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The Affordable Care Act established the Hospital Readmissions Reduction Program (HRRP) to reduce payments to hospitals with excessive readmissions in an effort to link payment to the quality of hospital care. Prior studies demonstrating an association of HRRP implementation with increased mortality after heart failure discharges have prompted concern for potential unintended adverse consequences of the HRRP. We examined the impact of these policies on coronary artery bypass graft (CABG) surgery outcomes using the Nationwide Readmissions Database and found that, in line with previously observed readmission trends for CABG, readmission rates continued to decline in the era of the HRRP, but that this did not come at the expense of increased mortality. These results suggest that inclusion of surgical procedures, such as CABG in the HRRP might be an effective cost-reducing measure that does not adversely affect quality of hospital care.

Objective The objective of this study was to examine the risk of immune-related adverse events (irAEs) in patients with a preexisting autoimmune disease (pAID) presenting with a cutaneous melanoma receiving an immune checkpoint inhibitor (ICI) therapy. Methods Data from the Surveillance, Epidemiology, and End Results cancer registries and linked Medicare claims between January 2010 and December 2015 was used to identify patients diagnosed with cutaneous melanoma who had pAID or received ICI or both. Patients were then stratified into 3 groups: ICI+pAID, non-ICI+pAID, and ICI+non-pAID. Inverse probability of treatment weighted Cox proportional hazards regression models were fitted to assess the risk of cardiac, pulmonary, endocrine, and neurological irAE. Results In total, 3704 individuals were included in the analysis. The majority of patients consisted of non-ICI+pAID patients (N=2706/73.1%), while 106 (2.9%) patients and 892 (24.1%) were classified as ICI+pAID and ICI+non-pAID, respectively. The risk of irAE was higher in the ICI+pAID group compared with the non-ICI+pAID and ICI+non-pAID, respectively (non-ICI: cardiac: hazard ratio [HR]=3.59, 95% confidence interval [CI]: 2.83-4.55; pulmonary: HR=3.94, 95% CI: 3.23-4.81; endocrine: HR=1.72, 95% CI: 1.53-1.93; neurological: HR=3.88, 95% CI: 2.30-6.57/non-pAID: cardiac: HR=3.83, 95% CI: 3.39-4.32; pulmonary: HR=2.08, 95% CI: 1.87-2.32; endocrine: HR=1.23, 95% CI: 1.14-1.32; neurological: HR=3.77, 95% CI: 2.75-5.18). Conclusions Patients with a pAID face a significantly higher risk of irAEs. Further research examining the clinical impact of these events on the patients' oncological outcome and quality of life is urgently needed given our findings of significantly worse rates of adverse events.

Background Immune checkpoint inhibitor (ICI) therapy has demonstrated impressive clinical benefits across cancers. However, adverse drug reactions (ADRs) occur in every organ system, often due to autoimmune syndromes. We sought to investigate the association between ICI therapy and nephrotoxicity using a pharmacovigilance database, hypothesizing that inflammatory nephrotoxic syndromes would be reported more frequently in association with ICIs. Methods We analyzed VigiBase, the World Health Organization pharmacovigilance database, to identify renal ADRs (rADRs), such as nephritis, nephropathy and vascular disorders, reported in association with ICI therapy. We performed a disproportionality analysis to explore if rADRs were reported at a different rate with one of the ICI drugs compared with rADRs in the entire database, using an empirical Bayes estimator as a significance screen and defining the effect size with a reporting odds ratio (ROR). Results We found 2341 rADR for all examined ICI drugs, with a disproportionality signal solely for nephritis [ROR = 3.67, 95% confidence interval (CI) 3.34–4.04]. Examining the different drugs separately, pembrolizumab, nivolumab and ipilimumab + nivolumab combination therapy had significantly higher reporting odds of nephritis than the other ICI drugs (ROR = 4.54, 95% CI 3.81–5.4; ROR = 3.94, 95% CI 3.40–4.56; ROR 3.59, 95% CI 2.71–4.76, respectively). Conclusions Using a pharmacovigilance method, we found increased odds of nephritis when examining rADRs associated with ICI therapy. Pembrolizumab, nivolumab and a combination of ipilimumab + nivolumab showed the highest odds. Clinicians should consider these findings and be aware of the increased risk of nephritis, especially in patients treated with pembrolizumab, when administering ICI therapy.

PURPOSE: We sought to investigate the association between Medicaid expansion under the Affordable Care Act and access to stage-appropriate definitive treatment for breast, colon, non–small-cell lung, and prostate cancer for underserved racial and ethnic minorities and at minority-serving hospitals (MSHs). METHODS: We conducted a retrospective, difference-in-differences study including minority patients with nonmetastatic breast, colon, non–small-cell lung, and prostate cancer and patients treated at MSHs between the age of 40 and 64, with tumors at stages eligible for definitive treatment from the National Cancer Database. We not only defined non-Hispanic Black and Hispanic cancer patients as racial and ethnic minorities but also report findings for non-Hispanic Black cancer patients separately. We examined the effect of Medicaid expansion on receipt of stage-appropriate definitive therapy, time to treatment initiation (TTI) within 30 days of diagnosis, and TTI within 90 days of diagnosis. RESULTS: Receipt of definitive treatment for minorities in expansion states did not change compared with minority patients in nonexpansion states. The proportion of racial and ethnic minorities in expansion states receiving treatment within 30 days increased (difference-in-differences: +3.62%; 95% CI, 1.63 to 5.61; P < .001) compared with minority patients in nonexpansion states; there was no change for TTI within 90 days. Analysis focused on Black cancer patients yielded similar results. In analyses stratified by MSH status, there was no change in receipt of definitive therapy, TTI within 30 days, and TTI within 90 days when comparing MSHs in expansion states with MSHs in nonexpansion states. CONCLUSION: In our cohort of cancer patients with treatment-eligible disease, we found no significant association between Medicaid expansion and changes in receipt of definitive treatment for breast, prostate, lung, and colon cancer for racial and ethnic minorities and at MSHs. Medicaid expansion was associated with improved TTI at the patient level for racial and ethnic minorities, but not at the facility level for MSHs. Targeted interventions addressing the needs of MSHs are still needed to continue mitigating national facility–level disparities in cancer outcomes.

To characterize pulmonary toxicities associated with the use of novel immune checkpoint inhibitors Adverse event reports from immune checkpoint inhibitors targeting PD-1/L1 and CTLA-4 were captured from the W.H.O pharmacovigilance database (VigiBase) up until Dec. 31st 2019 and were analyzed to evaluate for measures of association between the use of immune checkpoint inhibitors and pulmonary toxicities. Disproportionality analysis using both frequentist and Bayesian approaches were used to detect signals between pulmonary immune-related adverse events and the use of these agents. A total of 9202 adverse pulmonary immune checkpoint inhibitor-related events were captured up until 2019. Adverse pulmonary events were compromised of 1305 airway, 18 alveolar, 5491 interstitial, 898 pleural, 560 vascular and 939 non-specific pulmonary events. We found a common association between all immune checkpoint inhibitors studied and pneumonitis, interstitial lung disease, pulmonary embolism and respiratory failure. We also noted other associations between immune checkpoint inhibitors, however not as uniformly across agents. Most of these immune-related adverse drug reactions were noted to be severe and accounted for a significant source of mortality in the reported cases. Immune checkpoint inhibitors are associated with a spectrum of inflammatory pulmonary toxicities. The breadth of pulmonary complications and prevalence may be underappreciated with the use of these agents.

BACKGROUND Smoking, the most common risk factor for bladder cancer (BC), is associated with increased complications after radical cystectomy (RC), poorer oncologic outcomes, and higher mortality. The authors hypothesized that the effect of smoking on the probability of major complications increases with increasing age among patients who undergo RC. METHODS The authors analyzed the American College of Surgeons National Surgical Quality Improvement Program database (2011-2017), identified all patients undergoing RC using Current Procedural Terminology codes, and formed two groups according to smoking status (active smoker and nonsmoker [included former and never-smokers]). Patient characteristics and 30-day postoperative complications using the Clavien-Dindo Classification (CDC) were assessed. A multivariable logistic regression model was constructed that included age, sex, race, body mass index, operative time, comorbidities, chemotherapy status, and type of diversion with major complications (CDC ≥III) as the outcome variable, and explored the interaction between age and smoking status. RESULTS A total of 10,528 patients underwent RC, including 22.8% who were active smokers. The authors identified an interaction between age and smoking status (P = .045). Older patients were found to experience a stronger smoking effect than younger patients with regard to the probability of major complications. The risk of a major complication was the same for 50-year-old nonsmokers and smokers, but it increased from 17.8% to 21.7% for 70-year-old nonsmokers and smokers, respectively (P < .001). CONCLUSIONS Up to 20% of patients who undergo RC are active smokers, and these individuals have an increased risk of major complications. The effect of smoking is stronger with increasing age; the difference with regard to complications for smokers versus nonsmokers was found to increase substantially, wherein older smokers are at an especially high risk of complications.

Compared to low-volume hospitals, high-volume hospitals are associated with lower rates of perioperative morbidity and mortality. However, access to high-volume hospitals is unequal. We investigated racial and socioeconomic disparities among patients undergoing surgery for genitourinary malignancies at high-volume hospitals.We queried the National Cancer Database from 2004-2015 to identify patients who underwent radical prostatectomy, radical cystectomy, and nephrectomy for nonmetastatic prostate cancer, muscle-invasive urothelial bladder cancer, and kidney cancer, respectively. Hospitals were ranked based on their annual volume for the given procedure. The endpoint of our study was receipt of treatment at a high-volume hospital. Multivariable logistic regression models were used to identify predictors of treatment at a high-volume hospital.Our final cohort consisted of 397,242 prostate cancer patients, 39,480 bladder cancer patients, and 292,095 kidney cancer patients. For prostate and bladder cancer, Black race was associated with lower odds of treatment at a high-volume hospital (Odds Ratio [OR] 0.83, 95% confidence interval [CI] 0.79-0.87 and 0.71, 95%CI 0.58-0.87; reference: White). Higher education level and private insurance status were associated with greater odds of treatment across all 3 procedures (strongest effect for prostate cancer; higher education level: OR 1.63 [1.58-1.68]; private insurance 1.86 [1.77-1.97]). Moreover, an interaction was found between race and study period for all cancers examined (P0.001). Subgroup analyses revealed that Black patients were more likely to undergo radical prostatectomy at high-volume hospitals in 2013-2015 (OR 0.98, 95%CI 0.94-1.02) compared to 2004-2006 (OR 0.83, 95%CI 0.79-0.87).Across all procedures, patients with lower education status and lack of insurance were less likely to be treated at high-volume hospitals. For prostate cancer and bladder cancer, Black race was a negative predictor of treatment at high-volume hospitals. Further studies are needed to understand the root causes for this inequity.

BACKGROUND Venous thromboembolism (VTE) is a significant source of postoperative morbidity and mortality in patients undergoing common oncologic procedures. We sought to estimate the effect of surgical approach on the risk of developing a VTE. METHODS IBM Watson Health Marketscan Database was used to conduct this retrospective study. In total, 12 938 patients who underwent either a radical prostatectomy, partial colectomy, or hysterectomy via a minimally invasive or open approach. We used a propensity-weighted logistic regression analysis to assess the independent effect of surgical approach on VTE. The primary outcome of interest was the 90-day rate of VTE after surgery. RESULTS Patients undergoing minimally invasive surgery across all three surgical procedures were noted to have a lower odds of developing a VTE: (radical prostatectomy, odds ratio [OR]: 0.667, 95% confidence interval [CI]: 0.500-0.891; P = .006 |partial colectomy: OR, 0.620, 95% CI: 0.477-0.805; P

INTRODUCTION AND OBJECTIVE:Massachusetts (MA) is a northeastern state with universally mandated health insurance since 2006. Although Black men have generally worse prostate cancer outcomes, emergi...

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). 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). 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. 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.

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 Health insurance is a key mediator of health care disparities. Outcomes in bladder cancer, one of the costliest diseases to treat, may be especially sensitive to a patient's insurance status. METHODS The Surveillance, Epidemiology, and End Results registry and the National Cancer Data Base were used to identify individuals younger than 65 years who were diagnosed with bladder cancer from 2007 to 2014. The associations between the insurance status (privately insured, insured by Medicaid, or uninsured) and the following outcomes were evaluated: diagnosis with advanced disease, cancer-specific survival, delay in treatment longer than 90 days, treatment in a high-volume hospital, and receipt of neoadjuvant chemotherapy (NAC). RESULTS Compared with those with private insurance, uninsured and Medicaid-insured individuals were nearly twice as likely to receive a diagnosis of muscle-invasive bladder cancer (odds ratio [OR] for uninsured individuals, 1.90; 95% confidence interval [CI], 1.70-2.12; OR for Medicaid-insured individuals, 2.03; 95% CI, 1.87-2.20). They were also more likely to die of bladder cancer (adjusted hazard ratio [AHR] for uninsured individuals, 1.49; 95% CI, 1.31-1.71; AHR for Medicaid-insured individuals, 1.61; 95% CI, 1.46-1.79). Delays in treatment longer than 90 days were more likely for uninsured (OR, 1.36; 95% CI, 1.12-1.65) and Medicaid-insured individuals (OR, 1.22; 95% CI, 1.03-1.44) in comparison with the privately insured. Uninsured patients had lower odds of treatment at a high-volume facility, and Medicaid-insured patients had lower odds of receiving NAC (P

A previous study comparing external beam radiation therapy with/without brachytherapy (EBRT±BT) and radical prostatectomy (RP) for high-risk localized prostate cancer (PCa) did not find a difference in overall survival (OS) between the treatments. However, this study was limited by short follow-up and assessment of OS in patients of divergent age and comorbidities. We therefore compared OS of EBRT+BT versus RP in comparatively young (≤65yr) and healthy men (Charlson Comorbidity Index=0) with high-risk localized PCa in the National Cancer Database. Inverse probability of treatment weighting (IPTW) adjustment was used to balance baseline characteristics. Median follow-up was 92mo (interquartile range 78-108). Using IPTW-adjusted Cox regression analysis, EBRT+BT was associated with a higher risk of all-cause mortality compared with RP (hazard ratio=1.22, 95% confidence interval 1.05-1.43). In young and healthy men presenting with high-risk localized PCa, RP showed statistically significant OS benefit compared with EBRT+BT. PATIENT SUMMARY: In an analysis restricted to young and healthy men presenting with high-risk localized prostate cancer, initial radical prostatectomy is associated with an overall survival benefit compared with external beam radiation therapy plus brachytherapy.

Background Massachusetts is a northeastern state with universally mandated health insurance since 2006. Although Black men have generally worse prostate cancer outcomes, emerging data suggest that they may experience equivalent outcomes within a fully insured system. In this setting, the authors analyzed treatments and outcomes of non-Hispanic White and Black men in Massachusetts. Methods White and Black men who were 20 years old or older and had been diagnosed with localized intermediate- or high-risk nonmetastatic prostate cancer in 2004-2015 were identified in the Massachusetts Cancer Registry. Adjusted logistic regression models were used to assess predictors of definitive therapy. Adjusted and unadjusted survival models compared cancer-specific mortality. Interaction terms were then used to assess whether the effect of race varied between counties. Results A total of 20,856 men were identified. Of these, 19,287 (92.5%) were White. There were significant county-level differences in the odds of receiving definitive therapy and survival. Survival was worse for those with high-risk cancer (adjusted hazard ratio [HR], 1.50; 95% CI, 1.4-1.60) and those with public insurance (adjusted HR for Medicaid, 1.69; 95% CI, 1.38-2.07; adjusted HR for Medicare, 1.2; 95% CI, 1.14-1.35). Black men were less likely to receive definitive therapy (adjusted odds ratio, 0.78; 95% CI, 0.74-0.83) but had a 17% lower cancer-specific mortality (adjusted HR, 0.83; 95% CI, 0.7-0.99). Conclusions Despite lower odds of definitive treatment, Black men experience decreased cancer-specific mortality in comparison with White men in Massachusetts. These data support the growing body of research showing that Black men may achieve outcomes equivalent to or even better than those of White men within the context of a well-insured population. Lay summary There is a growing body of evidence showing that the excess risk of death among Black men with prostate cancer may be caused by disparities in access to care, with few or no disparities seen in universally insured health systems such as the Veterans Affairs and US Military Health System. Therefore, the authors sought to assess racial disparities in prostate cancer in Massachusetts, which was the earliest US state to mandate universal insurance coverage (in 2006). Despite lower odds of definitive treatment, Black men with prostate cancer experience reduced cancer-specific mortality in comparison with White men in Massachusetts. These data support the growing body of research showing that Black men may achieve outcomes equivalent to or even better than those of White men within the context of a well-insured population.

Background Radical cystectomy (RC) is associated with high morbidity. Objective To evaluate healthcare and surgical factors associated with high-quality RC surgery. Design, setting, and participants Patients within the prospective British Association of Urological Surgeons (BAUS) registry between 2014 and 2017 were included in this study. Outcome measurements and statistical analysis High-quality surgery was defined using pathological (absence of positive surgical margins and a minimum of a level I lymph node dissection template with a minimum yield of ten or more lymph nodes), recovery (length of stay ≤10 d), and technical (intraoperative blood loss, Take Home Message In this UK registry study of bladder cancer patients treated with radical cystectomy, we report that patients treated by a surgeon with a higher annual operative volume and a minimally invasive approach were associated with the receipt of high-quality surgery. Patients treated with high-quality surgery were more likely to be discharged alive following surgery.

Background Androgen deprivation therapy (ADT) is standard-of-care for advanced prostate cancer. Studies have generally found increased cardiovascular risks associated with ADT, but the comparative risk of newer agents is under-characterized. We defined the cardiac risks of abiraterone and enzalutamide, using gonadotropic releasing hormone (GnRH) agonists to establish baseline ADT risk. Methods We used VigiBase, the World Health Organization pharmacovigilance database, to identify cardiac adverse drug reactions (ADRs) in a cohort taking GnRH agonists, abiraterone, or enzalutamide therapy for prostate cancer, comparing them to all other patients. To examine the relationship, we used an empirical Bayes estimator to screen for significance, then calculated the reporting odds ratio (ROR), a surrogate measure of association. A lower bound of a 95% confidence interval (CI) of ROR > 1 reflects a disproportionality signal that more ADRs are observed than expected due to chance. Findings We identified 2,433 cardiac ADRs, with higher odds for abiraterone compared to all other VigiBase drugs for overall cardiac events (ROR 1•59, 95% CI 1•48—1•71), myocardial infarction (1•35, 1•16—1•58), arrythmia (2•04, 1•82—2•30), and heart failure (3•02, 2•60—3•51), but found no signal for enzalutamide. Patients on GnRH agonists also had increased risk of cardiac events (ROR 1•21, 95% CI 1•12—1•30), myocardial infarction (1•80, 1•61—2•03) and heart failure (2•06, 1•76—2•41). Interpretation We found higher reported odds of cardiac events for abiraterone but not enzalutamide. Our data may suggest that patients with significant cardiac comorbidities may be better-suited for therapy with enzalutamide over abiraterone. Funding None

Background Despite randomized data demonstrating better overall survival favoring radical nephrectomy, partial nephrectomy continues to be the treatment of choice for low-stage renal cell carcinoma. Methods We utilized the National Cancer Database to identify patients younger than 50 years diagnosed with low-stage renal cell carcinoma (cT1) treated with radical nephrectomy or partial nephrectomy (2004–2007). Inverse probability of treatment weighting adjustment was performed for all preoperative factors to account for confounding factors. Kaplan-Meier curves and Cox proportional hazards regression analyses were used to compare overall survival of patients in the two treatment arms. Sensitivity analysis was performed to explore the interaction of type of surgery and clinical stage on overall survival. Results Among the 3009 patients (median age = 44 years [interquartile range (IQR) = 40–47 years]), 2454 patients (81.6%) were treated with radical nephrectomy and 555 patients (18.4%) with partial nephrectomy. The median follow-up was 108.6 months (IQR = 80.2–124.3 months) during which 297 patients (12.1%) in the radical nephrectomy arm and 58 patients (10.5%) in the partial nephrectomy arm died. Following inverse probability of treatment weighting adjustment, there was no difference in overall survival between patients treated with partial nephrectomy and radical nephrectomy (hazard ratio = 0.83, 95% confidence interval = 0.63 to 1.10, P = .196). There were no statistically significant interactions between type of surgery and clinical stage on treatment outcome. Conclusions There was no difference in long-term overall survival between radical and partial nephrectomy in young and healthy patients. This patient cohort may have sufficient renal reserve over their lifetime, and preserving nephrons by partial nephrectomy may be unnecessary.

Key Points Question How do race-based disparities in prostate cancer outcomes differ geographically within the US? Findings In this cohort study of 229 771 men in 17 geographic registries within the Surveillance, Epidemiology, and End Results database, black men had a higher risk of mortality overall compared with white men. The greatest race-based survival difference was seen in men with low-risk prostate cancer in the Atlanta, Georgia, registry, where mortality risk among black men was increased more than 5-fold. Meaning These findings suggest that race-based survival differences in prostate cancer vary regionally, which may allow for targeted interventions to mitigate these disparities., This cohort study examines differences in prostate cancer mortality in white vs black men stratified by geographic region., 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.

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 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.

BACKGROUND Underinsured patients face significant barriers in accessing high-quality care. Evidence of whether access to high-volume surgical care is mediated by disparities in health insurance coverage remains wanting. METHODS The authors used the National Cancer Data Base to identify all adult patients who had a confirmed diagnosis of breast, prostate, lung, or colorectal cancer during 2004 through 2016. The odds of receiving surgical care at a high-volume hospital were estimated according to the type of insurance using multivariable logistic regression analyses for each malignancy. Then, the interactions between study period and insurance status were assessed. RESULTS In total, 1,279,738 patients were included in the study. Of these, patients with breast cancer who were insured by Medicare (odds ratio [OR], 0.75; P < .001), Medicaid (OR, 0.55; P < .001), or uninsured (OR, 0.50; P < .001); patients with prostate cancer who were insured by Medicare (OR, 0.87; P = .003), Medicaid (OR, 0.58; P = .001), or uninsured (OR, 0.36; P < .001); and patients with lung cancer who were insured by Medicare (OR, 0.84; P = .020), Medicaid (OR, 0.74; P = .001), or uninsured (OR, 0.48; P < .001) were less likely to receive surgical care at high-volume hospitals compared with patients who had private insurance. For patients with colorectal cancer, the effect of insurance differed by study period, and improved since 2011. For those on Medicaid, the odds of receiving care at a high-volume hospital were 0.51 during 2004 through 2007 and 0.99 during 2014 through 2016 (P for interaction = .001); for uninsured patients, the odds were 0.45 during 2004 through 2007 and 1.19 during 2014 through 2016 (P for interaction < .001) compared with patients who had private insurance. CONCLUSIONS Uninsured, Medicare-insured, and Medicaid-insured patients are less likely to receive surgical care at high-volume hospitals. For uninsured and Medicaid-insured patients with colorectal cancer, the odds of receiving care at high-volume hospitals have improved since implementation of the Patient Protection and Affordable Care Act of 2010.

With improvements in early detection and treatment, a growing proportion of the population now lives with a personal history of a cancer. Although many cancer survivors are in excellent health, the underlying risk factors and side effects of cancer treatment increase the risk of medical complications and secondary malignancies.The 2013 National Health Interview Survey was utilized to assess the association between personal history of cancer and receipt of U.S. Preventive Services Task Force-recommended services, comprising three cancer screening tests (mammography, colonoscopy, and Pap smear) and six general medical preventive care services (aspirin for prevention of cardiovascular disease; blood pressure, cholesterol, and diabetes screening; diet/activity counseling; and tobacco use counseling). For each preventive service, patients with a history that would preclude that test were excluded. One to three matching of cancer survivors to controls was performed using propensity scores generated from patient-level demographic variables. Conditional logistic regression models were employed to compare odds of screening between matched cohorts of cancer survivors and controls. The years of analysis were 2015 and 2017.A total of 2,639 cancer patients and 31,885 controls were extracted from the merged 2013 National Health Interview Survey. In the propensity score-matched cohorts of eligible adults, only one of the three cancer screening tests, colorectal, was more common in cancer survivors (OR=1.52, 95% CI=1.32, 1.75, p0.001), whereas breast and cervical cancer screening were not more common in survivors. By contrast, all of the medical screening tests, with the exception of diabetes screening, were more common among cancer survivors.The association between receipt of recommended preventive medical care and personal history of cancer varied, depending on the preventive service in question, but in the majority of preventive services assessed, cancer survivors had more frequent screening compared with non-cancer survivors.

The impact of variant histologies on overall survival (OS), as well as their influence on the response to neoadjuvant and adjuvant chemotherapy (AC) is well studied in patients diagnosed with bladder cancer. However, little is known about tumors with variant histologies of the upper urinary tract. The objective of this study was to assess the survival of the predominant variant histologies of tumors of the renal pelvis (RPT) after surgical intervention, and to examine the influence of AC on the OS of the different variant histologies. We identified 21,318 patients with RPT undergoing surgical intervention using the National Cancer Database for the period 2004–2015. We employed multivariable Cox proportional hazards regression models and Kaplan–Meier curves to evaluate the OS according to variant histology. Separate multivariable Cox regression models were used to assess the specific effect of AC on OS of the histological subgroups. The majority of patients were diagnosed with pure urothelial carcinoma (PUC) (96.1%). Overall, 826 patients were diagnosed with variant histologies (adenocarcinoma N = 298, squamous cell carcinoma N = 291, sarcomatoid N = 137, others N = 100). Compared to PUC, adenocarcinomas showed longer OS (HR 0.76, 95% confidence interval (CI) 0.62–0.94, p = 0.01), while sarcomatoid tumors had shorter OS (HR 1.59, 95% CI 1.12–2.26, p = 0.011). A subgroup analysis of patients undergoing AC showed a survival benefit in patients with PUC (HR 0.81, 95% CI 0.73–0.9, p

Early surgical resection remains the recommended treatment option for most small renal mass (≤4 cm). We examined the long-term overall survival (OS) of patients managed with delayed and immediate nephrectomy of cT1a renal cancer.We utilized the National Cancer Database (2005-2010) to identify 14,677 patients (immediate nephrectomy: 14,050 patients vs. late nephrectomy: 627 patients) aged70 years with Charlson Comorbidity Index 0 and cT1aN0M0 renal cell carcinoma. Immediate nephrectomy and late nephrectomy were defined as nephrectomy performed30 days and180 days from diagnosis, respectively. Inverse probability of treatment weighting-adjusted Kaplan-Meier curves and Cox proportional hazards regression analyses were used to compare OS of patients in the 2 treatment arms. Influence of patient age and Charlson Comorbidity Index on treatment effect was tested by interactions. Sensitivity analysis was performed to explore the outcome of delaying nephrectomy for12 months.Median patient age was 55 years with a median follow-up of 82.5 months. Inverse probability of treatment weighting-adjusted Kaplan-Meier curves suggest no significant difference between treatment arms (immediate nephrectomy [30 days] vs. delayed nephrectomy [180 days]) (Hazard ratio 0.96; 95% confidence interval 0.73-1.26; P = 0.77). This outcome was consistent between all patients regardless of age (P = 0.48). Sensitivity analysis reports no difference in OS even if nephrectomy was delayed by12 months (P = 0.60).We report that delayed and immediate nephrectomy for cT1a renal cell carcinoma confers comparable long-term OS. These findings suggest that a period of observation of between 6 and 12 months is safe to allow identification of renal masses, which will benefit from surgical resection.

While bladder cancer is less common among women, female sex is associated with worse oncological outcomes.To evaluate sex-specific differences in initial presentation and treatment patterns of muscle-invasive bladder cancer.A retrospective study using the National Cancer Database to identify individuals diagnosed with muscle-invasive bladder cancer (cT2-T4aN0M0) between 2004 and 2013.Multivariable logistic regression and negative binomial regression with Bonferroni correction were used to investigate seven treatment measures: care at a high-volume facility, receipt of definitive therapy, delayed treatment, receipt of neoadjuvant or adjuvant chemotherapy, receipt of pelvic lymph node dissection, and number of lymph nodes removed. The secondary outcome was overall survival.We identified 27525 patients, 27.4% of whom were females. Females were diagnosed significantly more often with nonurothelial carcinoma (15.1% vs 9.9%, p0.001), with squamous carcinoma being the most prevalent variant (46.9%). After Bonferroni correction, there was no difference in six out of seven treatment quality measures. Females were significantly less likely to experience delayed treatment (odds ratio 0.89, 95% confidence interval [CI] 0.84-0.93, p0.001). Females had significantly worse overall survival compared with males (hazard ratio 1.04, 95% CI 1.00-1.07, p=0.030). Limitations arise from the retrospective design of the study.Despite little difference in treatment quality measures, female sex is associated with worse overall survival among individuals with muscle-invasive bladder cancer. Our findings suggest that differences in treatment patterns are unlikely to explain the differences in overall survival. Future initiatives should focus on root causes for gender-specific differences in pathological staging and features at diagnosis.In this study, we did not find differences in the treatment of bladder cancer between men and women that could readily explain why women diagnosed with this disease are more likely to die.

INTRODUCTION AND OBJECTIVES:Current recommendations suggest that nephrectomy or thermal ablation is a recommended treatment option for small renal mass (≤4 cm). This study examined long-term overal...

INTRODUCTION AND OBJECTIVES:Medicaid expansion is a key provision by which the Affordable Care Act seeks to improve access to health insurance. However, there is concern over the quality and cost o...

INTRODUCTION AND OBJECTIVES:There is limited epidemiological evidence for the association between androgen deprivation therapy (ADT) and the risk of incident dementia, yet several studies show no s...

INTRODUCTION AND OBJECTIVES:Medicaid expansion is a key provision by which the Affordable Care Act seeks to improve access to health insurance. However, there is concern over the quality and cost o...

Introduction We evaluated patient, hospital, and cancer-specific factors associated with positive surgical margin (PSM) variability after radical prostatectomy in pT2 prostate cancer in the United States. Patients and Methods A total of 45,426 men from 1152 hospitals with pT2 prostate cancer and known margin status after radical prostatectomy were identified using the National Cancer Database (2010-2015). Data on patient, cancer, hospital factors, and surgical approach were extracted. A mixed effects logistic regression model was computed to examine factors associated with PSM and partial R2 values to assess the relative contributions of patient, cancer, and hospital variables to PSM status. Results Median PSM rate of 8.5% (interquartile range, 5.2%-13.0%). Robotic (odds ratio [OR], 0.90; 95% confidence interval [CI], 0.83-0.99) and laparoscopic (OR, 0.74; 95% CI, 0.64-0.90) surgical approach, academic institution (OR, 0.87; 95% CI, 0.76-1.00) and high hospital surgical volume (>297 cases [OR], 0.83; 95% CI, 0.70-0.99) were independently associated with a lower PSM. Black men (OR, 1.13; 95% CI, 1.01-1.26) and adverse cancer-specific features (prostate-specific antigen [PSA], 10-20; PSA >20; cT3 stage; Gleason 7, 8, 9-10; all P > .01) were independently associated with a higher PSM. Patient-specific, hospital-specific, and cancer-specific factors had a contribution of 2.3%, 3.9%, and 15.2%, respectively, to the variation in PSM. Facility had a contribution of 23.7% to the variation in PSM. Conclusion Cancer-specific factors account for 15.2% of PSM variation with the remaining 84.8% of PSM variation due to patient, hospital, and other factors not accounted within the model. Noncancer-specific factors represent addressable factors that are important for policy-makers in efforts to improve patient outcome.

Purpose Does surgical approach (minimally invasive vs. open) and type (radical vs. partial nephrectomy) affects opioid use and workplace absenteeism. Materials and Methods Retrospective multivariable regression analysis of 2,646 opioid-naïve patients between 18 and 64 undergoing radical or partial nephrectomy via either a minimally invasive vs. open approach for kidney cancer in the United States between 2012 and 2017 drawn from the IBM Watson Health Database was performed. Outcomes included: (1) opioid use in opioid-naïve patients as measured by opioid prescriptions in the post-operative setting at early, intermediate and prolonged time periods and (2) workplace absenteeism after surgery. Results Patients undergoing minimally invasive surgery had a lower odds of opioid use in the early and intermediate post-operative periods (early: odds ratio [OR], 0.77; 95% confidence interval [CI], 0.62–0.97; p=0.02, intermediate: OR, 0.60; 95% CI, 0.48–0.75; p, Graphical Abstract

Key Points Question What is the association between delays in treatment initiation for common cancers, as are necessary in resource-limited settings and pandemic conditions, with mortality? Findings In this cohort study including 2 241 706 patients with breast, prostate, non-small cell lung, and colon cancer, generally higher all-cause mortality was associated with increasing time to treatment, although the degree varied by cancer type and stage. Patients with colon and lung cancer had the highest mortality associated with increased time to treatment. Meaning These findings emphasize the importance of timely cancer treatment, and, in contrast to current pandemic-related guidelines, support more prompt definitive treatment for intermediate-risk and high-risk prostate cancer., This cohort study of patients with breast, prostate, non-small cell lung, and colon cancer assesses the association of time from diagnosis to treatment with all-cause mortality., Importance Resource limitations because of pandemic or other stresses on infrastructure necessitate the triage of time-sensitive care, including cancer treatments. Optimal time to treatment is underexplored, so recommendations for which cancer treatments can be deferred are often based on expert opinion. Objective To evaluate the association between increased time to definitive therapy and mortality as a function of cancer type and stage for the 4 most prevalent cancers in the US. Design, Setting, and Participants This cohort study assessed treatment and outcome information from patients with nonmetastatic breast, prostate, non-small cell lung (NSCLC), and colon cancers from 2004 to 2015, with data analyzed January to March 2020. Data on outcomes associated with appropriate curative-intent surgical, radiation, or medical therapy were gathered from the National Cancer Database. Exposures Time-to-treatment initiation (TTI), the interval between diagnosis and therapy, using intervals of 8 to 60, 61 to 120, 121 to 180, and greater than 180 days. Main Outcomes and Measures 5-year and 10-year predicted all-cause mortality. Results This study included 2 241 706 patients (mean [SD] age 63 [11.9] years, 1 268 794 [56.6%] women, 1 880 317 [83.9%] White): 1 165 585 (52.0%) with breast cancer, 853 030 (38.1%) with prostate cancer, 130 597 (5.8%) with NSCLC, and 92 494 (4.1%) with colon cancer. Median (interquartile range) TTI by cancer was 32 (21-48) days for breast, 79 (55-117) days for prostate, 41 (27-62) days for NSCLC, and 26 (16-40) days for colon. Across all cancers, a general increase in the 5-year and 10-year predicted mortality was associated with increasing TTI. The most pronounced mortality association was for colon cancer (eg, 5 y predicted mortality, stage III: TTI 61-120 d, 38.9% vs. 181-365 d, 47.8%), followed by stage I NSCLC (5 y predicted mortality: TTI 61-120 d, 47.4% vs 181-365 d, 47.6%), while survival for prostate cancer was least associated (eg, 5 y predicted mortality, high risk: TTI 61-120 d, 12.8% vs 181-365 d, 14.1%), followed by breast cancer (eg, 5 y predicted mortality, stage I: TTI 61-120 d, 11.0% vs. 181-365 d, 15.2%). A nonsignificant difference in treatment delays and worsened survival was observed for stage II lung cancer patients—who had the highest all-cause mortality for any TTI regardless of treatment timing. Conclusions and Relevance In this cohort study, for all studied cancers there was evidence that shorter TTI was associated with lower mortality, suggesting an indirect association between treatment deferral and mortality that may not become evident for years. In contrast to current pandemic-related guidelines, these findings support more timely definitive treatment for intermediate-risk and high-risk prostate cancer.

671 Background: Immune checkpoint inhibitors (ICIs) demonstrate impressive clinical benefit across a variety of cancers. NCCN guidelines for several cancers including renal cell carcinoma now support ICI monotherapy and combination therapy with ipilimumab. Cardiac toxicity is a rare but catastrophic adverse event associated with ICIs. We sought to define the comparative cardiac risk profile of ICI combination versus monotherapy in a real world setting. Methods: We used VigiBase, the World Health Organization database of case safety reports, which collects data from more than 130 countries to identify drug-associated adverse events. Using Medical Dictionary for Regulatory Activities terminology, we identified cardiac adverse events (AE) related to monotherapy (nivolumab, ipilimumab, pembrolizumab) or combination therapy (ipilimumab/nivolumab). To explore a possible relationship we used the reporting odds ratio (ROR), a surrogate measure of association using all other reactions as non-cases. A lower bound of a 95% confidence interval of ROR > 1 reflects a disproportionality signal that more AEs are observed than expected due to chance. Results: We found 7,644, 25,016, and 14,681, and 5,191 AEs for ipilimumab, nivolumab, pembrolizumab, and combination therapy respectively. No signal existed for overall cardiac events, but combination therapy was associated with significantly higher odds of pericarditis or myocarditis (ROR 6.9, 95% CI 5.7—8.3) versus pembrolizumab (5.6, 4.9—6.4), nivolumab (5.1, 4.6-5.7), or ipilimumab monotherapy (1.9, 1.4-2.7). Pericarditis and myocarditis with combination therapy was fatal for 23% of reported AEs, compared to 14%, 14%, and 20% for ipilimumab, nivolumab, and pembrolizumab (p = 0.003) respectively. Conclusions: Using validated pharmacovigilance methodology, we found significantly increased odds of myocarditis and pericarditis for all ICI, with the highest odds for combination therapy. These adverse events were often fatal. Further research is needed to identify patients at high risk for immunotherapy related cardiac toxicity.

34 Background: Gonadotropic releasing hormone (GnRH) agonists and antagonists are first-line for advanced prostate cancer, but may be associated with cardiac toxicity. Observational studies show a relatively lower risk for GnRH antagonists, but a randomized trial found no difference. We compared the reporting of cardiac events for GnRH agonists and antagonists. Methods: We used VigiBase, the World Health Organization global database of case safety reports, which collects data from more than 130 countries to extract drug-adverse event (AE) pairs. Using Medical Dictionary for Regulatory Activities terminology, we identified AEs related to GnRH antagonist (degarelix) or agonist (leuprolide, goserelin, triptorelin, histrelin) therapy for prostate cancer, including myocardial infarction, heart failure, cardiomyopathies, new-onset valvular dysfunction, and other major cardiac events. To explore a possible relationship we used the reporting odds ratio (ROR), a surrogate measure of association using all other reactions as non-cases. A lower bound of a 95% confidence interval of ROR > 1 reflects a disproportionality signal that more AEs are observed than expected. Results: We found 10,504 AEs for GnRH agonists, and 1,606 for GnRH antagonists; 805 (7.7%) were cardiac for agonists, and 102 for antagonists (6.4%). We found no signal for overall cardiac events or any subgrouping for GnRH antagonists, but identified a signal both for overall cardiac events (ROR 1.20, 95% CI 1.12-1.29) and myocardial infarction (1.76, 1.57-1.97) for GnRH agonists. Conclusions: Using validated pharmacovigilance methodology, we found a signal for myocardial infarction for GnRH agonists, but did not detect one for GnRH antagonists. As cardiovascular disease is the most common cause of non-cancer death in prostate cancer patients, this finding is of specific relevance in the current era of novel second-line anti-androgen therapies which may compound toxicity when added to first-line therapy. The relative cardiac toxicity of GnRH agonist therapy compared to GnRH antagonists merits renewed attention.

70 Background: The standard of care for advanced prostate cancer is androgen deprivation therapy (ADT). The novel second generation agents abiraterone and enzalutamide were initially approved in castration resistant disease, but are now being used in the hormone sensitive setting. The FDA issued a 2010 warning about cardiovascular risks associated with ADT, but the risk of novel agents is less well understood, especially in comparison to each other. We sought to define the comparative cardiac risk profile of enzalutamide and abiraterone. Methods: We used VigiBase, the World Health Organization database of individual case safety reports, which collects data from more than 130 countries to identify drug associated adverse events (AE). Using Medical Dictionary for Regulatory Activities terminology, we identified cardiac AEs related to abiraterone or enzalutamide therapy for prostate cancer. To explore a possible relationship we used the reporting odds ratio (ROR), a surrogate measure of association using all other reactions as non-cases. A lower bound of a 95% confidence interval of ROR > 1 reflects a disproportionality signal that more AEs are observed than expected due to chance. Results: Vigibase contained 8203 AEs for abiraterone and 26024 for enzalutamide; 808 (9.9%) were cardiac-related for abiraterone, and 1000 for enzalutamide (3.8%). We found no disproportionality signal for cardiac events or any subtype for enzalutamide, but identified significantly higher odds of overall cardiac events (ROR 1.64, 95% CI 1.53—1.76), myocardial infarction (1.34, 1.17—1.58), arrythmia (2.09, 1.87—2.34), and heart failure (3.35, 2.92—3.85) for patients taking abiraterone. Conclusions: Using validated pharmacovigilance methodology, we found significantly increased odds of cardiac events for abiraterone but not for enzalutamide. Clinicians may need to consider these findings in the context of their patients’ comorbidities when prescribing ADT.