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Background: In the current study, the authors sought to both characterize the national trends in proton therapy use for prostate cancer and determine the factors associated with receipt of this limited resource, using what to the best of their knowledge is the largest nationwide cancer registry.Methods: The National Cancer Data Base was used to identify 187,730 patients diagnosed with nonmetastatic prostate cancer from 2004 through 2012 who received external beam radiotherapy as their initial form of definitive therapy. Multivariable logistic regression analysis adjusted for sociodemographic and clinical factors was used to identify independent determinants of proton therapy use.Results: The rate of proton therapy use increased significantly from 2.3% in 2004 to 5.2% in 2011 and 4.8% in 2012 (P value for trend <.0001). Proton therapy for prostate cancer was much more likely to be delivered at an academic compared with nonacademic center and to patients who were white, younger, healthier, from metropolitan areas, from zip codes with higher median household incomes, and who did not have an advanced stage of or high-grade disease (all P<.0001). Compared with white patients, those who were black and Hispanic were found to be significantly less likely to receive proton therapy even after robust multivariable adjustments (adjusted odds ratio, 0.20 [95% confidence interval, 0.18-0.22; P<.0001] and adjusted odds ratio, 0.57 [95% confidence interval, 0.48-0.66; P<.0001], respectively).Conclusions: The use of proton therapy to treat patients with prostate cancer more than doubled from 2004 to 2012, with striking racial disparities in its use noted despite robust multivariable adjustments. Long-term follow-up is needed to determine whether the increased use of proton therapy for prostate cancer is justified, and ongoing efforts should be made to ensure equal access to resource-limited oncologic therapies. Cancer 2016;122:1505-12. © 2016 American Cancer Society. [ABSTRACT FROM AUTHOR]

Background: The objective of this study was to determine whether a very low presenting prostate-specific antigen (PSA) level was associated with greater prostate cancer-specific mortality (PCSM) among men with a Gleason score (GS) of 8 to 10.Methods: The Surveillance, Epidemiology, and End Results program was used to identify 328,904 men diagnosed with clinicalT1 (cT1)-4N0M0 prostate cancer between 2004 and 2010. A multivariate Fine-Gray competing risks regression analysis was used to determine PCSM as a function of the PSA level (≤ 2.5, 2.6-4, 4.1-10, 10.1-20, 20.1-40, or > 40 ng/mL) and GS (8-10 vs ≤ 7).Results: The median follow-up was 38 months. Among men with GS 8-10 disease, with a PSA level of 4.1 to 10 ng/mL as the referent, the adjusted hazard ratio for PCSM for men was 2.15 with a PSA level ≤ 2.5 ng/mL (95% confidence interval [CI], 1.65-2.79; P < .001), 1.60 with a PSA level of 2.6 to 4 ng/mL (95% CI, 1.22-2.10; P = .001), 1.60 with a PSA level of 10.1 to 20 ng/mL (95% CI, 1.41-1.82; P < .001), 2.08 with a PSA level of 20.1 to 40 ng/mL (95% CI, 1.81-2.38; P < .001), and 3.23 with a PSA level > 40 ng/mL (95% CI, 2.85-3.65; P < .001). This suggested a U-shaped distribution. There was a significant interaction between the PSA level and GS (P(interaction)  < .001) such that only a PSA level ≤ 2.5 ng/mL significantly predicted poorer PCSM among patients with GS 8-10 disease.Conclusions: Among patients with high-grade disease, patients with PSA levels ≤ 2.5 ng/mL or PSA levels of 2.6 to 4 ng/mL appear to have a higher risk for cancer-specific death in comparison with patients with PSA levels of 10.1 to 20 ng/mL, and this supports the notion that low PSA levels in GS 8-10 disease may be a sign of aggressive and very poorly differentiated or anaplastic low PSA-producing tumors. Patients with low-PSA, GS 8-10 disease should be considered for clinical trials studying the use of chemotherapy and other novel agents for very high-risk prostate cancers. [ABSTRACT FROM AUTHOR]

Abstract: Purpose: The National Radiation Oncology Registry (NROR) is a collaborative initiative of the Radiation Oncology Institute and the American Society of Radiation Oncology, with input and guidance from other major stakeholders in oncology. The overarching mission of the NROR is to improve the care of cancer patients by capturing reliable information on treatment delivery and health outcomes. Methods: The NROR will collect patient-specific radiotherapy data electronically to allow for rapid comparison of the many competing treatment modalities and account for effectiveness, outcome, utilization, quality, safety, and cost. It will provide benchmark data and quality improvement tools for individual practitioners. The NROR steering committee has determined that prostate cancer provides an appropriate model to test the concept and the data capturing software in a limited number of sites. The NROR pilot project will begin with this disease-gathering treatment and outcomes data from a limited number of treatment sites across the range of practice; once feasibility is proven, it will scale up to more sites and diseases. Results: When the NROR is fully implemented, all radiotherapy facilities, along with their radiation oncologists, will be solicited to participate in it. With the broader participation of the radiation oncology community, NROR has the potential to serve as a resource for determining national patterns of care, gaps in treatment quality, comparative effectiveness, and hypothesis generation to identify new linkages between therapeutic processes and outcomes. Conclusions: The NROR will benefit radiation oncologists and other care providers, payors, vendors, policy-makers, and, most importantly, cancer patients by capturing reliable information on population-based radiation treatment delivery. [Copyright &y& Elsevier]

Background Patterns of postoperative radiotherapy (RT) use in prostate cancer (PCa) after the publication of major randomized trials have not been well characterized. Objective To describe patterns of postoperative RT use after radical prostatectomy (RP) in patients with adverse pathologic features in the United States. Design, setting, and participants Retrospective analysis of 97 270 patients with PCa diagnosed between 2005 and 2011 whose presentation and outcomes were recorded in the National Cancer Data Base. Outcome measurements and statistical analysis Temporal changes in receipt of postoperative RT and factors associated with receipt of this treatment using the Cochran–Armitage trend test and multiple logistic regression, respectively. Results and limitations Between 2005 and 2011, receipt of postoperative RT decreased steadily from 9.1% to 7.3% ( p trend < 0.001). Use of RT with or without androgen deprivation therapy monotonically decreased with advancing age from 8.5% in patients aged 18–59 yr to 6.8% in patients aged 70–79 yr ( p trend < 0.001). Receipt of RT was higher at community cancer programs compared with teaching/research centers (14% vs 7.3%; odds ratio [OR]: 2.16; p < 0.001), in those with pT3-4 disease and positive margins compared with those with pT3-4 and negative margins (17% vs 5.9%; OR: 2.89; p < 0.001), and in patients with a Gleason score of 8–10 compared with those with a Gleason score of 2–6 (17% vs 4.2%; OR: 3.50; p < 0.001). Limitations include lack of postprostatectomy prostate-specific antigen level. Conclusions Postoperative RT use for localized PCa in patients with adverse pathologic features is declining in the United States. Patient summary In this report, we show that use of postoperative radiotherapy in patients with prostate cancer with adverse pathologic features is declining. Patients treated at community cancer programs, those with locally advanced disease and positive margins, and those with a high Gleason score were more likely to receive postoperative radiotherapy. [ABSTRACT FROM AUTHOR]

Purpose: Leaders in the oncology community are sounding a clarion call to promote "value" in cancer care decisions. Value in cancer care considers the clinical effectiveness, along with the costs, when selecting a treatment. To discuss possible solutions to the current obstacles to achieving value in the use of advanced technologies in oncology, the National Cancer Policy Forum of the National Academies of Sciences, Engineering, and Medicine held a workshop, "Appropriate Use of Advanced Technologies for Radiation Therapy and Surgery in Oncology" in July 2015. The present report summarizes the discussions related to radiation oncology.Methods and Materials: The workshop convened stakeholders, including oncologists, researchers, payers, policymakers, and patients. Speakers presented on key themes, including the rationale for a value discussion on advanced technology use in radiation oncology, the generation of scientific evidence for value of advanced radiation technologies, the effect of both scientific evidence and "marketplace" (or economic) factors on the adoption of technologies, and newer approaches to improving value in the practice of radiation oncology. The presentations were followed by a panel discussion with dialogue among the stakeholders.Results: Challenges to generating evidence for the value of advanced technologies include obtaining contemporary, prospective, randomized, and representative comparative effectiveness data. Proposed solutions include the use of prospective registry data; integrating radiation oncology treatment, outcomes, and quality benchmark data; and encouraging insurance coverage with evidence development. Challenges to improving value in practice include the slow adoption of higher value and the de-adoption of lower value treatments. The proposed solutions focused on engaging stakeholders in iterative, collaborative, and evidence-based efforts to define value and promote change in radiation oncology practice. Recent examples of ongoing or successful responses to the discussed challenges were provided.Conclusions: Discussions of "value" have increased as a priority in the radiation oncology community. Practitioners in the radiation oncology community can play a critical role in promoting a value-oriented framework to approach radiation oncology treatment. [ABSTRACT FROM AUTHOR]

Purpose: To determine whether a dose-response relationship exists for salvage radiation therapy (RT) of biochemical failure after prostatectomy for prostate cancer.Methods and Materials: Individual data from 1108 patients who underwent salvage RT at 10 academic centers were pooled. The cohort was enriched for selection criteria more likely associated with tumor recurrence in the prostate bed (margin positive and pre-RT prostate-specific antigen [PSA] level of ≤2.0 ng/mL) and without the confounding of planned androgen suppression. The cumulative incidence of biochemical failure and distant metastasis over time was computed, and competing risks hazard regression models were used to investigate the association between potential predictors and these outcomes. The association of radiation dose with outcomes was the primary focus.Results: With a 65.2-month follow-up duration, the 5- and 10-year estimates of freedom from post-RT biochemical failure (PSA level >0.2 ng/mL and rising) was 63.5% and 49.8%, respectively, and the cumulative incidence of distant metastasis was 12.4% by 10 years. A Gleason score of ≥7, higher pre-RT PSA level, extraprostatic tumor extension, and seminal vesicle invasion were associated with worse biochemical failure and distant metastasis outcomes. A salvage radiation dose of ≥66.0 Gy was associated with a reduced cumulative incidence of biochemical failure, but not of distant metastasis.Conclusions: The use of salvage radiation doses of ≥66.0 Gy are supported by evidence presented in the present multicenter pooled analysis of individual patient data. The observational reporting method, limited sample size, few distant metastasis events, modest follow-up duration, and elective use of salvage therapy might have diminished the opportunity to identify an association between the radiation dose and this endpoint. [ABSTRACT FROM AUTHOR]

Abstract: Background: Despite its lethal potential, many patients with muscle-invasive bladder cancer (MIBC) do not receive aggressive, potentially curative therapy consistent with established practice standards. Objective: To characterize the treatments received by patients with MIBC and analyze their use according to sociodemographic, clinical, pathologic, and facility measures. Design, setting, and participants: Using the National Cancer Data Base, we analyzed 28 691 patients with MIBC (stages II–IV) treated between 2004 and 2008, excluding those with cT4b tumors or distant metastases. Treatments included radical or partial cystectomy with or without chemotherapy (CT), chemoradiotherapy (CRT), radiation therapy (RT), or CT alone and observation following biopsy. Aggressive therapy (AT) was defined as radical or partial cystectomy or definitive RT/CRT (total dose ≥50Gy). Outcome measurements and statistical analysis: AT use and correlating variables were assessed by multivariable, generalized estimating equation models adjusted for facility clustering. Results and limitations: According to the database, 52.5% of patients received AT; 44.9% were treated surgically, 7.6% received definitive CRT or RT, and 25.9% of patients received observation only. AT use decreased with advancing age (odds ratio [OR]: 0.34 for age 81–90 yr vs ≤50 yr; p <0.001). AT use was also lower in racial minorities (OR: 0.74 for black race; p < 0.001), the uninsured (OR: 0.73; p < 0.001), Medicaid-insured patients (OR: 0.81; p = 0.01), and at low-volume centers (OR: 0.64 vs high-volume centers; p < 0.001). Use of AT was higher with increasing tumor stage (OR: 2.23 for T3/T4a vs T2; p < 0.001) and nonurothelial histology (OR: 1.25 and 1.43 for squamous and adenocarcinoma, respectively; p < 0.001). Study limitations include retrospective design and lack of information about patient and provider motivations regarding therapy selection. Conclusions: AT for MIBC appears underused, especially in the elderly and in groups with poor socioeconomic status. These data point to a significant unmet need to inform policy makers, payers, and physicians regarding appropriate therapies for MIBC. [Copyright &y& Elsevier]

Purpose: In the context of national calls for reorganizing cancer clinical trials, the National Cancer Institute sponsored a 2-day workshop to examine challenges and opportunities for optimizing radiotherapy quality assurance (QA) in clinical trial design. Methods and Materials: Participants reviewed the current processes of clinical trial QA and noted the QA challenges presented by advanced technologies. The lessons learned from the radiotherapy QA programs of recent trials were discussed in detail. Four potential opportunities for optimizing radiotherapy QA were explored, including the use of normal tissue toxicity and tumor control metrics, biomarkers of radiation toxicity, new radiotherapy modalities such as proton beam therapy, and the international harmonization of clinical trial QA. Results: Four recommendations were made: (1) to develop a tiered (and more efficient) system for radiotherapy QA and tailor the intensity of QA to the clinical trial objectives (tiers include general credentialing, trial-specific credentialing, and individual case review); (2) to establish a case QA repository; (3) to develop an evidence base for clinical trial QA and introduce innovative prospective trial designs to evaluate radiotherapy QA in clinical trials; and (4) to explore the feasibility of consolidating clinical trial QA in the United States. Conclusion: Radiotherapy QA can affect clinical trial accrual, cost, outcomes, and generalizability. To achieve maximum benefit, QA programs must become more efficient and evidence-based. [ABSTRACT FROM AUTHOR]

Background: Testicular cancer (TC) mortality rates have decreased over time, however it is unclear whether these improvements are consistent across all communities., Aims: The aim of this study was to analyze trends in TC incidence, mortality, and place of death (PoD) in the United States between 1999-2020 and identify disparities across race, ethnicity, and geographic location., Methods and Results: This cross-sectional study used CDC WONDER and NAACCR, to calculate age-adjusted rates of TC incidence and mortality, respectively. PoD data for individuals who died of TC were collected from CDC WONDER. Using Joinpoint analysis, longitudinal mortality trends were evaluated by age, race, ethnicity, US census region, and urbanization category. TC stage (localized vs metastatic) trends were also evaluated. Univariate and multivariate regression analysis identified demographic disparities for PoD. A total of 8,456 patients died of TC from 1999-2020. Average annual percent change (AAPC) of testicular cancer-specific mortality (TCSM) remained largely stable (AAPC, 0.4; 95% CI -0.2 to 0.9; p = 0.215). Men ages 25-29 experienced a significant increase in TCSM (AAPC, 1.3, p = 0.003), consistent with increased metastatic testicular cancer-specific incidence (TCSI) trend for this age group (AAPC, 1.6; p < 0.01). Mortality increased for Hispanic men (AAPC, 1.7, p < 0.001), with increased metastatic TCSI (AAPC, 2.5; p < 0.001). Finally, younger (<45), single, and Hispanic or Black men were more likely to die in medical facilities (all p < 0.001). The retrospective study design is a limitation., Conclusion: Significant increases in metastatic TC were found for Hispanic men and men aged 25-29 potentially driving increasing testicular cancer specific mortality in these groups. Evidence of racial and ethnic differences in place of death may also highlight treatment disparities., (© 2023 The Authors. Cancer Reports published by Wiley Periodicals LLC.)

Importance: The 2012 US Preventive Services Task Force (USPSTF) Grade D recommendation against prostate-specific antigen (PSA) screening for all men has been controversial, with data documenting a shift to a higher stage of disease at diagnosis. The association between the Grade D recommendation and prostate cancer-specific mortality (PCSM) among contemporary cohorts, however, is unclear., Objective: To evaluate PCSM rates between 1999 and 2019, comparing trends in rates before and after the change in the 2012 USPSTF screening guideline to assess its association with PCSM., Exposure: The 2012 USPSTF Grade D recommendation against PSA screening for all men., Design, Setting, and Participants: This cross-sectional study used Centers for Disease Control and Prevention Wide-ranging Online Data for Epidemiologic Research maintained by the National Center for Health Statistics to collect data on cause of death for all individuals who died of prostate cancer in the US from 1999 to 2019. Analysis was performed from January to August 2021., Main Outcomes and Measures: Trends in PCSM rates were calculated from 1999 to 2012 and from 2014 to 2019, with a washout year of 2013, using linear regression, with year and binary indicator of pre-2013 and post-2013 status as interaction terms. Trends were further analyzed by age, race and ethnicity, urbanization category, and US Census region. Other measures included diagnosis of localized or metastatic prostate cancer and overall cancer mortality., Results: A total of 618 095 patients died of prostate cancer in the US from 1999 to 2019. Age-adjusted PCSM decreased linearly at a rate of -0.273 per 100 000 population per year from 1999 to 2012 and stalled at a rate of -0.009 per 100 000 per year from 2014 to 2019 (P < .001). This finding was significant among men aged 60 years or older, especially among men aged 60 to 69 years, men aged 80 years or older, and among Black men. Men aged 60 to 64 years had a decreasing, age-adjusted PCSM rate of -0.0088 per 100 000 population per year prior to 2013 followed by an increasing rate of 0.0014 per 100 000 per year. Men aged 65 to 69 years had a decreasing, age-adjusted PCSM rate of -0.024 per 100 000 population per year prior to 2013 followed by an increasing rate of 0.0011 per 100 000 population per year. Men aged 80 years or older had the largest absolute difference between rates before and after 2013 compared with all other age groups, with a difference of 0.06 for men aged 80 to 84 years and 0.07 for men 85 aged years or older. Black men had a decreasing, age-adjusted PCSM rate of -0.700 per 100 000 population per year prior to 2013 followed by a flattened rate of -0.091 per 100 000 population per year. Changes were observed across races and ethnicities, urbanization categories, and US Census regions and were accompanied by increased diagnoses of metastatic disease, which are inconsistent with mortality trends across all malignant neoplasms., Conclusions and Relevance: This cross-sectional study using comprehensive PCSM data through 2019 demonstrated decreasing PCSM rates that flattened or increased after the 2012 USPSTF Grade D recommendation, suggesting that decreased PSA screening may be a factor associated with this change. This change was seen across ages, races and ethnicities, urbanization categories, and US Census regions. The updated 2018 USPSTF guideline supporting shared decision-making may reverse these trends in the coming years.

Importance: Black patients are less likely than White patients to receive guideline-concordant cancer care in the US. Proton beam therapy (PBT) is a potentially superior technology to photon radiotherapy for tumors with complex anatomy, tumors surrounded by sensitive tissues, and childhood cancers., Objective: To evaluate whether there are racial disparities in the receipt of PBT among Black and White individuals diagnosed with all PBT-eligible cancers in the US., Design, Setting, and Participants: This cross-sectional study evaluated Black and White individuals diagnosed with PBT-eligible cancers between January 1, 2004, and December 31, 2018, in the National Cancer Database, a nationwide hospital-based cancer registry that collects data on radiation treatment, even when it is received outside the reporting facility. American Society of Radiation Oncology model policies were used to classify patients into those for whom PBT is the recommended radiation therapy modality (group 1) and those for whom evidence of PBT efficacy is still under investigation (group 2). Propensity score matching was used to ensure comparability of Black and White patients' clinical characteristics and regional availability of PBT according to the National Academy of Medicine's definition of disparities. Data analysis was performed from October 4, 2021, to February 22, 2022., Exposure: Patients' self-identified race was ascertained from medical records., Main Outcomes and Measures: The main outcome was receipt of PBT, with disparities in this therapy's use evaluated with logistic regression analysis., Results: Of the 5 225 929 patients who were eligible to receive PBT and included in the study, 13.6% were Black, 86.4% were White, and 54.3% were female. The mean (SD) age at diagnosis was 63.2 (12.4) years. Black patients were less likely to be treated with PBT than their White counterparts (0.3% vs 0.5%; odds ratio [OR], 0.67; 95% CI, 0.64-0.71). Racial disparities were greater for group 1 cancers (0.4% vs 0.8%; OR, 0.49; 95% CI, 0.44-0.55) than group 2 cancers (0.3% vs 0.4%; OR, 0.75; 95% CI, 0.70-0.80). Racial disparities in PBT receipt among group 1 cancers increased over time (annual percent change = 0.09, P < .001) and were greatest in 2018, the most recent year of available data., Conclusions and Relevance: In this cross-sectional study, Black patients were less likely to receive PBT than their White counterparts, and disparities were greatest for cancers for which PBT was the recommended radiation therapy modality. These findings suggest that efforts other than increasing the number of facilities that provide PBT will be needed to eliminate disparities.

Importance: Proton beam therapy (PBT) is a potentially superior technology to photon radiotherapy for tumors with complex anatomy, those surrounded by sensitive tissues, and childhood cancers., Objective: To assess patterns of use of PBT according to the present American Society of Radiation Oncology (ASTRO) clinical indications in the US., Design, Setting, and Participants: Individuals newly diagnosed with cancer between 2004 and 2018 were selected from the National Cancer Database. Data analysis was performed from October 4, 2021, to February 22, 2022. ASTRO's Model Policies (2017) were used to classify patients into group 1, for which health insurance coverage for PBT treatment is recommended, and group 2, for which coverage is recommended only if additional requirements are met., Main Outcomes and Measures: Use of PBT., Results: Of the 5 919 368 patients eligible to receive PBT included in the study, 3 206 902 were female (54.2%), and mean (SD) age at diagnosis was 62.6 (12.3) years. Use of PBT in the US increased from 0.4% in 2004 to 1.2% in 2018 (annual percent change [APC], 8.12%; P < .001) due to increases in group 1 from 0.4% in 2010 to 2.2% in 2018 (APC, 21.97; P < .001) and increases in group 2 from 0.03% in 2014 to 0.1% in 2018 (APC, 30.57; P < .001). From 2010 to 2018, among patients in group 2, PBT targeted to the breast increased from 0.0% to 0.9% (APC, 51.95%), and PBT targeted to the lung increased from 0.1% to 0.7% (APC, 28.06%) (P < .001 for both). Use of PBT targeted to the prostate decreased from 1.4% in 2011 to 0.8% in 2014 (APC, -16.48%; P = .03) then increased to 1.3% in 2018 (APC, 12.45; P < .001). Most patients in group 1 treated with PBT had private insurance coverage in 2018 (1039 [55.4%]); Medicare was the most common insurance type among those in group 2 (1973 [52.5%])., Conclusions and Relevance: The findings of this study show an increase in the use of PBT in the US between 2004 to 2018; prostate was the only cancer site for which PBT use decreased temporarily between 2011 and 2014, increasing again between 2014 and 2018. These findings may be especially relevant for Medicare radiation oncology coverage policies.

The success of the use of novel therapies in the treatment of advanced urothelial carcinoma has contributed to growing interest in evaluating these therapies at earlier stages of the disease. However, trials evaluating these therapies in the neoadjuvant setting must have clearly defined study elements and appropriately selected end points to ensure the applicability of the trial and enable interpretation of the study results. To advance the development of rational trial design, a public workshop jointly sponsored by the US Food and Drug Administration and the Bladder Cancer Advocacy Network convened in August 2019. Clinicians, clinical trialists, radiologists, biostatisticians, patients, advocates and other stakeholders discussed key elements and end points when designing trials of neoadjuvant therapy for muscle-invasive bladder cancer (MIBC), identifying opportunities to refine eligibility, design and end points for neoadjuvant trials in MIBC. Although pathological complete response (pCR) is already being used as a co-primary end point, both individual-level and trial-level surrogacy for time-to-event end points, such as event-free survival or overall survival, remain incompletely characterized in MIBC. Additionally, use of pCR is limited by heterogeneity in pathological evaluation and the fact that the magnitude of pCR improvement that might translate into a meaningful clinical benefit remains unclear. Given existing knowledge gaps, capture of highly granular patient-related, tumour-related and treatment-related characteristics in the current generation of neoadjuvant MIBC trials will be critical to informing the design of future trials., (© 2021. This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply.)

The NCCN Clinical Practice Guidelines in Oncology for Bladder Cancer provide recommendations for the diagnosis, evaluation, treatment, and follow-up of patients with bladder cancer. These NCCN Guidelines Insights discuss important updates to the 2018 version of the guidelines, including implications of the 8th edition of the AJCC Cancer Staging Manual on treatment of muscle-invasive bladder cancer and incorporating newly approved immune checkpoint inhibitor therapies into treatment options for patients with locally advanced or metastatic disease., (Copyright © 2018 by the National Comprehensive Cancer Network.)

Background: Numerous management options exist for patients with prostate cancer; however, recent trends and their influencing factors are not well described., Objective: To describe modern patterns of care and factors associated with management choice using the National Cancer Database., Design, Setting, and Participants: Patients with localized prostate cancer diagnosed between 2004 and 2012 were included and grouped according to National Comprehensive Cancer Network guidelines into low, intermediate, or high risk., Outcome Measurements and Statistical Analysis: Trend analyses and multivariate logistic regression was used to identify factors associated with management., Results and Limitations: There were 598 640 patients who met the study criteria; 36.3% were classified as low risk, 43.8% intermediate risk, and 20.0% high risk. Over the study period, among low-risk patients, observation increased from 9.2% to 21.3%, while radical prostatectomy (RP) increased from 29.5% to 51.1% (p<0.001 for both). In contrast, external beam radiotherapy decreased from 24.3% to 14.5%, while brachytherapy decreased from 31.7% to 11.1%. A similar pattern was seen for patients with intermediate-risk or high-risk disease. Among high-risk patients, RP increased from 25.1% to 43.4% replacing external beam radiotherapy as the dominant therapy. On multivariate analysis, racial minorities, the uninsured, and low-income patients were less likely to receive RP. Low-risk patients in similar subgroups were significantly more likely to be observed. Limitations include potential miscoding or misclassification of variables., Conclusions: Patterns of care in localized prostate cancer are changing rapidly. While use of observation is increasing in low-risk groups, the use of RP is increasing across all risk groups with a concomitant decline in use of radiotherapy. Socioeconomic factors appear to influence management choice., Patient Summary: In this report we identify a recent significant increase in the use of radical prostatectomy for prostate cancer patients. Socioeconomic factors such as race, insurance type, and income may affect treatments offered to and received by patients., (Copyright © 2016 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Background: Clinically lymph node-positive (cN+) prostate cancer (PCa) is an often-fatal disease. Its optimal management remains largely undefined given a lack of prospective, randomized data to inform practice. We sought to describe modern practice patterns in the management of cN+ PCa and assess the effect of adding radiation therapy (RT) to androgen deprivation therapy (ADT) on survival using the National Cancer Data Base., Methods: Patients with cN+ PCa and without distant metastases diagnosed between 2004 and 2011 were included. Five-year overall survival for patients diagnosed between 2004 and 2006 and treated with ADT alone or ADT+RT were compared. Propensity score (PS) matching was used to balance baseline characteristics, and Cox multivariate regression analysis was used to estimate hazard ratios (HRs) for all-cause mortality., Results: Of 3540 total patients, 32.2% were treated with ADT alone and 51.4% received ADT+RT. Compared with ADT alone, patients treated with ADT+RT were younger and more likely to have private insurance, lower comorbidity scores, higher Gleason scores, and lower PSA values. After PS matching, 318 patients remained in each group. Compared with ADT alone, ADT+RT was associated with a 50% decreased risk of five-year all-cause mortality (HR = 0.50, 95% CI = 0.37 to 0.67, two-sided P < .001; crude OS rate: 71.5% vs 53.2%)., Conclusions: Using a large national database, we have identified a statistically significant survival benefit for patients with cN+ PCa treated with ADT+RT. These data, if appropriately validated by randomized trials, suggest that a substantial proportion of such patients at high risk for prostate cancer death may be undertreated, warranting a reevaluation of current practice guidelines., (© The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.)

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.)

Purpose: To examine the accuracy of clinical staging and its effects on outcome in bladder cancer (BC) patients treated with radical cystectomy (RC), using a large national database., Methods and Materials: A total of 16,953 patients with BC without distant metastases treated with RC from 1998 to 2009 were analyzed. Factors associated with clinical-pathologic stage discrepancy were assessed by multivariate generalized estimating equation models. Survival analysis was conducted for patients treated between 1998 and 2004 (n=7270) using the Kaplan-Meier method and Cox proportional hazards models., Results: At RC 41.9% of patients were upstaged, whereas 5.9% were downstaged. Upstaging was more common in females, the elderly, and in patients who underwent a more extensive lymphadenectomy. Downstaging was less common in patients treated at community centers, in the elderly, and in Hispanics. Receipt of preoperative chemotherapy was highly associated with downstaging. Five-year overall survival rates for patients with clinical stages 0, I, II, III, and IV were 67.2%, 62.9%, 50.4%, 36.9%, and 27.2%, respectively, whereas those for the same pathologic stages were 70.8%, 75.8%, 63.7%, 41.5%, and 24.7%, respectively. On multivariate analysis, upstaging was associated with increased 5-year mortality (hazard ratio [HR] 1.80, P<.001), but downstaging was not associated with survival (HR 0.88, P=.160). In contrast, more extensive lymphadenectomy was associated with decreased 5-year mortality (HR 0.76 for ≥10 lymph nodes examined, P<.001), as was treatment at an National Cancer Institute-designated cancer center (HR 0.90, P=.042)., Conclusions: Clinical-pathologic stage discrepancy in BC patients is remarkably common across the United States. These findings should be considered when selecting patients for preoperative or nonoperative management strategies and when comparing the outcomes of bladder sparing approaches to RC., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Purpose: In selected patients with muscle-invasive bladder cancer, combined-modality therapy (transurethral resection bladder tumor [TURBT], radiation therapy, chemotherapy) with salvage cystectomy, if necessary, can achieve survival rates similar to radical cystectomy. We investigated late pelvic toxicity after chemoradiotherapy for patients treated on prospective protocols., Patients and Methods: Between 1990 and 2002, 285 eligible patients enrolled on four prospective protocols (Radiation Therapy Oncology Group [RTOG] 8903, 9506, 9706, 9906) and 157 underwent combined-modality therapy, surviving >or= 2 years from start of treatment with their bladder intact. Rates of late genitourinary (GU) and GI toxicity were assessed using the RTOG Late Radiation Morbidity Schema, with worst toxicity grade (scale 0 to 5) occurring >or= 180 days after start of consolidation therapy reported for each patient. Persistence of toxicity was defined as grade 3+ toxicity not decreasing by at least one grade. Logistic and Cox regression analyses were performed to evaluate relationship between clinical characteristics, frequency, and time to late grade 3+ pelvic toxicity. Covariates included age, sex, stage, presence of carcinoma in situ, completeness of TURBT, and protocol., Results: Median follow-up was 5.4 years (range, 2.0 to 13.2 years). Seven percent of patients experienced late grade 3+ pelvic toxicity: 5.7% GU and 1.9% GI. In only one of nine patients did a grade 3+ GU toxicity persist. Notably there were no late grade 4 toxicities and no treatment-related deaths. None of the clinical variables studied predicted for late grade 3+ pelvic toxicity., Conclusion: Rates of significant late pelvic toxicity for patients completing combined-modality therapy for invasive bladder cancer and retaining their native bladder are low.