Malpractice Trends Involving Active Surveillance Across Cancers.

OBJECTIVE: To characterize malpractice trends related to active surveillance (AS) as a treatment strategy across cancers. BACKGROUND: Active surveillance is increasingly considered a viable management strategy for low-risk cancers. Since a subset of AS cases will progress, metastasize, or exhibit cancer-related mortality, a significant barrier to implementation is the perceived risk of litigation from missing the window for cure. Data on malpractice trends across cancers are lacking. METHODS: Westlaw Edge and LexisNexis Advance databases were searched from 1990 to 2022 for malpractice cases involving active surveillance in conjunction with thyroid cancer, prostate cancer, kidney cancer, breast cancer, or lymphoma. Queries included unpublished cases, trial orders, jury verdicts, and administrative decisions. Data were compiled on legal allegations, procedures performed, and verdicts or settlements rendered. RESULTS: Five prostate cancer cases were identified that pertained to active surveillance. Two cases involved alleged deliberate indifference from AS as a management strategy but were ruled as following the appropriate standard of care. In contrast, 3 cases involved alleged physician negligence for not explicitly recommending AS as a treatment option after complications from surgery occurred. All cases showed documented informed consent for AS, leading to defense verdicts in favor of the physicians. No cases of AS-related malpractice were identified for other cancer types. CONCLUSIONS: To date, no evidence of successful malpractice litigation for active surveillance in cancer has been identified. Given the legal precedent detailed in the identified cases and increasing support across national guidelines, active surveillance represents a sound management option in appropriate low-risk cancers, with no increased risk of medicolegal exposure.

Impact of Asian Race on Prognosis in De Novo Metastatic Prostate Cancer.

BACKGROUND: Little is known about the impact of Asian race on the long-term survival outcomes of males with de novo metastatic prostate cancer (PCa). Understanding racial disparities in survival is critical for accurate prognostic risk stratification and for informing the design of multiregional clinical trials. METHODS: This multiple-cohort study included individual patient-level data for males with de novo metastatic PCa from the following 3 cohorts: LATITUDE clinical trial data (n=1,199), the SEER program (n=15,476), and the National Cancer Database (NCDB; n=10,366). Primary outcomes were overall survival (OS) in LATITUDE and NCDB and OS and cancer-specific survival in SEER. RESULTS: Across all 3 cohorts, Asian patients diagnosed with de novo metastatic PCa had better survival than white patients. In LATITUDE, median OS was significantly longer in Asian versus white patients in the androgen deprivation therapy (ADT) + abiraterone + prednisone group (not reached vs 43.8 months; hazard ratio [HR], 0.45; 95% CI, 0.28-0.73; P=.001) as well as in the ADT + placebo group (57.6 vs 32.7 months; HR, 0.51; 95% CI, 0.33-0.78; P=.002). In SEER, among all patients diagnosed with de novo metastatic PCa, median OS was significantly longer in Asian versus white males (49 vs 39 months; HR, 0.76; 95% CI, 0.68-0.84; P<.001). Among those who received chemotherapy, Asian patients again had longer OS (52 vs 42 months; HR, 0.71; 95% CI, 0.52-0.96; P=.025). Using data on cancer-specific survival in SEER resulted in similar conclusions. In NCDB, Asian patients also had longer OS than white patients in aggregate and in subgroups of males treated with ADT or chemotherapy (aggregate: 38 vs 26 months; HR, 0.72; 95% CI, 0.62-0.83; P<.001; ADT subgroup: 41 vs 26 months; HR, 0.71; 95% CI, 0.60-0.84; P<.001; chemotherapy subgroup: 34 vs 25 months; HR, 0.67; 95% CI, 0.57-0.78; P<.001). CONCLUSIONS: Asian males have better OS and cancer-specific survival than white males with metastatic PCa across different treatment regimens. This should be considered when assessing prognosis and in designing multinational clinical trials.

Disparities in COVID-19 Disease Incidence by Income and Vaccination Coverage - 81 Communities, Los Angeles, California, July 2020-September 2021.

COVID-19 has disproportionately affected socially vulnerable communities characterized by lower income, lower education attainment, and higher proportions of minority populations, among other factors (1-4). Disparities in COVID-19 incidence and the impact of vaccination on incidence disparities by community income were assessed among 81 communities in Los Angeles, California. Median community vaccination coverage and COVID-19 incidence were calculated across household income strata using a generalized linear mixed effects model with Poisson distribution during three COVID-19 surge periods: two before vaccine availability (July 2020 and January 2021) and the third after vaccines became widely available in April 2021 (September 2021). Adjusted incidence rate ratios (aIRRs) during the peak month of each surge were compared across communities grouped by median household income percentile. The aIRR between communities in the lowest and highest median income deciles was 6.6 (95% CI = 2.8-15.3) in July 2020 and 4.3 (95% CI = 1.8-9.9) in January 2021. However, during the September 2021 surge that occurred after vaccines became widely availabile, model estimates did not identify an incidence disparity between the highest- and lowest-income communities (aIRR = 0.80; 95% CI = 0.35-1.86). During this surge, vaccination coverage was lowest (59.4%) in lowest-income communities and highest (71.5%) in highest-income communities (p<0.001). However, a significant interaction between income and vaccination on COVID-19 incidence (p<0.001) indicated that the largest effect of vaccination on disease incidence occured in the lowest-income communities. A 20% increase in community vaccination was estimated to have resulted in an additional 8.1% reduction in COVID-19 incidence in the lowest-income communities compared with that in the highest-income communities. These findings highlight the importance of improving access to vaccination and reducing vaccine hesitancy in underserved communities in reducing disparities in COVID-19 incidence.

Development and Validation of an Improved Pathological Nodal Staging System in Men with Prostate Cancer.

PURPOSE: Prostate cancer pathological nodal staging uses a single category for all node-positive patients. We sought to improve risk stratification by creating and validating a novel pathological nodal staging system incorporating number of metastatic lymph nodes (+LNs). MATERIALS AND METHODS: A total of 118,450 men who underwent radical prostatectomy for nonmetastatic prostate cancer in the National Cancer Database comprised our development cohort. Multivariable Cox proportional hazards analysis with restricted cubic splines was used to assess the nonlinear association between number of +LNs and overall mortality (OM). A novel staging system based on number of +LNs was derived by recursive partitioning analysis. The staging system was validated for prediction of OM and prostate-specific mortality in 105,568 men with nonmetastatic prostate cancer undergoing radical prostatectomy from the Surveillance, Epidemiology, and End Results database. Discrimination was assessed via Harrell's c-index. RESULTS: In multivariable Cox analysis, OM risk increased with higher number of +LNs up to 4 (HR 1.30 per each LN+, 95% CI 1.23-1.38), with a nonstatistically significant increase in risk (HR 1.05, 95% CI 0.99-1.11) beyond 4 +LN. In the development cohort, recursive partitioning analysis identified optimal cutoffs at 0 (N0: referent), 1 (N1: HR 1.40, 95% CI 1.25-1.58), 2 (N2: HR 1.67, 95% CI 1.40-1.99), 3-5 (N3a: HR 2.18, 95% CI 0.84-2.60) and ≥6 (N3b: HR 3.00, 95% CI 2.37-3.79) +LNs. In the validation cohort, these groups had markedly different 10-year OM (0+ LNs, N0: 15%; 1+ LN, N1: 35%; 2+ LNs, N2: 43%; 3-5 +LNs, N3a: 52%; and ≥6 +LNs, N3b: 59%; p <0.05) and prostate-specific mortality. The novel staging system improved survival classification over current staging for node-positive patients (optimism-corrected c-index 0.669 [95% CI 0.668-0.671] vs 0.649 [95% CI 0.648-0.651]). CONCLUSIONS: Pathological nodal staging in prostate cancer is improved with stratification by number of +LNs.

Variation in Communication of Competing Risks of Mortality in Prostate Cancer Treatment Consultations.

PURPOSE: Men with prostate cancer prefer patient-specific, quantitative assessments of longevity in shared decision making. We sought to characterize how physicians communicate the 3 components of competing risks-life expectancy (LE), cancer prognosis and treatment-related survival benefit-in treatment consultations. MATERIALS AND METHODS: Conversation related to LE, cancer prognosis and treatment-related survival benefit was identified in transcripts from treatment consultations of 42 men with low- and intermediate-risk disease across 10 multidisciplinary providers. Consensus of qualitative coding by multiple reviewers noted the most detailed mode of communication used to describe each throughout the consultation. RESULTS: Physicians frequently failed to provide patient-specific, quantitative estimates of LE and cancer mortality. LE was omitted in 17% of consultations, expressed as a generalization (eg "long"/"short") in 17%, rough number of years in 31%, probability of mortality/survival at an arbitrary timepoint in 17% and in only 19% as a specific number of years. Cancer mortality was omitted in 24% of consultations, expressed as a generalization in 7%, years of expected life in 2%, probability at no/arbitrary timepoint in 40% and in only 26% as the probability at LE. Treatment-related survival benefit was often omitted; cancer mortality was reported without treatment in 38%, with treatment in 10% and in only 29% both with and without treatment. Physicians achieved "trifecta"-1) quantifying probability of cancer mortality 2) with and without treatment 3) at the patient's LE-in only 14% of consultations. CONCLUSIONS: Physicians often fail to adequately quantify competing risks. We recommend the "trifecta" approach, reporting 1) probability of cancer mortality 2) with and without treatment 3) at the patient's LE.

Competing Risks of Mortality among Men with Biochemical Recurrence after Radical Prostatectomy.

PURPOSE: Men with biochemical recurrence after radical prostatectomy need information on competing risks of mortality to inform prognosis and guide treatment. We quantified the risk of prostate cancer metastasis and mortality, and other cause mortality across key clinical predictors. MATERIALS AND METHODS: We analyzed 1,225 men with biochemical recurrence after radical prostatectomy from 2001 to 2017 in the VA SEARCH database. Multivariable competing risks regression was used to identify predictors and quantify cumulative incidence of metastasis, prostate cancer specific mortality and other cause mortality. Recursive partitioning analysis was used to identify optimum variable cut points for prediction of prostate cancer specific mortality and other cause mortality. RESULTS: During a median followup of 5.6 years after biochemical recurrence (IQR 2.7-9.1), 243 (20%) men died of other causes and 68 (6%) died of prostate cancer. Multivariable competing risks regression showed that high D'Amico tumor risk and prostate specific antigen doubling time at biochemical recurrence less than 9 months were associated with metastasis and prostate cancer specific mortality (p ≤0.001). Ten-year prostate cancer specific mortality was 14% and 9% for those with high risk tumors and prostate specific antigen doubling time less than 9 months, respectively. Advanced age and worse comorbidity were associated with other cause mortality (p ≤0.001). Ten-year other cause mortality was higher among men 70 years old or older with any Charlson comorbidity (1-3+) (40% to 49%) compared to those with none (20%). Recursive partitioning analysis identified optimal variable cut points for prediction of prostate cancer specific mortality and other cause mortality, with 10-year prostate cancer specific mortality ranging from 3% to 59% and 10-year other cause mortality ranging from 17% to 50% across risk subgroups. CONCLUSIONS: Among men with biochemical recurrence after radical prostatectomy, there is significant heterogeneity in prognosis that can be explained by available clinical variables. Men in their 70s with any major comorbidity are 2 to 10 times more likely to die of other causes than of prostate cancer.

External Validation of the Prostate Cancer Specific Comorbidity Index: A Claims Based Tool for the Prediction of Life Expectancy in Men with Prostate Cancer.

PURPOSE: Accurate assessment of life expectancy is critical to treatment decision making in men with prostate cancer. We sought to externally validate the PCCI (Prostate Cancer Comorbidity Index) to predict long-term mortality in men with prostate cancer and make it operational using claims data. MATERIALS AND METHODS: We performed an observational study of 181,009 men with prostate cancer in the Veterans Affairs Health System who were diagnosed from 2000 to 2013. Overall mortality across the PCCI scores was analyzed using Kaplan-Meier and Cox proportional hazards analysis. Discrimination and calibration were measured using the C-index and the mean prediction error, respectively. RESULTS: Among men with a PCCI score of 0, 1-2, 3-4, 5-6, 7-9 and 10 or greater the 10-year overall mortality rate was 15%, 26%, 36%, 41%, 52% and 69%, respectively. Multivariable Cox analysis showed an increasing hazard of mortality with higher PCCI scores, including 1.22 (95% CI 1.18-1.27), 1.69 (95% CI 1.61-1.76), 2.08 (95% CI 2.00-2.17), 2.88 (95% CI 2.76-3.00) and 4.50 (95% CI 4.32-4.69) for a score of 1 to 2, 3 to 4, 5 to 6, 7 to 9 and 10 or greater, respectively. The C-index to predict overall mortality was 0.773. The mean absolute error to predict 10-year overall mortality was 0.032. Of the men with clinically localized disease, Gleason 6 or less with less than 10-year life expectancy and Gleason 7 or less with life expectancy less than 5 years as defined by the PCCI 3,999 of 12,185 (33%) and 1,038 of 3,930 (26%), respectively, underwent definitive local treatment. CONCLUSIONS: The PCCI is a claims based, externally validated tool to predict mortality in men with prostate cancer. Integrating the PCCI into clinical pathways may improve prostate cancer management through more accurate assessment of life expectancy.

SPARED Collaboration: Patient Selection for Partial Gland Ablation in Men with Localized Prostate Cancer.

PURPOSE: The SPARED CRN (Study of Prostate Ablation Related Energy Devices Coordinated Registry Network) is a private-public partnership between academic and community urologists, the FDA (U.S. Food and Drug Administration), the Medical Device Epidemiology Network and device manufacturers to examine the safety and effectiveness of technologies for partial gland ablation in men with localized prostate cancer. MATERIALS AND METHODS: We report on a recent workshop at the FDA with thought leaders to discuss a critical framework for partial gland ablation, focusing on patient selection, surgical planning, followup, study design and appropriate comparators in terms of adverse events and cancer control outcomes. We summarize salient points from experts in urology, oncology and epidemiology that were presented and discussed in an open forum. RESULTS: Given the challenges in achieving patient and physician equipoise to perform a randomized trial, as well as an inherent paradigm shift when comparing partial gland ablation (inability to assess prostate specific antigen recurrence) to whole gland treatments, the group focused on objective performance criteria and goals as a platform to guide the creation of single arm studies in the SPARED CRN. CONCLUSIONS: This summit lays the foundation for prospective, multi-center data collection and evaluation of novel medical devices and drug/device combinations for partial gland ablation.

Association of Social Media Presence with Online Physician Ratings and Surgical Volume Among California Urologists: Observational Study.

BACKGROUND: Urologists are increasingly using various forms of social media to promote their professional practice and attract patients. Currently, the association of social media on a urologists' practice is unknown. OBJECTIVES: We aimed to determine whether social media presence is associated with higher online physician ratings and surgical volume among California urologists. METHODS: We sampled 195 California urologists who were rated on the ProPublica Surgeon Scorecard website. We obtained information on professional use of online social media (Facebook, Instagram, Twitter, blog, and YouTube) in 2014 and defined social media presence as a binary variable (yes/no) for use of an individual platform or any platform. We collected data on online physician ratings across websites (Yelp, Healthgrades, Vitals, RateMD, and UCompareHealthcare) and calculated the mean physician ratings across all websites as an average weighted by the number of reviews. We then collected data on surgical volume for radical prostatectomy from the ProPublica Surgeon Scorecard website. We used multivariable linear regression to determine the association of social media presence with physician ratings and surgical volume. RESULTS: Among our sample of 195 urologists, 62 (32%) were active on some form of social media. Social media presence on any platform was associated with a slightly higher mean physician rating (ß coefficient: .3; 95% CI 0.03-0.5; P=.05). However, only YouTube was associated with higher physician ratings (ß coefficient: .3; 95% CI 0.2-0.5; P=.04). Social media presence on YouTube was strongly associated with increased radical prostatectomy volume (ß coefficient: 7.4; 95% CI 0.3-14.5; P=.04). Social media presence on any platform was associated with increased radical prostatectomy volume (ß coefficient: 7.1; 95% CI -0.7 to 14.2; P=.05). CONCLUSIONS: Urologists' use of social media, especially YouTube, is associated with a modest increase in physician ratings and prostatectomy volume. Although a majority of urologists are not currently active on social media, patients may be more inclined to endorse and choose subspecialist urologists who post videos of their surgical technique.

Development of a Nationally Representative Coordinated Registry Network for Prostate Ablation Technologies.

PURPOSE: The accumulation of data through a prospective, multicenter coordinated registry network is a practical way to gather real world evidence on the performance of novel prostate ablation technologies. Urological oncologists, targeted biopsy experts, industry representatives and representatives of the FDA (Food and Drug Administration) convened to discuss the role, feasibility and important data elements of a coordinated registry network to assess new and existing prostate ablation technologies. MATERIALS AND METHODS: A multiround Delphi consensus approach was performed which included the opinion of 15 expert urologists, representatives of the FDA and leadership from high intensity focused ultrasound device manufacturers. Stakeholders provided input in 3 consecutive rounds with conference calls following each round to obtain consensus on remaining items. Participants agreed that these elements initially developed for high intensity focused ultrasound are compatible with other prostate ablation technologies. Coordinated registry network elements were reviewed and supplemented with data elements from the FDA common study metrics. RESULTS: The working group reached consensus on capturing specific patient demographics, treatment details, oncologic outcomes, functional outcomes and complications. Validated health related quality of life questionnaires were selected to capture patient reported outcomes, including the IIEF-5 (International Index of Erectile Function-5), the I-PSS (International Prostate Symptom Score), the EPIC-26 (Expanded Prostate Cancer Index Composite-26) and the MSHQ-EjD (Male Sexual Health Questionnaire for Ejaculatory Dysfunction). Group consensus was to obtain followup multiparametric magnetic resonance imaging and prostate biopsy approximately 12 months after ablation with additional imaging or biopsy performed as clinically indicated. CONCLUSIONS: A national prostate ablation coordinated registry network brings forth vital practice pattern and outcomes data for this emerging treatment paradigm in the United States. Our multiple stakeholder consensus identifies critical elements to evaluate new and existing energy modalities and devices.

Early Urinary Catheter Removal Following Pelvic Colorectal Surgery: A Prospective, Randomized, Noninferiority Trial.

BACKGROUND: Because of the potential increased incidence of acute urinary retention, optimal timing of urinary catheter removal after major pelvic colorectal surgery remains unclear. OBJECTIVE: This study aims to compare the incidence of urinary retention following early catheter removal on postoperative day 1 vs standard catheter removal on day 3. DESIGN: This is a randomized, noninferiority trial. SETTING: This study was conducted at an urban teaching hospital. PATIENTS: Patients undergoing colorectal surgery below the peritoneal reflection were selected. INTERVENTIONS: A 1:1 randomization to early or standard catheter removal was performed. Patients in the early arm were administered an α-antagonist (prazosin 1 mg oral) 6 hours before catheter removal. MAIN OUTCOME MEASURES: The primary outcome measured was the incidence of acute urinary retention. RESULTS: One hundred forty-two patients were randomly assigned to early (n = 71) or standard (n = 71) catheter removal. Mean age was 44.8 ± 16.9 years, and the study cohort included 54% men. The most common operations were IPAA (66%) and low anterior resection (18%). The overall rate of retention was 9.2% (n = 13), with no difference between early (n = 6; 8.5%) or standard (n = 7; 9.9%) catheter removal (RR, 0.86; 95% CI, 0.30-2.42). The risk difference was -1.4% (95% CI, -8.3 to 11.1), confirming noninferiority. The rate of infection was significantly lower in early vs standard catheter removal (0% vs 11.3%; p = 0.01). Length of stay was significantly shorter after early vs standard catheter removal (4 days, interquartile range = 3-6 vs 5 days, interquartile range = 4-7; p = 0.03). LIMITATIONS: Patients and investigators were not blinded; a nonselective oral α-antagonist was used. CONCLUSIONS: Following pelvic colorectal surgery, early urinary catheter removal, when combined with the addition of an oral α-antagonist, is noninferior to standard urinary catheter removal and carries a lower risk of symptomatic infection and shorter hospital stay. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov (NCT01923129). See Video Abstract at http://links.lww.com/DCR/A738.

Limitations of the National Comprehensive Cancer Network® (NCCN®) Guidelines for Prediction of Limited Life Expectancy in Men with Prostate Cancer.

PURPOSE: National Comprehensive Cancer Network prostate cancer guidelines for the prediction of life expectancy recommend subtracting 50% of life table predicted longevity for those in the lowest quartile of health. However, it is unclear how to identify these men and if their survival is uniform. MATERIALS AND METHODS: We sampled records of 1,482 men diagnosed with prostate cancer from 1998 to 2004 at 2 VA hospitals. We identified men in the lowest quartile of health by age using Charlson scores, calculated their NCCN predicted life expectancy, and compared this with observed median survival in aggregate and across comorbidity subgroups. RESULTS: Men with Charlson scores of 2+ (age less than 75 years) and 3+ (age 75 years or older) comprised the lowest quartile of health. Among those younger than 65, 65 to 69, 70 to 74, 75 to 79 and 80 years or older, observed survival vs NCCN predicted life expectancy in years was similar at 10.4 vs 11.1, 10.0 vs 7.8, 6.2 vs 6.4, 4.4 vs 4.9 and 3.7 vs 3.3, respectively. Yet within the lowest quartile there was significant heterogeneity in survival among men with differing Charlson scores. For example, men age 65 to 69 years with Charlson scores 2, 3 and 4+ had an observed median survival greater than 13.3, 9.4 and 4.3 years, respectively. NCCN guidelines misclassified 10-year life expectancy in 24% and 56% of men age less than 65 and 65 to 69 years, and 5-year life expectancy in 18% of men age 70 to 74 years. CONCLUSIONS: While NCCN predictions matched observed survival on average for the lowest quartile of health, there was substantial heterogeneity in survival by Charlson scores. More granular assessments of life expectancy should be used for those at highest risk for mortality.

Patient function, long-term survival, and use of surgery in patients with kidney cancer.

BACKGROUND: Beyond age and comorbidity, functionality can shape the long-term survival potential of patients with cancer. Accordingly, herein the authors compared mortality and receipt of cancer-directed surgery according to patient function among older adults with kidney cancer. METHODS: Using Surveillance, Epidemiology, and End Results (SEER)-Medicare data from 2000 through 2009, the authors studied 28,326 elderly subjects with primary kidney cancer. Patient function was quantified using function-related indicators, claims indicative of dysfunction and disability. Adjusting for patient and cancer characteristics, competing risk regression was used to assess the relationship between function-related indicator count and cause-specific mortality and then generalized estimating equations were used to quantify the probability of surgery. RESULTS: A total of 13,619 adult patients (48.1%) with at least 1 function-related indicator were identified. A higher indicator category was associated with older age, greater comorbidity, female sex, unmarried status, lower socioeconomic status, and higher stage of disease (P<.001). Compared with patients with an indicator count of 0, those with an indicator count of 1 (hazard ratio, 1.10; 95% confidence interval [95% CI], 1.04-1.16) and ≥2 (hazard ratio, 1.46; 95% CI, 1.39-1.53) were found to have higher other-cause mortality. Conversely, kidney cancer mortality varied minimally with patient function. Patients with ≥ 2 indicators received cancer-directed surgery less often than those without disability (odds ratio, 0.61; 95% CI, 0.56-0.66), although treatment probabilities remained high for patients with locoregional disease and low for those with metastatic cancer. CONCLUSIONS: Among older adults with kidney cancer, functional health stands as a significant predictor of long-term survival. However, receipt of cancer-directed surgery appears largely determined by cancer stage. Patient function should be considered more heavily when determining treatment for older adults with kidney cancer. Cancer 2016;122:3776-3784. © 2016 American Cancer Society.

Use, complications, and costs of stereotactic body radiotherapy for localized prostate cancer.

BACKGROUND: Stereotactic body radiotherapy (SBRT) for localized prostate cancer has potential advantages over traditional radiotherapies. Herein, the authors compared national trends in use, complications, and costs of SBRT with those of traditional radiotherapies. METHODS: The authors identified men who underwent SBRT, intensity-modulated radiotherapy (IMRT), brachytherapy, and proton beam therapy as primary treatment of prostate cancer between 2004 and 2011 from Surveillance, Epidemiology, and End Results Program (SEER)-Medicare linked data. Temporal trend of therapy use was assessed using the Cochran-Armitage test. Two-year outcomes were compared using the chi-square test. Median treatment costs were compared using the Kruskal-Wallis test. RESULTS: A total of 542 men received SBRT, 9647 received brachytherapy, 23,408 received IMRT, and 800 men were treated with proton beam therapy. There was a significant increase in the use of SBRT and proton beam therapy (P<.001), whereas brachytherapy use decreased (P<.001). A higher percentage of patients treated with SBRT and brachytherapy had low-grade cancer (Gleason score ≤ 6 vs ≥ 7) compared with individuals treated with IMRT and proton beam therapy (54.0% and 64.2% vs 35.2% and 49.6%, respectively; P<.001). SBRT compared with brachytherapy and IMRT was associated with equivalent gastrointestinal toxicity but more erectile dysfunction at 2-year follow-up (P<.001). SBRT was associated with more urinary incontinence compared with IMRT and proton beam therapy but less compared with brachytherapy (P<.001, respectively). The median cost of SBRT was $27,145 compared with $17,183 for brachytherapy, $37,090 for IMRT, and $54,706 for proton beam therapy (P<.001). CONCLUSIONS: The use of SBRT and proton beam therapy for localized prostate cancer has increased over time. Despite men of lower disease stage undergoing SBRT, SBRT was found to be associated with greater toxicity but lower health care costs compared with IMRT and proton beam therapy. Cancer 2016;122:2496-504. © 2016 American Cancer Society.

Life Expectancy and Variation in Treatment for Early Stage Kidney Cancer.

PURPOSE: Patients with limited life expectancy are at risk for overtreatment of T1a kidney cancer. We sought to determine patterns of treatment for T1a kidney cancer in a nationally representative sample of patients with life expectancy less than 10 and less than 5 years. MATERIALS AND METHODS: We sampled 9,825 patients older than 65 years with clinical T1a kidney cancer diagnosed between 2000 and 2010 from the SEER (Surveillance, Epidemiology and End Results)-Medicare database. We performed competing risks regression to model survival by age/comorbidity and identified patients with life expectancy less than 10 and less than 5 years. Multivariate logistic regression was used to determine the probability of aggressive treatment with surgery or ablation among those with limited life expectancy. RESULTS: Life expectancy was less than 10 years in patients 66 to 80 years old with a Charlson score of 3+, in those 80 to 84 years old with a Charlson score of 1+ and in all patients 85 years old or older. Among those with life expectancy less than 10 years the multivariate probability of aggressive treatment was 85%, 84%, 82%, 75% and 50% in those 66 to 69, 70 to 74, 75 to 79, 80 to 84 and 85 years old or older, respectively. In those with life expectancy less than 10 years who were treated aggressively treatment was radical nephrectomy in 61%, partial nephrectomy in 24% and ablation in 14%. Among those with life expectancy less than 5 years (age 85 years or greater with a Charlson score of 3+) the multivariate probability of aggressive treatment was 41% and more often surgery than ablation (68% vs 32% of patients). CONCLUSIONS: The majority of patients with life expectancy less than 10 years and a significant minority with life expectancy less than 5 years were treated with surgery or ablation for T1a kidney cancer. Life expectancy should be better incorporated into treatment decision making for early stage kidney cancer.

Quality of diagnostic staging in patients with bladder cancer: a process-outcomes link.

BACKGROUND: Muscle sampling is often used as a surrogate for staging quality in patients with bladder cancer. The association of staging quality at diagnosis and survival was examined among patients with bladder cancer. METHODS: The clinical records of all individuals within the Los Angeles Surveillance, Epidemiology, and End Results registry with an incident diagnosis of non-muscle-invasive bladder cancer in 2004-2005 were reviewed. Patient demographics, tumor characteristics, staging quality (presence of muscle in the specimen and mention of muscle in the pathology report), and vital status were recorded. With mixed-effects and competing-risks regression analyses, the association of patient and tumor characteristics with staging quality and cancer-specific survival was quantified. RESULTS: The sample included 1865 patients, 335 urologists, and 27 pathologists. Muscle was reported to be present in 972 (52.1%), was reported to be absent in 564 (30.2%), and was not mentioned in 329 (17.7%) of the initial pathology reports. The presence of muscle did not differ according to the grade or depth of invasion. Mortality was associated with staging quality (P < .05). Among patients with high-grade disease, the 5-year cancer-specific mortality rates were 7.6%, 12.1%, and 18.8% when muscle was present, absent, and not mentioned, respectively. CONCLUSIONS: The omission of muscle in the specimen or its mention in the pathology report in nearly half of all diagnostic resections was associated with increased mortality, particularly in patients with high-grade disease. Because urologists cannot reliably discern between high- and low-grade or Ta and T1 disease, it is contended that patients with bladder cancer should undergo adequate muscle sampling at the time of endoscopic resection.

An Age Adjusted Comorbidity Index to Predict Long-Term, Other Cause Mortality in Men with Prostate Cancer.

PURPOSE: Accurate estimation of life expectancy is critical for men considering aggressive vs nonaggressive treatment of early stage prostate cancer. We created an age adjusted comorbidity index that predicts other cause mortality in men with prostate cancer. MATERIALS AND METHODS: We sampled 1,598 men consecutively diagnosed with prostate cancer between 1998 and 2004 at West Los Angeles and Long Beach Veterans Affairs hospitals. We used competing risks regression in testing and validation cohorts to determine the risk of nonprostate cancer related (ie other cause) mortality associated with age at diagnosis and PCCI score. We converted risk into a 10-point scoring system and calculated 2, 5 and 10-year cumulative incidence of other cause mortality by age adjusted PCCI scores. RESULTS: PCCI score and age were associated with similar hazards of other cause mortality in the testing and validation cohorts. Each 6-year increase in age at diagnosis of greater than 60 was equivalent to 1 additional PCCI point. After correcting PCCI score for age the age adjusted PCCI scores were strongly predictive of other cause mortality. The subhazard ratio of other cause mortality vs 0 for a score of 0, 1-2, 3-4, 5-6, 7-9 and 10+ was 2.0 (95% CI 1.3-3.0), 4.0 (95% CI 2.6-6.1), 8.7 (95% CI 5.7-13.3), 14.7 (95% CI 9.4-22.8) and 43.2 (95% CI 26.6-70.4), respectively. The 10-year cumulative incidence of other cause mortality was 10%, 19%, 35%, 60%, 79% and 99%, respectively. CONCLUSIONS: The age adjusted PCCI strongly stratifies the risk of long-term, other cause mortality. It may be incorporated into shared decision making to decrease overtreatment of older and chronically ill men with prostate cancer.

Self-Reported Health Status Predicts Other-Cause Mortality in Men with Localized Prostate Cancer: Results from the Prostate Cancer Outcomes Study.

BACKGROUND: Guidelines recommend against treating localized prostate cancer (PCa) in men with a greater than 10-year life expectancy. However, physicians have difficulty accurately estimating life expectancy. OBJECTIVE: We used data from a population-based observational study to develop a nomogram to estimate long-term other-cause mortality based on self-reported health status (SRHS), race/ethnicity, and age at diagnosis. DESIGN: This was an observational study. SUBJECTS: Men diagnosed with localized PCa from October 1994 through October 1995 participated in the study. MAIN MEASURES: Initial measures obtained 6 months after diagnosis included sociodemographic and tumor characteristics, treatment, and a single item on the SRHS, with response options ranging from excellent to poor. We used Surveillance, Epidemiology, and End-Results program data to determine date and cause of death through December 2010. We estimated other-cause mortality with proportional hazards survival analyses, accounting for competing risks. KEY RESULTS: We evaluated 2,695 men, of whom 74% underwent aggressive therapy (surgery or radiotherapy). At the initial survey, 18% reported excellent (E), 36% very good (VG), 31% good (G), and 15% fair/poor (F/P) health. Healthier men were younger, and more likely to be white, better educated, and to undergo surgery. At follow-up, 44% of the cohort had died; 78% of deaths were from causes other than PCa. SRHS predicted other-cause mortality; for men reporting E, VG, G, F/P health, the cumulative incidences of other-cause mortality were 20%, 29%, 40%, and 53%, respectively, p < 0.001. Compared to a reference of excellent SRHS, multivariable hazard ratios (95% CI) for other-cause mortality for men reporting VG, G, and F/P health were 1.22 (0.97-1.54), 1.73 (1.38-2.17), and 2.71 (2.11-3.48), respectively. CONCLUSIONS: Responses to a one-item SRHS measure were strongly associated with other-cause mortality 15 years after PCa diagnosis. Men reporting fair/poor health had substantial risks for other-cause mortality, suggesting limited benefit for undergoing aggressive treatment. SRHS can be considered in supporting informed decision-making about PCa treatment.

Improving Health Care for the Future Uninsured in Los Angeles County: A Community-Partnered Dialogue.

OBJECTIVE: To understand the health care access issues faced by Los Angeles (LA) County's uninsured and residually uninsured after implementation of the Affordable Care Act (ACA) and to identify potential solutions using a community-partnered dialogue. DESIGN: Qualitative study using a community-partnered participatory research framework. SETTING: Community forum breakout discussion. DISCUSSANTS: Representatives from LA County health care agencies, community health care provider organizations, local community advocacy and service organizations including uninsured individuals, and the county school district. MAIN OUTCOME MEASURES: Key structural and overarching value themes identified through community-partnered pile sort, c-coefficients measuring overlap between themes. RESULTS: Five overarching value themes were identified - knowledge, trust, quality, partnership, and solutions. Lack of knowledge and misinformation were identified as barriers to successful enrollment of the eligible uninsured and providing health care to undocumented individuals. Discussants noted dissatisfaction with the quality of traditional sources of health care and a broken cycle of trust and disengagement. They also described inherent trust by the uninsured in "outsider" community-based providers not related to quality. CONCLUSIONS: Improving health care for the residually uninsured after ACA implementation will require addressing dissatisfaction in safety-net providers, disseminating knowledge and providing health care through trusted nontraditional sources, and using effective and trusted partnerships between community and health care agencies with mutual respect. Community-academic partnerships can be a trusted conduit to discuss issues related to the health care of vulnerable populations.

Variation in treatment associated with life expectancy in a population-based cohort of men with early-stage prostate cancer.

BACKGROUND: Men with major comorbidities are at risk for overtreatment of prostate cancer due to uncertainty regarding their life expectancy. We sought to characterize life expectancy and treatment in a population-based cohort of men with differing ages and comorbidity burdens at diagnosis. METHODS: We sampled 96,032 men aged ≥66 years with early-stage prostate cancer who had Gleason scores ≤7 and were diagnosed during 1991 to 2007 from the Surveillance, Epidemiology, and End Results-Medicare database. We calculated cumulative incidence of other-cause mortality and determined treatment patterns among subgroups defined by age and Charlson comorbidity index scores. RESULTS: Overall, life expectancy was <10 years (10-year other-cause mortality rate, >50%) for 50,049 of 96,032 men (52%). Life expectancy differed by age and comorbidity score and was <10 years for men ages 66 to 69 years with Charlson scores ≥2, for men ages 70 to 74 years with Charlson scores ≥1, and for all men ages 75 to 79 years and ≥80 years. Among those who had a life expectancy <10 years, treatment was aggressive (surgery, radiation, or brachytherapy) for 68% of men aged 66 to 69 years, 69% of men aged 70 to 74 years, 57% of men aged 75 to 79 years, and 24% of men aged ≥80 years. Among these men, aggressive treatment was predominantly radiation therapy (50%, 53%, 63%, and 69%, respectively) and less frequently was surgery (30%, 25%, 13%, and 9%, respectively). Multivariate models revealed little variation in the probability of aggressive treatment by comorbidity status within age subgroups despite substantial differences in mortality. CONCLUSIONS: Men aged <80 years at diagnosis who have life expectancies <10 years often receive aggressive treatment for low-risk and intermediate-risk prostate cancer, mostly with radiation therapy.