Perioperative nivolumab versus observation in patients with renal cell carcinoma undergoing nephrectomy (PROSPER ECOG-ACRIN EA8143): an open-label, randomised, phase 3 study.

BACKGROUND: The standard of care for patients with intermediate-to-high risk renal cell carcinoma is partial or radical nephrectomy followed by surveillance. We aimed to investigate use of nivolumab before nephrectomy followed by adjuvant nivolumab in patients with high-risk renal cell carcinoma to determine recurrence-free survival compared with surgery only. METHODS: In this open-label, randomised, phase 3 trial (PROSPER EA8143), patients were recruited from 183 community and academic sites across the USA and Canada. Eligible patients were aged 18 years or older with an Eastern Cooperative Oncology Group performance status of 0-1, with previously untreated clinical stage T2 or greater or Tany N+ renal cell carcinoma of clear cell or non-clear cell histology planned for partial or radical nephrectomy. Selected patients with oligometastatic disease, who were disease free at other disease sites within 12 weeks of surgery, were eligible for inclusion. We randomly assigned (1:1) patients using permuted blocks (block size of 4) within stratum (clinical TNM stage) to either nivolumab plus surgery, or surgery only followed by surveillance. In the nivolumab group, nivolumab 480 mg was administered before surgery, followed by nine adjuvant doses. The primary endpoint was investigator-reviewed recurrence-free survival in patients with renal cell carcinoma assessed in all randomly assigned patients regardless of histology. Safety was assessed in all randomly assigned patients who started the assigned protocol treatment. This trial is registered with ClinicalTrials.gov, NCT03055013, and is closed to accrual. FINDINGS: Between Feb 2, 2017, and June 2, 2021, 819 patients were randomly assigned to nivolumab plus surgery (404 [49%]) or surgery only (415 [51%]). 366 (91%) of 404 patients assigned to nivolumab plus surgery and 387 (93%) of 415 patients assigned to surgery only group started treatment. Median age was 61 years (IQR 53-69), 248 (30%) of 819 patients were female, 571 (70%) were male, 672 (88%) were White, and 77 (10%) were Hispanic or Latino. The Data and Safety Monitoring Committee stopped the trial at a planned interim analysis (March 25, 2022) because of futility. Median follow-up was 30·4 months (IQR 21·5-42·4) in the nivolumab group and 30·1 months (21·9-41·8) in the surgery only group. 381 (94%) of 404 patients in the nivolumab plus surgery group and 399 (96%) of 415 in the surgery only group had renal cell carcinoma and were included in the recurrence-free survival analysis. As of data cutoff (May 24, 2023), recurrence-free survival was not significantly different between nivolumab (125 [33%] of 381 had recurrence-free survival events) versus surgery only (133 [33%] of 399; hazard ratio 0·94 [95% CI 0·74-1·21]; one-sided p=0·32). The most common treatment-related grade 3-4 adverse events were elevated lipase (17 [5%] of 366 patients in the nivolumab plus surgery group vs none in the surgery only group), anaemia (seven [2%] vs nine [2%]), increased alanine aminotransferase (ten [3%] vs one [<1%]), abdominal pain (four [1%] vs six [2%]), and increased serum amylase (nine [2%] vs none). 177 (48%) patients in the nivolumab plus surgery group and 93 (24%) in the surgery only group had grade 3-5 adverse events due to any cause, the most common of which were anaemia (23 [6%] vs 19 [5%]), hypertension (27 [7%] vs nine [2%]), and elevated lipase (18 [5%] vs six [2%]). 48 (12%) of 404 patients in the nivolumab group and 40 (10%) of 415 in the surgery only group died, of which eight (2%) and three (1%), respectively, were determined to be treatment-related. INTERPRETATION: Perioperative nivolumab before nephrectomy followed by adjuvant nivolumab did not improve recurrence-free survival versus surgery only followed by surveillance in patients with high-risk renal cell carcinoma. FUNDING: US National Institutes of Health National Cancer Institute and Bristol Myers Squibb.

Impact of rural location on receipt of standard of care treatment and survival for locally advanced bladder cancer in Louisiana.

OBJECTIVE: We aim to determine the effect of region of residence (urban vs. rural) on the odds of receiving standard of care treatment for locally advanced BCa in Louisiana and its impact on survival outcomes. METHODS: Using the Louisiana Tumor Registry, we identified American Joint Committee on Cancer (AJCC) stage II or III, BCa diagnoses in Louisiana residents between 2010 and 2020. Treatment received was classified as standard or non-standard of care according to American Urological Association (AUA) guidelines and location of residence was determined using Rural Urban Commuting Area-Tract-level 2010 (RUCA). Multivariable logistic regression analyses and multivariate cox proportional hazard analyses were performed. RESULTS: Of 983 eligible patients, 85.6% (841/983) lived in urban areas. Overall, only 37.5% received standard-of-care (SOC) for the definitive management of locally advanced bladder cancer. Individuals living in rural areas (OR 0.53, 95% CI: 0.31-0.91, p = 0.02) were less likely to receive standard of care treatment. Both rural residence and receipt of non-standard of care therapy were associated with an increased risk of bladder cancer-specific (adj HR 1.53, 95% CI: 1.09-2.14, p = 0.01 and adj HR: 1.85, 95% CI: 1.43-2.39, <0.0001) and overall mortality (adj HR: 1.28, 95% CI: 1.01-1.61, p = 0.04 and adj HR: 1.73 95% CI: 1.44-2.07, p < 0.0001). CONCLUSIONS: Most patients with locally advanced bladder cancer in Louisiana do not receive SOC therapy. Individuals living in rural locations are more likely to receive non-standard of care therapy than individuals in urban areas. Nonstandard of care treatment and rural residence are both associated with worse survival outcomes for Louisiana residents with locally advanced bladder cancer.

Clinical safety and efficacy of microwave ablation for small renal masses.

PURPOSE: CT-guided MWA is a safe and effective tool that should be utilized in the treatment of small renal masses (SRMs). We aim to clarify the utility of CT-guided MWA by examining patient outcomes such as recurrence, treatment success, changes in renal function, and complications. METHODS: A retrospective review of consecutive patients with SRMs who underwent same day renal mass biopsy (RMB) and CT-guided MWA between 2015 and 2022 was performed. Treatment safety was assessed by 30-day complications according to the Clavien-Dindo system and change in eGFR >30 days post-procedure. Treatment efficacy was defined by local recurrence and incomplete treatment rates and calculated using the Kaplan-Meier method. RESULTS: A total of 108 renal masses were found in 104 patients. The overall complication rate was 7.4% (8/108), of which 4 were major complications (3.7%). For those with renal function available >30 days post ablation, the median eGFR was 47.2 (IQR: 36.0, 57), compared to 52.3 (IQR: 43.7, 61.5) pre-ablation, p<0.0001. 5-year local recurrence free survival was 86%. Among those with biopsy proven malignancy (n= 66), there were five local recurrences (7.54%) occurring at a median of 25.1 months (IQR 19.9, 36.2) and one case (1.5%) of incomplete treatment. CONCLUSIONS: As the medical field continues to evolve towards less invasive interventions, MWA offers a valuable tool in the management of renal masses. With low major complication and recurrence rates, our findings support the utility of CT-guided MWA as a tool for treatment of SRMs.

Does Chemo-Radiotherapy Improve Survival Outcomes vs. Radiotherapy Alone for High-Grade cT1 Urothelial Carcinoma of the Bladder?

BACKGROUND: Non-muscle invasive bladder cancer (non-MIBC) that is high-grade and confined to the lamina propria (HGT1) often has an aggressive clinical course. Currently, there is limited data on the comparative effectiveness of RT vs. CRT for HGT1 non-MIBC. We hypothesized that CRT would be associated with improved overall survival (OS) vs. RT in HGT1 bladder cancer. METHODS: Patients diagnosed with HGT1 non-MIBC, and treated with transurethral resection of bladder tumor followed by either treatment with RT alone or CRT, were identified in the National Cancer Database. Inverse probability of treatment weighting (IPTW) was employed and weight-adjusted multivariable analysis (MVA) using Cox regression modeling was used to compare overall survival (OS) hazard ratios. OS was the primary endpoint, and was estimated using the Kaplan-Meier method and log-rank tests. RESULTS: A total of 259 patients with HGT1 UC were treated with: (i) RT alone (n = 123) or (ii) CRT (n = 136). Propensity-weighted MVA showed that combined modality treatment with CRT was associated with improved OS relative to radiation alone (Hazard Ratio [HR]: 0.62, 95% Confidence Interval (95% CI): 0.44-0.88, P = .007). Four-year OS for the CRT vs. RT alone was 36% and 19%, respectively (log-rank P <.008). CONCLUSION: For patients with HGT1 bladder cancer, concurrent CRT was associated with improved OS compared with radiation alone in a retrospective cohort. These results are hypothesis-generating. The NRG is currently developing a phase II randomized clinical trial comparing CRT to other novel, bladder preservation strategies.

Surgical challenges and considerations in Tri-modal therapy for muscle invasive bladder cancer.

Trimodal therapy (TMT) for muscle invasive bladder cancer has become an accepted alternative to radical cystectomy and has become integrated into national guidelines as standard a treatment option. The urologist plays a critical role in proper patient selection, thorough transurethral resection, ongoing cystoscopic surveillance and management of local recurrences. There exists multiple patient related and tumor related factors, which contribute to the selection of TMT vs. radical cystectomy for a patient with muscle invasive bladder cancer. Although the ideal patient for TMT has a tumor which can undergo a visibly complete resection, has no associated hydronephrosis, does not invade the prostatic urethra and is not associated with diffuse carcinoma in situ throughout the bladder, select patients who do not meet all these criteria can still be successfully treated with this approach. A multidisciplinary approach including urology, radiation oncology and medical oncology is paramount with clear communication of tumor location, timing of chemoradiation and repeat cystoscopic resection followed by surveillance. Nonmuscle invasive bladder cancer recurrences can occur in up to 26% of patients after completion of TMT, with many being treated by routine and standard therapy for non-muscle invasive bladder cancer. However, in this population after TMT, early salvage cystectomy should be considered in those with adverse features, including T1 disease, tumor greater than 3 cm, CIS, or lymphovascular invasion. Salvage cystectomy can be performed for local recurrences with acceptable oncologic control and no clear evidence of any greater risk of early complications; however, there may be a slightly increased risk for late complications, namely small bowel obstruction, ureteral stricture, and parastomal hernia. An understanding of these surgical considerations is of utmost importance to the treating urologist in selecting and managing a patient through TMT.

Impact of preoperative prostate magnetic resonance imaging on the surgical management of high-risk prostate cancer.

OBJECTIVE: To evaluate the effect of adding multiparametric magnetic resonance imaging (mpMRI) to pre-surgical planning on surgical decision making for the management of high-risk prostate cancer (HRPC). PATIENTS AND METHODS: A survey was designed to query multiple centers on surgical decisions of 41 consecutive HRPC cases seen from 2012 to 2015. HRPC was defined by the National Comprehensive Cancer Center Network guidelines. Six fellowship-trained urologic oncologists were asked for their surgical plan in regards to the degree of planned nerve-sparing and lymph node dissection. Two rounds of surveys were administered to six external urologic oncologists. The first survey included the case description only and the second included case description with mpMRI images and report. The correct surgical plan was analyzed by correlation of the degree of planned surgical excision and consistency with the final pathologic evaluation. A priori, an effect size of 20% change was used to determine statistical significance, at p < 0.05. RESULTS: All cases had at least one change to surgical planning after mpMRI review. Forty (98%) patients had a change in the degree of planned nerve sparing: wider excision in 32% and increased nerve sparing in 24%. After mpMRI the correct surgical plan change was made in 49% for the right and left 51%, decreasing the potential for positive margins. Lymph node dissection was altered from standard to extended lymph node dissection in 17%. CONCLUSIONS: Although mpMRI is not integrated in guidelines for preoperative planning in HRPC, its use may impact surgical planning, cancer control, and quality of life.

Prevalence and predictors of probable depression in prostate cancer survivors.

BACKGROUND: The early diagnosis and treatment of depression are cancer care priorities. These priorities are critical for prostate cancer survivors because men rarely seek mental health care. However, little is known about the epidemiology of depression in this patient population. The goal of this study was to describe the prevalence and predictors of probable depression in prostate cancer survivors. METHODS: The data were from a population-based cohort of North Carolinian prostate cancer survivors who were enrolled from 2004 to 2007 in the North Carolina-Louisiana Prostate Cancer Project (n = 1031) and were prospectively followed annually from 2008 to 2011 in the Health Care Access and Prostate Cancer Treatment in North Carolina study (n = 805). Generalized estimating equations were used to evaluate an indicator of probable depression (Short Form 12 mental composite score ≤48.9; measured at enrollment and during the annual follow-up) as a function of individual-level characteristics within the longitudinal data set. RESULTS: The prevalence of probable depression fell from 38% in the year of the cancer diagnosis to 20% 6 to 7 years later. Risk factors for probable depression throughout the study were African American race, unemployment, low annual income, younger age, recency of cancer diagnosis, past depression, comorbidities, treatment decisional regret, and nonadherence to exercise recommendations. CONCLUSIONS: Depression is a major challenge for prostate cancer survivors, particularly in the first 5 years after the cancer diagnosis. To the authors' knowledge, this is the first study to demonstrate an association between treatment decisional regret and probable depression.

Patterns and predictors of self-reported clinical diagnosis and treatment for depression in prostate cancer survivors.

BACKGROUND: Appropriate depression care is a cancer-care priority. However, many cancer survivors live with undiagnosed and untreated depression. Prostate cancer survivors may be particularly vulnerable, but little is known about their access to depression care. The goal of this study was to describe patterns and predictors of clinical diagnosis and treatment of depression in prostate cancer survivors. METHODS: Generalized estimating equations were used to evaluate indicators of self-reported clinical diagnosis and treatment depression as a function of individual-level characteristics within a longitudinal dataset. The data were from a population-based cohort of North Carolinian prostate cancer survivors who were enrolled from 2004 to 2007 on the North Carolina-Louisiana Prostate Cancer Project (N = 1,031), and prospectively followed annually from 2008 to 2011 on the Health Care Access and Prostate Cancer Treatment in North Carolina (N = 805). RESULTS: The average rate of self-reported clinical diagnosis of depression was 44% (95% CI: 39%-49%), which declined from 60% to 40% between prostate cancer diagnosis and 5-7 years later. Factors associated with lower odds of self-reported clinical diagnosis of depression include African-American race, employment, age at enrollment, low education, infrequent primary care visits, and living with a prostate cancer diagnosis for more than 2 years. The average rate of self-reported depression treatment was 62% (95% CI: 55%-69%). Factors associated with lower odds of self-reported depression treatment included employment and living with a prostate cancer diagnosis for 2 or more years. CONCLUSION: Prostate cancer survivors experience barriers when in need of depression care.

Multimedia psychoeducation for patients with cancer who are eligible for clinical trials: A randomized clinical trial.

BACKGROUND: Supporting patients' decision making about clinical trials may enhance trial participation. To date, few theory-based interventions have been tested to address this issue. The objective of the current study was aimed to evaluate the effect of a multimedia psychoeducation (MP) intervention, relative to a print education (PE) intervention, on patients' decision support needs and attitudes about clinical trials. METHODS: Patients with cancer who were eligible for participation in a National Cancer Institute therapeutic cancer clinical trial were recruited through the nationwide University of Rochester Cancer Center National Cancer Institute Community Oncology Research Program from 2014 to 2016 and were randomized to the MP or PE intervention. Assessments at baseline (before intervention), postintervention, and at a 2-month follow-up visit included patients' decision support needs, attitudes regarding clinical trials, and clinical trial participation. RESULTS: In total, 418 patients with various types of cancer were recruited (ages 26-89 years). Relative to the PE intervention, the MP intervention did not significantly affect decision support needs. However, patients in the MP arm reported significantly more positive attitudes about clinical trials and were more likely to participate in a clinical trial than those in the PE arm (69% vs 62%; P = .01). Furthermore, an improvement in attitudes about clinical trials significantly mediated the effect of the intervention on participation in clinical trials. CONCLUSIONS: The MP intervention was able to improve patient attitudes toward clinical trials compared with the PE intervention, and this improvement led to increased rates of participation in trials. The MP intervention could be disseminated to improve attitudes about clinical trials among patients with cancer.

Background and Update for S1602 "A Phase III Randomized Trial to Evaluate the Influence of BCG Strain Differences and T Cell Priming with Intradermal BCG Before Intravesical Therapy for BCG-naïve High-grade Non-muscle-invasive Bladder Cancer.

The S1602 Intergroup trial is a randomized phase III clinical trial that aims to test two important hypotheses: (1) priming with intradermal bacillus Calmette-Guérin (BCG) vaccine prior to standard intravesical BCG improves response to BCG in terms of recurrence-free survival and (2) Tokyo-172 BCG strain is non-inferior to TICE BCG in terms of time to high-grade recurrence. The study was approved by the Cancer Therapy Evaluation Program of the National Cancer Institute and activated in spring 2017. Here, we provide a synopsis of the study background, design, and update of the clinical trial.

Robotic Cystectomy.

Retrospective observational studies support the utility of robotic-assisted radical cystectomy (RARC). Randomized controlled trials (RCTs) have shown that RARC with extracorporeal urinary diversion may lead to decreased estimated blood loss, decreased rate of transfusion, similar oncologic outcomes, cost-effectiveness, and variable increased operative times. Although RCTs comparing RARC with open radical cystectomy are currently ongoing, it may be several years before the utility of RARC is known. The discussion on the role of cystectomy, indications, outcomes, care pathways, access to high-volume care centers, and efforts to decrease complications may prove as important as the technique itself.

The use of PET/CT in prostate cancer.

BACKGROUND: Positron emission tomography/computed tomography (PET/CT) has recently emerged as a promising diagnostic imaging platform for prostate cancer. Several radiolabelled tracers have demonstrated efficacy for cancer detection in various clinical settings. In this review, we aim to illustrate the diverse use of PET/CT with different tracers for the detection of prostate cancer. METHODS: We searched MEDLINE using the terms 'prostate cancer', 'PET', 'PET/CT' and 'PET/MR'). The current review was limited to 18F-NaF PET/CT, choline-based PET/CT, fluciclovine PET/CT and PSMA-targeted PET/CT, as these modalities have been the most widely adopted. RESULTS: NaF PET/CT has shown efficacy in detecting bone metastases with high sensitivity, but relatively low specificity. Currently, choline PET/CT has been the most extensively studied modality. Although having superior specificity, choline PET/CT suffers from low sensitivity, especially at low PSA levels. Nevertheless, choline PET/CT was found to significantly improve upon conventional imaging modalities (CIM) in the detection of metastatic lesions at biochemical recurrence (BCR). Newer methods using fluciclovine and PSMA-targeted radiotracers have preliminarily demonstrated great promise in primary and recurrent staging of prostate cancer. However, their superior efficacy awaits confirmation in larger series. CONCLUSIONS: PET/CT has emerged as a promising staging modality for both primary and recurrent prostate cancer. Newer tracers have increased detection accuracies for small, incipient metastatic foci. The clinical implications of these occult PET/CT detected disease foci require organized evaluation. Efforts should be aimed at defining their natural history as well as responsiveness and impact of metastasis-directed therapy.

Klinefelter Syndrome with Poor Risk Extragonadal Germ Cell Tumor.

Germ cell tumors are the most common malignancy in men aged 15-35 years old, with a small percentage presenting in an extragonadal location. These tumors are seldom identified in the gastrointestinal tract. There is increased risk of extragonadal germ cell tumors (EGCT) in men with Klinefelter syndrome (KS). We report a rare case of a 37-year-old male with KS and EGCT discovered in the duodenum and pelvis. After treatment with Bleomycin-Etoposide-Cisplatin (BEP), he developed growing teratoma syndrome (GTS) and myelodysplasia. Despite surgical excision of the pelvic growing teratoma, he unfortunately died secondary to complications of severe bone marrow suppression.

Outcome of patients with clinically node-positive bladder cancer undergoing consolidative surgery after preoperative chemotherapy: The M.D. Anderson Cancer Center Experience.

PURPOSE: Patients with urothelial cancer with nodal metastasis have a poor prognosis, with many deemed incurable. We report outcomes of a prospective clinical protocol of patients with clinically node-positive disease treated via a multimodality treatment approach. PATIENTS AND METHODS: A total of 55 patients with bladder urothelial carcinoma with concurrent node-positive disease including pelvic nodal and retroperitoneal lymph node (RPLN) involvement underwent preoperative chemotherapy followed by consolidative surgery between 1995 and 2010. Associations between clinicopathologic factors and outcomes were analyzed using log-rank test and Cox regression analysis. RESULTS: Median cancer-specific survival (CSS) was 26 months (95% CI: 12.9-not applicable) for all patients. A total of 30 (55%) patients had pN0 category disease at the time of surgical extirpation. Despite radiologic complete response after chemotherapy, 6 of 21 patients (29%) had pN+category disease. The 5-year CSS rate was 66% for pN0 category disease vs. 12% for pN+category disease (P<0.001). Radiologic complete response to chemotherapy was associated with a 5-year CSS rate of 60% vs. 33% for a partial response (P = 0.038). Although no recurrences occurred within the lymphadenectomy template, 2 (14%) patients with cM1 RPLN disease who did not undergo RPLN dissection had recurrences in the RPLN basin and died within 6 months. CONCLUSION: Multimodality treatment approach with upfront chemotherapy followed by surgery can result in a 66% 5-year CSS rate for patients rendered as having pN0 category disease despite initially presenting with node-positive disease. However, as those with residual disease do so poorly, further efforts in refining selection of patients for surgical consolidation are needed.

Comparison of Single-docking Robotic-assisted and Traditional Laparoscopy for Retroperitoneal Lymph Node Dissection During Nephroureterectomy With Bladder Cuff Excision for Upper-tract Urothelial Carcinoma.

OBJECTIVE: To compare the results of traditional laparoscopy and a simple, single-docking robotic approach for retroperitoneal lymph node dissection (RPLND), nephroureterectomy, and bladder cuff excision. MATERIALS AND METHODS: We evaluated 63 and 37 consecutive patients who underwent laparoscopic and robotic nephrouretectomy with RPLND, respectively, for upper-tract urothelial carcinoma (UTUC). RESULTS: Our robotic approach was associated with improved lymph node procurement (21.0 nodes [interquartile range 16.0-30.0]) when compared with laparoscopy (11.0 nodes [interquartile range 5.5-21.0]) (P < .0001). Major blood loss as defined by requiring a blood transfusion was less for the robotic group than for the laparoscopic cohort (8% vs 30%) (P = .012). In contrast, the robotic group had longer operative times (5.1 vs 3.9 hours) (P = .0001) and longer hospital stays (5.0 vs 4.0 days) (P = .0002). CONCLUSION: Our single-docking robotic technique for concomitant RPLND during nephrouretectomy is associated with improved lymph node yield.

The feasibility and safety of repeat cryosurgical ablation of localized prostate cancer.

BACKGROUND: The aim of the study was to assess the morbidity and efficacy of repeat cryoablation (CA) in the treatment of localized prostate cancer. METHODS: Twenty-seven patients with median age of 71 years (range 48-80) who underwent repeat CA between April 2003 and April 2011 at a single institution were included. The median initial prostate-specific antigens (PSA) and Gleason values were 6.2 ng/ml (range 4-23.6) and 7 (range 6-9), respectively. Twenty-four patients underwent two CA treatments, and three patients underwent three CA treatments. Pre- and perioperative parameters and oncological and functional outcomes were evaluated. RESULTS: No intraoperative complications occurred. After the first CA, PSA was undetectable in 10 patients, and the median nadir PSA value was 0.65 ng/ml (range 0.1-4.9). After the second CA, 4 patients had undetectable PSA, and the median nadir PSA value was 1.25 ng/ml (range 0.2-7.9). For patients who underwent a third CA treatment, no patients had undetectable PSA, and the subsequent median nadir PSA value was 1.6 ng/ml (range 0.4-4.5). Two patients had incontinence (1 pad per day) following repeat CA. One patient had urinary retention after the third CA treatment, and one had urethral stricture. The mean hospitalization and follow-up periods were 1 day (range 0-2) and 51.5 months (range 11-96), respectively. CONCLUSIONS: Repeat CA successfully reduced PSA levels, and complications were modest. We conclude that repeat CA is a feasible, safe, and effective treatment option for localized prostate cancer.

Clinical and prognostic factors for renal parenchymal, pelvis, and ureter cancers in SEER registries: collaborative stage data collection system, version 2.

BACKGROUND: The American Joint Committee on Cancer's (AJCC) 7th edition cancer staging manual reflects recent changes in cancer care practices. This report assesses changes from the AJCC 6th to the AJCC 7th edition stage distributions and the quality of site-specific factors (SSFs). METHODS: Incidence data for renal parenchyma and pelvis and ureter cancers from 18 Surveillance, Epidemiology, and End Results (SEER) registries were examined, including staging trends during 2004-2010, stage distribution changes between the AJCC 6th and 7th editions, and SSF completeness for cases diagnosed in 2010. RESULTS: From 2004 to 2010, the percentage of stage I renal parenchyma cancers increased from 50% to 58%, whereas stage IV and unknown stage cases decreased (18% to 15%, and 10% to 6%, respectively). During this period, the percentage of stage 0a renal pelvis and ureter cancers increased from 21% to 25%, and stage IV and unknown stage tumors decreased (20% to 18%, and 7% to 5%, respectively). Stage distributions under the AJCC 6th and 7th editions were about the same. For renal parenchymal cancers, 71%-90% of cases had known values for 6 required SSFs. For renal pelvis and ureter cancers, 74% of cases were coded as known for SSF1 (WHO/ISUP grade) and 47% as known for SSF2 (depth of renal parenchymal invasion). SSF values were known for larger proportions of cases with reported resections. CONCLUSIONS: Stage distributions between the AJCC 6th and 7th editions were similar. SSFs were known for more than two-thirds of cases, providing more detail in the SEER database relevant to prognosis.

Positive vascular wall margins have minimal impact on cancer outcomes in patients with non-metastatic renal cell carcinoma (RCC) with tumour thrombus.

OBJECTIVE: To evaluate the impact of microscopically positive vascular margins on recurrence and cancer-specific survival (CSS) in patients with renal cell carcinoma (RCC) with venous thrombus PATIENTS AND METHODS: We reviewed the records from the period 1993 to 2009 of consecutive patients treated surgically for RCC with venous tumour thrombus at the University of Texas MD Anderson Cancer Center. Patients with metastatic disease, positive soft tissue margins or gross residual disease at time of thrombectomy were excluded. The primary outcome measures were local or systemic disease recurrence, and CSS. Univariate and multivariate analysis were used to evaluate whether microscopically positive vascular margins were associated with RCC recurrence or CSS after nephrectomy with thrombectomy. RESULTS: A total of 256 patients with RCC were identified with a median (interquartile range) follow-up of 36.7 (18.4-63.5) months. Microscopic tumour was present at the margin of resection in 47 patients (18.4%). The median recurrence-free interval was significantly shorter in patients with positive vascular margins: 22.1 vs 70.2 months (P = 0.009). The rate of local recurrence was higher in patients with positive vein margins: 12.8 vs 4.3% (P < 0.01). Local recurrence without concomitant systemic recurrence was identified in only two of 256 (0.8%) patients. Patients with positive vascular margins had significantly worse CSS times compared with patients with negative vascular margins: 37.7 vs 93.0 months (P = 0.004). In multivariable analysis, positive vascular margins were found to be independently predictive of local recurrence but not of systemic recurrence or CSS. CONCLUSIONS: Complete surgical excision should always be attempted because positive vascular wall margins increase local recurrence rates. Invasion of RCC into the vein wall at the resection margin is associated with aggressive tumour biology, and the majority of patients with positive vascular wall margins experience systemic recurrence.

The role of lymph node dissection in renal cell carcinoma.

The role of lymph node dissection (LND) in the staging and treatment of renal cell carcinoma has long been a topic of debate. The controversy has focused on whether LND is purely an adjunctive staging procedure or has a therapeutic role in the management of this disease. Potential benefits include enhanced staging, better selection for adjuvant therapies/clinical trials, a decrease in recurrence rates, and improved disease-specific and overall survival. This article reviews the available literature on LND in renal cell carcinoma and discusses the potential benefits of aggressive surgical resection in select high-risk patients.