Differences in Survival of Clear Cell Metastatic Renal Cell Carcinoma According to Partial vs. Radical Cytoreductive Nephrectomy.

BACKGROUND: It is unknown whether previously reported other-cause mortality (OCM) advantage of partial cytoreductive nephrectomy (PCN) vs. radical cytoreductive nephrectomy (RCN) still applies to contemporary clear cell metastatic renal cell carcinoma (ccmRCC) patients. MATERIALS AND METHODS: We relied on the Surveillance, Epidemiology and End Results (SEER) database (2004-2019) to identify ccmRCC patients treated with PCN and RCN. Temporal trends of PCN rates within the SEER database were tabulated. After propensity score matching (PSM), cumulative incidence plots depicted 5-year OCM and cancer-specific mortality (CSM) of PCN and RCN patients. Multivariable Cox regression models tested for differences between PCN vs. RCN. RESULTS: Of 5149 study patients, 237 (5%) underwent PCN vs. 4912 (95%) RCN. In the SEER database 2004 to 2019, rates of PCN in ccmRCC patients increased from 3.0% to 8.0% (estimated annual percent change [EAPC]: 3.0%; P = .04). After PSM, 5-year OCM rates were 2.4 vs. 7.5% for respectively PCN vs. RCN patients (P = .036). 5-year CSM rates were 50.8 vs. 53.6% for respectively PCN and RCN patients (P = .57). In multivariable Cox regression models, PCN was associated with lower OCM (Hazard Ratio (HR): 0.39; 95% confidence interval (CI): 0.18-0.84; P = .02) but did not affect CSM rates (HR: 0.99; 95% CI: 0.76-1.29; P = .96). CONCLUSIONS: We confirm the existence of OCM advantage after PCN vs. RCN in contemporary ccmRCC patients.

Do patients with neurological disorders benefit from immersive virtual reality? A scoping review on the emerging use of the computer-assisted rehabilitation environment.

INTRODUCTION: Virtual reality (VR) is an advanced technology that creates simulated environments and conditions. By offering the possibility of combining motor, cognitive, and well-being in conjunction with the potential to manipulate multi-sensorial features in a safe environment, VR has emerged as a promising powerful rehabilitation tool. Among advanced VR systems, various authors have highlighted promising effects in the rehabilitation of the computer-assisted rehabilitation environment (CAREN - Motekforce Link; Amsterdam, The Netherlands). In our scoping review, we aimed to map the existing evidence on the use of CAREN in the rehabilitation of neurological patients. EVIDENCE ACQUISITION: This scoping review was conducted following the PRISMA guidelines. A search was carried out for all peer-reviewed articles published until June 30, 2023, using the following databases: PubMed, Embase, Cochrane Database, PeDro and Web of Science. The following terms have been used: ("Cognitive Rehabilitation" OR "Motor Rehabilitation" OR "CAREN" or "Computer-Assisted Rehabilitation Environment") AND ("Virtual Reality" OR "Rehab"). EVIDENCE SYNTHESIS: From the assessed studies, only seven met the inclusion criteria: 1) one study concerned cognitive rehabilitation in patients suffering from Parkinson's Disease (PD); 2) one was on the usability of CAREN in PD patients; 3) two studies related to the influence of emotional components to CAREN rehabilitation; 4) three studies were related to motor rehabilitation using CAREN, and involved individuals with PD, Multiple Sclerosis, TBI, respectively. Generally, the few assessed studies demonstrate that CAREN is a safe and potentially effective tool to treat different symptoms (including gait and vestibular disturbances, executive function, depressive mood, and anxiety) in patients with different neurological disorders. CONCLUSIONS: The reviewed literature indicated the potential use of CAREN in improving motor and cognitive skills with conflicting results on emotional aspects. However, since the data comes from few and small sample size studies, further research is needed to confirm the effectiveness of the tool in neurorehabilitation.

Efficacy of non-immersive virtual reality-based telerehabilitation on postural stability in Parkinson's disease: a multicenter randomized controlled trial.

BACKGROUND: The implementation of regular prolonged, and effective rehabilitation in people with Parkinson's disease is essential for ensuring a good quality of life. However, the continuity of rehabilitation care may find barriers related to economic, geographic, and social issues. In these scenarios, telerehabilitation could be a possible solution to guarantee the continuity of care. AIM: To investigate the efficacy of non-immersive virtual reality-based telerehabilitation on postural stability in people with Parkinson's disease, compared to at-home self-administered structured conventional motor activities. DESIGN: Multicenter randomized controlled trial. SETTING: Five rehabilitation hospitals of the Italian Neuroscience and Rehabilitation Network. POPULATION: Individuals diagnosed with Parkinson's disease. METHODS: Ninety-seven participants were randomized into two groups: 49 in the telerehabilitation group (non-immersive virtual reality-based telerehabilitation) and 48 in the control group (at-home self-administered structured conventional motor activities). Both treatments lasted 30 sessions (3-5 days/week for, 6-10 weeks). Static and dynamic balance, gait, and functional motor outcomes were registered before and after the treatments. RESULTS: All participants improved the outcomes at the end of the treatments. The primary outcome (mini-Balance Evaluation Systems Test) registered a greater significant improvement in the telerehabilitation group than in the control group. The gait and endurance significantly improved in the telerehabilitation group only, with significant within-group and between-group differences. CONCLUSIONS: Our results showed that non-immersive virtual reality-based telerehabilitation is feasible, improves static and dynamic balance, and is a reasonably valuable alternative for reducing postural instability in people with Parkinson's disease. CLINICAL REHABILITATION IMPACT: Non-immersive virtual reality-based telerehabilitation is an effective and well-tolerated modality of rehabilitation which may help to improve access and scale up rehabilitation services as suggested by the World Health Organization's Rehabilitation 2030 agenda.

Predictors of mid-term functional outcomes for robot-assisted Madigan simple prostatectomy: results of a multicentric series according to the BPH-6 achievement.

BACKGROUND: BPH-6 achievement remains an objective far to be evaluated for every technique currently available for the surgical management of bladder outlet obstruction (BOO) with the goal of preserving ejaculatory function. The aim of this study was to evaluate predictors of BPH-6 achievement of urethral-sparing robot assisted simple prostatectomy (us-RASP) on a large series performed at two tertiary-care centers. METHODS: Two institutional us-RASP datasets were merged, considering eligible all patients with a follow-up >12 months. Baseline, perioperative and functional data according to BPH-6 endpoint were assessed. Descriptive analysis was used. Frequencies and proportions were reported for categorical variables while medians and interquartile ranges (IQRs) were reported for continuously coded variables. A logistic regression model was built to identify predictors of BPH-6 achievement. For all statistical analyses, a two-sided P<0.05 was considered significant. RESULTS: Study cohort consisted of 94 eligible patients. The median follow-up was 40.7 months (IQR 31.3-54.2). Overall BPH-6 achievement was 54.7%. Compared to baseline, reduction of ≥30% in IPSS was observed in 93.6% of patients, reduction of <6 points for SHIM in 95.7% and response to MSHQ-EjD question 3 indicating emission of semen in 72.6%, respectively. On multivariable analysis, prostate volume between 110-180 mL (OR 0.09; 95% CI 0.01-0.92; P=0.043) and higher preoperative SHIM score (OR 1.18; 95% CI 1.05-1.32; P<0.01) were independent predictors of BPH-6 metric achievement. CONCLUSIONS: us-RASP may provide a complete resolution of BOO and preservation of ejaculatory function in sexually active men with a prostate volume ranging 110-180 mL.

Obstetrical Trauma: Reducing the Burden of Trauma Transfer to Tertiary Care Centers.

BACKGROUND: In rural state trauma systems, management of the obstetrical trauma patient often defaults to transfer to level I trauma centers. We evaluate the necessity of transferring obstetrical trauma patients without severe maternal injury. MATERIALS AND METHODS: A retrospective 5-year review of obstetrical trauma patients admitted to a rural state-level I trauma center was conducted. Injury severity measures such as abdominal AIS, ISS, and GCS were correlated with outcomes. Furthermore, the impact of maternal and gestational age on uterine compromise, uterine irritability, and the need for cesarean section intervention are presented. RESULTS: Twenty-one percent of patients were transferred from outside facilities with a median age of 29 years, average ISS of 3.9 ± 5.6, GCS of 13.8 ± 3.6, and abdominal AIS of 1.6 ± .8. Outcomes included maternal fatality of 2%, fetal demise of 4%, 6% experienced premature rupture of membranes, 9% experienced fetal placental compromise, 15% had uterine contractions, 15% of cesarean deliveries, and fetal decelerations occurred in 4%. Predictors of fetal compromise are strongly associated with high maternal ISS and low GCS. DISCUSSION: The frequency of traumatic injury in this unique population of patients is fortunately limited. The best predictor for fetal demise and uterine irritability is maternal injury severity, measured by ISS and GCS. Therefore, without severe maternal trauma, obstetrical trauma patients with minor injuries can safely be managed at non-tertiary care facilities with obstetrical capabilities.

Adverse upgrading and/or upstaging in contemporary low-risk prostate cancer patients.

BACKGROUND: Upgrading and/or upstaging in low-risk prostate cancer (PCa) patients may represent an indication for active treatment instead of active surveillance (AS). We addressed contemporary upgrading and/or upstaging rates in a large population based-cohort of low-risk PCa patients. MATERIALS AND METHODS: Whitin the SEER database (2010-2015), NCCN low-risk PCa patients were identified across management modalities: radical prostatectomy (RP), radiotherapy (RT) and non-local treatment (NLT). In RP patients, upgrading and/or upstaging rates were assessed in logistic regression models. RESULTS: Overall, of 27,901 low-risk PCa patients, 38% underwent RP vs 28% RT vs 34% NLT. RP patients were the youngest and harbored the highest percentage of positive cores and a higher rate of cT2a than NLT. At RP, 46.2% were upgraded to GGG ≥ 2, 6.0% to GGG ≥ 3 and 10.5% harbored nonorgan-confined stage (NOC, pT3-4 or pN1). Of NOC patients, 1.6% harbored GGG ≥ 3, 6.3% harbored GGG2 and 2.6% harbored GGG1. Of pT2 patients, 4.4% harbored GGG ≥ 3, 33.9% harbored GGG2 and 51.3% harbored GGG1. Age, PSA, percentage of positive cores and number of positive cores independently predicted the presence of NOC and/or GGG ≥ 3, but with low accuracy (63.9%). CONCLUSIONS: In low-risk PCa, critical changes between tumor grade and stage at biopsy vs RP may be expected in very few patients: NOC with GGG ≥ 3 in 1.6% and NOC with GGG2 in 6.3%. Other patients with upgrading and/or upstaging combinations will invariably harbor either pT2 or GGG1 that far less critically affect PCa prognosis.

Outcomes of robotic-assisted versus open radical cystectomy in a large-scale, contemporary cohort of bladder cancer patients.

BACKGROUND AND OBJECTIVES: To test for differences in perioperative outcomes and total hospital costs (THC) in nonmetastatic bladder cancer patients undergoing open (ORC) versus robotic-assisted radical cystectomy (RARC). METHODS: We relied on the National Inpatient Sample database (2016-2019). Statistics consisted of trend analyses, multivariable logistic, Poisson, and linear regression models. RESULTS: Of 5280 patients, 1876 (36%) versus 3200 (60%) underwent RARC versus ORC. RARC increased from 32% to 41% (estimated annual percentage change [EAPC]: + 8.6%; p = 0.02). Rates of transfusion (8% vs. 16%), intraoperative (2% vs. 3%), wound (6% vs. 10%), and pulmonary (6% vs. 10%) complications were lower in RARC patients (all p < 0.05). Moreover, median length of stay (LOS) was shorter in RARC (6 vs. 7days; p < 0.001). Conversely, median THC (31,486 vs. 27,162$; p < 0.001) were higher in RARC. Multivariable logistic regression-derived odds ratios addressing transfusion (0.49), intraoperative (0.53), wound (0.68), and pulmonary (0.71) complications favored RARC (all p < 0.01). In multivariable Poisson and linear regression models, RARC was associated with shorter LOS (Rate ratio:0.86; p < 0.001), yet higher THC (Coef.:5,859$; p < 0.001). RARC in-hospital mortality was lower (1% vs. 2%; p = 0.04). CONCLUSIONS: RARC complications, LOS, and mortality appear more favorable than ORC, but result in higher THC. The favorable RARC profile contributes to its increasing popularity throughout the United States.

Rates of metastatic prostate cancer in newly diagnosed patients: Numbers needed to image according to risk level.

BACKGROUND: The numbers needed to image to identify pelvic lymph node and/or distant metastases in newly diagnosed prostate cancer (PCa) patients according to risk level are unknown. METHODS: Relying on Surveillance, Epidemiology, and End Results (2010-2016), we tabulated rates and proportions of patients with (a) lymph node or (b) distant metastases according to National Comprehensive Cancer Network (NCCN) risk level and calculated the number needed to image (NNI) for both endpoints. Multivariable logistic regression analyses were performed. RESULTS: Of 145,939 newly diagnosed PCa patients assessable for analyses of pelvic lymph node metastases (cN1), 4559 (3.1%) harbored cN1 stage: 13 (0.02%), 18 (0.08%), 63 (0.3%), 512 (2.8%), and 3954 (14.9%) in low, intermediate favorable, intermediate unfavorable, high, and very high-risk levels. These resulted in NNI of 4619, 1182, 319, 35, and 7, respectively. Of 181,109 newly diagnosed PCa patients assessable for analyses of distant metastases (M1a-c ), 8920 (4.9%) harbored M1a-c stage: 50 (0.07%), 45 (0.1%), 161 (0.5%), 1290 (5.1%), and 7374 (22.0%) in low, intermediate favorable, intermediate unfavorable, high, and very high-risk. These resulted in NNI of 1347, 602, 174, 20, and 5, respectively. CONCLUSIONS: Our observations perfectly validated the NCCN recommendations for imaging in newly diagnosed high and very high-risk PCa patients. However, in unfavorable intermediate-risk PCa patients, in whom bone and soft tissue imaging is recommended, the NNI might be somewhat elevated to support routine imaging in clinical practice.

Cancer-specific mortality in patients with non-metastatic renal cell carcinoma who have undergone a nephrectomy and are eligible for adjuvant pembrolizumab.

BACKGROUND: Data in patients with malignant melanoma, who have been previously treated with pembrolizumab as adjuvant therapy, show a reduction in pembrolizumab efficacy upon rechallenge. We examined this scenario in patients with non-metastatic renal cell carcinoma (RCC) eligible for adjuvant pembrolizumab after nephrectomy. We hypothesized that a proportion of such patients will either require re-treatment with pembrolizumab upon metastatic progression prior to cancer-specific mortality (CSM) or die from other cause mortality (OCM). MATERIALS AND METHODS: We identified within the SEER database 10,635 patients, between 2004 and 2017, with a diagnosis of non-metastatic intermediate-high and high risk RCC, who had undergone nephrectomy and fulfilled criteria for enrollment in KEYNOTE-564. Kaplan-Meier analyses addressed overall survival (OS), CSM and OCM. RESULTS: 9,825 (92.4%) of the 10,635 patients had intermediate-high risk RCC and 9,456 (88.9%) underwent radical nephrectomy. Additionally, 760 (7.1%) harbored sarcomatoid features. In Kaplan-Meier analyses, median OS was 9.8 (9.1-11.4) years. At 10-years of follow-up, CSM rate was 36% and OCM rate was 22%. CONCLUSIONS: Based on CSM, our observations indicate that by 10-years of follow-up 36% of patients treated with adjuvant pembrolizumab will require a rechallenge, in a setting where a checkpoint inhibitor may have reduced efficacy. Moreover, at 10-years of follow-up, 22% of patients with RCC, previously treated with adjuvant pembrolizumab, will die of other causes. These percentages should be strongly considered prior to routine use of adjuvant pembrolizumab, especially given an OS benefit has not been proven.

Contemporary seminal vesicle invasion rates in NCCN high-risk prostate cancer patients.

BACKGROUND: Contemporary seminal vesicle invasion (SVI) rates in National Cancer Comprehensive Network (NCCN) high-risk prostate cancer (PCa) patients are not well known but essential for treatment planning. We examined SVI rates according to individual patient characteristics for purpose of treatment planning. MATERIALS AND METHODS: Within Surveillance, Epidemiology, and End Results (SEER) database (2010-2015), 4975 NCCN high-risk patients were identified. In the development cohort (SEER geographic region of residence: South, North-East, Mid-West, n = 2456), we fitted a multivariable logistic regression model predicting SVI. Its accuracy, calibration, and decision curve analyses (DCAs) were then tested versus previous models within the external validation cohort (SEER geographic region of residence: West, n = 2519). RESULTS: Out of 4975 patients, 28% had SVI. SVI rate ranged from 8% to 89% according to clinical T stage, prostate-specific antigen (PSA), biopsy Gleason Grade Group and percentage of positive biopsy cores. In the development cohort, these variables were independent predictors of SVI. In the external validation cohort, the current model achieved 77.6% accuracy vs 73.7% for Memorial Sloan Kettering Cancer Centre (MSKCC) vs 68.6% for Gallina et al. Calibration was better than for the two alternatives: departures from ideal predictions were 6.0% for the current model vs 9.8% for MSKCC vs 38.5% for Gallina et al. In DCAs, the current model outperformed both alternatives. Finally, different nomogram cutoffs allowed to discriminate between low versus high SVI risk patients. CONCLUSIONS: More than a quarter of NCCN high-risk PCa patients harbored SVI. Since SVI positivity rate varies from 8% to 89%, the currently developed model offers a valuable approach to distinguish between low and high SVI risk patients.

Survival after radical prostatectomy versus radiation therapy in clinical node-positive prostate cancer.

AIM: To compare overall mortality (OM), cancer-specific mortality (CSM), and other cause mortality (OCM) rates between radical prostatectomy (RP) versus radiotherapy (RT) in clinical node-positive (cN1) prostate cancer (PCa). MATERIALS AND METHODS: Within Surveillance, Epidemiology, End Results (SEER) (2004-2016), we identified 4685 cN1 PCa patients, of whom 3589 (76.6%) versus 1096 (24.4%) were treated with RP versus RT. After 1:1 propensity score matching (PSM), Kaplan-Meier plots and Cox regression models tested the effect of RP versus RT on OM, while cumulative incidence plots and competing-risks regression (CRR) models addressed CSM and OCM between RP and RT patients. All analyses were repeated after the inverse probability of treatment weighting (IPTW). For CSM and OCM analyses, the propensity score was used as a covariate in the regression model. RESULTS: Overall, RT patients were older, harbored higher prostate-specific antigen values, higher clinical T and higher Gleason grade groups. PSM resulted in two equally sized groups of 894 RP versus 894 RT patients. After PSM, 5-year OM, CSM, and OCM rates were, respectively, 15.4% versus 25%, 9.3% versus 17%, and 6.1% versus 8% for RP versus RT (all p < 0.001) and yielded respective multivariate hazard ratios (HRs) of 0.63 (0.52-0.78, p < 0.001), 0.66 (0.52-0.86, p < 0.001), 0.71 (0.5-1.0, p = 0.05), all favoring RP. After IPTW, Cox regression models yielded HR of 0.55 (95% confidence interval [CI] = 0.46-0.66) for OM, and CRR yielded HRs of 0.49 (0.34-0.70) and 0.54 (0.36-0.79) for, respectively, CSM and OCM, all favoring RP (all p < 0.001). CONCLUSIONS: RP may hold a CSM advantage over RT in cN1 PCa patients.

Non-organ confined stage and upgrading rates in exclusive PSA high-risk prostate cancer patients.

BACKGROUND: The pathological stage of prostate cancer with high-risk prostate-specific antigen (PSA) levels, but otherwise favorable and/or intermediate risk characteristics (clinical T-stage, Gleason Grade group at biopsy [B-GGG]) is unknown. We hypothesized that a considerable proportion of such patients will exhibit clinically meaningful GGG upgrading or non-organ confined (NOC) stage at radical prostatectomy (RP). MATERIALS AND METHODS: Within the Surveillance, Epidemiology, and End Results database (2010-2015) we identified RP-patients with cT1c-stage and B-GGG1, B-GGG2, or B-GGG3 and PSA 20-50 ng/ml. Rates of GGG4 or GGG5 and/or rates of NOC stage (≥ pT3 and/or pN1) were analyzed. Subsequently, separate univariable and multivariable logistic regression models tested for predictors of NOC stage and upgrading at RP. RESULTS: Of 486 assessable patients, 134 (28%) exhibited B-GGG1, 209 (43%) B-GGG2, and 143 (29%) B-GGG3, respectively. The overall upgrading and NOC rates were 11% and 51% for a combined rate of upgrading and/or NOC stage of 53%. In multivariable logistic regression models predicting upgrading, only B-GGG3 was an independent predictor (odds ratio [OR]: 5.29; 95% confidence interval [CI]: 2.21-14.19; p < 0.001). Conversely, 33%-66% (OR: 2.36; 95% CI: 1.42-3.95; p = 0.001) and >66% of positive biopsy cores (OR: 4.85; 95% CI: 2.84-8.42; p < 0.001), as well as B-GGG2 and B-GGG3 were independent predictors for NOC stage (all p ≤ 0.001). CONCLUSIONS: In cT1c-stage patients with high-risk PSA baseline, but low- to intermediate risk B-GGG, the rate of upgrading to GGG4 or GGG5 is low (11%). However, NOC stage is found in the majority (51%) and can be independently predicted with percentage of positive cores at biopsy and B-GGG.

Renal surgery for kidney cancer: is preoperative proteinuria a predictor of functional and survival outcomes after surgery? A systematic review of the literature.

INTRODUCTION: Proteinuria is considered both a known marker for the severity of chronic kidney disease (CKD) and a robust predictor of future renal function and cardiovascular morbidity and mortality in a general population. The urological community has long overlooked proteinuria as a marker of renal function. Recently, the American Urological Association (AUA) clinical practice guideline addressed this issue and suggested introducing proteinuria assessment prior to kidney cancer surgery. The aim of this systematic review was to provide evidence of proteinuria as a predictor of renal function impairment and survival outcomes after kidney surgery for renal tumors. EVIDENCE ACQUISITION: A systematic search was performed by using three search engines (PubMed, Embase®, and Web of Science) from January 2010 to November 2020. Study selection followed the PRISMA guidelines. After screening, ten articles and abstracts fully compatible with the PICOS were included in this systematic review. EVIDENCE SYNTHESIS: Overall, a total of 11,705 patients who underwent partial nephrectomy (PN) or radical nephrectomy (RN) were analyzed. When used as a binomial variable, proteinuria prior to surgery was detected from 10% to 33% of patients. Relying on both proteinuria and estimated glomerular filtration rate (eGFR) in the assessment of renal function yielded up to 33% higher rates of patients with preoperative renal impairment. Moreover, proteinuria increased the risk of long-term renal impairment after PN and RN as well as patients with preoperative proteinuria undergoing PN exhibited a greater risk of postoperative acute kidney injury (AKI). Among eligible studies, proteinuria was associated with diabetes, obesity, metabolic syndrome, hypertension and cardiovascular disease. Finally, proteinuria was an independent predictor of overall mortality, but not of cancer-specific mortality. CONCLUSIONS: Proteinuria yields a prognostic power beyond that provided by estimated glomerular filtration rate (eGFR) among patients undergoing renal cancer surgery, supporting its introduction in the preoperative assessment of renal function. However, well-designed multicenter prospective studies would be necessary to corroborate these results and provided urological community with high-grade recommendation for clinical practice.

Cancer-specific survival after radical prostatectomy versus external beam radiotherapy in high-risk and very high-risk African American prostate cancer patients.

BACKGROUND: To test for differences in cancer-specific mortality (CSM) rates between radical prostatectomy (RP) vs external beam radiotherapy (EBRT) in National Comprehensive Cancer Network (NCCN) high-risk African American patients, as well as Johns Hopkins University (JHU) high-risk and very high-risk patients. MATERIALS AND METHODS: Within the Surveillance, Epidemiology, and End Results database (2010-2016), we identified 4165 NCCN high-risk patients, of whom 1944 (46.7%) and 2221 (53.3%) patients qualified for JHU high-risk or very high-risk definitions. Of all 4165 patients, 1390 (33.5%) were treated with RP versus 2775 (66.6%) with EBRT. Cumulative incidence plots and competing risks regression models addressed CSM before and after 1:1 propensity score matching between RP and EBRT NCCN high-risk patients. Subsequently, analyses were repeated separately in JHU high-risk and very high-risk subgroups. Finally, all analyses were repeated after landmark analyses were applied. RESULTS: In the NCCN high-risk cohort, 5-year CSM rates for RP versus EBRT were 2.4 versus 5.2%, yielding a multivariable hazard ratio of 0.50 (95% confidence interval [CI] 0.30-0.84, p = 0.009) favoring RP. In JHU very high-risk patients 5-year CSM rates for RP versus EBRT were 3.7 versus 8.4%, respectively, yielding a multivariable hazard ratio of 0.51 (95% CI: 0.28-0.95, p = 0.03) favoring RP. Conversely, in JHU high-risk patients, no significant CSM difference was recorded between RP vs EBRT (5-year CSM rates: 1.3 vs 1.3%; multivariable hazard ratio: 0.55, 95% CI: 0.16-1.90, p = 0.3). Observations were confirmed in propensity score-matched and landmark analyses adjusted cohorts. CONCLUSIONS: In JHU very high-risk African American patients, RP may hold a CSM advantage over EBRT, but not in JHU high-risk African American patients.

Effect of Chemotherapy on Overall Survival in Contemporary Metastatic Prostate Cancer Patients.

INTRODUCTION: Randomized clinical trials demonstrated improved overall survival in chemotherapy exposed metastatic prostate cancer patients. However, real-world data validating this effect with large scale epidemiological data sets are scarce and might not agree with trials. We tested this hypothesis. MATERIALS AND METHODS: We identified de novo metastatic prostate cancer patients within the Surveillance, Epidemiology, and End Results (SEER) database (2014-2015). Kaplan-Meier plots and Cox regression models tested for overall survival differences between chemotherapy-exposed patients vs chemotherapy-naïve patients. All analyses were repeated in propensity-score matched cohorts. Additionally, landmark analyses were applied to account for potential immortal time bias. RESULTS: Overall, 4295 de novo metastatic prostate cancer patients were identified. Of those, 905 (21.1%) patients received chemotherapy vs 3390 (78.9%) did not. Median overall survival was not reached at 30 months follow-up. Chemotherapy-exposed patients exhibited significantly better overall survival (61.6 vs 54.3%, multivariable HR:0.82, CI: 0.72-0.96, p=0.01) at 30 months compared to their chemotherapy-naïve counterparts. These findings were confirmed in propensity score matched analyses (multivariable HR: 0.77, CI:0.66-0.90, p<0.001). Results remained unchanged after landmark analyses were applied in propensity score matched population. CONCLUSIONS: In this contemporary real-world population-based cohort, chemotherapy for metastatic prostate cancer patients was associated with better overall survival. However, the magnitude of overall survival benefit was not comparable to phase 3 trials.

Improvement in overall and cancer-specific survival in contemporary, metastatic prostate cancer chemotherapy exposed patients.

INTRODUCTION: Over the last decade, multiple clinical trials demonstrated improved survival after chemotherapy for metastatic prostate cancer (mPCa). However, real-world data validating this effect within large-scale epidemiological data sets are scarce. We addressed this void. MATERIALS AND METHODS: Men with de novo mPCa were identified and systemic chemotherapy status was ascertained within the Surveillance, Epidemiology, and End Results database (2004-2016). Patients were divided between historical (2004-2013) versus contemporary (2014-2016). Chemotherapy rates were plotted over time. Kaplan-Meier plots and Cox regression models with additional multivariable adjustments addressed overall and cancer-specific mortality. All tests were repeated in propensity-matched analyses. RESULTS: Overall, 19,913 patients had de novo mPCa between 2004 and 2016. Of those, 1838 patients received chemotherapy. Of 1838 chemotherapy-exposed patients, 903 were historical, whereas 905 were contemporary. Chemotherapy rates increased from 5% to 25% over time. Median overall survival was not reached in contemporary patients versus was 24 months in historical patients (hazard ratio [HR]: 0.55, p < 0.001). After propensity score matching and additional multivariable adjustment (age, prostate-specific antigen, GGG, cT-stage, cN-stage, cM-stage, and local treatment) a HR of 0.55 (p < 0.001) was recorded. Analyses were repeated for cancer-specific mortality after adjustment for other cause mortality in competing risks regression models and recorded virtually the same findings before and after propensity score matching (HR: 0.55, p < 0.001). CONCLUSIONS: In mPCa patients, chemotherapy rates increased over time. A concomitant increase in survival was also recorded.