alternative treatment options are available. These treatment options include active surveillance (AS), radiofrequency ablation (RFA), cryoablation (CA), microwave ablation (MWA), or stereotactic body radiotherapy (SBRT). In the present overview, the efficacy, safety, and outcome of these different options are summarized, particularly focusing on recent developments. Databases of MEDLINE (through PubMed), EMBASE, and the Cochrane Library were systematically searched according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) criteria. The search was performed in December 2016, and included a search period from 2010 to 2016. The terms and synonyms used were renal cell carcinoma, active surveillance, radiofrequency ablation, microwave ablation, cryoablation and stereotactic body radiotherapy. The database search identified 2806 records, in total 73 articles were included to assess the rationale and clinical evidence of alternative treatment modalities for small renal masses. The methodological quality of the included articles varied between level 2b and level 4. Alternative treatment modalities, such as AS, RFA, CA, MWA, and SBRT, are treatment options especially for those patients who are unfit to undergo an invasive treatment. There are no randomized controlled trials available comparing surgery and less invasive modalities, leading to a low quality on the reported articles. A case-controlled registry might be an alternative to compare outcomes of noninvasive treatment modalities in the future.

Simple tumor enucleation may not decrease oncologic outcomes for T1 renal cell carcinoma: A systematic review and meta-analysis

ObjectiveTo evaluate the clinical efficacy and safety of simple tumor enucleation (TE) for clinical T1 renal cell carcinoma. Materials and methodsA systematic search of PubMed, EMBASE, and Cochrane Central Register of Controlled Trials databases was performed to identify all trials that compared TE and traditional partial nephrectomy (PN) for patients with clinical T1 renal cell carcinoma. ResultsA total of 7 studies involving 3,218 patients were identified and included in this meta-analysis. Compared with the PN group, the TE group had significantly shorter estimated operation times (mean difference [MD] = −21.93; 95% CI: −31.07 to −12.78; P< 0.001), shorter warm ischemia times (MD = −1.96; 95% CI: −3.80 to −0.13; P = 0.04), less blood loss (MD = −36.63; 95% CI: −57.49 to −15.77; P = 0.0006), and lower surgical complication rates (odds ratio [OR] = 0.66; 95% CI: 0.47–0.92; P = 0.02). Furthermore, there was no significant difference between the 2 groups in hospital stay duration (MD = −0.46; 95% CI: −0.93 to 0.02; P = 0.06), changes in estimated glomerular filtration rate (MD = 3.35; 95% CI: −2.78 to 9.48; P = 0.28), positive surgical margin rates (OR = 0.34; 95% CI: 0.10–1.14; P = 0.08), and local recurrence rates (OR = 0.71; 95% CI: 0.24–2.06; P = 0.52). ConclusionCompared to traditional PN, TE is an effective and safe treatment for T1 renal tumors, and TE appears to have acceptable early oncology outcomes. Owing to the limited number of clinical trials and the predominantly retrospective data on this subject, there is a need for properly designed studies to confirm our findings.

Impact of warm ischaemia time on postoperative renal function after partial nephrectomy for clinical T1 renal cell carcinoma: a propensity score-matched study.

To analyse the effect of prolonged warm ischaemia time (WIT) on long-term renal function after partial nephrectomy (PN), as controversy still exists as to whether prolonged WIT adversely affects the incidence of chronic kidney disease (CKD) after PN. We reviewed data from 1816 patients who underwent PN for a clinical T1 renal tumour. The propensity scores for prolonged WIT were calculated with the shorter WIT group (<30 min) matched to the longer WIT group (≥30 min) in a 2:1 ratio. Multivariate analysis was used to determine independent predictors for occurrence of postoperative CKD [defined as an estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73 m2 ] and major renal function deterioration (MRFD; defined as an eGFR decrease of ≥25% postoperatively). After propensity score matching, there was no significant difference in CKD-free survival between the two WIT groups (P = 0.787). Furthermore, longer WIT did not show any significant associations with postoperative CKD-free survival [hazard ratio (HR) 1.002, 95% confidence interval (CI) 0.989-1.015; P = 0.765) and MRFD-free survival (HR 1.014, 95% CI 1.000-1.028; P = 0.055). From further subgroup analyses using more specific WIT thresholds (≤20, 21-30, 31-40, 41-50, ≥50 min) and status of preoperative CKD, no significant differences were noted in CKD and MRFD-free survival amongst the subgroups (all P > 0.05). Prolonged WIT was not associated with increased incidence of CKD or MRFD after PN.

Association of race and margin status among patients undergoing robotic partial nephrectomy for T1 renal cell carcinoma: Results from a population-based cohort

ObjectiveTo assess the relationship of race and margin status among patients undergoing robotic partial nephrectomy (RPN) for T1 renal tumors from a contemporary population-based cohort. MethodsUsing the National Cancer Database, we identified patients with localized renal cell carcinoma (RCC) (clinical T1N0M0) who underwent RPN from 2010 to 2013. The primary outcome was positive surgical margins (PSM). Multivariable logistic regression analyses were used to assess the association between race and PSM adjusting for patient clinicopathologic and hospital factors. ResultsAmong 12,515 patients undergoing RPN in our cohort, 8.3% had PSM (n = 1,045). When compared to white patients undergoing RPN for T1 RCC with PSM (7.9%), we observed a higher proportion of PSM among African American (AA) (10.8%; P = 0.005) and Hispanic/Latino patients (8.8%; P = 0.005), respectively. On multivariable analysis, AA patients had higher odds of PSM compared to white patients (odds ratio = 1.40; P = 0.008). Other factors associated with higher odds of PSM were treatment at nonacademic centers relative to academic centers (10.4% vs. 6.9%; odds ratio = 1.57; P<0.001). ConclusionsIn this contemporary population-based cohort, AA patients undergoing RPN for localized RCC tumors are at higher risk for PSM. These results suggest potential differences in quality of care and patient selection of RPN by race.

Transforming the Perioperative Treatment Paradigm in Non-Metastatic RCC-A Possible Path Forward.

In 2017, there is no adjuvant systemic therapy proven to increase overall survival in non-metastatic renal cell carcinoma (RCC). The anti-PD-1 antibody nivolumab improves overall survival in metastatic treatment refractory RCC and is generally tolerable. Mouse solid tumor models have revealed a benefit with a short course of neoadjuvant PD-1 blockade compared to adjuvant therapy. Two ongoing phase 2 studies of perioperative nivolumab in RCC patients have shown preliminary feasibility and safety with no surgical delays or complications. The recently opened PROSPER RCC trial (A Phase 3 RandOmized Study Comparing PERioperative Nivolumab vs. Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy; EA8143) will examine if the addition of perioperative nivolumab to radical or partial nephrectomy can improve clinical outcomes in patients with high risk localized and locally advanced RCC. With the goal of increasing cure and recurrence-free survival (RFS) rates in non-metastatic RCC, we are executing a three-pronged, multidisciplinary approach of presurgical priming with nivolumab followed by resection and adjuvant PD-1 blockade. We plan to enroll 766 patients with clinical stage ≥T2 or node positive M0 RCC of any histology in this global, randomized, unblinded, phase 3 National Clinical Trials Network study. The investigational arm will receive two doses of nivolumab 240 mg IV prior to surgery followed by adjuvant nivolumab for 9 months. The control arm will undergo the current standard of care: surgical resection followed by observation. Patients are stratified by clinical T stage, node positivity, and histology. The trial is powered to detect a 14.4% absolute benefit in the primary endpoint of RFS from the ASSURE historical control of 55.8% to 70.2% at 5 years (HR = 0.70). The study is also powered to detect a significant overall survival benefit (HR 0.67). Key safety, feasibility, and quality of life endpoints are incorporated. PROSPER RCC exemplifies team science with a host of planned correlative work to investigate the impact of the baseline immune milieu and changes after neoadjuvant priming on clinical outcomes.

Impact of Perioperative Infection on Cancer Specific Survival after Nephrectomy for Renal Cell Carcinoma.

Several case reports have documented rare spontaneous cancer regression following systemic infections. Immune related targeted therapies are now available for many cancers, including renal cell carcinoma. We hypothesized that perioperative infection after nephrectomy for renal cell carcinoma may impact long-term cancer specific survival. We performed a retrospective cohort study using SEER (Surveillance, Epidemiology and End Results)-Medicare claims data from 2004 to 2011. ICD-9 and CPT codes were used to identify patients older than 65 years who underwent radical or partial nephrectomy for renal cell carcinoma. Patients hospitalized for infection within 30 days of surgery were identified. Study exclusion criteria included death within 90 days of surgery, immunodeficiency and metastatic disease at diagnosis. Kaplan-Meier curves were used to evaluate cancer specific survival between infection vs no infection groups. A Cox proportional hazards model was created to assess survival while controlling for age, gender, race, Elixhauser index, tumor grade, tumor size, histological subtype, AJCC (American Joint Committee on Cancer) stage, systemic therapy and geographic region. Of 8,967 patients 493 (5.5%) were hospitalized for infection after nephrectomy. Median age was 74 years (IQR 69-79), the mean ± SD Elixhauser index was 4.9 ± 7.4 and median followup was 42 months (IQR 22-67). Following nephrectomy univariable Cox regression showed a nonsignificant improvement in cancer specific survival in patients with a serious infection requiring hospitalization (HR 0.84, 95% CI 0.69-1.00, p = 0.054). Cox multivariable regression revealed significant improvement in cancer specific survival for the same population (HR 0.75, 95% CI 0.57-0.99, p = 0.04). Thiseffect was primarily due to patients with larger (7 cm or greater) tumors (HR 0.67, 95% CI 0.44-0.99, p = 0.049). No impact was observed among patients with smaller (less than 7 cm) tumors (HR 0.82, 95% CI 0.57-1.19, p=0.3). In patients with T2 (7 cm or greater) renal cell carcinoma who undergo nephrectomy perioperative infection may improve cancer specific survival.