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PURPOSE Adjuvant endocrine therapy (ET) can reduce the risk of recurrence among females with hormone receptor-positive breast cancer. Overall, initiation and adherence to ET are suboptimal, though reasons are not well described. The study's objective was to better understand ET decision making, prescribing, and patient management from oncology providers' perspectives. METHODS Using purposive sampling, we recruited oncology providers who saw five or more breast cancer patients per week (n=20). We conducted 30-45-minute telephone interviews, using a semistructured guide to elicit perspectives on ET use. We used thematic content analysis to systematically identify categories of meaning and double-coded transcripts using Atlas.ti. RESULTS Providers recommend ET to all eligible patients except those with contraindications or other risk factors. Providers base their ET prescribing decisions on the patient's menopausal status, side effects, and comorbidities. ET is typically discussed multiple times: at the onset of breast cancer treatment and in more detail after other treatment completion. Providers felt that the associated recurrence risk reduction is the most compelling argument for patients during ET decision making. While providers rarely perceived noninitiation as a problem, nonadherence was prevalent, often due to unresolvable side effects. CONCLUSION From the clinicians' perspectives, side effects from ET are the dominant factor in nonadherence. Efforts to improve adherence should focus on strategies to minimize side effects and ensure clinicians and patients are well informed regarding optimal side effect management. This finding has important implications for novel endocrine regimens that offer improved outcomes through longer duration or more intensive therapy.

Although racial disparities in health-related quality of life (HRQOL) among women with breast cancer (BC) are well documented, less is known about HRQOL changes over time among women of different races. Our objective was to assess racial differences in HRQOL during active treatment and survivorship phases of BC care. We used data from the third phase of the Carolina Breast Cancer Study (CBCS-III). CBCS-III enrolled 3000 women in North Carolina aged 20–74 years diagnosed with BC between 2008 and 2013. HRQOL assessments occurred 5 and 25 months post diagnosis, representing distinct phases of care. HRQOL measures included the Functional Assessment of Cancer Therapy for BC and Functional Assessment of Chronic Illness Therapy for Spiritual Well-Being. Analysis of covariance models were employed to assess racial differences in changes in HRQOL. The cohort included 2142 Non-Hispanic White (n = 1105) and Black women (n = 1037) who completed both HRQOL assessments. During active treatment, Whites reported physical and functional scores 2–2.5 points higher than Blacks (p

Oncotype DX testing (ODX), a tumor gene expression test, may improve breast cancer care, however, communicating results remains challenging. We identified patient-centered communication strategies/gaps for discussing ODX results. We applied a patient-centered communication framework to analyze qualitative interviews with oncologists about how they communicate about ODX with patients, using template analysis in Atlas.ti. Overall, providers discussed four patient-centered communication domains: exchanging information, assessing uncertainty, making decisions and cross-cutting themes. Providers did not report discussing emotional aspects of managing uncertainty, assessing decision-making preferences, and evaluating decisions. A patient-centered approach may be a model for communicating about tumor gene expression tests.

Racial minority cancer patients may experience underuse of antiemetic medications to prevent chemotherapy-induced nausea and vomiting (CINV). In addition to its adverse implications for quality of life, antiemetic underuse may contribute to observed disparities in acute illness during chemotherapy. To understand the potential contribution of CINV prophylaxis to breast cancer disparities, we assessed racial variation in potent antiemetic use and post-chemotherapy utilization related to CINV and the relationship between the two.We used SEER-Medicare data to evaluate the health care utilization in the 14 days following chemotherapy initiation among black and white women receiving highly emetogenic chemotherapy for breast cancer. We used modified Poisson regression to assess the relationship between (1) race and CINV-related utilization and (2) NK1 use and CINV-related utilization, overall and stratified by race. We report adjusted risk ratios (aRR) and 95 % confidence intervals (CI).The study included 1130 women. Black women were 11 % less likely than white women to use neurokinin-1 receptor antagonists (NK1s) for CINV prophylaxis (p = 0.02); however, they experienced fewer CINV-related encounters following chemotherapy (unadjusted RR = 0.63, 95 %CI = 0.40-0.99; p = 0.05). After adjustment for clinical covariates, estimates were similar but no longer statistically significant (p = 0.07). Among white women, NK1 use was associated with increased CINV-related utilization (aRR NK1 users vs. non-users: 1.35, 95 % CI = 1.07-1.69, p = 0.01), likely resulting from unmeasured confounders.Black women were less likely to use NK1s- and CINV-related services. Racial variation in CINV-related services use may be partly explained by differential symptom reporting or access to care.

Chemotherapy-induced nausea and vomiting (CINV) is a major concern for cancer patients and, if uncontrolled, can seriously compromise quality of life (QOL) and other treatment outcomes. Because of the expense of antiemetic medications used to prevent CINV (particularly oral medications filled through Medicare Part D), disparities in their use may exist. We used 2006–2012 SEER-Medicare data to evaluate the use of neurokinin-1 receptor antagonists (NK1s), a potent class of antiemetics, among black and white women initiating highly emetogenic chemotherapy for the treatment of early-stage breast cancer. We used modified Poisson regression to assess the relationship between race and (1) any NK1 use, (2) oral NK1 (aprepitant) use, and (3) intravenous NK1 (fosaprepitant) use. We report adjusted risk ratios (aRR) and 95 % confidence intervals (CI). The study included 1130 women. We observed racial disparities in use of any NK1 (aRR: 0.68, 95 % CI 0.51–0.91) and in use of oral aprepitant specifically (aRR: 0.54, 95 % CI 0.35–0.83). We did not observe disparities in intravenous fosaprepitant use. After controlling for variables related to socioeconomic status, disparities in NK1 and aprepitant use were reduced but not eliminated. We found racial disparities in women’s use of oral NK1s for the prevention of CINV. These disparities may be partly explained by racial differences in socioeconomic status, which may translate into differential ability to afford the medication.

292 Background: Chemotherapy-induced nausea and vomiting (CINV) is a major concern for cancer patients and, if uncontrolled, it can have serious implications for patients’ treatment outcomes, including quality of life. Guidelines recommend the use of an NK1 receptor antagonist to prevent CINV among patients beginning chemotherapy with a high risk of causing the side effect. However, barriers to use of oral NK1s (i.e., aprepitant) exist. In many cases, patients are required to fill a prescription for aprepitant at their home pharmacy. As well, the drug is expensive, costing over $500 under Medicare Part D, and patients may be responsible for a large portion of that cost. These barriers may contribute to racial disparities as they disproportionately affect minority patients. Methods: We used 2006-2012 SEER-Medicare data to evaluate the use of NK1s among black and white women initiating adjuvant chemotherapy with an anthracylcline and cyclophosphamide for early-stage breast cancer. NK1 use during the first chemotherapy cycle was measured using Medicare Part D and Part B claims. We used modified Poisson regression to assess the relationship between race and (1) any NK1 use, (2) oral NK1 (aprepitant) use, and (3) intravenous NK1 (fosaprepitant) use. We report adjusted risk ratios (aRR) and 95% confidence intervals (CI). Results: Of 1,015 eligible women (911 white; 104 black), 38% of white and 28% of black women received any NK1 at the start of their chemotherapy regimen. In adjusted analyses, black women were 30% less likely than white women to receive any NK1 (aRR black vs. white: 0.70, 95% CI: 0.52-0.94). This disparity was driven by a 44% gap in orally administered NK1s (aprepitant) (aRR: 0.56 95% CI: 0.35-0.89). We did not observe disparities in intravenous fosaprepitant use (aRR: 0.77, 95% CI: 0.46-1.28, NS). After controlling for variables related to socioeconomic status, disparities in NK1 and aprepitant use were reduced but not eliminated. Conclusions: Our study found racial disparities in women’s use of oral NK1s for the prevention of CINV. These disparities may be partly explained by racial differences in women’s ability to afford the medication.

Purpose Trastuzumab is a key component of adjuvant therapy for stage I to III human epidermal growth factor receptor 2 (HER2)–positive breast cancer. The rates and patterns of trastuzumab use have never been described in a population-based sample. The recent addition of HER2 information to the SEER-Medicare database offers an opportunity to examine patterns of trastuzumab use and to evaluate possible disparities in receipt of trastuzumab. Methods We examined a national cohort of Medicare beneficiaries with incident stage I to III HER2-positive breast cancer diagnosed in 2010 and 2011 (n = 1,362). We used insurance claims data to track any use of trastuzumab in the 12 months after diagnosis as well as to identify chemotherapy drugs used in partnership with trastuzumab. We used modified Poisson regression analysis to evaluate the independent effect of race on likelihood of receiving trastuzumab by controlling for clinical need, comorbidity, and community-level socioeconomic status. Results Overall, 50% of white women and 40% of black women received some trastuzumab therapy. Among women with stage III disease, 74% of whites and 56% of blacks received trastuzumab. After adjustment for tumor characteristics, poverty, and comorbidity, black women were 25% less likely to receive trastuzumab within 1 year of diagnosis than white women (risk ratio, 0.745; 95% CI, 0.60 to 0.93). Conclusion Approxemately one half of patients 65 years of age and older with stage I to III breast cancer do not receive trastuzumab-based therapy, which includes many with locally advanced disease. Significant racial disparities exist in the receipt of this highly effective therapy. Further research that identifies barriers to use and increases uptake of trastuzumab could potentially improve recurrence and survival outcomes in this population, particularly among minority women.

Background: Insurance may lengthen or inhibit time to follow-up after positive screening mammography. We assessed the association between insurance status and time to initial diagnostic follow-up after a positive screening mammogram.Methods: Using 1995–2010 data from a North Carolina population-based registry of breast imaging and cancer outcomes, we identified women with a positive screening mammogram. We compared receipt of follow-up within 60 days of screening using logistic regression and evaluated time to follow-up initiation using Cox proportional hazards regression.Results: Among 43,026 women included in the study, 73% were Conclusions: We found differences in time to initial diagnostic follow-up after a positive screening mammogram by insurance status and age group. Uninsured women younger than 65 years at a positive screening event had delayed follow-up.Impact: Replication of these findings and examination of their clinical significance warrant additional investigation. Cancer Epidemiol Biomarkers Prev; 25(11); 1474–82. ©2016 AACR.

32 Background: Recent data suggest that the adverse financial impact of cancer is an underappreciated source of potential harm to patients, also known as “financial toxicity”. Little is known about the financial impact of cancer in patients with widespread, incurable disease, despite the relatively high cost of their care. We conducted a national survey of patients with metastatic breast cancer to address this gap. Methods: We partnered with the Metastatic Breast Cancer Network to field an online survey of metastatic breast cancer patients over a fourteen-day period using Qualtrics. The survey required approximately 20 minutes to complete, and participants were offered a $10 Amazon gift card. Survey items included sociodemographic information, health insurance status, cost-related communication with providers, post-treatment financial burden, financial coping strategies, and emotional well-being. We report financial outcomes stratified by health insurance status, as insurance is an important protective mechanism against health-related financial shocks. Results: 1,513 participants responded from 41 states. More than a third of these women (35%) were uninsured. Uninsured individuals more often reported refusing or delaying treatment due to cost (98% vs. 41% of insured, p < .001) and were also more likely to report skipping non-medical bills (40% vs. 16%, p < .001), stopping work after diagnosis (65% vs. 46%, p < .001), or being contacted by a collections agency (77% vs. 36%, p < .001). Despite this, insured participants reported higher cost-related emotional distress, including being “quite a bit” or “very” stressed about not knowing cancer costs (53% vs. 32%, p < .001) and about financial stress on their family due to their cancer (52% vs. 27%, p < .001). Conclusions: Metastatic breast cancer patients reported an unprecedented level of cancer-related financial harm and significant worry about the financial legacy left behind in the wake of their illness. Health insurance expansion is a necessary, but insufficient strategy to address this financial burden; additional interventions to prevent and mitigate cancer-related financial harm are urgently needed.

114 Background: Cancer-related financial burden is a growing problem that has been linked to psychosocial distress, treatment delays and non-adherence, and excess mortality risk. Comprehensive cancer centers often provide financial support resources to mitigate financial burden, but the scope of these services and the processes involved are poorly understood. We conducted an in-depth qualitative analysis of key health system stakeholders to understand these processes and identify areas for improvement. Methods: Semi-structured interviews were conducted with 12 stakeholders involved in the financial assistance process at a public comprehensive cancer center. Interviews elicited descriptions of programs, perceived strengths and weakness, and the stakeholders' roles in helping patients obtain financial assistance. A codebook was developed inductively and interviews were coded in duplicate, with codes added as new themes emerged. Coded data were used to develop and revise a system-wide process map of financial support resources. Results: Stakeholders described numerous resources for financial assistance, both internal (e.g., Charity Care) and external (e.g., manufacturer assistance). Although participants described feeling pride at helping patients obtain assistance, numerous barriers were identified, including delays in processing applications, duplicative processes, insufficient time to address patients' concerns, lack of dedicated staff to address the complexity of navigating resources, and perception that existing resources are inadequate to meet patient needs. Conclusions: Processes required to obtain financial support for cancer patients often place a high administrative burden on patients who must proactively seek resources, understand complex eligibility criteria and complete multiple, often overlapping applications, even within comprehensive cancer center environments. Dedicated financial navigators may assist patients in accessing existing available resources, and health systems should consider moving beyond patient-activated pathways of access to financial support to avoid exacerbating disparities for the most vulnerable patients.

Black women suffer from a persistent disparity in breast cancer mortality after controlling for prognostic and sociodemographic factors, suggesting that differential receipt or efficacy of treatment may contribute to their poorer outcomes. Black women are more likely to experience delays in diagnostic workup and initiation of treatment, but it is not known whether i) timeliness of subsequent care is also impacted, and ii) racial disparities in time to treatment initiation and completion persist among black and white women with comparable clinical and sociodemographic characteristics. The Carolina Breast Cancer Study Phase III is a large population-based cohort of North Carolina women newly diagnosed with breast cancer. This study was restricted to black and white women undergoing surgery for the treatment of nonmetastatic disease. We investigated mean differences in the distribution of time from diagnosis to earliest surgery, chemotherapy, or radiation treatment (treatment initiation) and once started, time to treatment completion (treatment duration) by race. Only treatment-oriented surgeries excluding biopsies were included in this analysis, and last or definitive surgery was defined as the final treatment-oriented surgery occurring prior to recurrence and within 18 months of diagnosis. Cumulative incidence curves were used to graphically examine the distributions of time to treatment initiation and treatment duration, and general linear models were used to estimate crude and adjusted mean differences in time to treatment initiation and duration between black and white women. We also conducted stratified analyses to examine racial disparities by age and stage at diagnosis, hormone receptor (HR) and human epidermal growth factor receptor 2 (HER2) positivity, treatment pathway (surgery only, surgery plus chemotherapy, surgery plus radiation, or all three modalities), marital status, education level, income, and insurance type. A total of 1,328 black and 1,331 white women met study inclusion criteria. Overall, black women had an average of 3.68 additional days to treatment initiation and 34.26 days longer treatment duration than white women, for 37.94 days longer total treatment time (95% confidence interval (CI): 34.21-41.67). Adjustment for clinical and sociodemographic factors resulted in a greater estimated mean difference in time to initiate treatment (4.04 days, 95% CI: 3.08-5.00), while it attenuated the mean difference in treatment duration towards the null (9.07 days, 95% CI: 6.82-11.32). Black women experienced significantly longer time to initiate treatment and treatment duration in nearly every stratum of clinical or sociodemographic factor examined. Black women with stage II or III tumors had significantly longer time to initiate treatment than white women (4.50 and 7.84 days, respectively), and after starting treatment, treatment duration was approximately 25 days longer for black women with stage I and II disease. Black women undergoing radiation and/or chemotherapy had longer time to initiate treatment and significantly longer treatment durations. Having a college education or higher or being insured through Medicaid were associated with the greatest mean differences in time to treatment initiation comparing black and white women. Younger age at diagnosis, HR+ or HER2- disease, being unmarried, having less than a high school education, and being uninsured were associated with the greatest mean differences in treatment duration by race. Overall, black women experienced longer intervals between diagnosis and treatment initiation and greater treatment durations after controlling for clinical and sociodemographic factors. Racial disparities were more pronounced in examination of treatment duration, suggesting that interventions to improve care coordination and timeliness should be targeted at high-risk groups. Citation Format: Sophie E. Mayer, Melissa Troester, Stephanie B. Wheeler, Andrew Olshan, Lisa A. Carey, Jessica Tse, Katherine E. Reeder-Hayes. Temporal patterns of breast cancer treatment initiation and completion among black and white women in the Carolina Breast Cancer Study [abstract]. In: Proceedings of the Tenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2017 Sep 25-28; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2018;27(7 Suppl):Abstract nr PR11.

544Background: Pt-reported outcomes reflect toxicity of anticancer drugs, and can be measured using “moderate, severe or very severe” ratings (MSVS) that mirror physician-assessed CTCAE grades 2-4....

e13581Background: A variety of patient factors have been shown to affect breast cancer risk and prognosis. Recent studies have suggested that these factors may also be associated with quantitative ...

546Background: CRx completion is essential to Tx effectiveness and may depend on pt-reported toxicities rated “moderate, severe or very severe” (MSVS) that mirror physician-assessed CTCAE grades 2-...

154 Background: Compared to their White counterparts, Hispanic women with breast cancer are more likely to report pain, depression, and other mental health concerns. As such, this group may benefit from supportive medication use following diagnosis. However, little is known about their uptake of supportive medication, relative to White patients. In particular, it is unknown if this varies by nativity. This study’s objectives were to assess supportive medication use and investigate potential disparities in use by ethnicity/nativity. Methods: We used the Surveillance, Epidemiology and End Results data linked with Medicare claims to identify women 65+ years diagnosed with incident breast cancer between July 1, 2007 and December 31, 2011. Use of supportive medications (defined as opioid pain and non-opioid psychotropic medications) within 90 days of diagnosis was the primary outcome. We categorized ethnicity/nativity as U.S-Born Non-Hispanic, U.S-Born Hispanic, Foreign-Born Non-Hispanic, and Foreign-Born Hispanic. Poisson models were used to examine associations between ethnicity/nativity and supportive medication use, adjusting for tumor, treatment, and demographic characteristics. We estimated adjusted risk ratios and 95% confidence intervals for all estimates. Results: This study included 23,091 women, of whom 88% were U.S-Born Non-Hispanics, 4% U.S-Born Hispanics, 6% Foreign-Born Non-Hispanics, and 2% Foreign-Born Hispanics. We observed significant adjusted differences in supportive medication use by ethnicity/nativity. Compared to US-Born Non-Hispanics, Foreign-Born Hispanics and Non-Hispanics were 5% (95% CI 0.92-0.98, p = 0.005) and 10% (95% CI 0.85-0.96, p = 0.0005) less likely to receive supportive medications, respectively. U.S-Born Hispanics were 5% (95% CI 1.02-1.09) more likely to receive supportive medications. Conclusions: This work highlights potential disparities in supportive care, and the need to address the psychosocial needs of Foreign-Born women to improve the equity of breast cancer care. Future studies should explore if differences observed in this study are reflective of true health disparities or differential patient preferences.

Decision-making about advanced cancer treatment is complex and may be influenced by patients' family context, including the presence of children. We explored how parental values and concerns motivate patients' preferences about aggressiveness of advanced cancer treatment as well as preferences for palliative care and hospice services.We conducted semi-structured interviews with 42 patients with advanced cancer who had at least one child under 18 years. We created and applied thematic codes. Descriptive analyses were used to report the number of participants who mentioned each code.The majority of participants (29/42) reported that having children influenced their preferences for advanced cancer care. For most parents, extending life to maximize the time they had left to parent their children was important in guiding treatment preferences. Others prioritized preserving their physical condition and parental functioning and remaining physically close to their children. Many parents discussed life extension and parental functioning preservation as competing priorities. Most of the sample expressed interest in palliative care services and hospice, but responses by several participants reflected concerns about dying at home and lack of clarity about the role of early palliative care.Parents in our sample expressed that maximizing time with their children and preserving parental functioning were important concerns underlying their preferences for advanced cancer care. Future research should assess the palliative and end-of-life care needs and preferences of parents with advanced cancer, which may differ from those of non-parents. Copyright © 2016 John WileySons, Ltd.

It is unknown whether racial differences exist in adjuvant chemotherapy initiation among women with similar oncotype DX (ODX) risk scores. We examined whether adjuvant chemotherapy initiation varied by race. Data come from the Phase III, Carolina Breast Cancer Study, a longitudinal, population-based study of North Carolina women diagnosed with breast cancer between 2008 and 2014. We used modified Poisson regression and report adjusted relative risk (aRR) and 95 % confidence intervals (95 %CI) to estimate the association between race and adjuvant chemotherapy initiation across ODX risk groups among women who received the test (n = 541). Among women who underwent ODX testing, 54.2, 37.5, and 8.3 % of women had tumors classified as low-, intermediate-, and high-risk groups, respectively. We observed no racial variation in adjuvant chemotherapy initiation. Increasing ODX risk score (aRR = 1.39, 95 %CI = 1.22, 1.58) and being married (aRR = 2.92, 95 %CI = 1.12, 7.60) were independently associated with an increased likelihood of adjuvant chemotherapy in the low-risk group. Among women in the intermediate-risk group, ODX risk score (aRR = 1.15, 95 %CI = 1.11, 1.20), younger age (aRR = 1.95, 95 %CI = 1.35, 2.81), larger tumor size (aRR = 1.70, 95 %CI = 1.22, 2.35), and higher income were independently associated with increased likelihood of adjuvant chemotherapy initiation. No racial differences were found in adjuvant chemotherapy initiation among women receiving ODX testing. As treatment decision-making becomes increasingly targeted with the use of genetic technologies, these results provide evidence that test results may drive treatment in a similar way across racial subgroups.

Background. In this paper, we provide background and context regarding the potential for a new data-sharing platform, the Project Data Sphere (PDS) initiative, funded by financial and in-kind contributions from the CEO Roundtable on Cancer, to transform cancer research and improve patient outcomes. Given the relatively modest decline in cancer death rates over the past several years, a new research paradigm is needed to accelerate therapeutic approaches for oncologic diseases. Phase III clinical trials generate large volumes of potentially usable information, often on hundreds of patients, including patients treated with standard of care therapies (i.e., controls). Both nationally and internationally, a variety of stakeholders have pursued data-sharing efforts to make individual patient-level clinical trial data available to the scientific research community. Potential Benefits and Risks of Data Sharing. For researchers, shared data have the potential to foster a more collaborative environment, to answer research questions in a shorter time frame than traditional randomized control trials, to reduce duplication of effort, and to improve efficiency. For industry participants, use of trial data to answer additional clinical questions could increase research and development efficiency and guide future projects through validation of surrogate end points, development of prognostic or predictive models, selection of patients for phase II trials, stratification in phase III studies, and identification of patient subgroups for development of novel therapies. Data transparency also helps promote a public image of collaboration and altruism among industry participants. For patient participants, data sharing maximizes their contribution to public health and increases access to information that may be used to develop better treatments. Concerns about data-sharing efforts include protection of patient privacy and confidentiality. To alleviate these concerns, data sets are deidentified to maintain anonymity. To address industry concerns about protection of intellectual property and competitiveness, we illustrate several models for data sharing with varying levels of access to the data and varying relationships between trial sponsors and data access sponsors. The Project Data Sphere Initiative. PDS is an independent initiative of the CEO Roundtable on Cancer Life Sciences Consortium, built to voluntarily share, integrate, and analyze comparator arms of historical cancer clinical trial data sets to advance future cancer research. The aim is to provide a neutral, broad-access platform for industry and academia to share raw, deidentified data from late-phase oncology clinical trials using comparator-arm data sets. These data are likely to be hypothesis generating or hypothesis confirming but, notably, do not take the place of performing a well-designed trial to address a specific hypothesis. Prospective providers of data to PDS complete and sign a data sharing agreement that includes a description of the data they propose to upload, and then they follow easy instructions on the website for uploading their deidentified data. The SAS Institute has also collaborated with the initiative to provide intrinsic analytic tools accessible within the website itself. As of October 2014, the PDS website has available data from 14 cancer clinical trials covering 9,000 subjects, with hopes to further expand the database to include more than 25,000 subject accruals within the next year. PDS differentiates itself from other data-sharing initiatives by its degree of openness, requiring submission of only a brief application with background information of the individual requesting access and agreement to terms of use. Data from several different sponsors may be pooled to develop a comprehensive cohort for analysis. In order to protect patient privacy, data providers in the U.S. are responsible for deidentifying data according to standards set forth by the Privacy Rule of the U.S. Health Insurance Portability and Accountability Act of 1996. Using Data Sharing to Improve Outcomes in Cancer: The “Prostate Cancer Challenge.” Control-arm data of several studies among patients with metastatic castration-resistant prostate cancer (mCRPC) are currently available through PDS. These data sets have multiple potential uses. The “Prostate Cancer Challenge” will ask the cancer research community to use clinical trial data deposited in the PDS website to address key research questions regarding mCRPC. General themes that could be explored by the cancer community are described in this article: prognostic models evaluating the influence of pretreatment factors on survival and patient-reported outcomes; comparative effectiveness research evaluating the efficacy of standard of care therapies, as illustrated in our companion article comparing mitoxantrone plus prednisone with prednisone alone; effects of practice variation in dose, frequency, and duration of therapy; level of patient adherence to elements of trial protocols to inform the design of future clinical trials; and age of subjects, regional differences in health care, and other confounding factors that might affect outcomes. Potential Limitations and Methodological Challenges. The number of data sets available and the lack of experimental-arm data limit the potential scope of research using the current PDS. The number of trials is expected to grow exponentially over the next year and may include multiple cancer settings, such as breast, colorectal, lung, hematologic malignancy, and bone marrow transplantation. Other potential limitations include the retrospective nature of the data analyses performed using PDS and its generalizability, given that clinical trials are often conducted among younger, healthier, and less racially diverse patient populations. Methodological challenges exist when combining individual patient data from multiple clinical trials; however, advancements in statistical methods for secondary database analysis offer many tools for reanalyzing data arising from disparate trials, such as propensity score matching. Despite these concerns, few if any comparable data sets include this level of detail across multiple clinical trials and populations. Conclusion. Access to large, late-phase, cancer-trial data sets has the potential to transform cancer research by optimizing research efficiency and accelerating progress toward meaningful improvements in cancer care. This type of platform provides opportunities for unique research projects that can examine relatively neglected areas and that can construct models necessitating large amounts of detailed data. The full potential of PDS will be realized only when multiple tumor types and larger numbers of data sets are available through the website.

We examined the current literature to understand factors that influence endocrine therapy (ET) adherence among racial/ethnic and socioeconomic subpopulations of breast cancer patients. We searched PubMed and PsycINFO databases for studies from January 1, 1978, to June 20, 2014, and January 1, 1991, to June 20, 2014, respectively, and hand-searched articles from relevant literature reviews. We abstracted and synthesized results within a social ecological framework. Fourteen articles met all inclusion criteria. The majority of included articles reported significant underuse of ET among minority and low-income women. Modifiable intrapersonal, interpersonal, and community-level factors are associated with ET use, and these factors vary across subgroups. Both race/ethnicity and socioeconomic status are associated with ET use in most settings. Variation in factors associated with ET use across subgroups indicates the need for more nuanced research and targeted interventions among breast cancer patients.

e18299 Background: High cancer treatment costs are associated with considerable distress and worse outcomes in cancer patients, a phenomenon known as “financial toxicity”. We examined changes in health-related quality of life (HRQoL) among women experiencing financial toxicity after cancer diagnosis compared to cancer patients without financial toxicity in a racially diverse cohort of breast cancer patients. Methods: HRQoL was self-reported at approximately 5 and 25 months post-diagnosis using the Functional Assessment of Cancer Treatment (FACT-G) in a prospective, population-based, cohort study with oversampling of Black and young (

e18293 Background: Racial variation in the adverse financial impact of cancer may contribute to observed differences in the initiation and completion of guideline-recommended adjuvant treatments. We describe racial differences in the financial impact of breast cancer diagnosis in a large, population-based, prospective cohort study. Methods: Patients were recruited via rapid case ascertainment through the North Carolina cancer registry as part of the Carolina Breast Cancer Study, with oversampling of black women and women younger than 50. Participants provided medical records and survey data on demographics, socioeconomic status, treatments, and financial impact of cancer. We used chi-square tests and multivariable logistic regression to understand racial differences in financial impact of breast cancer through 25 months post-diagnosis. Results: Our sample included 1,196 non-Hispanic blacks and 1,236 non-Hispanic whites. Since diagnosis, compared to white women, black women more often reported: any adverse financial impact of cancer (59% vs 39%, p < 0.0001); lost income (49% vs 35%, p < 0.0001); lost job due to cancer (13% vs 6%, p < 0.0001); financial barriers to treatment (24% vs 10%, p < 0.0001); transportation barriers to treatment (15% vs 3%, p < 0.0001); and lost health insurance (9% vs 3%, p < 0.0001). In multivariable models, black women had higher odds of: experiencing any adverse financial impact of cancer (Adjusted Odds Ratio [AOR]: 1.9 (1.6-2.3)); losing income (AOR: 1.5 (1.3-1.9)); losing their job (AOR: 2.1 (1.5-2.8)); experiencing financial barriers to treatment (AOR: 2.2 (1.7-2.9)); experiencing transportation barriers to treatment (AOR: 4.8 (3.2-7.1)); and losing their health insurance (AOR: 2.6 (1.7-4.1)). Conclusions: Compared to whites, black women with breast cancer experience significantly worse financial impact of cancer. Disproportionate financial strain may contribute to higher stress, lower treatment compliance, and worse outcomes, among black women. Efforts to alleviate the adverse financial impact of cancer treatment and to improve communication between patients and providers about potential financial distress may be particularly valuable for black women, due to their greater financial vulnerability.

10060 Background: Age-related accumulation of senescent cells plays a causal role in some aspects of mammalian aging. We have shown that the total-body burden of senescent cells can be estimated by measuring the expression of the p16 tumor suppressor, a canonical effector of senescence, in human CD3+ PBTC (Liu et al, Aging Cell, 2009). Expression of p16 increases more than 10-fold over an adult human lifespan, and this rate of accumulation is accelerated by age-promoting exposures such as CRx or stem cell transplant (Sanoff et al, JNCI 2014; Wood et al, EbioMed 2016). Increased molecular age as evidenced by increased expression of p16 prior to CRx predicts a patient’s risk of CRx toxicity independently of chronological age (DeMaria et al, Cancer Discovery, 2017).This study investigates the impact of different types of CRx (A vs NoA) regimens on PBTC p16expression in pts with EBC. Methods: EBC pts who received neoAdj or Adj CRx had blood samples drawn for p16 assay prior to CRx initiation and again between 2 months and 1.5 years after the end of CRx. Expression of p16 mRNA in PBTC was determined using TaqMan real-time quantitative reverse transcription PCR. T-test compared p16change between A and NA groups. Results: 70 pts were evaluable. Pt. characteristics: median age 49 (range 32-76); 52 (74%) White, 14 (20%) black, 4 unknown; 39 (56%) ER or PR+ and HER2 neg, 18 (26%) triple negative, 13 (19%) HER-2 pos (all received trastuzumab). 53 pts (76%) had A (47 AC + taxane, 6 AC no taxane) and 17 (24%) NoA (all TC). Expression of p16 increased 2.0-fold in patients who received A-based CRx compared to 1.2-fold in NoA CRx (p = 0.04). There was no relationship of race, ER, PR or HER-2 status on change in p16expression. Conclusions: This study is ongoing and further results will be presented at the ASCO meeting. In this sample of EBC patients treated with A vs. NoA CRx regimens, A-based CRx is more strongly associated with increased biologic aging of T-cells compared to NoA CRx. These changes are equivalent of increased biologic aging of PBTC of 11 years (A) vs.6 years (NoA) and may have major consequences on the long-term survival of these pts.

TPS1125 Background: Immunotherapy is a promising strategy to treat advanced TNBC, an aggressive subtype of BC lacking expression of estrogen and progesterone receptors and HER2. TNBC response to antibodies targeting programmed cell death protein 1 (PD-1) or its ligand (PD-L1) are modest (< 20%); high expression of PD-L1 is associated with enhanced response. The presence of intratumoral regulatory T cells (Tregs), potent suppressors of the immune response, dampens response to checkpoint inhibitors. The capacity of cyclophosphamide (Cy), a cytotoxic with known activity in BC, to deplete Tregs is well-established. Preclinical mouse models of TNBC illustrate Treg depletion with improved outcome when Cy is administered prior to PD-1 inhibition. We are testing the hypothesis that a single dose of Cy given prior to pembrolizumab (pembro) will improve progression free survival (PFS) beyond historical control in advanced TNBC. Methods: This phase II, single-arm, multicenter study will evaluate pembro 200 mg IV every 3 weeks following a single priming dose of Cy 300 mg/m2 IV in patients (pts) with advanced TNBC who have received ≥1 prior therapy in the metastatic setting. The primary objective is to estimate PFS for Cy + pembro in advanced TNBC pts. A co-primary objective is to describe reduction in circulating Tregs. Secondary objectives include overall response rate (ORR, RECIST 1.1), duration of response (DOR), disease control rate (DCR) and overall survival (OS). Determination of ORR based on immune response criteria (irRECIST) and association of immunogenomic features with PFS are exploratory. Statistical considerations: A sample size of 36 pts has an 80% power to detect change in median PFS from 1.9 (null) to 2.9 (alternative hypothesis) months at a 0.05 significance level. Assuming 10% dropout rate, we will enroll 40 pts. We will also be able to detect a 67% reduction in Tregs with 80% power and one-sided alpha = 0.05. Correlative studies: Archival primary and/or metastatic tissues are required of all pts to evaluate molecular subtype, gene signature expression, T and B cell receptor repertoires, and PD-1 and PD-L1 expression; correlations with outcome will be performed. Clinical trial information: NCT02768701.

95 Background: Studies show palliative care (PC) delivered concurrently with cancer treatment improves outcomes, yet integration of PC with inpatient oncology is lacking. A promising approach to improve integration is a triggered palliative care consultation (TPCC), which is primarily based on clinical criteria (e.g. metastatic disease) and may include multiple strategies to support its use. This study evaluated the impact of two TPCC approaches on PC consult implementation (uptake and timeliness) in the solid tumor medical (MED) and gynecologic oncology (GYN) services at an academic medical center. Methods: MED TPCC used multiple strategies (chart review to identify eligible patients, training, clinician prompting); GYN TPCC used a single strategy (written guideline of clinical criteria for initiating a consult). PC consult information was obtained from medical charts and linked to all hospital encounter data for MED and GYN. The timeframe was 2010-2016 with TPCC onset in 2014 (GYN) and 2015 (MED). We compared PC consult implementation in GYN (single strategy) vs no strategy and MED (multiple strategies) vs GYN (single strategy). Difference-in-differences and modified Poisson regression was used to evaluate whether PC consult implementation differed after initiating strategies, adjusting for patient demographic and clinical characteristics. Results: Our sample included 5,873 MED and 3,889 GYN hospitalizations. Overall 8.8% of MED and 11.0% of GYN hospitalizations involved a PC consult. In regression analyses, use of a single strategy was associated with increased PC consult uptake vs no strategy (aRR: 1.45, p < .05), while use of multiple strategies was associated with increased PC consult uptake vs use of a single strategy (aRR: 2.34, p < .001). Across all comparisons, the strategies did not significantly impact PC consult timeliness. Conclusions: This study compared PC consult implementation across two inpatient oncology services and found a TPCC approach supported by multiple strategies had the greatest impact on uptake. Questions remain regarding which TPCC approach can most effectively achieve sustainability of uptake and PC consult timeliness in inpatient settings.

78 Background: A sustainable, standardized approach for quality assessment and improvement is increasingly expected in oncology. This requires oncology leaders to identify processes and infrastructure to facilitate sustainable initiatives for practice refinement. To date, few summative reports of lessons learned, key success factors, and barriers to regular quality improvement have been reported. Methods: After IRB protocol approval, a focus group of 11 diverse physician oncology leaders was conducted, using a guide developed through multiple discussions by investigators. The physicians represented diverse organizations with community-based, private practice and academic settings. Data analysis of interview transcripts was performed iteratively, with a grounded theory approach with a method called “constant comparisons”, with related open and axial coding techniques. Transcripts were coded independently by two or three coders, and the resulting code lists integrated prior to final analysis. Differences in coding were resolved by consensus. Results: Overall, physician quality leaders discussed needs and barriers in 5 major domains: coordination of care, communication, finances, value, and quality improvement. Two major themes emerged: rapid change cycles in a dynamic landscape of practice--changing business models and care delivery, new expensive drugs, oral chemotherapy--and their respective unintended consequences on quality of care, e.g. financial toxicity for patients, misalignment of financial incentives and a quality agenda. Participants discussed responding to these changes and key factors in harnessing the practice model to deliver quality care. Conclusions: Cancer care delivery is rapidly evolving and undergoing intrinsic cycles of quality improvement. This project helps to inform systemic quality improvement efforts targeted towards oncology practices by identifying areas of concern and highlighting key factors to be addressed to achieve value, alignment and quality of care. Institutional culture and infrastructure including resources and incentives for quality improvement/measurement were identified as critical success factors.

250 Background: Gene expression profiles (GEPs) have been rapidly and widely adopted to guide chemotherapy decisions in early hormone receptor-positive (HR+) breast cancer, but not all eligible patients receive testing. Patient-level predictors of testing have been reported. However, the role of provider and insurance factors in GEP use has not been well described. Racial disparities in access to testing are also under-studied. Methods: We used state cancer registry data linked to claims from multiple insurance payers to identify 11,958 patients eligible for GEP testing between 2005 and 2012. For each patient, we characterized specialty and breast cancer volume for the provider deemed most likely to make the testing decision. We identified claims for the most commonly used GEP (OncotypeDX) and used adjusted incidence rate models to examine predictors of testing, stratified by nodal status (N0 versus N1). Results: Overall, 26% of eligible patients were tested with rates increasing over time. In multivariable analyses among N0 patients, black women were 12% less likely than clinically similar whites to be tested. Patients treated by a general surgeon were less likely to be tested than those treated by oncologic specialists, while those seen by middle-volume providers were significantly more likely to be tested than patients of the highest-volume providers. Black women with N1 disease were 27% less likely to be tested. Among N1 patients, testing was most common among patients of highest-volume providers and declined consistently with provider volume. Private insurance increasing the likelihood of testing for N0, but not N1 disease. Conclusions: Insurance status and provider characteristics appear to influence the likelihood of GEP testing for early breast cancer, but do not fully explain racial disparities in access to testing. Black women are less likely than whites to receive testing in either the node-negative or node-positive setting after adjustment for clinical factors. These date suggest a need to develop quality programs that enable uptake of appropriate breast cancer genomic tests, with a focus on elimination of disparities.

170 Background: Endocrine therapy under-utilization puts women at increased risk for breast cancer recurrence. The objective of this study was to determine if health-related quality of life (HRQOL) was significantly associated with under-utilization. Methods: Data came from the third phase of the population-based Carolina Breast Cancer Study. We included 1,599 women with hormone receptor positive disease aged 20-74 years. HRQOL was measured using the Functional Assessment of Cancer Therapy for Breast Cancer, on average, 5-months post-diagnosis. HRQOL domains included physical, functional, social, emotional, and spiritual well-being and breast cancer concerns. HRQOL subgroups were derived using latent profile analysis. Under-utilization was defined as not initiating or adhering to endocrine therapy by 36-months post-diagnosis. Multivariable logit models estimated adjusted odds ratios (aOR) between HRQOL subgroups and under-utilization. The subgroup with the best HRQOL scores across domains was the reference category. Chemotherapy and race-stratified models were estimated, separately. Results: Initiation analyses included 953 women with hormone receptor positive breast cancer who had not begun endocrine therapy by their 5-month survey, of whom 154 never initiated. Adherence analyses included 1,114 initiators, of whom 211 were non-adherent. HRQOL was not significantly associated with non-initiation except among non-chemotherapy users, with membership in the poorest subgroup associated with an increased odds of non-initiation (aOR 5.5; 1.7-17.4). Membership the two poorest HRQOL subgroups was associated with non-adherence (aOR 2.2; 1.2-4.0 and aOR1.9; 1.1-3.6), respectively. Membership in the poorest HRQOL subgroup was associated with non-adherence among non-chemotherapy users (aOR 2.1; 1.2-5.1). Conclusions: Our results suggest that women with poor HRQOL during active treatment may be at increased risk for under-utilization. Focusing on HRQOL, a modifiable factor, may improve targeting of future interventions early in the breast cancer continuum to improve endocrine therapy initiation, adherence, and breast cancer recurrence.

Objective: There are over 3 million women in the United States living with breast cancer or who have a history of breast cancer. As the number of women undergoing treatments and surviving breast cancer grows, characterizing changes in health-related quality of life (HRQOL) is critical to ensuring patient-centered breast cancer care. Breast cancer risk and burden varies systemically between Black and White women. Black women are more likely to be diagnosed at younger ages and with more aggressive breast cancer tumors. Although racial disparities in HRQOL are well documented, less is known about differences in HRQOL at distinct phases of breast cancer care. Our objective was to assess racial disparities in HRQOL between active treatment and survivorship phases of the breast cancer care continuum. Methods: The study used data from the third phase of the Carolina Breast Cancer Study (CBCS-III). CBCS-III enrolled 3,000 women in North Carolina aged 20-74 years diagnosed with invasive, pathologically confirmed breast cancer between 2008 and 2013. HRQOL assessments occurred 5- and 25-months after diagnosis, respectively, representing distinct phases of care. The Functional Assessment of Cancer Therapy for Breast Cancer and the Functional Assessment of Chronic Illness Therapy for Spiritual Well-Being measured HRQOL. We implemented three approaches (Institute of Medicine, Residual Direct Effect and interactive effects of race and socioeconomic factors) to assessing racial disparities to better understand if racial disparities in HRQOL changes existed and to identify potential mediators of disparities in HRQOL. Analysis of covariance models assessed racial differences in changes in HRQOL between active treatment and survivorship. Adjusted models included demographic, socioeconomic, tumor and treatment characteristics. Results: The cohort included 2,142 Non-Hispanic White (52%) and Black (48%) women with breast cancer who completed both HRQOL assessments. During active treatment, White women reported significantly better physical and functional HRQOL than Black women, but spiritual HRQOL was 2 points higher for Black women. At 25-months post-diagnosis, White women reported HRQOL scores well above U.S norms across physical, social, emotional and functional well-being domains. Black women, however, continued to report physical well-being scores 1.2 points below the U.S norm and 2.3 points below their White breast cancer counterparts. Once demographic, socioeconomic, tumor and treatment characteristics were adjusted for, racial differences narrowed and were not considered clinically meaningful. Conclusions: Racial differences in physical and functional HRQOL may be mediated by socioeconomic factors. Psychosocial and spiritual HRQOL seem well supported, mitigating negative effects of breast cancer care, especially among Black women. These results inform opportunities for improving the quality and equity of supportive services for women with breast cancer. Citation Format: Laura C. Pinheiro, Cleo A. Samuel, Katherine E. Reeder-Hayes, Stephanie B. Wheeler, Andrew F. Olshan, Bryce B. Reeve. Understanding Racial Differences in Health-Related Quality of Life in a Diverse, Population-Based Cohort of Breast Cancer Survivors in North Carolina. [abstract]. In: Proceedings of the Ninth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2016 Sep 25-28; Fort Lauderdale, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2017;26(2 Suppl):Abstract nr B25.

Background. Mitoxantrone was approved for use in metastatic castrate-resistant prostate cancer (mCRPC) based on pain palliation without observed survival benefit in a small phase III trial in 1996. To re-evaluate for possible survival benefits in a larger contemporary sample and to demonstrate analytic uses of the newly available Project Data Sphere online resource, we used data from control arms of completed clinical trials to compare survival and toxicity among patients with postdocetaxel mCRPC treated with mitoxantrone and prednisone. Patients and Methods. Control arm data from two phase III randomized control trials, SUN 1120 and TROPIC, were used to examine the efficacy of mitoxantrone plus prednisone (n = 305) versus prednisone alone (n = 257) among patients with postdocetaxel mCRPC. Propensity score matching was used to balance patient characteristics between the separate trials, conditioned on age and key prognostic variables of survival. The primary outcome was overall survival. Secondary endpoints evaluated safety. Results. Median survival was similar among patients receiving mitoxantrone plus prednisone versus prednisone alone (385 days vs. 336 days; deceleration factor = 0.04; 95% confidence interval: −0.12 to 0.22). Prevalence of several any-grade toxicity, including fatigue, back pain, and peripheral neuropathy, was increased among patients who received mitoxantrone. Conclusion. There was no significant survival benefit for mitoxantrone plus prednisone over prednisone alone among men with mCRPC after docetaxel therapy. This finding is consistent with prior studies showing no survival advantage with mitoxantrone in the predocetaxel setting. Furthermore, our data suggest that mitoxantrone may be associated with increased toxicity compared with prednisone alone.

Aim: Although PET imaging is sometimes used in follow-up of pancreatic cancer, evidence regarding comparative effectiveness of PET and older imaging modalities is limited. Patients & methods: Linked cancer registry and Medicare claims data were analyzed to examine patterns of imaging and effects on treatment patterns and survival among newly diagnosed pancreatic cancer patients from 2003 to 2007. Results: 12% of patients received PET during follow-up. In a time-varying exposure model, computed tomography/MRI was associated with lower mortality risk relative to PET in surgical patients (HR: 0.66; 95% CI: 0.52–0.83). In a subset analysis, type of follow-up imaging before 180 days was not associated with mortality after 180 days (computed tomography/MRI vs PET; hazard ratio: 0.98; 95% CI: 0.84–1.16). Conclusion: Follow-up PET is uncommon among Medicare beneficiaries with pancreatic cancer, and is generally used late in the disease course. This pattern of PET use was not associated with decreased mortality risk compared with conventional imaging.

Parents with life-limiting illness anticipate the loss of their parental role and the long-term consequences of their illness on their children. The purpose of this study was to examine relationships between parenting concerns, quality of life (QOL), and symptoms of depression and anxiety in parents with advanced cancer who have dependent children.Sixty-three parents diagnosed with a Stage IV solid malignancy completed the Hospital Anxiety Depression Scale (HADS), Parenting Concerns Questionnaire (PCQ), and Functional Assessment of Cancer Therapy-General (FACT-G). The Medical Outcomes Study Social Support Survey (social support) and Eastern Cooperative Oncology Group (ECOG) performance status were assessed as potential covariates. We performed descriptive statistics and multivariable linear regression models for depression, anxiety, and QOL measures.Mean PCQ score was 2.3 (SD 0.9), reflecting mild to moderate parenting concerns. Average depression and anxiety scores were 6.0 (SD 4.2) and 8.2 (SD 3.9), respectively. PCQ scores were associated with depressive symptoms (r = 0.46, p 0.001), anxiety symptoms (r = 0.52, p 0.0001), and QOL scores (r = -0.60, p 0.001). The relationship of PCQ scores to anxiety symptoms (B = 1.5 p = 0.016) and QOL (B = -5.7, p = 0.02) remained significant after controlling for ECOG status, social support, and treatment status.Parenting concerns are associated with anxiety and depressive symptoms and worse QOL in parents diagnosed with advanced cancer. Further studies that evaluate how parental status affects coping and psychological distress in advanced cancer are needed.Copyright © 2015 John WileySons, Ltd.

Endocrine therapy (ET) is the cornerstone of adjuvant therapy for hormone-receptor positive (HR+) breast cancer. The survival gap between African-American (AA) and white women with breast cancer is most pronounced in HR+ subtypes, and could be related to differences in ET use. The relationship between race and initiation of ET is not well defined. We investigated patterns of ET initiation by race in a diverse cohort of women covered by commercial health insurance. We identified 2,640 women with incident HR+ breast cancer in the North Carolina Central Cancer Registry whose records linked to commercial insurance claims using the Integrated Cancer Information and Surveillance System (ICISS) database. The sample included women age

Existing evidence suggests that preoperative breast magnetic resonance imaging (MRI) might not improve surgical outcomes in the general breast cancer population. To determine if patients differentially benefit from breast MRI, we examined surgical outcomes—initial mastectomy, reoperation, and final mastectomy rates—among patients grouped by histologic type. We identified women diagnosed with early-stage breast cancer from 2004 to 2007 in the SEER-Medicare dataset. We classified patients as having invasive ductal carcinoma (IDC), invasive lobular carcinoma (ILC), mixed ductal/lobular carcinoma (IDLC) or other histologic type. Medicare claims were used to identify breast MRI and definitive surgeries during the initial surgical treatment episode. We used propensity score methods to account for the differential likelihood of exposure to MRI. Of the 20,332 patients who met our inclusion criteria for this study, 12.2 % had a preoperative breast MRI. Patients with ILC as compared to other histologic groups were most likely to receive MRI [OR 2.32; 95 % CI (2.02–2.67)]. In the propensity score-adjusted analyses, breast MRI was associated with an increased likelihood of an initial mastectomy for all patients and among all histologic subgroups. Among patients with ILC, having a breast MRI was associated with lower odds of a reoperation [OR 0.59; 95 % CI (0.40–0.86)], and an equal likelihood of a final mastectomy compared to similar patients without a breast MRI. Overall and among patients with IDC and IDLC, breast MRI was not significantly associated with a likelihood of a reoperation but was associated with greater odds of a final mastectomy. Our study provides evidence in support of the targeted use of preoperative breast MRI among patients with ILC to improve surgical planning; it does not provide evidence for the routine use of breast MRI among all newly diagnosed breast cancer patients or among patients with IDC.

BACKGROUND Practice-based research networks (PBRNs) are promising for accelerating not only research, but also dissemination of research-based evidence into broader community practice. Sentinel lymph node biopsy (SLNB) is an innovation in breast cancer care associated with equivalent survival and lower morbidity, as compared with standard axillary lymph node dissection. We examined the diffusion of SLNB into practice and whether affiliation with the Community Clinical Oncology Program (CCOP), a cancer-focused PBRN, was associated with more rapid uptake of SLNB. RESEARCH DESIGN Surveillance Epidemiology and End Results-Medicare data were used to study women diagnosed with stage I or II breast cancer in the years 2000-2005 and undergoing breast-conserving surgery with axillary staging (n=6226). The primary outcome was undergoing SLNB. CCOP affiliation of the surgical physician was ascertained from NCI records. Multivariable generalized linear modeling with generalized estimating equations was used to measure association between CCOP exposure and undergoing SLNB, controlling for potential confounders. RESULTS Women treated by a CCOP physician had significantly higher odds of receiving SLNB compared with women treated by a non-CCOP physician (OR 2.68; 95% CI, 1.35-5.34). The magnitude of this association was larger than that observed among patients treated by physicians operating in medical school-affiliated hospitals (OR 1.76; 95% CI, 1.30-2.39). CONCLUSIONS Women treated by CCOP-affiliated physicians were more likely to undergo SLNB irrespective of the hospital's medical school affiliation, suggesting that the CCOP PBRN may play a role in the rapid adoption of research-based innovation in community practice.

Levetiracetamisanovelantiepilepticdrugusedfor the treatment of partial and generalized epilepsy. Its mechanism of action is unclear, though it is thought to bind to a presynaptic vesicle protein that ultimately reduces the synaptic release of glutamate, impeding conduction of epileptic action potentials across the synapse. 1 Levetiracetam is frequently used owing to its ease of oral administration, excellent bioavailability, and low rate of drug interactions as it is not metabolized by the liver or bound significantly to serum proteins. 2,3 Adverse cognitive effects are atypical; however, adverse effects in the central nervous system (CNS) are relatively common, with behavioral symptoms occurring in up to 16% of patients in randomized controlled trials. 4 Frequently reported behavioral symptoms include depression, hostility, agitation, emotional lability, anger, nervousness, and depersonalization. Nonbehavioral CNS effects include sedation,headache,andasthenia. 5 Psychosisisinfrequently associated with levetiracetam, occurring in approximately 1% of patients, but well described in multiple case reports. 6,7 Researchers have explored the use of levetiracetam as a mood stabilizer for treatment of both depressive and manic phases of bipolar disorder with mixed results. 8–10 Despite the known association between levetiracetam and aggression and irritability, there are no reported cases in the literature of levetiracetam precipitating manic symptoms. In the following case report, we describe the acute onset of mania after levetiracetam therapy in a woman with no history of mania or hypomania.

e21548Background: Cancer patients in phase 1 clinical trials may be at risk of misunderstanding the objective of the trial (therapeutic misconception) or their own likelihood of benefit from partic...

10052Background: The incidence of specific complications of adjuvant chemotherapy in breast cancer is well documented in clinical trials. However, the effect of chemotherapy on functional outcomes ...

Triple negative breast cancer (TNBC) is an aggressive subtype of the disease against which targeted therapies that significantly improve the prognosis for hormone receptor-positive and HER2-overexpressing breast cancers are ineffective. This article summarizes our current understanding of the biology of TNBC as it relates to the efficacy of standard and investigational therapies. It reviews promising preliminary results that have been achieved with chemotherapeutic agents including the platinum analogs and agents that inhibit DNA repair by targeting poly ADP-ribose polymerase (PARP), while anti-angiogenic therapies and those that target the epidermal growth factor receptor (EGFR) have had more limited success. Agents that target a number of other pathways which appear to influence the biologic aggressiveness of TNBC, including src and PI3K, are in early stage clinical trials. As we learn more about TNBC, and which of its characteristics determine treatment response and resistance, we should become better able to select appropriate therapies for biologically defined patient subgroups, and reduce the clinical burden of this disease.

Scientific advances are rapidly reshaping cancer care. Much original research takes 17 years before yielding patient care benefits,1 and so the accelerating pace of discovery places a premium on the need for rapid translation of research into practice. The National Institutes of Health has clearly recognized this need.2–5 As one means of addressing it, the National Cancer Institute (NCI) has emphasized moving beyond traditional teaching systems by linking academic centers to community practitioners who treat the majority of cancer patients. For example, the NCI Community Clinical Oncology Program (CCOP) effectively connects the NCI Cooperative Groups (researchers primarily at academic centers developing and managing clinical trials) with a nationwide provider-based research network of community physicians treating cancer patients and enrolling them on clinical trials.6 CCOP organizational goals include not only enrolling patients on trials, but also accelerating the diffusion of evidence-based innovations into practice, among others.2,6–10 Sentinel lymph node biopsy (SLNB) is an important innovation in breast cancer treatment. In breast cancer, the presence or absence of cancer in the axillary lymph nodes is the most important predictor of recurrence and death. On the basis of lymph node involvement, treatment may variably include more extensive surgery, radiation therapy, or chemotherapy; therefore, accurate assessment of lymph nodes is critical in determining the optimal treatment plan.11,12 Axillary lymph node dissection (ALND) has long been an effective means of assessing lymph node involvement and an integral part of treatment.13,14 ALND is an extensive procedure in which 10 or more lymph nodes are removed and a surgical drain is placed, followed by one or more night stays in a hospital. It is associated with considerable surgical morbidity including lymphedema, nerve paresthesias, axillary seromas, and infections.15 Several studies have demonstrated that a newer procedure, SLNB, is a safe and accurate alternative for examining lymph nodes. SLNB and ALND are equivalent in terms of disease control and patient survival. Because it necessitates removal of only 1 to 3 nodes, SLNB is associated with substantially fewer and less severe morbidities and commonly no overnight hospital stay.16–24 Accordingly, SLNB has been widely adopted by surgeons as an innovative alternative to routine ALND for axillary staging in early breast cancer. As with many other innovations, adoption of SLNB has not been uniform.25 Factors previously shown to be associated with variation in use of SLNB include patient characteristics (eg, age, race, insurance coverage) and organizational factors (eg, surgical volumes, being an NCI-designated cancer center).26–31 Although prior research has established that these organizational characteristics are relevant, a more specific question remains largely unanswered: Are organizational affiliations relating to teaching and research associated with accelerated adoption of innovative breast cancer treatments? This study examines the diffusion of SLNB among organizations providing breast cancer treatment, and hypothesizes that research and teaching affiliation are associated with accelerated innovation diffusion.

To evaluate differences in use of sentinel lymph node biopsy (SLNB) by age and race in Medicare recipients with early-stage breast cancer, we examined Surveillance, Epidemiology and End Results—Medicare linked data for women undergoing breast conserving surgery for stage I or II breast cancer, including axillary staging, between January 2000 and December 2002. Multivariable generalized linear modeling with generalized estimating equations was used to identify predictors of receiving SLNB versus standard axillary lymph node dissection as the primary axillary staging modality. Women were significantly less likely to receive SLNB as their primary staging procedure if they were African American (OR 0.65), greater than 80 years of age (OR 0.71 vs. age

6560 Background: Differential endocrine therapy (ET) use by race may contribute to disparities in breast cancer outcomes. The goal of this study was to examine racial variation in ET adherence, sid...

e20645 Background: Adjuvant endocrine therapy (ET) plays an important role in reducing risk of recurrence among women with hormone receptor positive breast cancer. Although the literature suggests ...

135 Background: Hispanics are the fastest growing demographic group in the United States and cancer is the leading cause of death in this population. Hispanic immigrants encounter a number of challenges when confronting end-of-life care: geographical and cultural separation from families; language and educational barriers; fear of discrimination; and in the case of undocumented immigrants, fear of deportation. The experiences of Hispanic patients with advanced cancer who are parents of dependent-age children are essentially unknown. Therefore, we used qualitative methods to identify the palliative care and end-of-life needs of this unique population. Methods: We recruited five Spanish-speaking, Hispanic mothers with metastatic cancer to complete a semi-structured interview about their experiences. The interviews addressed coping with advanced illness, sources of distress, parenting changes, medical decision-making strategies, and communication about illness. Data were analyzed using traditional content analysis techniques. Results: Participants were all female, ages 34-43 year old. On average, they had 3.4 children and 8.2 years of education. Common themes were: (1) the financial burden of cancer; (2) low social support for parenting and household responsibilities; (3) lack of perceived role in medical decision-making; (4) and religion as primary source of coping and hope. We also identified several communication barriers in conducting a palliative care study with this population. Conclusions: Future palliative care studies can improve Spanish-speaking Hispanics’ comprehension by incorporating Spanish vocabulary into the interviews and providing greater explanation of concepts such as shared decision-making, cancer staging, palliative care, and hospice. Greater awareness of financial concerns and insufficient social support may help oncology providers and researchers develop interventions to help Hispanic parents with advanced cancer. Further studies are needed to learn more about the unmet needs of end-of-life care for this demographic group.

65 Background: When patients with metastatic cancer have dependent children, they may be less likely to acknowledge the terminal nature of their illness and more willing to accept toxic treatments for small improvements in survival, compared to patients without children. Our mixed methods study sought to clarify the role of parental concerns in treatment decision-making. Methods: We recruited 63 patients with metastatic cancer who have children

6565 Background: The benefit of bisphosphonate drugs in adjuvant breast cancer care has been a topic of clinical debate. A recently presented meta-analysis of clinical trials by Coleman et al (2013...

1077 Background: Response to neoadjuvant chemotherapy (NAC) is an increasingly recognized intermediate marker for prognosis, but we still lack validated prognostic tools that incorporate tumor factors and response. This study aimed to create a prognostic model and nomogram for 5-year distant relapse-free survival (DRFS) and to develop a web application for providers and patients to predict the probability of distant relapse within 5 years. Methods: The prognostic model was developed using data from patients treated with NAC in the UNC Neoadjuvant Database and the Cox proportional hazards method. Patients who received NA trastuzumab were included in model data, but patients who received NA endocrine therapy were not included. The model was internally validated with bootstrap resampling, and externally validated with an independent, public data set (n=411) (Cancer Res 2011;71(24 Suppl):Abs S5-2). A web tool was developed to calculate probability of 5-year DRFS. Results: Four-hundred and seven stage I-III patients, including 106 relapse events, were used for model development. The following factors were ultimately included in the model: RCB class, age, overall grade, HER2 status, hormone receptor (HR) status, and an interaction term between age and HR status. Validation showed agreement between predicted and observed outcomes in all patients and more specifically HR+/HER2- and HR-/HER2- patients (Table). There were an insufficient number of HER2+ patient in the validation data to reliably analyze that subgroup. Conclusions: An externally validated predictive modelincorporating patient, tumor, and response variables is accurate in predicting 5-year distant relapse risk for patients undergoing NAC. The model can be conveniently accessed as an online application at www.NeoadjuvantRelapse.info for precise risk prediction. [Table: see text]

6104 Background: Sentinel lymph node biopsy (SLNB) for breast cancer was introduced into clinical practice in the late 1990s as an alternative to axillary lymph node dissection (ALND). Provider-based research networks (PBRNs) are believed to promote diffusion of innovations like SLNB into clinical practice; however, evidence of this association is limited. This study examines the diffusion of SLNB for early-stage breast cancer through the Community Clinical Oncology Program (CCOP), a community-based PBRN. Methods: We identified women undergoing breast conserving surgery with axillary staging for stage I or II breast cancer between January 2000 and December 2003 using Surveillance Epidemiology and End Results-Medicare data (n=6,226). The primary outcome was receipt of SLNB vs. ALND, and exposure was care received from CCOP physicians or institutions between diagnosis and surgery. Exposure was quantified as both a binary measure of ever seeing a CCOP, and as a proportion of all their claims associated with a CCOP. Covariates included race, age, marital status, education, Medicaid eligibility, comorbidity, tumor grade, stage, estrogen receptor status, year of diagnosis, SEER region, and other institutional characteristics such as NCI center designation, cooperative group, and medical school affiliation. Multivariable generalized linear modeling with generalized estimating equations was used to measure association between CCOP exposure and receipt of SLNB. Results: Women who received a higher proportion of their care from a CCOP-affiliated physician or hospital were more likely to receive SLNB. A 10% increase in the proportion of CCOP-affiliated claims was associated with a greater odds of receiving SLNB (OR 1.14; 95% CI 1.08, 1.20), after controlling for covariates. Similarly, sensitivity analysis of the binary indicator of CCOP exposure also showed greater odds of receiving SLNB (OR 1.32; 95%CI 1.01, 1.74). Conclusions: The quality of cancer care delivered in community settings can be influenced by provider-based research networks. Our findings contribute to the growing body of evidence that community-based PBRNs can facilitate adoption of cancer innovations outside of academic medical centers.