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Background: Early treatment of hepatocellular carcinoma (HCC) is associated with improved survival, but many patients with HCC do not receive therapy. We aimed to examine factors associated with HCC treatment and survival among incident patients with HCC in a statewide cancer registry. Materials and Methods: All patients with HCC from 2003 through 2013 were identified in the North Carolina cancer registry. These patients were linked to insurance claims from Medicare, Medicaid, and large private insurers in North Carolina. Associations between prespecified covariates and more advanced HCC stage at diagnosis (ie, multifocal cancer), care at a liver transplant center, and provision of HCC treatment were examined using multivariate logistic regression. A Cox proportional hazards model was developed to assess the association between these factors and survival. Results: Of 1,809 patients with HCC, 53% were seen at a transplant center Conclusions: In this population-based cohort of patients with HCC, Medicare/Medicaid insurance, rural residence, and Black race were associated with lower provision of HCC treatment and poorer survival. Efforts should be made to improve access to care for these vulnerable populations.

To estimate the association between provider and team experience and adherence to guidelines, survival, and utilization among colorectal cancer patients in North Carolina.The analysis cohort included 7295 patients diagnosed with incident stage II/III colorectal cancer between 2004 and 2013 who received surgery.Primary outcomes included adherence to guidelines: consultation with a medical oncologist (stage III), receipt of adjuvant chemotherapy (stage III), and receipt of surveillance colonoscopy posttreatment. Secondary outcomes included 5-year overall survival, number of surveillance radiology studies, any unplanned hospitalization, and any emergency department visit. The primary predictors were measures of provider volume and patient sharing across surgeons and medical oncologists. Regression analyses adjusted for patient and provider characteristics.Patients whose surgeons shared40% of their colorectal cancer patients in the previous year with a medical oncologist were (1) more likely to have had a consultation with a medical oncologist [marginal effect (ME)=13.3 percentage points, P-value0.001], (2) less likely to receive a surveillance colonoscopy within 12 months (ME=3.5 percentage points, P-value=0.049), and (3) received more radiology studies (ME=0.254 studies, P-value=0.029). Patients whose surgeon and medical oncologist shared20% of their colorectal cancer patients with each other in the previous year had a higher likelihood of receiving adjuvant chemotherapy (ME=11.5 percentage points, P-value0.001) and surveillance colonoscopy within 12 months (ME=6.7 percentage points, P-value=0.030) and within 18 months (ME=6.2 percentage points, P-value=0.054).Our study shows that team experience is associated with patients' quality of care, survival, and utilization.

BACKGROUND Systematic coding systems are used to define clinically meaningful outcomes when leveraging administrative claims data for research. How and when these codes are applied within a research study can have implications for the study validity and their specificity can vary significantly depending on treatment received. SUBJECTS Data are from the Surveillance, Epidemiology, and End Results-Medicare linked dataset. STUDY DESIGN We use propensity score methods in a retrospective cohort of prostate cancer patients first examined in a recently published radiation oncology comparative effectiveness study. RESULTS With the narrowly defined outcome definition, the toxicity event outcome rate ratio was 0.88 per 100 person-years (95% confidence interval, 0.71-1.08). With the broadly defined outcome, the rate ratio was comparable, with 0.89 per 100 person-years (95% confidence interval, 0.76-1.04), although individual event rates were doubled. Some evidence of surveillance bias was suggested by a higher rate of endoscopic procedures the first year of follow-up in patients who received proton therapy compared with those receiving intensity-modulated radiation treatment (11.15 vs. 8.90, respectively). CONCLUSIONS This study demonstrates the risk of introducing bias through subjective application of procedure codes. Careful consideration is required when using procedure codes to define outcomes in administrative data.

BACKGROUND African American (AA) patients with colon cancer (CC) experience worse outcomes than whites partly due to differential treatment. The National Cancer Institute's Community Clinical Oncology Program (CCOP), a provider-based research network, adopts and diffuses innovative CC treatments quickly. The authors hypothesized that CCOP participation would lessen racial differences in the receipt of oxaliplatin, an innovative treatment for CC, among patients with stage III CC in the community. METHODS Using Surveillance, Epidemiology, and End Results (SEER)-Medicare data, the authors performed a population-based retrospective cohort study of AA and white individuals aged ≥66 years who were diagnosed with AJCC stage III CC from 2003 through 2005. Generalized estimating equations were used to calculate the odds of receiving an oxaliplatin-containing regimen. Predicted probabilities of oxaliplatin receipt for race-CCOP combinations were calculated. The absolute difference in oxaliplatin receipt between races was estimated using the interaction contrast ratio. RESULTS Of 2971 included individuals, 36% received oxaliplatin, 29.5% were CCOP-affiliated, and 7.6% were AA. On multivariate analysis, early diffusion of oxaliplatin was not found to be associated with race or CCOP participation. The probability of receiving oxaliplatin for AAs participating in a CCOP (0.46) was nearly double that of AAs who were not participating in a CCOP (0.25; P

Background: An objective measure is needed to identify frail older adults with cancer who are at increased risk for poor health outcomes. The primary objective of this study was to develop a frailty index from a cancer-specific geriatric assessment (GA) and evaluate its ability to predict all-cause mortality among older adults with cancer. Patients and Methods: Using a unique and novel data set that brings together GA data with cancer-specific and long-term mortality data, we developed the Carolina Frailty Index (CFI) from a cancer-specific GA based on the principles of deficit accumulation. CFI scores (range, 0-1) were categorized as robust (0-0.2), pre-frail (0.2-0.35), and frail (>0.35). The primary outcome for evaluating predictive validity was all-cause mortality. The Kaplan-Meier method and log-rank tests were used to compare survival between frailty groups, and Cox proportional hazards regression models were used to evaluate associations. Results: In our sample of 546 older adults with cancer, the median age was 72 years, 72% were women, 85% were white, and 47% had a breast cancer diagnosis. Overall, 58% of patients were robust, 24% were pre-frail, and 18% were frail. The estimated 5-year survival rate was 72% in robust patients, 58% in pre-frail patients, and 34% in frail patients (log-rank test, P

The development of a more robust observational research data infrastructure would help to address gaps in the evidence base regarding optimal approaches to treating cancer among the growing and complex population of older adults. To demonstrate the feasibility of building such a resource, information from a sample of older adults with cancer was linked using three distinct but complementary data sources. Results are reported to highlight the potential for data linkage to improve the characterization of health status among older adults with cancer and the possibility to conduct passive follow‐up for outcomes of interest over time., Older adults (aged 65 years and older) diagnosed with cancer account for most cancer‐related morbidity and mortality in the United States but are often underrepresented on clinical trials. Recent attention from a variety of professional, research, regulatory, and patient advocacy groups has centered on data linkage and data sharing as a means to capture patient information and outcomes outside of clinical trials to accelerate progress in the fight against cancer. The development of a more robust observational research data infrastructure would help to address gaps in the evidence base regarding optimal approaches to treating cancer among the growing and complex population of older adults. To demonstrate the feasibility of building such a resource, we linked information from a sample of older adults with cancer in North Carolina using three distinct, but complementary, data sources: (a) the Carolina Senior Registry, (b) the North Carolina Central Cancer Registry, and (c) North Carolina fee‐for‐service Medicare claims data. A description of the linkage process, metrics, and characteristics of the final cohort is reported. This study highlights the potential for data linkage to improve the characterization of health status among older adults with cancer and the possibility to conduct passive follow‐up for outcomes of interest over time. Extensions of these linkage efforts in partnership with other institutions will enhance our ability to generate evidence that can inform the management of older adults with cancer.

Survival after sorafenib initiation in newly diagnosed Medicare beneficiaries with hepatocellular carcinoma (HCC) is exceptionally short, suggesting that trial results are not generalizable to all HCC patients. The downsides of sorafenib use—high drug-related symptom burden and high drug cost—must be considered in light of this minimal benefit., Background. Phase III trials show sorafenib improves survival in advanced hepatocellular carcinoma (HCC). Because of narrow trial eligibility, results may not be generalizable to a broader HCC population. We sought to evaluate the effectiveness of initial sorafenib versus no treatment among Medicare beneficiaries with advanced HCC. Materials and Methods. Patients with advanced HCC diagnosed from 2008 to 2011 were identified from the Surveillance, Epidemiology, and End Results–Medicare database. Eligible patients received initial sorafenib or no therapy and were covered by Medicare parts A, B, and D. Sorafenib use and outcomes were described in this population. Using a propensity score (PS)-matched sample, we compared the effectiveness of sorafenib versus no treatment by Cox proportional hazards and binomial regression, using a landmark requiring all patients to survive ≥60 days after diagnosis. Results. Of 1,532 patients, 27% received initial sorafenib. Median duration of sorafenib use was 60 days (interquartile range [IQR], 30–107 days), and median survival from first prescription was 3 months (IQR, 1–8 months). In the PS-matched cohort, median survival was 3 months from the 60-day landmark in sorafenib-treated (n = 223) and 2 months in untreated (n = 223) patients (adjusted hazard ratio, 0.95 [95% confidence interval (CI), 0.78–1.16]). Sorafenib was associated with a nonsignificant reduction in mortality at 3 months (44% versus 51%; adjusted risk ratio, 0.88 [95% CI, 0.72–1.07]), but no reduction thereafter. Conclusion. Survival after sorafenib initiation in newly diagnosed Medicare beneficiaries with HCC is exceptionally short, suggesting trial results are not generalizable to all HCC patients. The downsides of sorafenib use—high drug-related symptom burden and high drug cost—must be considered in light of this minimal benefit. Implications for Practice: The findings of a median survival of only 3 months in Medicare beneficiaries with HCC prescribed sorafenib as first-line therapy highlight the questionable value of sorafenib in this population. Patients should be cautioned that outside of the narrow confines of randomized trials, their life expectancy may be very short, and any benefit of sorafenib is likely to be quite small. Given that sorafenib causes considerable adverse effects and offers no symptom palliation, supportive care should be discussed as a reasonable alternative to sorafenib, particularly for patients who have a poor performance status or advanced cirrhosis.

Background Optimal administration of transarterial chemoembolization (TACE), the standard approach for intermediate-stage hepatocellular carcinoma (HCC), requires clinical and technical expertise. We sought to evaluate whether TACE retains its effectiveness when administered across a broad range of health care settings. Furthermore, as the use of yttrium(90) (Y(90)) radioembolization has been increasing, we explored the comparative effectiveness of Y(90) as an alternative to TACE. Methods Patients with HCC diagnosed from 2004 through 2009 treated initially with TACE or Y(90) were identified from the SEER-Medicare linkage. Key covariates included prediagnosis α-fetoprotein (AFP) screening, complications of cirrhosis, and tumor extent. Effect of treatment, patient, and health care system factors on overall survival (OS) was evaluated using multivariable Cox proportional hazards. Stratified OS estimates are provided. Propensity score (PS) weighting was used to compare effectiveness of Y(90) with TACE. Results Of 1528 patients who underwent intra-arterial embolization, 577 received concurrent chemotherapy (eg, TACE). Median OS was 21 months (95% CI, 18-23) following TACE and 9 months (95% CI, 1-41) following Y(90). Refined survival estimates stratified by stage, AFP screening, and liver comorbidity are presented. The 90-day mortality rate after TACE was 21% to 25% in patients with extrahepatic spread or vascular invasion. In the PS-weighted analysis, Y(90) was associated with inferior survival, with an adjusted hazard ratio of 1.39 (95% CI, 1.02-1.90). Conclusions The effectiveness of TACE is generalizable to Medicare patients receiving care in a variety of treatment settings. However, early posttreatment mortality is high in patients with advanced disease. We found no evidence of improved outcomes with Y(90) compared with TACE. Survival estimates from this large cohort can be used to provide prognostic information to patients considering palliative TACE.

10033 Background: Our ability to optimize the care of older adults with cancer and comorbid illnesses is insufficient as most clinical trials lack systematic measurement of comorbidities. The primary purpose of this study was to evaluate the prevalence and impact of patient-reported comorbidity on survival using various comorbidity scoring algorithms. Methods: We utilized a unique linkage of the Carolina Senior Registry, an institutional registry (NCT01137825) that contains geriatric assessment data, with the North Carolina Central Cancer Registry to obtain mortality data. Comorbidity was assessed using a patient-reported version of the Older Americans Resources and Services Questionnaire (OARS) Physical Health subscale that includes information regarding 13 specific comorbid conditions and the degree to which each impairs function (“not at all” to “a great deal”). Multivariable Cox proportional hazard regression models were used to evaluate the association between comorbidities and all-cause mortality. Results: 539 patients were successfully linked to mortality data. Median age 72, 72% female, 85% Caucasian, 47% breast cancer, and 12% lung cancer. 92% of participants reported at least one comorbid condition, mean of 2.7 conditions (range 0-10), with arthritis and hypertension the most common (52 and 50%, respectively). 62% of patients with a comorbid illness reported a functional limitation related to comorbidity. Both the presence of 3 or more total comorbidities (hazard ratio (HR) 1.44, CI 1.08-1.92) and 2 or more comorbidities impacting function (HR 1.46, CI 1.09-1.95) increased mortality. After adjusting for age, cancer type, and stage, the risk of death increased 12% for each comorbid condition impacting function (HR 1.12, CI 1.02-1.24), but did not significantly increase for the number of comorbid conditions alone (HR 1.07, CI 0.99-1.15). Conclusions: Comorbid conditions in older adults with cancer are highly prevalent, frequently impair function, and impact survival. Comorbid conditions that impair function have a greater impact on survival than the presence of comorbidity alone. Comorbidity assessment should be incorporated in clinical trials and can be measured via a simple one-page patient-reported questionnaire.

Objective This study characterizes the surgical oncology workforce as a baseline for future workforce projections. Background Measuring the capacity of the surgical oncology workforce is difficult due to the wide variety of surgeons who contribute to surgical cancer care. We hypothesize that the bulk of surgical oncology care is provided by general surgeons. Methods Using Medicare claims data linked to the North Carolina Central Cancer Registry, all patients 65 years or older who had a diagnosis of incident cancer of the bladder, breast, colon/rectum, esophagus, gallbladder, kidney, liver, lung, skin (melanoma-only), ovary, pancreas, prostate, small bowel, stomach, or uterus in 2005 and who underwent an extirpative procedure for cancer were identified. The proportion of procedures performed by different types of providers was examined. Results A total of 7759 patients underwent 16,734 extirpative surgical procedures. Excluding procedures for gynecologic/urologic malignancies, the proportion of procedures performed by general surgeons and surgical oncologists was 48% and 12%, respectively. Patients treated by general surgeons were more likely to be older, female, minority, and from areas of high poverty. For each tumor type, travel distances were shorter for patients treated by general surgeons than those treated by specialists. Conclusions Workforce projections must account for the significant overlap in the scope of services delivered by providers of different specialties and for the large contribution of general surgeons to cancer care. Efforts to improve the quality of cancer care need to move beyond centralization and focus on educating the surgeons who are providing the bulk of oncology care.

Context There has been rapid adoption of newer radiation treatments such as intensity-modulated radiation therapy (IMRT) and proton therapy despite greater cost and limited demonstrated benefit compared with previous technologies. Objective To determine the comparative morbidity and disease control of IMRT, proton therapy, and conformal radiation therapy for primary prostate cancer treatment. Design, Setting, and Patients Population-based study using Surveillance, Epidemiology, and End Results–Medicare-linked data from 2000 through 2009 for patients with nonmetastatic prostate cancer. Main Outcome Measures Rates of gastrointestinal and urinary morbidity, erectile dysfunction, hip fractures, and additional cancer therapy. Results Use of IMRT vs conformal radiation therapy increased from 0.15% in 2000 to 95.9% in 2008. In propensity score–adjusted analyses (N = 12 976), men who received IMRT vs conformal radiation therapy were less likely to receive a diagnosis of gastrointestinal morbidities (absolute risk, 13.4 vs 14.7 per 100 person-years; relative risk [RR], 0.91; 95% CI, 0.86-0.96) and hip fractures (absolute risk, 0.8 vs 1.0 per 100 person-years; RR, 0.78; 95% CI, 0.65-0.93) but more likely to receive a diagnosis of erectile dysfunction (absolute risk, 5.9 vs 5.3 per 100 person-years; RR, 1.12; 95% CI, 1.03-1.20). Intensity-modulated radiation therapy patients were less likely to receive additional cancer therapy (absolute risk, 2.5 vs 3.1 per 100 person-years; RR, 0.81; 95% CI, 0.73-0.89). In a propensity score–matched comparison between IMRT and proton therapy (n = 1368), IMRT patients had a lower rate of gastrointestinal morbidity (absolute risk, 12.2 vs 17.8 per 100 person-years; RR, 0.66; 95% CI, 0.55-0.79). There were no significant differences in rates of other morbidities or additional therapies between IMRT and proton therapy. Conclusions Among patients with nonmetastatic prostate cancer, the use of IMRT compared with conformal radiation therapy was associated with less gastrointestinal morbidity and fewer hip fractures but more erectile dysfunction; IMRT compared with proton therapy was associated with less gastrointestinal morbidity.

Background Despite increasing recognition of the significance of learning from errors, little is known about how learning climate contributes to error reduction. Objectives The purpose of this study was to investigate whether learning climate moderates the relationship between error-producing conditions and medication errors. Methods A cross-sectional descriptive study was done using data from 279 nursing units in 146 randomly selected hospitals in the United States. Error-producing conditions included work environment factors (work dynamics and nurse mix), team factors (communication with physicians and nurses' expertise), personal factors (nurses' education and experience), patient factors (age, health status, and previous hospitalization), and medication-related support services. Poisson models with random effects were used with the nursing unit as the unit of analysis. Results A significant negative relationship was found between learning climate and medication errors. It also moderated the relationship between nurse mix and medication errors: When learning climate was negative, having more registered nurses was associated with fewer medication errors. However, no relationship was found between nurse mix and medication errors at either positive or average levels of learning climate. Learning climate did not moderate the relationship between work dynamics and medication errors. Discussion The way nurse mix affects medication errors depends on the level of learning climate. Nursing units with fewer registered nurses and frequent medication errors should examine their learning climate. Future research should be focused on the role of learning climate as related to the relationships between nurse mix and medication errors.

We examined the extent to which studies aimed at testing interventions to improve antiretroviral adherence have targeted the facilitators of and barriers known to affect adherence. Of the 88 reports reviewed, 41 were reports of descriptive studies conducted with U.S. HIV-positive women and 47 were reports of intervention studies conducted with U.S. HIV-positive persons. We extracted from the descriptive studies all findings addressing any factor linked to antiretroviral adherence and from the intervention studies, information on the nature of the intervention, the adherence problem targeted, the persons targeted for the intervention, and the intervention outcomes desired. We discerned congruence between the prominence of substance abuse as a factor identified in the descriptive studies as a barrier to adherence and its prominence as the problem most addressed in those reports of intervention studies that specified the problems targeted for intervention. We also discerned congruence between the prominence of family and provider support as factors identified in the descriptive studies as facilitators of adherence and the presence of social support as an intervention component and outcome variable. Less discernible in the reports of intervention studies was specific attention to other factors prominent in the descriptive studies, which may be due to the complex nature of the problem, individualistic and rationalist slant of interventions, or simply the ways interventions were presented. Our review raises issues about niche standardization and intervention tailoring, targeting, and fidelity.

e15131 Background: TACE is standard initial therapy for patients (pts) with intermediate stage HCC. Nonrandomized comparisons from specialty centers suggest Y90 may be as effective as TACE but adequately powered studies in similar risk pts have not been conducted. We sought to examine the comparative effectiveness of TACE vs Y90 in routine care settings. Methods: Pts diagnosed with HCC from 2004-2009 treated initially with TACE or Y90 were identified from SEER-Medicare, including pts eligible on the basis of disability. Key covariates included age, diagnoses for complications and cause of cirrhosis, stage. Treatment was determined from procedure codes. Multilevel Poisson models clustered by hospital compared frequency of emergency room (ER) visits and hospital admissions ≤90 days from treatment. Survival (OS) in the entire cohort was compared using multivariable Cox proportional hazards. We used PS weighting to compare the relative risk (RR) of mortality of Y90 to TACE among pts with similar risk as those...

6531 Background: Readmission rates after major cancer surgery are high (20-45%). Many patients are readmitted to a hospital different than where surgery was performed. We hypothesize that readmissi...

3 Background: Comparative effectiveness research is urgently needed in prostate cancer because of the rapid adoption of newer and costlier radiation treatments such as IMRT and PT despite limited demonstrated benefit compared to prior technologies. We compared the morbidity and disease control outcomes of IMRT, PT and the older CRT for primary prostate cancer treatment. Methods: Population-based study using Surveillance, Epidemiology, and End Results (SEER)-Medicare linked data from 2000 through 2009 for patients with non-metastatic prostate cancer. Propensity score adjustment was used to balance demographic, disease and institutional characteristics. Rates of morbidity (gastrointestinal, urinary, erectile dysfunction, hip fractures) and additional cancer therapy (surrogate for recurrence) were calculated. Results: IMRT use increased from 0.15% in 2000 to 95.9% in 2008. In propensity score-adjusted analyses, men who received IMRT vs. CRT were less likely to be diagnosed with GI morbidity (13.4 vs. 14.7 per 100 person-years, p Conclusions: IMRT vs. CRT was associated with less GI morbidity and hip fractures, more erectile dysfunction, and less need for additional cancer therapy. This large-scale population-based study is the first to suggest a simultaneous reduction in disease recurrence and morbidity in patients treated with IMRT vs. CRT for localized prostate cancer. Proton therapy did not significantly improve outcomes compared to IMRT, but had increased GI morbidity. These results provide new and long-needed information to decision-makers regarding the currently available evidence on the comparative effectiveness of different RT techniques.