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Background and Objective: There exists ongoing debate about the benefits and harms of prostate-specific antigen (PSA) screening for prostate cancer. This study sought to evaluate the association of county-level PSA screening rates with county-level incidence of metastatic prostate cancer and prostate cancer mortality in the USA., Methods: This ecological study used data from the 2004-2012 Behavioral Risk Factor Surveillance System (BRFSS) to build a multilevel mixed-effect model with poststratification using US Census data to estimate county-level PSA screening rates for all 3143 US counties adjusted for age, race, ethnicity, and county-level poverty rates. The exposure of interest was average county-level PSA screening rate from 2004 to 2012, defined as the proportion of men aged 40-79 yr who underwent PSA screening within the prior 2 yr. The primary outcomes were county-level age-adjusted incidence of regional/distant prostate cancer during 2015-2019 and age-adjusted prostate cancer mortality during 2016-2020., Key Findings and Limitations: A total of 416 221 male BRFSS respondents aged 40-79 yr met the inclusion criteria and were used in the multilevel mixed-effect model. The model was poststratified using 63.4 million men aged 40-79 yr from all 3143 counties in the 2010 Decennial Census. County-level estimated PSA screening rates exhibited geographic variability and were pooled at the state level for internal validation with direct BRFSS state-level estimates, showing a strong correlation with Pearson correlation coefficients 0.77-0.90. A 10% higher county-level probability of PSA screening in 2004-2012 was associated with a 14% lower county-level incidence of regional/distant prostate cancer in 2015-2019 (rate ratio 0.86, 95% confidence interval [CI] 0.85-0.87, p < 0.001) and 10% lower county-level prostate cancer mortality in 2016-2020 (rate ratio 0.90, 95% CI 0.89-0.91, p < 0.001)., Conclusions and Clinical Implications: In this population-based ecological study of all US counties, higher PSA screening rates were associated with a lower incidence of regional/distant prostate cancer and lower prostate cancer mortality at extended follow-up., Patient Summary: US counties with higher rates of prostate-specific antigen (PSA) screening had significantly lower rates of metastatic prostate cancer and prostate cancer mortality in subsequent years. These data may inform shared decision-making regarding PSA screening for prostate cancer., (Copyright © 2023 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

We analyzed trends in prostate-specific antigen (PSA) screening for prostate cancer, with a focus on the impact of the 2018 US Preventive Services Task Force (USPSTF) recommendations and the COVID-19 outbreak. Using National Health Interview Survey data, we performed difference-in-difference (DID) analyses to examine the PSA screening trend for men aged 55-69 yr, the target population in the 2018 USPSTF update, with men aged >69 yr included as the reference and adjustment for sociodemographic factors. We found that PSA screening increased for men aged 55-69 yr (+4.6%, 95% confidence interval [CI] 1.7-7.5%) or >69 yr (+6.5%, 95% CI 2.7-10.4%) in 2019 (after the 2018 recommendations) in comparison to 2015. There was a decrease in PSA screening for men aged 55-69 yr in 2021 in comparison to 2019 (after the COVID-19 outbreak in 2020) of -3.1% (95%CI -0.4% to -5.8%). Adjusted DID analysis revealed no significant variations in the rate of change in PSA screening between the two age groups following both events. Despite its observational nature, our design mitigates major challenges in inferring causal relationships. Our results suggest a causal relationship between the 2018 screening guidelines and an increase in screening rates for men aged 55-69 yr. Conversely, they also indicate that preventive care disruptions related to COVID-19 may have induced deceleration or potentially reversal of these advances. PATIENT SUMMARY: We used data from a large national survey to study the rate of prostate-specific antigen (PSA) screening for prostate cancer in the USA in response to the 2018 United States Preventive Services Task Force recommendations and to the COVID-19 pandemic. We found an increase in PSA screening in 2019 among men aged 55-69 yr, the target population in the 2018 recommendations, as well as men aged >69 yr. However, this increase was reduced after the COVID-19 outbreak. It remains to be seen how PSA screening continues to change as the world recovers from COVID-19., (Copyright © 2023 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Background: Patients undergoing resection of renal cell carcinoma are at risk of disease relapse. We evaluated the effectiveness of the mammalian target of rapamycin inhibitor everolimus administered after surgery., Methods: In this randomised, double-blind, phase 3 trial, we enrolled adults with histologically confirmed renal cell carcinoma who had undergone a full surgical resection and were at intermediate-high or very high risk of recurrence at 398 academic and community institution centres in the USA. After nephrectomy, patients were randomly assigned (1:1) via a central web-based application using a dynamic balancing algorithm to receive 10 mg oral everolimus daily or placebo for 54 weeks. The primary endpoint was recurrence-free survival. Efficacy analyses included all eligible, randomly assigned patients; safety analysis included all patients who received treatment. This trial is registered with ClinicalTrials.gov, NCT01120249 and is closed to new participants., Findings: Between April 1, 2011, and Sept 15, 2016, a total of 1545 patients were randomly assigned to receive everolimus (n=775) or placebo (n=770), of whom 755 assigned to everolimus and 744 assigned to placebo were eligible for inclusion in the efficacy analysis. With a median follow-up of 76 months (IQR 61-92), recurrence-free survival was longer with everolimus than with placebo (5-year recurrence-free survival 67% [95% CI 63-70] vs 63% [60-67]; stratified log-rank p=0·050; stratified hazard ratio [HR] 0·85, 95% CI 0·72-1·00; p=0·051) but did not meet the prespecified p value for statistical significance of 0·044. Recurrence-free survival was longer with everolimus than with placebo in the very-high-risk group (HR 0·79, 95% CI 0·65-0·97; p=0·022) but not in the intermediate-high-risk group (0·99, 0·73-1·35; p=0·96). Grade 3 or higher adverse events occurred in 343 (46%) of 740 patients who received everolimus and 79 (11%) of 723 who received placebo., Interpretation: Postoperative everolimus did not improve recurrence-free survival compared with placebo among patients with renal cell carcinoma at high risk of recurrence after nephrectomy. These results do not support the adjuvant use of everolimus for renal cell carcinoma after surgery., Funding: US National Institutes of Health, National Cancer Institute, National Clinical Trials Network, Novartis Pharmaceuticals Corporation, and The Hope Foundation., Competing Interests: Declaration of interests CWR reports research funding from Ayala, Bristol Myers Squibb, Daiichi Sankyo, Deciphera, Exelixis, Genentech, Novartis, Karyopharm, Merck, Nektar, Pfizer, Xynomic, Bayer, OSI, PF Argentum IP Holdings, Rain Therapeutics, and Shasqi; consulting fees from Synox, Daiichi-Sankyo, AVEO, Exelixis, AstraZeneca, and Bristol Myers Squibb; and payment for expert testimony from Pfizer, GSK, and Boehringer Ingelheim. EIH reports research funding from Astellas Pharma, Arvinas, AstraZeneca, BioXcel Therapeutics, Bristol Myers Squibb, Calibr, Calithera Biosciences, Caris Life Sciences, Corcept Therapeutics, Corvis Pharmaceuticals, Daiichi Sankyo, Eisai, Exelixis, Five Prime Therapeutics, Fortis Therapeutics, GSK, Gilead Sciences, Harpoon Therapeutics, Roche, Infinity Pharmaceuticals, iTeos Therapeutics, Janssen, Merck Sharp & Dohme, Merck, Mirati Therapeutics, Modra Pharmaceuticals, Oncolys BioPharma, Peloton Therapeutics, Pfizer, Pharmacyclics, POINT Biopharma, and Seattle Genetics; consulting fees from Astellas Pharma; honoraria from Bayer, Sanofi, and Seattle Genetics; support for attending meetings and travel from Astellas Pharma, Caris Life Sciences, Sanofi, and Seattle Genetics; participation on a data safety monitoring board or advisory board for Astellas Pharma, AstraZeneca, Bayer, Sanofi, and Janssen; and leadership or fiduciary role for Zero End of Cancer and Michigan American Cancer Society. MNS reports grants or contracts from Advaxis, Harpoon, Bristol Myers Squibb, Genocea, Bellicum, Xencor, Exelixis, and Seattle Genetics; consulting fees from Janssen, Exelixis, Bristol Myers Squibb, and Xencor; and data safety monitoring board or advisory board participation for AstraZeneca. ASA reports consulting fees from Bristol Myers Squibb, Pfizer, and AstraZeneca; data safety monitoring board or advisory board participation for Eisai; and research grants paid from Merck, Bristol Myers Squibb, V Foundation, AstraZeneca, and NCCN. SKP reports support for attending meetings and travel from Ipsen and CRISPR Therapeutics. IP reports consulting fees from Nouscom, Iovance, Nektar, and Regeneron. JIC reports grants or contracts from Merck, Bristol Myers Squibb, Aveo, Instil Bio, Hookipa, and Castle Biosciences. TKC reports support for research, advisory boards, consultancy, and honoraria from AstraZeneca, Aravive, Aveo, Bayer, Bristol Myers Squibb, Calithera, Circle Pharma, Eisai, EMD Serono, Exelixis, GSK, IQVA, Infinity, Ipsen, Janssen, Kanaph, Lilly, Merck, Nikang, Nuscan, Novartis, Pfizer, Roche, Sanofi/Aventis, Surface Oncology, Takeda, Tempest, Up-To-Date, and CME events (Peerview, OncLive, MJH, and others); institutional patents filed on molecular alterations and immunotherapy response and toxicity, and ctDNA; equity interest in Tempest, Pionyr, Osel, Precede Bio, and CureResponse; committee participation in NCCN, NCI GU Steering Committee, ASCO/ESMO, ACCRU, and KidneyCan; and grant funding from Dana-Farber/Harvard Cancer Center Kidney SPORE (2P50CA101942-16) and Program 5P30CA006516-56, the Kohlberg Chair at Harvard Medical School and the Trust Family, Michael Brigham, Pan Mass Challenge, Hinda and Arthur Marcus Fund, and Loker Pinard Funds for Kidney Cancer Research at DFCI. NA reports research funding from Arnivas, Astellas, AstraZeneca, Bavarian Nordic, Bayer, Bristol Myers Squibb, Calithera, Celldex, Clovis, Crispr, Eisai, Eli Lilly, EMD Serono, Exelixis, Genentech, Gilead, GSK, Immunomedics, Janssen, Lava, Medivation, Merck, Nektar, Neoleukin, New Link Genetics, Novartis, Oric, Pfizer, Prometheus, Rexahn, Roche, Sanofi, Seattle Genetics, Takeda, and Tracon; and consulting fees from Eisai, Seattle Genetics, EMD Serono, Janssen, Exelixis, Bayer, Astellas, AstraZeneca, Immunomedics, Bristol Myers Squibb, Aveo, Genentech, Merck, Lilly, Gilead, and Foundation Medicine. RGU reports a leadership or fiduciary role for Haymarket Media, Genentech, and Merck. NBH reports grants or contracts from DOD KCRC Clinical Consortium Award; consulting fees from Merck, Eisai, Bristol Myers Squibb, Aveo, and Exelixis; participation on a data safety monitoring board or advisory board for Roche; a leadership or fiduciary role for NIH GU Steering Committee; and being ECOG-ACRIN GU co-chair. UNV reports grants or contracts from Merck and Bristol Myers Squibb; consulting fees from Bayer, Exelixis, Merck, Gilead, Bristol Myers Squibb, and Alekermes; honoraria from Sanofi, Bayer, and Exelixis; and a leadership or fiduciary role for Michigan Society of Hematology/Oncology. IMT reports NCI and SWOG funding for SWOG GU Committee Chair. All other authors declare no competing interests., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Importance: Geographic access, including mode of transportation, to health care facilities remains understudied., Objective: To identify sociodemographic factors associated with public vs private transportation use to access health care and identify the respondent, trip, and community factors associated with longer distance and time traveled for health care visits., Design, Setting, and Participants: This cross-sectional study used data from the 2017 National Household Travel Survey, including 16 760 trips or a nationally weighted estimate of 5 550 527 364 trips to seek care in the United States. Households that completed the recruitment and retrieval survey for all members aged 5 years and older were included. Data were analyzed between June and August 2022., Exposures: Mode of transportation (private vs public transportation) used to seek care., Main Outcomes and Measures: Survey-weighted multivariable logistic regression models were used to identify factors associated with public vs private transportation and self-reported distance and travel time. Then, for each income category, an interaction term of race and ethnicity with type of transportation was used to estimate the specific increase in travel burden associated with using public transportation compared a private vehicle for each race category., Results: The sample included 12 092 households and 15 063 respondents (8500 respondents [56.4%] aged 51-75 years; 8930 [59.3%] females) who had trips for medical care, of whom 1028 respondents (6.9%) were Hispanic, 1164 respondents (7.8%) were non-Hispanic Black, and 11 957 respondents (79.7%) were non-Hispanic White. Factors associated with public transportation use included non-Hispanic Black race (compared with non-Hispanic White: adjusted odds ratio [aOR], 3.54 [95% CI, 1.90-6.61]; P < .001) and household income less than $25 000 (compared with ≥$100 000: aOR, 7.16 [95% CI, 3.50-14.68]; P < .001). The additional travel time associated with use of public transportation compared with private vehicle use varied by race and household income, with non-Hispanic Black respondents with income of $25 000 to $49 999 experiencing higher burden associated with public transportation (mean difference, 81.9 [95% CI, 48.5-115.3] minutes) than non-Hispanic White respondents with similar income (mean difference, 25.5 [95% CI, 17.5-33.5] minutes; P < .001)., Conclusions and Relevance: These findings suggest that certain racial, ethnic, and socioeconomically disadvantaged populations rely on public transportation to seek health care and that reducing delays associated with public transportation could improve care for these patients.

Background: Since tobacco smoking represents the most established risk factor for bladder cancer, we sought to assess the ecological association between tobacco smoking prevalence and bladder cancer incidence and to contrast it with lung cancer., Methods: The annual overall tobacco smoking prevalence rates were extracted from the Report of the Surgeon General and the Center for Disease Control between 1953 and 1983. The overall age-adjusted incidence rates for bladder and lung cancers were derived from the Surveillance, Epidemiology, and End Results database between 1983 and 2013 (30-year latency period). Weighted least square regression models were used to assess bladder and lung cancer incidence rate differences (IRD) related to trends in tobacco smoking prevalence. A Wald test was used to compare whether the prevalence of tobacco smoking, as an explanatory variable, differentially predicts bladder versus lung cancer incidence rates., Results: The associations between tobacco smoking prevalence and bladder cancer incidence were not significant in the overall (IRD = +0.04; 95%CI (-0.14; +0.22); p = 0.63), male (IRD = +0.07; 95%CI (-0.09; +0.23); p = 0.37), or female (IRD = +0.12; 95%CI (-0.01; +0.25); p = 0.06) populations. There was an association between tobacco smoking prevalence and lung cancer incidence in the overall (IRD: +3.55; 95%CI ( +3.09; +4.00); p < 0.001), male (IRD: +4.82; 95%CI (+4.44; +5.20); p < 0.001), and female (IRD: +3.55; 95%CI (+3.12; +3.99); p < 0.001) populations. The difference between the observed associations of tobacco smoking prevalence with bladder versus lung cancer incidence was also significant in all examined populations ( p < 0.001)., Conclusions: Variations in tobacco smoking prevalence only partially explained the trends in the incidence of bladder cancer, indicating that its etiology is complex.

Importance: The COVID-19 pandemic has had a distinct spatiotemporal pattern in the United States. Patients with cancer are at higher risk of severe complications from COVID-19, but it is not well known whether COVID-19 outcomes in this patient population were associated with geography., Objective: To quantify spatiotemporal variation in COVID-19 outcomes among patients with cancer., Design, Setting, and Participants: This registry-based retrospective cohort study included patients with a historical diagnosis of invasive malignant neoplasm and laboratory-confirmed SARS-CoV-2 infection between March and November 2020. Data were collected from cancer care delivery centers in the United States., Exposures: Patient residence was categorized into 9 US census divisions. Cancer center characteristics included academic or community classification, rural-urban continuum code (RUCC), and social vulnerability index., Main Outcomes and Measures: The primary outcome was 30-day all-cause mortality. The secondary composite outcome consisted of receipt of mechanical ventilation, intensive care unit admission, and all-cause death. Multilevel mixed-effects models estimated associations of center-level and census division-level exposures with outcomes after adjustment for patient-level risk factors and quantified variation in adjusted outcomes across centers, census divisions, and calendar time., Results: Data for 4749 patients (median [IQR] age, 66 [56-76] years; 2439 [51.4%] female individuals, 1079 [22.7%] non-Hispanic Black individuals, and 690 [14.5%] Hispanic individuals) were reported from 83 centers in the Northeast (1564 patients [32.9%]), Midwest (1638 [34.5%]), South (894 [18.8%]), and West (653 [13.8%]). After adjustment for patient characteristics, including month of COVID-19 diagnosis, estimated 30-day mortality rates ranged from 5.2% to 26.6% across centers. Patients from centers located in metropolitan areas with population less than 250 000 (RUCC 3) had lower odds of 30-day mortality compared with patients from centers in metropolitan areas with population at least 1 million (RUCC 1) (adjusted odds ratio [aOR], 0.31; 95% CI, 0.11-0.84). The type of center was not significantly associated with primary or secondary outcomes. There were no statistically significant differences in outcome rates across the 9 census divisions, but adjusted mortality rates significantly improved over time (eg, September to November vs March to May: aOR, 0.32; 95% CI, 0.17-0.58)., Conclusions and Relevance: In this registry-based cohort study, significant differences in COVID-19 outcomes across US census divisions were not observed. However, substantial heterogeneity in COVID-19 outcomes across cancer care delivery centers was found. Attention to implementing standardized guidelines for the care of patients with cancer and COVID-19 could improve outcomes for these vulnerable patients.

Our study aimed to assess inequities in the clinical trial participation for the selected patient groups. We searched the Food and Drug Administration (FDA) database and extracted phase-III clinical trial data from MEDLINE for each approved drug by the FDA between January 1, 2006, and June 30, 2020. We analyzed the inclusion/exclusion criteria, participation according to gender, ethnic group, performance score, the positivity of HBV and HCV, and HIV, having comorbidities and brain metastasis. We compared the findings with that of the general population by retrieving data from the Surveillance, Epidemiology and End Results (SEER) database. We identified 142 phase III pivotal oncology trials that enrolled 105 397 patients. The proportion of female patients in trials was lower than their relative prevalence in the general population from SEER region (36% vs 49.6%, P < .001). The rates of black patients included were lower than their relative prevalence from SEER region (2.1% vs 9.8%, P < .001). 1.3% and 0.8% of patients had HBV and HCV infections, respectively. The patients' numbers with organ dysfunction were not established due to insufficient data from clinical trials. 1.6% of all patients had controlled brain metastasis. Black patients, women and patients with brain metastasis or with HBV and HCV were underrepresented. Our study underscores the importance of expanding the inclusion/exclusion criteria of pivotal oncology trials to be more representative of patients seen in clinical practice., (© 2021 UICC.)

Purpose: Nearly all men with prostate cancer treated with androgen receptor (AR) signaling inhibitors (ARSIs) develop resistance via diverse mechanisms including constitutive activation of the AR pathway, driven by AR genomic structural alterations, expression of AR splice variants (AR-Vs), or loss of AR dependence and lineage plasticity termed neuroendocrine prostate cancer. Understanding these de novo acquired ARSI resistance mechanisms is critical for optimizing therapy., Materials and Methods: A novel liquid biopsy technology was used to collect mRNA from circulating tumor cells (CTCs) to measure expression of AR-Vs, AR targets, and neuroendocrine prostate cancer markers. An institutional review board-approved prospective cohort (N = 99) was used to identify patterns of gene expression. Two prospective multicenter phase II clinical trials of ARSIs for men with castration-resistant prostate cancer (ClinicalTrials.gov: NCT01942837 [enzalutamide, N = 21] and NCT02025010 [abiraterone, N = 27]) were used to further validate these findings., Results: Hierarchical clustering of CTC transcripts identified two distinct clusters. Cluster 2 (C2) exhibited increased expression of AR-regulated genes and was associated with worse overall survival (median 8.6 v 22.4 months; P < .01; hazard ratio [HR] = 3.45 [1.9 to 6.14]). In multivariable analysis, C2 was prognostic independent of other clinicopathologic variables. AR-V status was not significant when accounting for C2. Upon further validation in pooled multicenter phase II trials, C2 was associated with worse overall survival (15.2 months v not reached; P < .01; HR = 8.43 [2.74 to 25.92]), prostate-specific antigen progression-free survival (3.6 v 12 months; P < .01; HR = 4.64 [1.53 to 14.11]), and radiographic progression-free survival (2.7 v 40.6 months; P < .01; HR = 4.64 [1.82 to 17.41])., Conclusion: We demonstrate that a transcriptional profile detectable in CTCs obtained from liquid biopsies can serve as an independent prognostic marker beyond AR-V7 in patients with metastatic prostate cancer and can be used to identify the emergence of multiple ARSI resistance mechanisms. This is currently being investigated in additional prospective trials., Competing Interests: Hamid EmamekhooConsulting or Advisory Role: Exelixis, Bayer, Bristol Myers Squibb, Cardinal Health, Seattle GeneticsResearch Funding: Bristol Myers Squibb, Exelixis, Replimune, Merck, Calithera Biosciences, Roche/GenentechTravel, Accommodations, Expenses: DAVA Pharmaceuticals Rana R. McKayConsulting or Advisory Role: Janssen, Novartis, Tempus, Exelixis, Pfizer, Bristol Myers Squibb, Astellas Medivation, Dendreon, Bayer, Sanofi, Merck, Vividion Therapeutics, Calithera Biosciences, AstraZenecaResearch Funding: Pfizer, Bayer, Tempus Xiao X. WeiHonoraria: OncLiveConsulting or Advisory Role: NovartisResearch Funding: Bristol Myers SquibbTravel, Accommodations, Expenses: Corvus Pharmaceuticals Rebecca SilverResearch Funding: Bayer Michael J. MorrisConsulting or Advisory Role: Bayer, Endocyte, Advanced Accelerator Applications, ORIC Pharmaceuticals, Johnson & Johnson, Curium Pharma, AthenexResearch Funding: Bayer, Sanofi, Endocyte, Progenics, Corcept Therapeutics, Roche/Genentech, JanssenTravel, Accommodations, Expenses: Endocyte, Fujifilm Felix Y. FengConsulting or Advisory Role: Astellas, Bayer, BlueEarth Diagnostics, Celgene, EMD Serono, Genentech, Janssen, Myovant, Ryovant, Bristol Myers Squibb, Exact Sciences, Varian, Bluestar Genomics, SerimmunResearch Funding: Zenith Epigenetics Howard I. ScherConsulting or Advisory Role: Janssen, Amgen, Janssen Research & Development, Menarini Silicon Biosystems, WIRB-Copernicus Group, ESSA, Ambry Genetics/Konica Minolta, Pfizer, Bayer, Sun PharmaResearch Funding: Janssen, Illumina, Epic Sciences, Menarini Silicon Biosystems, Thermofisher Scientific BiomarkersPatents, Royalties, Other Intellectual Property: BioNTech—Intellectual Property Rights, Elucida Oncology—Intellectual Property Rights, MabVAX—Intellectual Property Rights, Y-mAbs Therapeutics Inc—Intellectual Property RightsTravel, Accommodations, Expenses: Asterias Biotherapeutics, Menarini Silicon Biosystems, Amgen, WIRB-Copernicus Group, Konica Minolta, ESSA, Prostate Cancer Foundation, Sanofi, Bayer, Phosplatin Therapeutics Dana RathkopfConsulting or Advisory Role: Janssen, Genentech, AstraZeneca, Bayer, Myovant SciencesResearch Funding: Janssen Oncology, Medivation, Celgene, Takeda, Millennium, Ferring, Novartis, Taiho Pharmaceutical, AstraZeneca, Genentech/Roche, TRACON Pharma, Bayer, Phosplatin Therapeutics Scott M. DehmConsulting or Advisory Role: Celgene, Oncternal Therapeutics, Janssen Research & DevelopmentResearch Funding: Janssen Research & Development, Medivation/AstellasPatents, Royalties, Other Intellectual Property: Royalties from licensing genome-engineered prostate cancer cell lines Toni K. ChoueiriEmployment: Dana Farber Cancer HospitalLeadership: Dana Farber Cancer Hospital, NCCN, KidneyCAN, ASCOStock and Other Ownership Interests: Pionyr, Tempest TherapeuticsHonoraria: NCCN, UpToDate, Michael J. Hennessy Associates, ASCO, Harborside Press, Analysis Group, AstraZeneca, Alexion Pharmaceuticals, Sanofi/Aventis, Bayer, Bristol Myers Squibb, Genentech/Roche, GlaxoSmithKline, Merck, Novartis, Peloton Therapeutics, Pfizer, Corvus Pharmaceuticals, Ipsen, Foundation Medicine, Eisai, PlatformQ Health, Clinical Care Options, Navinata Health, Kidney Cancer Association, Exelixis, Prometheus, Lpath, The New England Journal of Medicine, Lancet Oncology, Cerulean Pharma, Alligent, EMD Serono, HERON, Lilly, Janssen Oncology, IQvia, Aveo, NCI GU Steering CommitteeConsulting or Advisory Role: Pfizer, Bayer, Novartis, GlaxoSmithKline, Merck, Bristol Myers Squibb, Roche/Genentech, Eisai, Foundation Medicine, Cerulean Pharma, AstraZeneca, Exelixis, Prometheus, Alligent, Ipsen, Corvus Pharmaceuticals, Lpath, Alexion Pharmaceuticals, Sanofi/Aventis, Peloton Therapeutics, UpToDate, NCCN, Michael J. Hennessy Associates, Analysis Group, Kidney Cancer Association, Clinical Care Options, PlatformQ Health, Navinata Health, Harborside Press, ASCO, The New England Journal of Medicine, Lancet Oncology, EMD Serono, HERON, Lilly, ESMOResearch Funding: Pfizer, Novartis, Merck, Exelixis, TRACON Pharma, GlaxoSmithKline, Bristol Myers Squibb, AstraZeneca, Peloton Therapeutics, Roche/Genentech, Celldex, Agensys, Eisai, Takeda, Prometheus, Ipsen, Corvus Pharmaceuticals, Cerulean Pharma, Seattle Genetics/Astellas, Bayer, Foundation Medicine, Roche, Calithera Biosciences, Analysis Group, NCI, Gateway for Cancer Research, Congressionally Directed Medical Research Programs (DOD)Patents, Royalties, Other Intellectual Property: International Patent Application No. PCT/US2018/058430, titled “Biomarkers of Clinical Response and Benefit to Immune Checkpoint Inhibitor Therapy,” and International Patent Application No. PCT/US2018/12209, titled “PBRM1 Biomarkers Predictive of Anti-Immune Checkpoint Response”Travel, Accommodations, Expenses: Pfizer, Bayer, Novartis, GlaxoSmithKline, Merck, Bristol Myers Squibb, Roche/Genentech, Eisai, Foundation Medicine, Cerulean Pharma, AstraZeneca, Exelixis, Prometheus, Alligent, Ipsen, Corvus Pharmaceuticals, Lpath, Alexion Pharmaceuticals, Sanofi/Aventis, UpToDate, Peloton Therapeutics, NCCN, Michael J. Hennessy Associates, Analysis Group, Kidney Cancer Association, Clinical Care Options, PlatformQ Health, Harborside Press, Navinata Health, The New England Journal of Medicine, Lancet Oncology, EMD Serono, HERON, Lilly, ESMOOther Relationship: Medical writing and editorial assistance support might have been funded by Communications companies funded by pharmaceutical companies such as ClinicalThinking, Health Interactions, Envision Pharma Group, Fishawack Group of Companies, Parexel Susan HalabiEmployment: ASCO Andrew J. ArmstrongHonoraria: Astellas Scientific and Medical Affairs IncConsulting or Advisory Role: Bayer, Dendreon, Pfizer, Astellas Scientific and Medical Affairs Inc, Clovis Oncology, AstraZeneca, Merck, Bristol Myers SquibbResearch Funding: Dendreon, Bayer, Pfizer, Novartis, Janssen Oncology, Astellas Pharma, Gilead Sciences, Roche/Genentech, Bristol Myers Squibb, Constellation Pharmaceuticals, Merck, AstraZeneca, BeiGenePatents, Royalties, Other Intellectual Property: Circulating tumor cell novel capture technologyTravel, Accommodations, Expenses: Astellas Scientific and Medical Affairs Inc Alexander W. WyattHonoraria: Janssen, Astellas Pharma, AstraZeneca, Merck, AstraZeneca CanadaConsulting or Advisory Role: AstraZenecaResearch Funding: ESSA Mary-Ellen TaplinHonoraria: Janssen-Ortho, Clovis Oncology, Astellas Pharma, Incyte, UpToDate, Research to Practice, Pfizer, Bayer, Amgen, AstraZeneca, Progenics, Guidepoint Global, Celgene, Merck, GlaxoSmithKline, Myovant Sciences, Roivant, AbbVie, Arcus Biosciences, Constellation PharmaceuticalsConsulting or Advisory Role: Janssen-Ortho, Bayer, Guidepoint Global, Best Doctors Inc, UpToDate, Clovis Oncology, Research to Practice, Myovant Sciences, Incyte, Pfizer, AstraZeneca, Arcus VenturesResearch Funding: Janssen-Ortho, Medivation, Bayer, PfizerTravel, Accommodations, Expenses: Medivation, Janssen Oncology, Tokai Pharmaceuticals, Astellas Pharma, Incyte, Pfizer, Clovis Oncology, Bayer Shuang G. ZhaoEmployment: Exact Sciences (I)Patents, Royalties, Other Intellectual Property: Patent applications pending with Decipher Biosciences, Exact Sciences Joshua M. LangStock and Other Ownership Interests: Salus DiscoveryConsulting or Advisory Role: Sanofi, Immunomedics, Janssen, Pfizer/Astellas, 4D PharmaResearch Funding: Medivation, Agensys, GlaxoSmithKline, Immunomedics, Bristol Myers Squibb, JanssenPatents, Royalties, Other Intellectual Property: I am listed on the patent on a technology for rare cell capture and analysis. This technology has been licensed by Salus Discovery LLC although no commercial products are availableNo other potential conflicts of interest were reported.

Background: Axitinib plus pembrolizumab showed superior overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) versus sunitinib in a randomised phase III trial in patients with advanced renal-cell carcinoma (RCC). We report long-term efficacy and safety of the axitinib/pembrolizumab from the phase I trial (NCT02133742), after 46-55 months from study initiation (data cut-off date, 23rd July 2019)., Methods: Fifty-two treatment-naïve patients with advanced RCC were treated with oral axitinib 5 mg twice daily and intravenous pembrolizumab 2 mg/kg every 3 weeks. PFS, duration of response (DoR) and OS were summarised using the Kaplan-Meier method., Results: At a median follow-up of 42.7 months (95% confidence interval [CI]: 41.1-44.1), median OS was not reached; 38 (73.1%) patients were alive. The probability of being alive at 4 years was 66.8% (95% CI: 49.1-79.5). Median PFS in the overall population was 23.5 months (95% CI: 15.4-30.4). ORR was 73.1%; five patients had complete response. Median DoR was 22.1 months (95% CI: 15.1-34.5). Grade III/IV adverse events (AEs) were reported in 38 (73.1%) patients and 20 (38.5%) discontinued treatment because of AEs: 17 (32.7%) discontinued axitinib, 13 (25.0%) discontinued pembrolizumab, and 10 (19.2%) discontinued both drugs. Common AEs included diarrhoea (84.6%), fatigue (80.8%), hypertension (53.8%), cough (48.1%) and dysphonia (48.1%). There were no new AE terms reported and no treatment-related deaths., Conclusions: In patients with advanced RCC with ~4 years of follow-up, combination axitinib/pembrolizumab continued to demonstrate clinical benefit, with no new safety signals., Competing Interests: Conflict of interest statement MB Atkins reports institutional research support from Bristol-Myers Squibb, Merck, Pfizer, and Genentech; consulting fees from Pfizer, Novartis, Genentech-Roche, Merck, Exelixis, Eisai, Boehringer Ingelheim, Aveo, Array, Idera, Aduro, Immunocore, Iovance, NewLink, Pharma, Surface, Alexion, Acceleron, COTA, Amgen, Up-to-Date, and AstraZeneca; roles in advisory boards for Bristol-Myers Squibb, Merck, Novartis, Arrowhead, Pfizer, Glactone, Werewolf, Fathom, Pneuma, Leads Pharma, Pyxis; and stock option in Werewolf and Pyxis. ER Plimack reports consulting fees from and/or served roles in advisory boards for Bristol-Myers Squibb, Exelixis, Genentech, Incyte, Janssen, Merck, AstraZeneca, and Pfizer; and grant or clinical trial support from Astellas, AstraZeneca, Bristol-Myers Squibb, Genentech, Merck, Peloton, and Pfizer. I Puzanov reports consulting fees from and/or served on advisory boards for Amgen, Roche, and AbbVie and clinical trial support through his institution from Merck, Amgen, Roche, Nektar, Idera, and Bristol-Myers Squibb. MN Fishman reports research funding from Bristol-Myers Squibb, Exelixis, Eisai, Genentech, Acceleron, Merck, Prometheus / Clinigen, Nektar, Alkermes, and Pfizer; and speakers bureau roles for Astellas, Bristol-Myers Squibb, Exelixis, EMD Serono, Pfizer; and paid roles in advisory boards for Alkermes, Clinigen, Eisai, Merck, Pfizer, Seattle Genetics. DF McDermott reports consulting fees from Bristol-Myers Squibb, Pfizer, Novartis, Genentech-Roche, Merck, Eisai, Array BioPharma, Prometheus, and Exelixis. DC Cho reports consulting fees from Pfizer, Genentech, Prometheus, Bristol-Myers Squibb, PureTech Health, Torque Pharmaceuticals, and Exelixis. U Vaishampayan reports research support from Astellas, Bristol-Myers Squibb, and Exelixis and consulting fees from Exelixis, Merck, Alkermes, Pfizer, Pfizer, Bayer, and Bristol-Myers Squibb. S George reports consulting fees from and advisory roles for Pfizer, Exelixis, Bristol-Myers Squibb, Sanofi/Genzyme, Genentech, Bayer, Corvus, EMD Serono, Seattle Genetics/Astellas, Eisai, and Merck and institutional grant support from Bristol-Myers Squibb, Novartis, Bayer, Pfizer, Merck, Seattle Genetics/Astellas, Eisai, Calithera Biosciences, Immunomedics, Corvus Pharmaceuticals, and Agensys. JC Tarazi, W Duggan, M Thakur, and KC Fernandez reports being employees of Pfizer and stock or stock options in Pfizer. R Perini reports an employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. TK Choueiri reports research support (institutional and personal) from AstraZeneca, Alexion, Bayer, Bristol-Myers Squibb/E.R. Squibb & Sons LLC, Cerulean, Eisai, Foundation Medicine Inc, Exelixis, Ipsen, TRACON, Genentech, Roche, Roche Products Ltd, F. Hoffmann-La Roche, GlaxoSmithKline, Merck, Novartis, Peloton, Pfizer, Prometheus, Corvus, Calithera, Analysis Group, Sanofi/Aventis, Takeda, National Cancer Institute (NCI), National Institutes of Health (NIH), and Department of Defense (DOD); honoraria from AstraZeneca, Alexion, Sanofi/Aventis, Bayer, Bristol-Myers Squibb/E.R. Squibb & Sons LLC, Cerulean, Eisai, Foundation Medicine Inc, Exelixis, Genentech, Roche, Roche Products Ltd, F. Hoffmann-La Roche, GlaxoSmithKline, Merck, Novartis, Peloton, Pfizer, EMD Serono, Prometheus, Corvus, Ipsen, Up-to-Date, Analysis Group, National Comprehensive Cancer Network (NCCN), Michael J. Hennessy (MJH) Associates Inc, Research to Practice, Lpath, Kidney Cancer journal, Clinical Care Options, PlatformQ, Navinata Health, Harborside Press, American Society of Medical Oncology, New England Journal of Medicine, Lancet Oncology, Heron Therapeutics, Lilly, American Society of Clinical Oncology (ASCO), and European Society of Medical Oncology (ESMO); provided consultancy or advisory services to AstraZeneca, Alexion, Sanofi/Aventis, Bayer, Bristol-Myers Squibb/E.R. Squibb & Sons LLC, Cerulean, Eisai, Foundation Medicine Inc, Exelixis, Genentech, Heron Therapeutics, Lilly, Roche, GlaxoSmithKline, Merck, Novartis, Peloton, Pfizer, EMD Serono, Prometheus, Corvus, Ipsen, Up-to-Date, NCCB, Analysis Group, Pionyr, and Tempest; stock ownership in Pionyr and Tempest; contributions toward International Patent Application No. PCT/US2018/12,209, entitled “PBRM1 Biomarkers Predictive of Anti-Immune Checkpoint Response,” filed January 3, 2018, claiming priority to U.S. Provisional Patent Application No. 62/445,094, filed January 11, 2017, and International Patent Application No. PCT/US2018/058,430, entitled “Biomarkers of Clinical Response and Benefit to Immune Checkpoint Inhibitor Therapy,” filed October 31, 2018, claiming priority to U.S. Provisional Patent Application No. 62/581,175, filed November 3, 2017; and travel, accommodations, and expenses in relation to consulting, advisory roles, and/or honoraria., (Copyright © 2020 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Background: Prostate cancer ranks among the top 5 cancers in contribution to national expenditures. Previous reports have identified that 5% of the population accounts for 50% of the nation's annual health care spending. To date, the assessment of the top 5% resource-patients among men diagnosed with prostate cancer (PCa) has never been performed. We investigate the determinants and health care utilization of high resource-patients diagnosed with PCa using a population-based cohort using the Surveillance, Epidemiology, and End Results Medicare-linked database., Methods: Men aged ≥66-year-old with a primary diagnosis of PCa in 2009 were identified. High resource spenders were defined as the top 5% of the sum of the total cost incurred for all services rendered per beneficiary. The spending in each group and predictors of being a high resource-patient were assessed., Results: The top 5% resource-patients consisted of 646 men who spent a total of $62,474,504, comprising 26% of the total cost incurred for all 12,875 men who were diagnosed with PCa in 2009. Of the top 5% resource-patients, the average amount spent per patient was $96,710 vs. $14,664 among the bottom 95% resource-patients. In adjusted analyses, older (odds ratio [OR]: 1.02, 95% confidence interval [CI]: 1.00-1.03), Charlson Comorbidity Index ≥2 (OR: 3.78, 95% CI: 3.10-4.60) men, and advanced disease (metastasis OR: 2.29, 95% CI: 1.68-3.11) were predictors of being a top 5% resource-patient. Of these patients, 210 men died within 1 year of PCa diagnosis (32.5%) vs. 606 men of the bottom 95% resource-patients (5.0%, P < 0.001)., Conclusion: Five percent of men diagnosed with PCa bore 26% of the total cost incurred for all men diagnosed with the disease in 2009. Multimorbidity and advanced disease stage represent the primary drivers of being a high-resource PCa patient. Multidisciplinary care and shared decision-making is encouraged for such patients to better manage cost and quality of care., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Among 2,186 U.S. adults with invasive cancer and laboratory-confirmed SARS-CoV-2 infection, we examined the association of COVID-19 treatments with 30-day all-cause mortality and factors associated with treatment. Logistic regression with multiple adjustments (e.g., comorbidities, cancer status, baseline COVID-19 severity) was performed. Hydroxychloroquine with any other drug was associated with increased mortality versus treatment with any COVID-19 treatment other than hydroxychloroquine or untreated controls; this association was not present with hydroxychloroquine alone. Remdesivir had numerically reduced mortality versus untreated controls that did not reach statistical significance. Baseline COVID-19 severity was strongly associated with receipt of any treatment. Black patients were approximately half as likely to receive remdesivir as white patients. Although observational studies can be limited by potential unmeasured confounding, our findings add to the emerging understanding of patterns of care for patients with cancer and COVID-19 and support evaluation of emerging treatments through inclusive prospective controlled trials. SIGNIFICANCE: Evaluating the potential role of COVID-19 treatments in patients with cancer in a large observational study, there was no statistically significant 30-day all-cause mortality benefit with hydroxychloroquine or high-dose corticosteroids alone or in combination; remdesivir showed potential benefit. Treatment receipt reflects clinical decision-making and suggests disparities in medication access. This article is highlighted in the In This Issue feature, p. 1426 ., (©2020 American Association for Cancer Research.)

Background: Evidence for androgen deprivation therapy (ADT) and risk of dementia is both limited and mixed. We aimed to assess the association between ADT and risk of dementia among men with localized and locally advanced prostate cancer (PCa)., Methods: We conducted a retrospective cohort study using SEER-Medicare-linked data among 100,414 men aged ≥ 66 years and diagnosed with localized and locally advanced PCa (cT1-cT4) between 1992 and 2009. We excluded men with a history of stroke, dementia, or use of psychiatric services. Men were followed until death or administrative end of follow-up at 36 months. Inverse-probability weighted Fine-Gray models were used to estimate hazard ratios (HR) and 95% confidence intervals (CI) for Alzheimer's, all-cause dementia, and use of psychiatric services by duration of pharmacologic ADT (0, 1-6, and ≥ 7 months)., Results: Among 100,414 men with PCa (median age 73 [IQR: 69-77] years; 84% white, 10% black), 38% (n = 37,911) received ADT within 6 months of diagnosis. Receipt of any pharmacologic ADT was associated with a 17% higher risk of all-cause dementia (HR 1.17, 95% CI 1.07-1.27), 23% higher risk of Alzheimer's (HR 1.23, 95% CI 1.11-1.37), and 10% higher risk of psychiatric services use, though the confidence interval included the null (HR 1.10, 95% CI 1.00-1.22). Longer duration of ADT (≥7 months) was associated with a 25% higher risk of all-cause dementia, 34% higher risk of Alzheimer's, and 9% higher risk of psychiatric services, compared with no ADT., Conclusions: Our study supports an association between pharmacologic ADT and higher risk of all-cause dementia, Alzheimer's, and use of psychiatric services among men with localized and locally advanced PCa.

National and international consortia will play a key role in understanding the effects of the coronavirus disease 2019 (COVID-19) pandemic on cancer patients. The COVID-19 and Cancer Consortium (CCC19) aims to collect and analyze observational data at scale to inform clinical practice in real-time., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Importance: While racial disparities in prostate cancer mortality are well documented, it is not well known how these disparities vary geographically within the US., Objective: To characterize geographic variation in prostate cancer-specific mortality differences between black and white men., Design, Setting, and Participants: This cohort study included data from 17 geographic registries within the Surveillance, Epidemiology, and End Results (SEER) database from January 1, 2007, to December 31, 2014. Inclusion criteria were men 18 years and older with biopsy-confirmed prostate cancer. Men missing data on key variables (ie, cancer stage, Gleason grade group, prostate-specific antigen level, and survival follow-up data) were excluded. Analysis was performed from September 5 to December 25, 2018., Exposure: Patient SEER-designated race (ie, black, white, or other)., Main Outcomes and Measures: Fine and Gray competing-risks regression analyses were used to evaluate the difference in prostate-cancer specific mortality between black and white men. A stratified analysis by Gleason grade group was performed stratified as grade group 1 and grade groups 2 through 5., Results: The final cohort consisted of 229 771 men, including 178 204 white men (77.6%), 35 006 black men (15.2%), and 16 561 men of other or unknown race (7.2%). Mean (SD) age at diagnosis was 64.9 (8.8) years. There were 4773 prostate cancer deaths among white men and 1250 prostate cancer deaths among black men. Compared with white men, black men had a higher risk of mortality overall (adjusted hazard ratio [AHR], 1.39 [95% CI, 1.30-1.48]). In the stratified analysis, there were 4 registries in which black men had worse prostate cancer-specific survival in both Gleason grade group 1 (Atlanta, Georgia: AHR, 5.49 [95% CI, 2.03-14.87]; Greater Georgia: AHR, 1.88 [95% CI, 1.10-3.22]; Louisiana: AHR, 1.80 [95% CI, 1.06-3.07]; New Jersey: AHR, 2.60 [95% CI, 1.53-4.40]) and Gleason grade groups 2 through 5 (Atlanta: AHR, 1.88 [95% CI, 1.46-2.45]; Greater Georgia: AHR, 1.29 [95% CI, 1.07-1.56]; Louisiana: AHR, 1.28 [95% CI, 1.07-1.54]; New Jersey: AHR, 1.52 [95% CI, 1.24-1.87]), although the magnitude of survival difference was lower than for Gleason grade group 1 in each of these registries. The greatest race-based survival difference for men with Gleason grade group 1 disease was in the Atlanta registry., Conclusions and Relevance: These findings suggest that population-level differences in prostate cancer survival among black and white men were associated with a small set of geographic areas and with low-risk prostate cancer. Targeted interventions in these areas may help to mitigate prostate cancer care disparities at the national level.

Objectives: To assess whether Medicare expenditures for men with incident prostate cancer, treated in Accountable Care Organizations (ACOs) differ from those of men treated in non-ACOs., Methods: Using the 20% Medicare sample, total charges for 1 year following an initial diagnosis of prostate cancer were abstracted from Medicare claims. Prostate cancer expenditures were calculated by subtracting total charges from the year prior to diagnosis. Propensity score weighting was used to balance baseline characteristics of men treated in ACOs and non-ACOs, and between treatment modalities (radiation, prostatectomy, and expectant management). A propensity score weighted regression model was then used to estimate mean expenditures for men with prostate cancer treated in ACOs and non ACOs and to test the association between ACO status and costs., Results: We identified 3297 men treated in ACOs for localized prostate cancer versus 24,088 in the non-ACO cohort. The weighted total charges for each treatment modality were $32,358 (radiation), $27,662 (prostatectomy), and $11,134 (expectant management). In our propensity score weighted regression model, the association between charges and ACO status was not significant, nor was the interaction between treatment type and costs. This was true both overall, and in a stratified analysis by treatment type., Conclusions: There was no significant difference in Medicare spending on prostate cancer care based on provider ACO affiliation, regardless of treatment type. Although the effects of ACOs on clinical care are complex, this study adds to a growing body of evidence suggesting that ACOs fail to achieve significantly lower charges in certain clinical settings.

Background: The introduction of immune checkpoint inhibitors has led to a survival benefit in patients with advanced melanoma; however data on the adoption of immunotherapy in the community are scarce., Methods: Using the National Cancer Database, we identified 4725 patients aged ≥20 diagnosed with metastatic melanoma in the United States between 2011 and 2015. Multinomial regression was used to identify factors associated with the receipt of treatment at a low vs. high immunotherapy prescribing hospital, defined as the bottom and top quintile of hospitals according to their proportion of treating metastatic melanoma patients with immunotherapy., Results: We identified 246 unique hospitals treating patients with metastatic melanoma. Between 2011 and 2015, the proportion of hospitals treating at least 20% of melanoma patients with immunotherapy within 90 days of diagnosis increased from 14.5 to 37.7%. The mean proportion of patients receiving immunotherapy was 7.8% (95% Confidence Interval [CI] 7.47-8.08) and 50.9% (95%-CI 47.6-54.3) in low and high prescribing hospitals, respectively. Predictors of receiving care in a low prescribing hospital included underinsurance (no insurance: relative risk ratio [RRR] 2.44, 95%-CI 1.28-4.67, p = 0.007; Medicaid: RRR 2.10, 95%-CI 1.12-3.92, p = 0.020), care in urban areas (RRR 2.58, 95%-CI 1.34-4.96, p = 0.005) and care at non-academic facilities (RRR 5.18, 95%CI 1.69-15.88, p = 0.004)., Conclusion: While the use of immunotherapy for metastatic melanoma has increased over time, adoption varies widely across hospitals. Underinsured patients were more likely to receive treatment at low immunotherapy prescribing hospitals. The variation suggests inequity in access to these potentially life-saving drugs.

Background: There are race-based differences in bladder cancer survival. To better understand this phenomenon, this study was designed to assess the statistical contributions of tumor, treatment, and access variables to race-based differences in survival., Methods: Data were extracted from the National Cancer Data Base on black and white adults with muscle-invasive bladder cancer from 2004 to 2015. The impact of tumor, access, and treatment variables on differences in survival was inferred by the performance of sequential propensity score-weighted analyses in which black and white patients were balanced with respect to demographics and health status (comorbidities) tumor characteristics, treatment, and access-related variables. The propensity score-weighted hazard of death (black vs white) was calculated after each iteration., Results: This study identified 44,577 patients with a median follow-up of 77 months. After demographics and health status were balanced, black race was associated with 18% worse mortality (hazard ratio, 1.18; 95% confidence interval [CI], 1.12-1.25; P < .001). Balancing by tumor characteristics reduced this to 16%, balancing by treatment reduced this to 10%, and balancing by access-related variables resulted in no difference. Access-related variables explained 40% (95% CI, 22.9%-57.0%) of the excess risk of death in blacks, whereas treatment factors explained 35% (95% CI, 22.2%-46.9%). The contribution of tumor characteristics was not significant., Conclusions: In the models, differences in survival for black and white patients with bladder cancer are best explained by disparities in access and treatment, not tumor characteristics. Access to care is likely a key factor in racial disparities in cancer., (© 2019 American Cancer Society.)

Purpose: We investigated the quality of care at minority serving hospitals compared to other institutions for men with localized intermediate and high risk prostate cancer., Materials and Methods: Using the National Cancer Database we identified 536,539 men 40 years old or older who presented with localized intermediate and high risk prostate cancer in the United States between 2004 and 2015. Institutions were ranked according to the proportion of black and Hispanic patients treated at a given institution, and the top decile institutions were defined as minority serving hospitals. We used multivariable analyses to characterize the association between minority serving hospitals and 3 end points, including receipt of definitive treatment, time to definitive treatment and receipt of androgen deprivation therapy in young (65 years or younger) and healthy (no comorbidity) men treated with external beam radiation therapy., Results: A total of 162 and 1,168 hospitals were defined as minority and nonminority serving hospitals, respectively. On multivariable analyses treatment at minority serving hospitals was associated with decreased odds of receiving definitive treatment (adjusted OR 0.73, 95% CI 0.62-0.85, p <0.001). Adjusted mean ± SE time to treatment was significantly longer at minority serving hospitals compared to nonminority serving hospitals (4.9 ± 2.2 days, p = 0.024). Among young and healthy men there was no association between treatment at a minority serving hospital and receipt of androgen deprivation therapy in conjunction with external beam radiation (AOR 0.90, 95% CI 0.75-1.09, p = 0.291)., Conclusions: Treatment at a minority serving hospital was associated with lower odds of receiving definitive therapy and longer time to definitive therapy for localized intermediate and high risk prostate cancer despite adjustment for race. This suggests that some racial disparities in prostate cancer may be explained by the sites at which racial and/or ethnic minorities receive care.

Background: Racial differences in prostate cancer (PCa) outcomes in the United States may be due to differences in tumor biology and race-based differences in access and treatment. We designed a study to estimate the relative contribution of these factors on Black/White disparities in overall survival (OS) in advanced PCa., Methods: We identified Black and White men aged ≥ 40 years with metastatic or locally advanced PCa (cN+ cM+ and/or T3/4) between 2004 and 2010 using the National Cancer Database. We employed sequential propensity score weighting procedures to generate simulated cohorts of Black and White patients with equal demographics, access to care, treatment, and tumor characteristics. Adjusted survival analyses were used to compare survival in these simulated cohorts. The changes in relative survival after each weighting procedure were used to infer the contribution of each set of variables on the excess risk of mortality in Blacks., Results: In total, 35,611 men met inclusion criteria, 5927 (16.77%) of whom were Black. Survival was significantly worse for Black men after adjusting for demographics and comorbidities (hazard ratio (HR) 1.27, 95%-confidence interval (95%-CI) 1.2-1.34, p < 0.001). After simulating equal access to care, there was no significant difference in survival between races (HR 1.04, 95%-CI 0.97-1.12, p = 0.276), despite worse tumor characteristics in Blacks. After simulating equal treatment and equivalent tumor characteristics, Black men had a better survival than Whites (HR 0.93, 95%-CI 0.86-1.01, p = 0.071 and HR 0.92, 95%-CI 0.84-1.00, p = 0.043, respectively). Overall, access-related variables explained 84.7% of the excess risk of death in Black men., Conclusion: Our analysis of men with advanced PCa revealed worse OS among Blacks. However, when access to care, treatment, and cancer characteristics are accounted for, Black race was associated with better OS. These findings suggest that initiatives to improve access to care may represent an effective tool to reduce disparities in PCa outcomes.

Background: The consequences of low prostate-specific antigen (PSA) in high-grade (Gleason 8-10) prostate cancer are unknown., Objective: To evaluate the clinical implications and genomic features of low-PSA, high-grade disease., Design, Setting, and Participants: This was a retrospective study of clinical data for 494 793 patients from the National Cancer Data Base and 136 113 patients from the Surveillance, Epidemiology, and End Results program with cT1-4N0M0 prostate cancer (median follow-up 48.9 and 25.0 mo, respectively), and genomic data for 4960 patients from the Decipher Genomic Resource Information Database. Data were collected for 2004-2017., Outcome Measurements and Statistical Analysis: Multivariable Fine-Gray and Cox regressions were used to analyze prostate cancer-specific mortality (PCSM) and all-cause mortality, respectively., Results and Limitations: For Gleason 8-10 disease, using PSA 4.1-10.0ng/ml (n=38 719) as referent, the distribution of PCSM by PSA was U-shaped, with an adjusted hazard ratio (AHR) of 2.70 for PSA ≤2.5ng/ml (n=3862, p<0.001) versus 1.97, 1.36, and 2.56 for PSA of 2.6-4.0 (n=4199), 10.1-20.0 (n=17 372), and >20.0ng/ml (n=16 114), respectively. By contrast, the distribution of PCSM by PSA was linear for Gleason ≤7 (using PSA 4.1-10.0ng/ml as the referent, n=359 898), with an AHR of 0.41 (p=0.13) for PSA ≤2.5ng/ml (n=37 812) versus 1.38, 2.28, and 4.61 for PSA of 2.6-4.0 (n=54 152), 10.1-20.0 (n=63 319), and >20.0ng/ml (n=35 459), respectively (p interaction <0.001). Gleason 8-10, PSA ≤2.5ng/ml disease had a significantly higher PCSM than standard high-risk/very high-risk disease with PSA >2.5ng/ml (AHR 2.15, p=0.002; 47-mo PCSM 14% vs 4.9%). Among Gleason 8-10 patients treated with radiotherapy, androgen deprivation therapy was associated with a survival benefit for PSA >2.5ng/ml (AHR 0.87; p<0.001) but not ≤2.5ng/ml (AHR 1.36; p=0.084; p interaction =0.021). For Gleason 8-10 tumors, PSA ≤2.5ng/ml was associated with higher expression of neuroendocrine/small-cell markers compared to >2.5ng/ml (p=0.046), with no such relationship for Gleason ≤7 disease., Conclusions: Low-PSA, high-grade prostate cancer has very high risk for PCSM, potentially responds poorly to androgen deprivation therapy, and is associated with neuroendocrine genomic features., Patient Summary: In this study, we found that low-prostate-specific antigen, high-grade prostate cancer has a very high risk for prostate cancer death, may not respond well to androgen deprivation therapy, and is associated with neuroendocrine genomic features. These findings suggest that current nomograms and treatment paradigms may need modification., (Copyright © 2018. Published by Elsevier B.V.)

Background: Prior studies have only considered the association between static marital status and cancer-specific outcomes. We aim to measure the effect of recent divorce on cancer-specific outcomes., Methods: There were 83,804 patients with 2 malignancies, diagnosed 12 to 60 months apart, from 1973-2006 from the Surveillance, Epidemiology, and End Results database. Patients were identified as newly divorced if married at their first diagnosis and single/divorced at their second. Multivariable logistic regression and competing-risks regression were used to analyze the association of becoming newly divorced or newly married with cancer-specific outcomes from the second malignancy, including advanced diagnosis (T4 or N1 or M1), receipt of treatment, and cancer-specific survival., Results: Four percent became newly divorced and 3.4% became newly married. Compared with long-term married, newly divorced patients were most likely to be diagnosed with advanced disease (adjusted odds ratio [AOR] 1.31; 95% confidence interval [CI], 1.19-1.43), followed by long-term divorced (AOR 1.18; 95% CI, 1.11-1.25), and were least likely to receive curative treatment (AOR 0.74; 95% CI, 0.67-0.81). Newly divorced patients had the worst cancer-specific survival (adjusted hazard ratio [AHR] 1.17; 95% CI, 1.05-1.30, P = .005), followed by long-term divorced (AHR 1.08; 95% CI, 1.01-1.16, P = .032), while newly married patients had similar cancer-specific survival to long-term married (AHR 0.96; 95% CI, 0.85-1.08, P = .46)., Conclusion: Recent divorce, which represents an acute disruption of a patient's social support network, was associated with the worst cancer outcomes, followed by long-term divorce. Clinicians should consider recent divorce as a risk factor for worse cancer outcomes, and encourage appropriate screening, treatment, and access to social and financial supports for recently divorced patients., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: The use of neoadjuvant chemotherapy (NAC) before radical cystectomy (RC) is supported by results from several randomized control trials, including SWOG-8710., Objective: To look at the effectiveness of NAC before RC in current real world practice in the USA., Design, Setting, and Participants: We used the National Cancer Data Base (NCDB) to identify patients with nonmetastatic muscle-invasive urothelial carcinoma of the bladder who underwent RC between 2004 and 2012., Intervention: Receipt of NAC before RC., Outcome Measurements and Statistical Analysis: The primary endpoint was overall survival (OS). Secondary endpoints were rates of complete pathologic response (pT0), positive pathologic lymph nodes (pN+), and margin status. Using a landmark analysis to adjust for an immortal-time bias, OS comparison was performed using Cox regression analysis. Furthermore, logistic regression models examining secondary outcomes were fitted. To adjust for potential selection bias, propensity score-weighted analyses were performed., Results and Limitations: Of 8732 patients who underwent RC, 1619 (19%) received NAC. Following propensity score adjustment, receipt of NAC was not associated with an OS benefit (hazard ratio 0.97; p=0.591). On secondary outcome analysis, higher pT0 rates (odds ratio 5.03; p<0.001) were recorded among patients who received NAC, although rates of pT0 were lower than for patients treated with NAC within the SWOG-8710 trial (13% vs 38%). Limitations include the retrospective design and limited details available regarding type of chemotherapy., Conclusions: Important baseline differences between patients from the SWOG-8710 trial and those in general urologic practice exist. After adjusting for immortal-time bias, we did not find a clear survival advantage of NAC before RC when compared to RC alone in current general urology practice in the USA., Patient Summary: The benefit of chemotherapy before radical cystectomy is supported by few randomized control trials. In this study, using a large national data set from the USA we found that preoperative chemotherapy is not associated with a survival benefit in all patients in general urology practice. Hence, better selection criteria are needed to determine who will benefit the most from chemotherapy before radical cystectomy., (Copyright © 2018 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Background: Previous studies combining PD-1 checkpoint inhibitors with tyrosine kinase inhibitors of the VEGF pathway have been characterised by excess toxicity, precluding further development. We hypothesised that axitinib, a more selective VEGF inhibitor than others previously tested, could be combined safely with pembrolizumab (anti-PD-1) and yield antitumour activity in patients with treatment-naive advanced renal cell carcinoma., Methods: In this ongoing, open-label, phase 1b study, which was done at ten centres in the USA, we enrolled patients aged 18 years or older who had advanced renal cell carcinoma (predominantly clear cell subtype) with their primary tumour resected, and at least one measureable lesion, Eastern Cooperative Oncology Group performance status 0-1, controlled hypertension, and no previous systemic therapy for renal cell carcinoma. Eligible patients received axitinib plus pembrolizumab in a dose-finding phase to estimate the maximum tolerated dose, and additional patients were enrolled into a dose-expansion phase to further establish safety and determine preliminary efficacy. Axitinib 5 mg was administered orally twice per day with pembrolizumab 2 mg/kg given intravenously every 3 weeks. We assessed safety in all patients who received at least one dose of axitinib or pembrolizumab; antitumour activity was assessed in all patients who received study treatment and had an adequate baseline tumour assessment. The primary endpoint was investigator-assessed dose-limiting toxicity during the first two cycles (6 weeks) to estimate the maximum tolerated dose and recommended phase 2 dose. This study is registered with ClinicalTrials.gov, number NCT02133742., Findings: Between Sept 23, 2014, and March 25, 2015, we enrolled 11 patients with previously untreated advanced renal cell carcinoma to the dose-finding phase and between June 3, 2015, and Oct 13, 2015, we enrolled 41 patients to the dose-expansion phase. All 52 patients were analysed together. No unexpected toxicities were observed. Three dose-limiting toxicities were reported in the 11 patients treated during the 6-week observation period (dose-finding phase): one patient had a transient ischaemic attack and two patients were only able to complete less than 75% of the planned axitinib dose because of treatment-related toxicity. At the data cutoff date (March 31, 2017), 25 (48%) patients were still receiving study treatment. Grade 3 or worse treatment-related adverse events occurred in 34 (65%) patients; the most common included hypertension (n=12 [23%]), diarrhoea (n=5 [10%]), fatigue (n=5 [10%]), and increased alanine aminotransferase concentration (n=4 [8%]). The most common potentially immune-related adverse events (probably related to pembrolizumab) included diarrhoea (n=15 [29%]), increased alanine aminotransferase concentration (n=9 [17%]) or aspartate aminotransferase concentration (n=7 [13%]), hypothyroidism (n=7 [13%]), and fatigue (n=6 [12%]). 28 (54%) patients had treatment-related serious adverse events. At data cutoff, 38 (73%; 95% CI 59·0-84·4) patients achieved an objective response (complete or partial response)., Interpretation: The treatment combination of axitinib plus pembrolizumab is tolerable and shows promising antitumour activity in patients with treatment-naive advanced renal cell carcinoma. Whether or not the combination works better than a sequence of VEGF pathway inhibition followed by an anti-PD-1 therapy awaits the completion of a phase 3 trial comparing axitinib plus pembrolizumab with sunitinib monotherapy (NCT02853331)., Funding: Pfizer Inc., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Purpose: The management of locally advanced prostate cancer remains controversial. We compared the effect of primary external beam radiation therapy vs radical prostatectomy for locally advanced prostate cancer., Materials and Methods: We retrospectively analyzed the records of 2,935 elderly men 65 years old or older in the SEER (Surveillance, Epidemiology and End Results)-Medicare linked database who underwent external beam radiation therapy or radical prostatectomy for locally advanced prostate cancer. Propensity adjusted Cox proportional hazard and regression models were fit to examine urinary and gastrointestinal toxicities, the use of androgen deprivation therapy, and overall and prostate cancer specific mortality., Results: A total of 1,429 men (48.69%) underwent radical prostatectomy and had a median followup of 11.47 years (IQR 6.17-17.17) years. A total of 1,506 men (51.31%) received external beam radiation therapy and had a median followup of 7.04 years (IQR 4.11-10.51, p <0.001). Patients treated with radical prostatectomy were at significantly higher risk for urinary and sexual toxicities (HR 1.93, 95% CI 1.66-2.24 and HR 5.50, 95% CI 3.59-8.42, respectively). However, they were at lower risk for gastrointestinal toxicities (HR 0.75, 95% CI 0.65-0.86) than those treated with external beam radiation therapy. Radical prostatectomy was associated with lower odds of androgen deprivation therapy 5 years after primary treatment (OR 0.53, 95% CI 0.41-0.69, p <0.001). External beam radiation therapy was associated with higher overall and prostate specific mortality (HR 1.41, 95% CI 1.09-1.82 and HR 2.35, 95% CI 1.85-2.98, respectively)., Conclusions: We found significant toxicity and survival differences in elderly men who underwent primary external beam radiation therapy vs radical prostatectomy for locally advanced prostate cancer. While our findings must be interpreted within the limitations of studies that rely on administrative claims, they may yet help tailor individual therapies for elderly men who present with locally advanced prostate cancer., (Copyright © 2017 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Background: In 2012, the United States Preventive Services Task Force (USPSTF) recommended against prostate-specific antigen (PSA) screening, despite evidence that Black men are at a higher risk of prostate cancer-specific mortality (PCSM). We evaluated whether Black men of potentially screening-eligible age (55-69 years) are at a disproportionally high risk of poor outcomes., Patients and Methods: The SEER database was used to study 390 259 men diagnosed with prostate cancer in the United States between 2004 and 2011. Multivariable logistic regression modeled the association between Black race and stage of presentation, while Fine-Gray competing risks regression modeled the association between Black race and PCSM, both as a function of screening eligibility (age 55-69 years versus not)., Results: Black men were more likely to present with metastatic disease (adjusted odds ratio [AOR] 1.65; 1.58-1.72; P < 0.001) and were at a higher risk of PCSM (adjusted hazard ratio [AHR] 1.36; 1.27-1.46; P < 0.001) compared to non-Black men. There were significant interactions between race and PSA-screening eligibility such that Black patients experienced more disproportionate rates of metastatic disease (AOR 1.76; 1.65-1.87 versus 1.55; 1.47-1.65; Pinteraction < 0.001) and PCSM (AHR 1.53; 1.37-1.70 versus 1.25; 1.14-1.37; Pinteraction = 0.01) in the potentially PSA-screening eligible group than in the group not eligible for screening., Conclusions: Racial disparities in prostate cancer outcome among Black men are significantly worse in PSA-screening eligible populations. These results raise the possibility that Black men could be disproportionately impacted by recommendations to end PSA screening in the United States and suggest that Black race should be included in the updated USPSTF PSA screening guidelines., (© The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)

Background: Most major cancer organizations seek to reduce sociodemographic disparities in high-risk cancers partly by increasing access to theoretically high-quality, academic-oriented cancer care. The objective of this study was to determine whether academic centers have less sociodemographic treatment disparities than community centers using high-risk prostate cancer as a test case., Methods: The National Cancer Data Base was used to identify 138,019 patients who were diagnosed with nonmetastatic, high-risk prostate cancer from 2004 to 2012. Multivariable logistic analysis was used to identify independent determinants of definitive therapy. The Gray test and multivariable Cox regression were used to analyze the timing of therapy. All analyses were stratified by academic versus community cancer center., Results: Compared with white or privately insured patients, black, Hispanic, and uninsured patients with prostate cancer were less likely to receive definitive therapy at both community centers (adjusted odds ratio: 0.60 [95% confidence interval (CI), 0.56-0.64], 0.69 [95% CI, 0.61-0.78], and 0.25 [95% CI, 0.22-0.30], respectively) and academic cancer centers (adjusted odds ratio: 0.50 [95% CI, 0.46-0.54], 0.56 [95% CI, 0.50-0.64], and 0.31 [95% CI, 0.28-0.36], respectively). Among patients who received definitive therapy, black, Hispanic, and uninsured patients were more likely to experience treatment delays at both community centers (≥15, ≥ 10, and ≥19 days, respectively; all Gray P < .001) and academic centers (≥19, ≥ 11, and ≥18 days, respectively); treatment delays were observed among the aforementioned groups even after multivariable Cox regression analysis (P < .001 for all adjusted hazard ratios)., Conclusions: Nationally, academic cancer centers demonstrate similarly high rates of sociodemographic disparities in cancer treatment patterns as community cancer centers. Making community centers conform to academic center standards may not necessarily reduce treatment disparities. Cancer 2016;122:3371-3377. © 2016 American Cancer Society., (© 2016 American Cancer Society.)

Introduction: It remains largely unknown if there are racial disparities in outcomes of prostate cancer (PCa) for Asian American and Pacific Islanders (PIs) (AAPIs). We examined differences in diagnosis, management, and survival of AAPI ethnic groups, relative to their non-Hispanic White (NHW) counterparts., Methods: Patients (n = 891,100) with PCa diagnosed between 1988 and 2010 within the surveillance, epidemiology, and end results database were extracted and stratified by ethnic group: Chinese, Japanese, Filipino, Hawaiian, Korean, Vietnamese, Asian Indian/Pakistani, PI, and Other Asian. The effect of ethnic group on stage at presentation, rates of definitive treatment, and PCa-specific mortality was assessed. The severity at diagnosis was defined as: localized (TxN0M0), regional (TxN1M0), or metastatic (TxNxM1)., Results: Relative to NHWs, Asian Indian/Pakistani, Filipino, Hawaiian, and PI men had significantly worse outcomes. Filipino (odds ratio [OR] = 1.38, 95% CI: 1.27-1.51), Hawaiian, (OR = 1.70, 95% CI: 1.41-2.04), Asian Indian/Pakistani (OR = 1.37, 95% CI: 1.15-1.64), and PI men (OR = 1.90, 95% CI: 1.46-2.49) were more likely to present with metastatic PCa (P<0.001). In patients with localized PCa, Filipino men were less likely to receive definitive treatment (OR = 0.91; 95% CI: 0.84-0.97; P = 0.005). Most AAPI groups had lower rates of PCa death except for Hawaiian (hazard ratio = 1.52; 95% CI: 1.30-1.77; P<0.0001) and PI men (hazard ratio = 1.43; 95% CI: 1.12-1.82; P<0.0001)., Conclusions: Compared with NHWs, AAPI groups were more likely to present with advanced PCa but had better cancer-specific survival. Conversely, Hawaiian and PI men were at greater risk for PCa-specific mortality. Given the different cancer profiles, our results show that there is a need for disaggregation of AAPI data., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Purpose: Although black men represent a high risk population for prostate specific antigen screening for prostate cancer, recommendations in black men are unclear. To our knowledge the resultant effect of conflicting recommendations and disparities in access to care on prostate specific antigen screening in black men is unknown., Materials and Methods: We compared the rate of self-reported prostate specific antigen screening in black men relative to that in nonHispanic white men. The BRFSS (Behavioral Risk Factor Surveillance System) 2012 data set was used to identify asymptomatic men 40 to 99 years old who reported undergoing prostate specific antigen screening in the last 12 months. Age, education, income, residence location, marital status, health insurance, regular access to a health care provider and a health care provider recommendation to undergo screening were extracted. Subgroup analyses by race and age were performed using complex samples logistic regression models to assess the odds of undergoing prostate specific antigen screening., Results: In 2012 there were 122,309 survey respondents (weighted estimate 54.5 million) in the study population, of whom 29% of black and 32% of nonHispanic white men reported undergoing prostate specific antigen screening. Younger black males had higher rates and odds of screening than nonHispanic white men of a similar age (ages 45 to 49, 50 to 54 and 55 to 59 years OR 1.66, 1.58 and 1.36, respectively). Among black men only a higher education level (graduates vs nongraduates OR 2.12), regular access to a health care provider (OR 2.05) and a health care provider recommendation for screening (OR 8.43) were independently associated with prostate specific antigen screening., Conclusions: Despite long-standing disparities in health care access black males 45 to 60 years old have a higher rate and probability of prostate specific antigen screening than nonHispanic white men. Among black men educational attainment had a more pronounced association. In contrast the association with health care provider recommendations was less pronounced relative to that in nonHispanic white men. Future research may shed more light on the gamut of factors that influence the decision making process for prostate specific antigen testing., (Copyright © 2016 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Importance: There is extensive evidence suggesting that black men with localized prostate cancer (PCa) have worse cancer-specific mortality compared with their non-Hispanic white counterparts., Objective: To evaluate racial disparities in the use, quality of care, and outcomes of radical prostatectomy (RP) in elderly men (≥ 65 years) with nonmetastatic PCa., Design, Setting, and Participants: This retrospective analysis of outcomes stratified according to race (black vs non-Hispanic white) included 2020 elderly black patients (7.6%) and 24,462 elderly non-Hispanic white patients (92.4%) with localized PCa who underwent RP within the first year of PCa diagnosis in the Surveillance, Epidemiology, and End Results (SEER)-Medicare database between 1992 and 2009. The study was performed in 2014., Main Outcomes and Measures: Process of care (ie, time to treatment, lymph node dissection), as well as outcome measures (ie, complications, emergency department visits, readmissions, PCa-specific and all-cause mortality, costs) were evaluated using Cox proportional hazards regression. Multivariable conditional logistic regression and quantile regression were used to study the association of racial disparities with process of care and outcome measures., Results: The proportion of black patients with localized prostate cancer who underwent RP within 90 days was 59.4% vs 69.5% of non-Hispanic white patients (P <  001). In quantile regression of the top 50% of patients, blacks had a 7-day treatment delay compared with non-Hispanic whites. (P <  001). Black patients were less likely to undergo lymph node dissection (odds ratio [OR], 0.76 [95% CI, 0.66-0.80]; P < .001) but had higher odds of postoperative visits to the emergency department (within 30 days: OR, 1.48 [95% CI, 1.18-1.86]); after 30 days or more (OR, 1.45 [95% CI, 1.19-1.76]) and readmissions (within 30 days: OR, 1.28 [95% CI, 1.02-1.61]); ≥ 30 days (OR, 1.27 [95% CI, 1.07-1.51]) compared with non-Hispanic whites. The surgical treatment of black patients was associated with a higher incremental annual cost (the top 50% of blacks spent $1185.50 (95% CI , $804.85-1 $1566.10; P < .001) more than the top 50% of non-Hispanic whites). There was no difference in PCa-specific mortality (P = .16) or all-cause mortality (P = .64) between black and non-Hispanic white men., Conclusions and Relevance: Blacks treated with RP for localized PCa are more likely to experience adverse events and incur higher costs compared with non-Hispanic white men; however, this does not translate into a difference in PCa-specific or all-cause mortality., Competing Interests: disclosures: All other authors have nothing to disclose All authors confirm that all here with-reported conflict of interest disclosure information is accurate, complete, up-to-date.

Objective: To identify contemporary, clinically low-risk patients with ≥50% cores positive and compare the risk of upgrading at prostatectomy with other low- or intermediate-risk patients., Materials and Methods: We studied 14,902 patients with prostate cancer in the Surveillance, Epidemiology, and End Results database in 2010-2011 treated with prostatectomy. Patients were categorized by National Comprehensive Cancer Network clinical risk groups, separating low-risk patients by percent positive biopsy cores (PBC). We measured incidence of pathologic high-risk disease, defined as pT3a-T4 or Gleason 8-10, and multivariable logistic regression was used to determine if patients with clinical low-risk disease and ≥50% PBC were similar to other low- or intermediate-risk patients. This analysis was repeated with favorable and unfavorable intermediate risk., Results: At prostatectomy, 9.2% of clinically low-risk patients with <50% PBC, 18.6% of clinically low-risk patients with ≥50% PBC, and 27.6% of clinically intermediate-risk patients had occult, high-risk disease (P <.001). On multivariable logistic regression, low-risk patients with ≥50% PBC were more likely than low-risk patients with <50% PBC to have pathologic high-risk disease (adjusted odds ratio [AOR] 2.28, 95% confidence interval 1.90-2.73, P <.001), had similar risk to favorable intermediate patients overall (AOR 1.09, 0.91-1.31, P = .33), and had higher risk than favorable intermediate patients aged over 60 years (AOR 1.28, 1.00-1.64, P = .04). Low-risk patients with ≥50% PBC had a mean tumor size similar to unfavorable intermediate-risk patients (21.3 vs 21.0 mm, P = .82)., Conclusion: Nearly 1 in 5 clinically low-risk prostate cancer patients with ≥50% PBC harbor occult pT3a-T4 or Gleason 8-10, suggesting that national guidelines should not classify low-risk patients with ≥50% cores positive as "low risk," and patients should be made aware of this excess risk if considering active surveillance., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Introduction: In order to help inform the discussion about the risks versus benefits of prostate cancer screening among older men, we determined whether advanced age is associated with a higher probability of harboring high-grade or high-risk disease., Patients and Methods: The Surveillance, Epidemiology, and End Results (SEER) database was used to identify 383,039 men diagnosed with prostate cancer in 2004-2011. The percentage of patients diagnosed with low-, intermediate-, or high-risk disease or a Gleason score of 6, 7, or 8 to 10 was calculated by age range. As a secondary analysis, we examined whether this relationship was different in 2010-2011 versus 2007-2008 (before and after the 2009 publication of screening trials)., Results: The probability of Gleason score 8 to 10 or high-risk disease increased significantly with increasing age. The percentage of Gleason score 8 to 10 disease among men ages 50 to 54, 70 to 74, and 80 to 84 years was 8.9%, 16.2%, and 28.5%, respectively, and the percentage of high-risk disease was 14.3%, 22.4%, and 38.7% (P < .001). There were similar relationships among men with stage T1c disease. In addition, older men experienced a significant increase in the relative probability of high-risk or high-grade disease from 2007-2008 to 2010-2011., Conclusion: In this large US-based cohort, older men had a much higher probability of high-grade or high-risk prostate cancer. Physicians and patients should take into account the higher risk of more aggressive or advanced disease in older men when discussing the risks and benefits of prostate-specific antigen screening with healthy older men with a substantial life expectancy., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Introduction and Objectives: The quality of medical care to US veterans, as provided by the Veterans Health Administration, has recently been subjected to heightened scrutiny. We sought to report prostate-specific antigen screening (PSAS) in a contemporary cohort of veteran men (VM) vs. nonveteran men (NVM). We hypothesize that VM are less likely to receive age-appropriate PSAS compared with NVM., Materials and Methods: We identified VM and NVM aged 55 to 69 years without history of prostate cancer who underwent PSA testing in the year preceding that of the 2012 Behavioral Risk Factor and Surveillance System survey. The prevalence of PSAS among VM and NVM was determined in aggregate and on a state-by-state basis. Complex samples logistic regression models calculated the odds of PSAS based on veteran status, adjusted for patient/demographic characteristics., Results: In all, 56,962 responses were collected, yielding a weighted estimate of 23.7 million men, of which 30.5% were VM. Overall, 45.2% (CI: 43.9%-46.5%) of VM reported PSAS compared with only 37.5% (CI: 36.5%-38.5%) of NVM. VM were more likely to have health insurance (92.0%; CI: 91.3%-92.8% vs. 86.2%; CI: 85.4%-87.0%) and a regular health care provider (89.0%; CI: 88.2%-89.8% vs. 85.9%; CI: 85.1%-86.6%) compared with NVM. Unadjusted prevalence of PSAS varied widely across the United States for VM and NVM. In multivariable analyses, VM had higher odds for PSAS (odds ratio = 1.10, CI: 1.02%-1.18%)., Conclusions: Contrary to our initial hypothesis, our findings suggest a continued pattern of greater preventive health services use by veterans. VM were more likely to undergo PSAS than NVM. This is, in part, attributable to better access to primary care and health insurance. Nonetheless, heterogeneity in screening practices remained largely dependent on geography., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Purpose: To examine the potential relationship between androgen deprivation therapy and other-cause mortality (OCM) in patients with prostate cancer treated with medical primary-androgen deprivation therapy, prostatectomy, or radiation., Methods: A total of 137,524 patients with non-metastatic PCa treated between 1995 and 2009 within the Surveillance Epidemiology and End Results Medicare-linked database were included. Cox-regression analysis tested the association of ADT with OCM. A 40-item comorbidity score was used for adjustment., Results: Overall, 9.3% of patients harbored stage III-IV disease, and 57.7% of patients received ADT. The mean duration of ADT exposure was 22.9 months (median: 9.1; IQR: 2.8-31.5). Mean and median follow-up were 66.9, and 60.4 months, respectively. At 10 years, overall-OCM rate was 36.5%; it was 30.6% in patients treated without ADT vs. 40.1% in patients treated with ADT (p < 0.001). In multivariable-analysis, ADT was associated with an increased risk of OCM (Hazard-ratio [HR]: 1.11, 95% Confidence-interval [95% CI]: 1.08-1.13). Patients with no comorbidity (10-year OCM excess risk: 9%) were more subject to harm from ADT than patients with high comorbidity (10-year OCM excess risk: 4.7%)., Conclusions: In patients with PCa, treatment with medical ADT may increase the risk of mortality due to causes other than PCa. Whether this is a simple association or a cause-effect relationship is unknown and warrants further study in prospective studies., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

Background: Targeted therapies (TTs) have revolutionized metastatic renal cell carcinoma (mRCC) treatment in the past decade, largely replacing immunotherapy including high-dose interleukin-2 (HD IL-2) therapy. We evaluated trends in HD IL-2 use for mRCC in the TT era., Methods: Our cohort comprised a weighted estimate of all patients undergoing HD IL-2 treatment for mRCC from 2004 to 2012 using the Premier Hospital Database. We assessed temporal trends in HD IL-2 use including patient, disease, and hospital characteristics stratified by era (pre-TT uptake: 2004-2006, uptake: 2007-2009, and post-TT uptake: 2010-2012) and fitted multivariable regression models to identify predictors of treatment toxicity and tolerability., Results: An estimated 2,351 patients received HD IL-2 therapy for mRCC in the United States from 2004 to 2012. The use decreased from 2004 to 2008. HD IL-2 therapy became increasingly centralized in teaching hospitals (24% of treatments in 2004 and 89.5% in 2012). Most patients who received HD IL-2 therapy were men, white, younger than 60 years, had lung metastases, and were otherwise healthy. Vasopressors, intensive care unit admission, and hemodialysis were necessary in 53.4%, 33.0%, and 7.1%, respectively. Factors associated with toxicities in multivariable analyses included being unmarried, male sex, and multiple metastatic sites. African Americans and patients with single-site metastases were less likely to receive multiple treatment cycles., Conclusions: HD IL-2 therapy is used infrequently for mRCC in the United States, and its application has diminished with the uptake of TT. Patients are being increasingly treated in teaching hospitals, suggesting a centralization of care and possible barriers to access. A recent slight increase in HD IL-2 therapy use likely reflects recognition of the inability of TT to effect a complete response., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Objective: To examine racial disparities in end-of-life (EOL) care among black and white patients dying of prostate cancer (PCa)., Methods: Relying on the SEER-Medicare database, 3789 patients who died of metastatic PCa between 1999 and 2009 were identified. Information was assessed regarding diagnostic care, therapeutic interventions, hospitalizations, intensive care unit (ICU) admissions, and emergency department visits in the last 12 months, 3 months, and 1 month of life. Logistic regression tested the relationship between race and the receipt of diagnostic care, therapeutic interventions, and high-intensity EOL care., Results: Overall, 729 patients (19.24%) were black. In the 12-months preceding death, laboratory tests (odds ratio [OR], 0.51; 95% CI, 0.36-0.72), prostate-specific antigen test (OR, 0.54; 95% CI, 0.43-0.67), cystourethroscopy (OR, 0.71; 95% CI, 0.56-0.90), imaging procedure (OR, 0.58; 95% CI, 0.41-0.81), hormonal therapy (OR, 0.53; 95% CI, 0.44-0.65), chemotherapy (OR, 0.59; 95% CI, 0.48-0.72), radiotherapy (OR, 0.74; 95% CI, 0.61-0.90), and office visit (OR, 0.38; 95% CI, 0.28-0.50) were less frequent in black versus white patients. Conversely, high-intensity EOL care, such as ICU admission (OR, 1.27; 95% CI, 1.04-1.58), inpatient admission (OR, 1.49; 95% CI, 1.09-2.05), and cardiopulmonary resuscitation (OR, 1.72; 95% CI, 1.40-2.11), was more frequent in black versus white patients. Similar trends for EOL care were observed at 3-month and 1-month end points., Conclusions: Although diagnostic and therapeutic interventions are less frequent in black patients with end-stage PCa, the rate of high-intensity and aggressive EOL care is higher in these individuals. These disparities may indicate that race plays an important role in the quality of care for men with end-stage PCa., (Copyright © 2015 by the National Comprehensive Cancer Network.)

Background: Racial disparities in cancer survival outcomes have been primarily attributed to underlying biologic mechanisms and the quality of cancer care received. Because prior literature shows little difference exists in the socioeconomic status of non-Hispanic whites and Asian Americans, any difference in cancer survival is less likely to be attributable to inequalities of care. We sought to examine differences in cancer-specific survival between whites and Asian Americans., Methods: The Surveillance, Epidemiology, and End Results Program was used to identify patients with lung (n = 130 852 [16.9%]), breast (n = 313 977 [40.4%]), prostate (n = 166 529 [21.4%]), or colorectal (n = 165 140 [21.3%]) cancer (the three leading causes of cancer-related mortality within each sex) diagnosed between 1991 and 2007. Fine and Gray's competing risks regression compared the cancer-specific mortality (CSM) of eight Asian American groups (Chinese, Filipino, Hawaiian/Pacific Islander, Japanese, Korean, other Asian, South Asian [Indian/Pakistani], and Vietnamese) to non-Hispanic white patients. All P values were two-sided., Results: In competing risks regression, the receipt of definitive treatment was an independent predictor of CSM (hazard ratio [HR] = 0.37, 95% confidence interval [CI] = 0.35 to 0.40; HR = 0.55, 95% CI = 0.53 to 0.58; HR = 0.61, 95% CI = 0.60 to 0.62; and HR = 0.27, 95% CI = 0.25 to 0.29) for prostate, breast, lung, and colorectal cancers respectively, all P < .001). In adjusted analyses, most Asian subgroups (except Hawaiians and Koreans) had lower CSM relative to white patients, with hazard ratios ranging from 0.54 (95% CI = 0.38 to 0.78) to 0.88 (95% CI = 0.84 to 0.93) for Japanese patients with prostate and Chinese patients with lung cancer, respectively., Conclusions: Despite adjustment for potential confounders, including the receipt of definitive treatment and tumor characteristics, most Asian subgroups had better CSM than non-Hispanic white patients. These findings suggest that underlying genetic/biological differences, along with potential cultural variations, may impact survival in Asian American cancer patients., (© The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.)

Background: Previous prognostic models for second-line systemic therapy in patients with metastatic renal cell carcinoma have not been studied in the setting of targeted therapy. We sought to validate the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) model in patients with metastatic renal cell carcinoma receiving next-line targeted therapy after progression on first-line targeted therapy., Methods: In this population-based study, we analysed patients who received second-line targeted therapy for metastatic renal cell carcinoma at 19 centres in Canada, USA, Greece, Japan, Singapore, South Korea, and Denmark. The primary endpoint was overall survival since the initiation of second-line therapy. We compared the prognostic performance of the IMDC model with the three-factor MSKCC model used for previously treated patients for overall survival since the start of second-line targeted therapy., Findings: Between Jan 1, 2005, and Nov 30, 2012, we included 1021 patients treated with second-line targeted therapy. Median overall survival since the start of second-line targeted therapy was 12·5 months (95% CI 11·3-14·3). Five of six predefined factors in the IMDC model (anaemia, thrombocytosis, neutrophilia, Karnofsky performance status [KPS] <80, and <1 year from diagnosis to first-line targeted therapy) were independent predictors of poor overall survival on multivariable analysis. The concordance index using all six prognostic factors (ie, also including hypercalcaemia) was 0·70 (95% CI 0·67-0·72) with the IMDC model and was 0·66 (95% CI 0·64-0·68) with the three-factor MSKCC model. When patients were divided into three risk categories using IMDC criteria, median overall survival was 35·3 months (95% CI 28·3-47·8) in the favourable risk group (n=76), 16·6 months (14·9-17·9) in the intermediate risk group (n=529), and 5·4 months (4·7-6·8) in the poor risk group (n=261)., Interpretation: The IMDC prognostic model can be applied to patients previously treated with targeted therapy, in addition to previously validated populations in first-line targeted therapy. The IMDC prognostic model in the second-line targeted therapy setting has an improved prognostic performance and is applicable to a more contemporary patient cohort than that of the three-factor MSKCC model., Funding: DF/HCC Kidney Cancer SPORE P50 CA101942-01, Kidney Cancer Research Network of Canada, Canadian Institute for Health Research, Trust Family, Loker Pinard, Michael Brigham, and Gerald DeWulf., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

Purpose: Definitive treatment of high-risk prostate cancer with radical prostatectomy or radiation improves survival. We assessed whether racial disparities in the receipt of definitive therapy for prostate cancer vary by regional income., Patients and Methods: A cohort of 102,486 men (17,594 African American [AA] and 84,892 non-Hispanic white) with localized high-risk prostate cancer (prostate-specific antigen >20 ng/ml or Gleason ≥ 8 or stage ≥ cT2c) diagnosed from 2004 to 2010 was identified in the Surveillance, Epidemiology, and End Results database. Income was measured at the census-tract-level. We used multivariable logistic regression to assess patient and cancer characteristics associated with the receipt of definitive therapy for prostate cancer. Multivariable Fine and Gray competing risks analysis was used to evaluate factors associated with prostate cancer death., Results: Overall, AA men were less likely to receive definitive therapy than white men (adjusted odds ratio [AOR] = 0.51; 95% CI: 0.49-0.54; P<0.001), and there was a significant race/income interaction (Pinteraction = 0.016) such that there was a larger racial treatment disparity in the bottom income quintile (AOR = 0.49; 95% CI: 0.45-0.55; P<0.001) than in the top income quintile (AOR = 0.60; 95% CI: 0.51-0.71; P<0.001). After a median follow-up of 35 months, AA men in the bottom income quintile suffered the greatest prostate cancer mortality (adjusted hazard ratio = 1.47; 95% CI: 1.17-1.84; P = 0.001), compared with white men in the top income quintile., Conclusions: Racial disparities in the receipt of definitive therapy for high-risk prostate cancer are greatest in low-income communities, suggesting that interventions to reduce racial disparities should target low-income populations first., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Background: Evidence-based consensus guidelines recommend only observation for men with low-risk prostate cancer and life expectancy less than 10 years. This report describes the incidence, drivers, cost, and morbidity of overtreatment of low-risk prostate cancer within the United States., Methods: The SEER-Medicare Program was used to identify 11,744 men aged 66 years or older diagnosed with low-risk prostate cancer in 2004 through 2007. Overtreatment of prostate cancer was defined as definitive treatment of a patient with a life expectancy of less than 10 years. Expected survival was estimated using NCCN methodology. Costs were the amount paid by Medicare in years after minus year before diagnosis. Toxicities were relevant Medicare diagnoses/interventions. P values are 2-sided., Results: Of 3001 men with low-risk prostate cancer and a life expectancy of less than 10 years, 2011 men (67%) were overtreated. On multivariable logistic regression, overtreated men were more likely to be married (odds ratio [OR], 1.29; 95% CI, 1.05-1.59; P=.02), reside in affluent regions (P<.001), and harbor more advanced disease at diagnosis (P<.001). Two-year toxicity was greater in overtreated patients (P<.001). Relative to active surveillance/watchful waiting/observation, the median additional cost per definitive treatment was $18,827 over 5 years; the cumulative annual cost attributable to overtreatment in the United States was $58.7 million. The ability to avoid treating the 80% of men with low-grade disease who will never die of prostate cancer would save $1.32 billion per year nationally., Conclusions: Overtreatment of low-risk prostate cancer is partially driven by sociodemographic factors and occurs frequently, with marked impact on patient quality of life and health-related costs., (Copyright © 2015 by the National Comprehensive Cancer Network.)

Background: Androgen deprivation therapy (ADT) might increase the risk of acute kidney injury (AKI) in patients with prostate cancer (PCa)., Objective: To examine the impact of ADT on AKI in a large contemporary cohort of patients with nonmetastatic PCa representing the US population., Design, Setting, and Participants: Overall, 69 292 patients diagnosed with nonmetastatic PCa between 1995 and 2009 were abstracted from the Surveillance Epidemiology and End Results-Medicare database., Outcomes Measurements and Statistical Analyses: Patient in both treatment arms (ADT vs. no ADT) were matched using propensity-score methodology. Ten-year AKI rates were estimated. Competing-risks regression analyses tested the association between ADT and AKI, after adjusting for the risk of death during follow-up., Results and Limitations: Overall, the 10-yr AKI rates were 24.9% versus 30.7% for ADT-naive patients versus those treated with ADT, respectively (p<0.001). When patients were stratified according to the type of ADT, the 10-yr AKI rates were 31.1% versus 26.0% for men treated with gonadotropin-releasing hormone (GnRH) agonists and bilateral orchiectomy, respectively (p<0.001). In multivariable analyses, the administration of GnRH agonists (hazard ratio [HR]: 1.24; 95% confidence interval [CI], 1.18-1.31; p<0.001), but not bilateral orchiectomy (HR: 1.11; 95% CI, 0.96-1.29; p=0.1), was associated with the risk of experiencing AKI. Our study is limited by its retrospective design., Conclusions: ADT is associated with an increased risk of AKI in patients with nonmetastatic PCa. In particular, the administration of GnRH agonists, but not surgical castration, may substantially increase the risk of experiencing AKI. These observations should help provide physicians with better patient selection to reduce the risk of AKI., Patient Summary: The administration of gonadotropin-releasing hormone agonists, but not bilateral orchiectomy, increases the risk of acute kidney injury (AKI) in patients with prostate cancer (PCa). These observations should help provide physicians with better patient selection to reduce the risk of AKI in PCa patients., (Copyright © 2014 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Objectives: Treating high-risk prostate cancer (CaP) with definitive therapy improves survival. We evaluated whether having health insurance reduces racial disparities in the use of definitive therapy for high-risk CaP., Materials and Methods: The Surveillance, Epidemiology, and End Results Program was used to identify 70,006 men with localized high-risk CaP (prostate-specific antigen level > 20 ng/ml or Gleason score 8-10 or stage > cT3a) diagnosed from 2007 to 2010. We used multivariable logistic regression to analyze the 64,277 patients with complete data to determine the factors associated with receipt of definitive therapy., Results: Compared with white men, African American (AA) men were significantly less likely to receive definitive treatment (adjusted odds ratio [AOR] = 0.60; 95% CI: 0.56-0.64; P < 0.001) after adjusting for sociodemographics and known CaP prognostic factors. There was a significant interaction between race and insurance status (P interaction = 0.01) such that insurance coverage was associated with a reduction in racial disparity between AA and white patients regarding receipt of definitive therapy. Specifically, the AOR for definitive treatment for AA vs. white was 0.38 (95% CI: 0.27-0.54, P < 0.001) among uninsured men, whereas the AOR was 0.62 (95% CI: 0.57-0.66, P < 0.001) among insured men., Conclusions: AA men with high-risk CaP were significantly less likely to receive potentially life-saving definitive treatment when compared with white men. Having health insurance was associated with a reduction in this racial treatment disparity, suggesting that expansion of health insurance coverage may help reduce racial disparities in the management of aggressive cancers., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Objective: To examine the burden of mental health issues (MHI), namely anxiety, depressive disorders, and suicide, in a population-based cohort of older men with localized prostate cancer and to evaluate associations with primary treatment modality., Patients and Methods: A total of 50,856 men, who were 65 years of age or older with clinically localized prostate cancer diagnosed between 1992 and 2005 and without a diagnosis of mental illness at baseline, were abstracted from the Surveillance, Epidemiology, and End Results-Medicare database. The primary outcome of interest was the development of MHI (anxiety, major depressive disorder, depressive disorder not elsewhere classified, neurotic depression, adjustment disorder with depressed mood, and suicide) after the diagnosis of prostate cancer., Results: A total of 10,389 men (20.4%) developed MHI during the study period. Independent risk factors for MHI included age ≥ 75 years (hazard ratio [HR] = 1.29); higher comorbidity (Charlson comorbidity index ≥ 3, HR = 1.63); rural hospital location (HR = 1.14); being single, divorced, or widowed (HR = 1.12); later year of diagnosis (HR = 1.05); and urinary incontinence (HR = 1.47). Black race (HR = 0.79), very high-income status (HR = 0.87), and definitive treatment (radical prostatectomy [RP], HR = 0.79; radiotherapy [RT], HR= 0.85, all P<0.001) predicted a lower risk of MHI. The rates of MHI at 10 years were 29.7%, 29.0%, and 22.6% in men undergoing watchful waiting (WW), RT, and RP, respectively., Conclusion: Older men with localized prostate cancer had a significant burden of MHI. Men treated with RP or RT were at a lower risk of developing MHI, compared with those undergoing WW, with median time to development of MHI being significantly greater in those undergoing RP compared with those undergoing RT or WW., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Purpose: To evaluate the relationship between age and race on the receipt of definitive therapy among men with high-risk prostate cancer (CaP)., Methods: We used the Surveillance, Epidemiology and End Results Program to identify 62,644 men with high-risk CaP (PSA >20 or Gleason 8-10 or stage ≥cT3a) diagnosed from 2004 to 2010. Multivariable logistic regression analysis modeled the interaction between age and race and its association with receipt of definitive therapy on 57,674 patients (47,879 white men; 9,795 African American [AA] men) with complete data on the covariates of interest., Results: Among men age ≥70, AA men had a higher risk of CaP-specific mortality (PCSM) compared to white men after adjusting for sociodemographic and prostate cancer-specific factors (Adjusted HR 1.20; 95% CI 1.02-1.38; P=0.02). Nevertheless, a significant interaction between race and age was found (Pinteraction=0.01), such that the adjusted odds of receiving definitive treatment for AA vs. white was 0.67 (95% CI 0.62-0.73; P<0.001) among men age <70, but was 0.60 (95% CI 0.55-0.66; P<0.001) among men age ≥70, suggesting increased racial disparity in the receipt of definitive treatment among older men., Conclusion: AA men with high-risk CaP are less likely to receive definitive therapy than white men. This disparity is significantly larger among men age ≥70, despite excess PCSM among AA men in this group. With a rapidly expanding population of older minority men, this disparity should be urgently addressed to prevent increasing disparities in cancer care., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Background: The Affordable Care Act (ACA) aims to expand health insurance coverage to over 30 million previously uninsured Americans. To help evaluate the potential impact of the ACA on prostate cancer care, we examined the associations between insurance coverage and prostate cancer outcomes among men <65 years old who are not yet eligible for Medicare., Methods: The Surveillance, Epidemiology and End Results Program was used to identify 85 203 men aged <65 years diagnosed with prostate cancer from 2007 to 2010. Multivariable logistic regression modeled the association between insurance status and stage at presentation. Among men with high-risk disease, the associations between insurance status and receipt of definitive therapy, prostate cancer-specific mortality (PCSM) and all-cause mortality were determined using multivariable logistic, Fine and Gray competing-risks and Cox regression models, respectively., Results: Uninsured patients were more likely to be non-white and come from regions of rural residence, lower median household income and lower education level (P<0.001 for all cases). Insured men were less likely to present with metastatic disease (adjusted odds ratio (AOR) 0.23; 95% confidence interval (CI) 0.20-0.27; P<0.001). Among men with high-risk disease, insured men were more likely to receive definitive treatment (AOR 2.29; 95% CI 1.81-2.89; P<0.001), and had decreased PCSM (adjusted hazard ratio 0.56; 95% CI 0.31-0.98; P=0.04) and all-cause mortality (adjusted hazard ratio 0.60; 0.39-0.91; P=0.01)., Conclusions: Insured men with prostate cancer are less likely to present with metastatic disease, more likely to be treated if they develop high-risk disease and are more likely to survive their cancer, suggesting that expanding health coverage under the ACA may significantly improve outcomes for men with prostate cancer who are not yet eligible for Medicare.

Objective: To determine whether African Americans (AAs) with intermediate- to high-risk prostate cancer (PCa) receive similar treatment as white patients and whether any observed disparities are narrowing with time., Methods: We used Surveillance, Epidemiology, and End Results to identify 128,189 men with localized intermediate- to high-risk PCa (prostate-specific antigen ≥10 ng/mL, Gleason score ≥7, or T stage ≥T2b) diagnosed from 2004 to 2010. We used multivariate logistic regression analyses to determine the impact of race on the receipt of definitive treatment., Results: AA men were significantly less likely to receive curative-intent treatment than white men (adjusted odds ratio [AOR], 0.82; 95% confidence interval [CI], 0.79-0.86; P <.001). There was no evidence of this disparity narrowing over time (Pinteraction 2010 vs 2004 = .490). Disparities in the receipt of treatment between AA and white men were significantly larger in high-risk (AOR, 0.60; 95% CI, 0.56-0.64; P <.001) than in intermediate-risk disease (AOR, 0.92; 95% CI, 0.88-0.97; P = .04; Pinteraction <.001). After adjusting for treatment, demographics, and prognostic factors, AA men had a higher risk of prostate cancer-specific mortality (adjusted hazard ratio, 1.12; 95% CI, 1.01-1.25; P = .03)., Conclusion: AA men with intermediate- to high-risk PCa are less likely to be treated with curative intent than white men. This disparity is worse in high-risk disease and is not improving over time. Factors underlying this treatment disparity should be urgently studied as it is a potentially correctable contributor to excess PCa mortality among AA patients., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Purpose: Surgery and radiation therapy represent the only curative options for many patients with solid malignancies. However, despite the recommendations of their physicians, some patients refuse these therapies. This study characterized factors associated with refusal of surgical or radiation therapy as well as the impact of refusal of recommended therapy on patients with localized malignancies., Methods and Materials: We used the Surveillance, Epidemiology, and End Results program to identify a population-based sample of 925,127 patients who had diagnoses of 1 of 8 common malignancies for which surgery and/or radiation are believed to confer a survival benefit between 1995 and 2008. Refusal of oncologic therapy, as documented in the SEER database, was the primary outcome measure. Multivariable logistic regression was used to investigate factors associated with refusal. The impact of refusal of therapy on cancer-specific mortality was assessed with Fine and Gray's competing risks regression., Results: In total, 2441 of 692,938 patients (0.4%) refused surgery, and 2113 of 232,189 patients (0.9%) refused radiation, despite the recommendations of their physicians. On multivariable analysis, advancing age, decreasing annual income, nonwhite race, and unmarried status were associated with refusal of surgery, whereas advancing age, decreasing annual income, Asian American race, and unmarried status were associated with refusal of radiation (P<.001 in all cases). Refusal of surgery and radiation were associated with increased estimates of cancer-specific mortality for all malignancies evaluated (hazard ratio [HR], 2.80, 95% confidence interval [CI], 2.59-3.03; P<.001 and HR 1.97 [95% CI, 1.78-2.18]; P<.001, respectively)., Conclusions: Nonwhite, less affluent, and unmarried patients are more likely to refuse curative surgical and/or radiation-based oncologic therapy, raising concern that socioeconomic factors may drive some patients to forego potentially life-saving care., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Purpose: The Patient Protection and Affordable Care Act (ACA) will likely improve insurance coverage for most young adults, but subsets of young adults in the United States will face significant premium increases in the individual market. We examined the association between insurance status and cancer-specific outcomes among young adults., Methods: We used the SEER program to identify 39,447 patients age 20 to 40 years diagnosed with a malignant neoplasm between 2007 and 2009. The association between insurance status and stage at presentation, employment of definitive therapy, and all-cause mortality was assessed using multivariable logistic or Cox regression, as appropriate., Results: Patients who were uninsured were more likely to be younger, male, nonwhite, and unmarried than patients who were insured and were also more likely to be from regions of lower income, education, and population density (P < .001 in all cases). After adjustment for pertinent confounding variables, an association between insurance coverage and decreased likelihood of presentation with metastatic disease (odds ratio [OR], 0.84; 95% CI, 0.75 to 0.94; P = .003), increased receipt of definitive treatment (OR, 1.95; 95% CI, 1.52 to 2.50; P < .001), and decreased death resulting from any cause (hazard ratio, 0.77; 95% CI, 0.65 to 0.91; P = .002) was noted., Conclusion: The improved coverage fostered by the ACA may translate into better outcomes among most young adults with cancer. Extra consideration will need to be given to ensure that patients who will face premium increases in the individual market can obtain insurance coverage under the ACA., (© 2014 by American Society of Clinical Oncology.)

Background: To the authors' knowledge, it remains unknown whether race-based differences in cancer outcomes have changed with time. In the current study, the authors assessed whether racial disparities in cancer-specific mortality have improved over the last 20 years., Methods: The Surveillance, Epidemiology, and End Results program was used to identify 2,713,474 patients diagnosed between 1988 and 2007 with either lung, breast, prostate, or colorectal cancer (the leading 3 causes of cancer-related mortality among each sex). After exclusions, 1,001,978 patients remained eligible for analysis. The impact of race on cancer-specific mortality was assessed using the regression model of Fine and Gray; an interaction model evaluated trends over time., Results: African Americans presented with a more advanced stage of disease (P < .001) and underwent definitive therapy less often (P < .001) than whites. After adjustment for demographics and year of diagnosis, African Americans were found to have higher estimates of cancer-specific mortality than whites for all cancers combined (hazards ratio, 1.28; 95% confidence interval, 1.26-1.30 [P < .001]) and within each individual cancer (each P < .05). These differences did not change significantly between 1988 through 1997 and 1998 through 2007, except among patients with breast cancer, in whom survival disparities increased. These findings remained significant after adjustment for stage of disease at presentation and receipt of definitive therapy (hazards ratio for breast cancer mortality in African Americans vs whites: 1.37 from 1988-1997 and 1.53 from 1998-2007; P for interaction, < .001)., Conclusions: The survival gap for African Americans has not closed over time. Race-based differences in outcome persist independent of stage of disease and treatment, suggesting that additional strategies beyond screening and improving access to care, such as further research into tumor biologies disproportionately affecting African Americans, are needed to improve survival for African American patients with cancer., (© 2014 American Cancer Society.)

Objectives: Among considerable efforts to improve quality of surgical care, expedited measures such as a selective referral to high-volume institutions have been advocated. Our objective was to examine whether racial, insurance and/or socioeconomic disparities exist in the use of high-volume hospitals for complex surgical oncological procedures within the USA., Design, Setting and Participants: Patients undergoing colectomy, cystectomy, oesophagectomy, gastrectomy, hysterectomy, lung resection, pancreatectomy or prostatectomy were identified retrospectively, using the Nationwide Inpatient Sample, between years 1999 and 2009. This resulted in a weighted estimate of 2 508 916 patients., Primary Outcome Measures: Distribution of patients according to race, insurance and income characteristics was examined according to low-volume and high-volume hospitals (highest 20% of patients according to the procedure-specific mean annual volume). Generalised linear regression models for prediction of access to high-volume hospitals were performed., Results: Insurance providers and county income levels varied differently according to patients' race. Most Caucasians resided in wealthier counties, regardless of insurance types (private/Medicare), while most African Americans resided in less wealthy counties (≤$24 999), despite being privately insured. In general, Caucasians, privately insured, and those residing in wealthier counties (≥$45 000) were more likely to receive surgery at high-volume hospitals, even after adjustment for all other patient-specific characteristics. Depending on the procedure, some disparities were more prominent, but the overall trend suggests a collinear effect for race, insurance type and county income levels., Conclusions: Prevailing disparities exist according to several patient and sociodemographic characteristics for utilisation of high-volume hospitals. Efforts should be made to directly reduce such disparities and ensure equal healthcare delivery.

Purpose: To examine the impact of marital status on stage at diagnosis, use of definitive therapy, and cancer-specific mortality among each of the 10 leading causes of cancer-related death in the United States., Methods: We used the Surveillance, Epidemiology and End Results program to identify 1,260,898 patients diagnosed in 2004 through 2008 with lung, colorectal, breast, pancreatic, prostate, liver/intrahepatic bile duct, non-Hodgkin lymphoma, head/neck, ovarian, or esophageal cancer. We used multivariable logistic and Cox regression to analyze the 734,889 patients who had clinical and follow-up information available., Results: Married patients were less likely to present with metastatic disease (adjusted odds ratio [OR], 0.83; 95% CI, 0.82 to 0.84; P < .001), more likely to receive definitive therapy (adjusted OR, 1.53; 95% CI, 1.51 to 1.56; P < .001), and less likely to die as a result of their cancer after adjusting for demographics, stage, and treatment (adjusted hazard ratio, 0.80; 95% CI, 0.79 to 0.81; P < .001) than unmarried patients. These associations remained significant when each individual cancer was analyzed (P < .05 for all end points for each malignancy). The benefit associated with marriage was greater in males than females for all outcome measures analyzed (P < .001 in all cases). For prostate, breast, colorectal, esophageal, and head/neck cancers, the survival benefit associated with marriage was larger than the published survival benefit of chemotherapy., Conclusion: Even after adjusting for known confounders, unmarried patients are at significantly higher risk of presentation with metastatic cancer, undertreatment, and death resulting from their cancer. This study highlights the potentially significant impact that social support can have on cancer detection, treatment, and survival.