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Clinical trial participants do not reflect the racial and ethnic diversity of people with cancer. ASCO and the Association of Community Cancer Centers collaborated on a quality improvement study to enhance racial and ethnic equity, diversity, and inclusion (EDI) in cancer clinical trials. The groups conducted a pilot study to examine the feasibility, utility, and face validity of a two-part clinical trial site self-assessment to enable diverse types of research sites in the United States to (1) review internal data to assess racial and ethnic disparities in screening and enrollment and (2) review their policies, programs, procedures to identify opportunities and strategies to improve EDI. Overall, 81% of 62 participating sites were satisfied with the assessment; 82% identified opportunities for improvement; and 63% identified specific strategies and 74% thought the assessment had potential to help their site increase EDI. The assessment increased awareness about performance (82%) and helped identify specific strategies (63%) to increase EDI in trials. Although most sites (65%) were able to provide some data on the number of patients that consented, only two sites were able to provide all requested trial screening, offering, and enrollment data by race and ethnicity. Documenting and evaluating such data are critical steps toward improving EDI and are key to identifying and addressing disparities more broadly. ASCO and Association of Community Cancer Centers will partner with sites to better understand their processes and the feasibility of collecting screening, offering, and enrollment data in systematic and automated ways.

A concerted commitment across research stakeholders is necessary to increase equity, diversity, and inclusion (EDI) and address barriers to cancer clinical trial recruitment and participation. Racial and ethnic diversity among trial participants is key to understanding intrinsic and extrinsic factors that may affect patient response to cancer treatments. This ASCO and Association of Community Cancer Centers (ACCC) Research Statement presents specific recommendations and strategies for the research community to improve EDI in cancer clinical trials. There are six overarching recommendations: (1) clinical trials are an integral component of high-quality cancer care, and every person with cancer should have the opportunity to participate; (2) trial sponsors and investigators should design and implement trials with a focus on reducing barriers and enhancing EDI, and work with sites to conduct trials in ways that increase participation of under-represented populations; (3) trial sponsors, researchers, and sites should form long-standing partnerships with patients, patient advocacy groups, and community leaders and groups; (4) anyone designing or conducting trials should complete recurring education, training, and evaluation to demonstrate and maintain cross-cultural competencies, mitigation of bias, effective communication, and a commitment to achieving EDI; (5) research stakeholders should invest in programs and policies that increase EDI in trials and in the research workforce; and (6) research stakeholders should collect and publish aggregate data on racial and ethnic diversity of trial participants when reporting results of trials, programs, and interventions to increase EDI. The recommendations are intended to serve as a guide for the research community to improve participation rates among people from racial and ethnic minority populations historically under-represented in cancer clinical trials. ASCO and ACCC will work at all levels to advance the recommendations in this publication.

PURPOSE Timely lung cancer surgery is a metric of high-quality cancer care and improves survival for early-stage non–small-cell lung cancer. Historically, Black patients experience longer delays to surgery than White patients and have lower survival rates. Antiracism interventions have shown benefits in reducing racial disparities in lung cancer treatment. METHODS We conducted a secondary analysis of Accountability for Cancer Care through Undoing Racism and Equity, an antiracism prospective pragmatic trial, at five cancer centers to assess the impact on overall timeliness of lung cancer surgery and racial disparities in timely surgery. The intervention consisted of (1) a real-time warning system to identify unmet care milestones, (2) race-specific feedback on lung cancer treatment rates, and (3) patient navigation. The primary outcome was surgery within 8 weeks of diagnosis. Risk ratios (RRs) and 95% CIs were estimated using log-binomial regression and adjusted for clinical and demographic factors. RESULTS A total of 2,363 patients with stage I and II non–small-cell lung cancer were included in the analyses: intervention (n = 263), retrospective control (n = 1,798), and concurrent control (n = 302). 87.1% of Black patients and 85.4% of White patients in the intervention group ( P = .13) received surgery within 8 weeks of diagnosis compared with 58.7% of Black patients and 75.0% of White patients in the retrospective group ( P < .01) and 64.9% of Black patients and 73.2% of White patients ( P = .29) in the concurrent group. Black patients in the intervention group were more likely to receive timely surgery than Black patients in the retrospective group (RR 1.43; 95% CI, 1.26 to 1.64). White patients in the intervention group also had timelier surgery than White patients in the retrospective group (RR 1.10; 95% CI, 1.02 to 1.18). CONCLUSION Accountability for Cancer Care through Undoing Racism and Equity is associated with timelier lung cancer surgery and reduction of the racial gap in timely surgery.

It is not known whether chemotherapy-related symptom experiences differ between Black and White women with early breast cancer (Stage I–III) receiving current chemotherapy regimens and, in turn, influences dose delay, dose reduction, early treatment discontinuation, or hospitalization. Patients self-reported their race and provided symptom reports for 17 major side effects throughout chemotherapy. Toxicity and adverse events were analyzed separately for anthracycline and non-anthracycline regimens. Fisher’s exact tests and two-sample t-tests compared baseline patient characteristics. Modified Poisson regression estimated relative risks of moderate, severe, or very severe (MSVS) symptom severity, and chemotherapy-related adverse events.Please check and confirm that the authors and their respective affiliations have been correctly identified and amend if necessary.no changes In 294 patients accrued between 2014 and 2020, mean age was 58 (SD13) and 23% were Black. For anthracycline-based regimens, the only significant difference in MSVS symptoms was in lymphedema (41% Black vs 20% White, p = .04) after controlling for axillary surgery. For non-anthracycline regimens, the only significant difference was MSVS peripheral neuropathy (41% Blacks vs. 23% White) after controlling for taxane type (p = .05) and diabetes (p = .05). For all other symptoms, severity scores were similar. Dose reduction differed significantly for non-anthracycline regimens (49% Black vs. 25% White, p = .01), but not for anthracycline regimens or in dose delay, early treatment discontinuation, or hospitalization for either regimen. Except for lymphedema and peripheral neuropathy, Black and White patients reported similar symptom severity during adjuvant chemotherapy. Dose reductions in Black patients were more common for non-anthracycline regimens. In this sample, there were minimal differences in patient-reported symptoms and other adverse outcomes in Black versus White patients.

PURPOSE: Residents of communities facing social vulnerability (eg, poverty) have limited access to clinical trials, leaving them susceptible to experiencing poor health outcomes. We examined the association between North Carolina county-level social vulnerability and available multiple myeloma (MM) trials. METHODS: Using a novel data linkage between ClinicalTrials.gov, the 2019 American Community Survey, and the Centers for Disease Control and Prevention's Social Vulnerability Index, we investigated at the county level (1) availability of MM trial sites and (2) the relationship between Social Vulnerability Index and MM trial site availability using logistic regression. RESULTS: Between 2002 and 2021, 229 trials were registered across 462 nonunique trial sites in 34 counties. Nearly 50% of trial sites were in academic medical centers, 80% (n = 372) of all trials were industry-sponsored, 60% (n = 274) were early-phase, and 50% (n = 232) were for patients with relapsed or refractory MM. Counties with low as opposed to high poverty rates had six times greater odds of having ≥ 1 MM trial sites (odds ratio [OR], 5.60; 95% CI, 1.85 to 19.64; P = .004). Counties with the lowest percentage of Black Indigenous Persons of Color and non-native English speakers had 77% lower odds (OR, 0.23; 95% CI, 0.07 to 0.69; P = .011) of having ≥ 1 trial sites. The effect remained significant after accounting for the presence of five academic medical centers (n = 95; OR, 0.18; 95% CI, 0.05 to 0.6; P = .008) and adjustment for metropolitan, suburban, or rural status (OR, 0.25; 95% CI, 0.07 to 0.81; P = .025). CONCLUSION: Counties with the lowest poverty rates had more MM trial sites, whereas those with the lowest percentage of Black Indigenous Persons of Color populations had fewer MM trial sites. Multilevel efforts are needed to improve the availability and access to trials for socially vulnerable populations.

Background: Representation of Black individuals with cancer in biospecimen research remains disproportionately low compared to white counterparts. Clinicians and research staff are responsible for informing, inviting, and consenting patients to participate in such research. We sought to understand clinician and research staff perspectives on engaging Black patients in biospecimen research. Methods: We conducted 10 in-depth interviews with purposively sampled clinicians and research staff at a large academic cancer center in North Carolina between January and August 2022. Participants underwent semi-structured interviews (duration 45-60 minutes) and were asked open ended questions about biospecimen research barriers in general, barriers specific to people who identify as Black or African American, and considerations when discussing biospecimen research with Black patients. Interview transcripts were analyzed using thematic analysis. Results: Perceived patient related barriers to biospecimen donation included pain from sample collection, invasive sample collection, lack of to time or transportation, medical research mistrust, health literacy, and limited knowledge of opportunities for involvement. Many felt that these barriers were faced by both Black and non-Black patients. However, some felt for Black patients, these barriers existed within the context of historical injustices in medicine, current bias in health care and socioeconomic inequities, while others felt socioeconomic status not race was more of a concern. Clinician and research staff identified barriers to discussing biospecimen research included lack of time given busy clinical practice and concern with patients’ physical and emotional state. Patients’ race was not considered a barrier. When asked about considerations for discussing biospecimen research specifically with Black patients, participants felt time to establish rapport and trust, readiness to discuss historical injustices in biomedical research, reminding participants research is voluntary, and having in person discussions were important. Few felt that patient race was not relevant to these discussions. Conclusion: Some clinicians and research staff acknowledge that historical injustices and current racial bias in biomedical research and health care contribute to low representation of Black individuals in biospecimen research, while others did not. Further research is needed to assess whether race and/or racism agnostic approaches versus acknowledgement of structural racism’s influence on biomedical research and health care have an impact on fair representation of Black individuals in biospecimen research. Sponsored by the Lung Cancer Research Foundation Research Grant on Disparities in Lung Cancer Citation Format: Aaron Carpenter, Hayley N. Morris, Annabella Opoku, Alison Hilton, Jessica Carda-Auten, Randall Teal, Jeenn A. Barreiro-Rosado, Lauren Matthews, Oluwatumilara Akeke, Ashley Rankin Collins, Marjory Charlot. Research team perspectives on engaging Black patients with cancer in biospecimen research. [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 5535.

Background: Participation of racially diverse populations in research is necessary to advance cancer care. However, representation of Black individuals in biospecimen cancer research remains low and requires being asked to engage in research. We sought to understand the experiences, beliefs, and knowledge about biospecimen research among Black patients with lung cancer. Methods: Semi-structured interviews with a purposive sample of 15 Black patients diagnosed with lung cancer were conducted between January and August 2022 at a large academic center in North Carolina. Interviews were digitally recorded and transcribed and analyzed using thematic analysis. Results: Themes related to who should initiate discussions about biospecimen donation, what should be considered before donation, and communication strategies to increase participation of Black patients with cancer in biospecimen research emerged from the interviews. Most participants indicated that discussions about biospecimen donation should be initiated by trusted and knowledgeable members of the medical team and most expressed trusting their providers. Some also expressed the importance of including family members in discussions about medical and research decisions. Some participants felt it was important to consider if donating specimens would cause pain or would require additional procedures. Recommended communication strategies to facilitate participation included use of simple and easily understood language in addition to messaging related to how biospecimen donation would benefit others. Participants also felt cultural humility, respect, and empathy during research recruitment would help enhance enrollment of Black participants in biospecimen research. Of note, all participants reported never being asked to participate in biospecimen research and felt that underrepresentation of Black participants may be due to not being asked. Conclusion: Black participants in this study have not been asked to participate in biospecimen research but are willing to be engaged in conversations about research from their medical team. Simply being asked, trusting their medical provider, cultural humility, and framing the message on how the research will benefit others are some of the recommended strategies to enhance research participation among Black patients. Future research should incorporate these strategies into an intervention to assess the impact on recruiting Black individuals in biomedical research. Sponsored by the Lung Cancer Research Foundation Research Grant on Disparities in Lung Cancer Citation Format: Jeenn A. Barreiro-Rosa, Oluwatumilara Akeke, Annabella Opoku, Alison Hilton, Jessica Carda-Auten, Randall Teal, Aaron Carpenter, Hayley N. Morris, Lauren Matthews, Ashley Rankin Collins, Marjory Charlot. “Simply ask and explain”: perspectives from Black patients with lung cancer on strategies to address racial disparities in biospecimen research participation. [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 5534.

PURPOSE There is increasing interest in implementing digital systems for remote monitoring of patients’ symptoms during routine oncology practice. Information is limited about the clinical utility and user perceptions of these systems. METHODS PRO-TECT is a multicenter trial evaluating implementation of electronic patient-reported outcomes (ePROs) among adults with advanced and metastatic cancers receiving treatment at US community oncology practices (ClinicalTrials.gov identifier: NCT03249090 ). Questions derived from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) are administered weekly by web or automated telephone system, with alerts to nurses for severe or worsening symptoms. To elicit user feedback, surveys were administered to participating patients and clinicians. RESULTS Among 496 patients across 26 practices, the majority found the system and questions easy to understand (95%), easy to use (93%), and relevant to their care (91%). Most patients reported that PRO information was used by their clinicians for care (70%), improved discussions with clinicians (73%), made them feel more in control of their own care (77%), and would recommend the system to other patients (89%). Scores for most patient feedback questions were significantly positively correlated with weekly PRO completion rates in both univariate and multivariable analyses. Among 57 nurses, most reported that PRO information was helpful for clinical documentation (79%), increased efficiency of patient discussions (84%), and was useful for patient care (75%). Among 39 oncologists, most found PRO information useful (91%), with 65% using PROs to guide patient discussions sometimes or often and 65% using PROs to make treatment decisions sometimes or often. CONCLUSION These findings support the clinical utility and value of implementing digital systems for monitoring PROs, including the PRO-CTCAE, in routine cancer care.

Background Participating in clinical trials is a metric of high-quality cancer care and improves survival. However, Black individuals with cancer are less likely to be enrolled in clinical trials and experience a disproportionate burden of cancer mortality compared to Whites. Patient-engaged research is one potential strategy to address racial inequities in clinical trials, but little is known about best practices for engaging Black individuals and communities impacted by cancer in research partnerships. Methods We used a community engaged research approach to establish a patient advisory council (PAC) representative of the patient population served by a safety net hospital cancer center. We outline the process of establishing the PAC and the lessons learned. Results The inaugural PAC included 7 members representative of the cancer center’s patient demographics. PAC members developed a patient centered vision, mission and action plan. PAC and community-academic research partners experienced the transformative power of centering the lived experiences of patients of color to promote health equity in cancer research. Conclusion Establishing a patient advisory council at a safety net hospital cancer care center provided a platform for engaging a hardly reached population in patient centered research. Supplementary Information The online version contains supplementary material available at 10.1186/s40900-021-00317-7., Plain English summary Participating in clinical trials is an important measure of high-quality cancer care and improves survival. However, Black individuals with cancer are less likely to participate in clinical trials and are more likely to die from cancer compared to Whites. Including Black patients as research partners is one way to improve racial equity in clinical trial participation. We established a patient advisory council (PAC) including patients and caregivers with similar racial demographics as the patients receiving care at a safety net hospital cancer center. PAC members partnered with the research team to develop a vision, mission, and action plan to improve research participation among patients of color. PAC members used their lived experiences and training from the research team to help develop a strategy to improve representation of patients of color in cancer research. This paper is focused on the PAC development process. Supplementary Information The online version contains supplementary material available at 10.1186/s40900-021-00317-7.

Equity in vaccine outreach and delivery has been prioritized given the disproportionate harms of the COVID-19 pandemic on communities of color and those with lower socioeconomic status. Health systems have largely communicated availability or signup for vaccines to patients through electronic patient portal messages, emails, or online materials; however, rates of portal use and internet access are limited among rural populations, individualswith lower socioeconomic status, and racial and ethnic minority patients. For purposes of this analysis, these groups are referred collectively as marginalized populations. Reliance on these media as the primary means for communication may inadvertently widen vaccination disparities.

Background Women with obesity are at higher risk for high-grade and/or advanced-stage breast cancer in comparison with women without obesity. Many women with a high body mass index (BMI) at breast cancer diagnosis experience further weight gain during and after treatment. This study investigated Black and White patient perspectives on conversations with their oncologists about weight and weight management. Methods Focus groups using a virtual platform (Zoom) were conducted with women after primary treatment for stage I to III breast cancer who were 21 years or older and had a BMI ≥ 30 kg/m2 : 2 with Black women (n = 12) and 2 with White women (n = 14). Results Participants asked that their oncologists be "transparent" about weight gain as a potential side effect of their cancer treatment and how excess weight might affect their prognosis and survival. They asked to be "seen as an individual" to facilitate both person-centered and culturally appropriate conversations about behavioral changes needed for weight management. Participants urged clinicians to take the lead in initiating conversations about weight to underscore its importance in cancer care and survivorship. They welcomed actionable recommendations about nutrition and exercise from either the oncology clinician or a specialist. Participants offered specific suggestions on how clinicians could initiate weight-related conversations, beginning with questions eliciting patients' perspectives on their weight and lifestyle. Conclusions Many women with early-stage breast cancer and obesity have concerns about weight and weight gain and urge their oncologists to use an active and personalized approach in recommending and supporting efforts at weight management. Lay summary Focus group discussions with Black and White women with early-stage breast cancer and obesity have elicited patient perspectives on conversations with their oncologists about weight and weight management. Many patients have concerns about weight and weight gain and urge their oncologists to use an active and personalized approach in recommending and supporting efforts at weight management.

Objective: Smoking cessation studies tailored for low-income and racial/ethnic minority cancer patients are limited. African American and low-socioeconomic status (SES) smokers have higher...

The COVID-19 pandemic and the simultaneous increased focus on structural racism and racial/ethnic disparities across the United States have shed light on glaring inequities in U.S. health care, both in oncology and more generally. In this article, we describe how, through the lens of fundamental ethical principles, an ethical imperative exists for the oncology community to overcome these inequities in cancer care, research, and the oncology workforce. We first explain why this is an ethical imperative, centering the discussion on lessons learned during 2020. We continue by describing ongoing equity-focused efforts by ASCO and other related professional medical organizations. We end with a call to action—all members of the oncology community have an ethical responsibility to take steps to address inequities in their clinical and academic work—and with guidance to practicing oncologists looking to optimize equity in their research and clinical practice.

Background Insufficient social support is associated with increased mortality among older adults. Lung cancer is primarily a disease of older adults and is the leading cause of all cancer deaths. We assessed the association of social support with outcomes among older adults with lung cancer. Materials and methods Adults age 65 and older with lung cancer with a completed geriatric assessment (GA) were assessed. Emotional social support (ES) and tangible (material, instrumental) support (TS) measures and patient characteristics were obtained from the GA. The electronic health record was used to extract clinical variables. Simple linear regression models evaluated the association between social support scales with patient and clinical factors. Results 79 adults were assessed. White race was positively associated with ES score (p=.04), while higher BMI (p=.03), depression (p=.03) and anxiety (p=.02) were associated with worse ES. Higher BMI was associated with higher/better TS score (p=.02) while living alone was associated with lower/worse TS score (p=.03). Completion of platinum-based doublet chemotherapy with immunotherapy as planned was associated with higher ES scores (p=.02) and higher TS scores (p=.02). Disease progression was associated with lower ES scores (p=.03). Conclusion Social support may influence clinical outcomes in older adults with lung cancer. As lung cancer often portends to poor prognosis, social support may be an important prognostic indicator.

6530 Background: Only a small fraction of patients with cancer participate in treatment trials. Patients identifying as members of racial and ethnic minority groups are consistently underrepresented in these trials. A recent systematic review reported that patients, regardless of race and ethnicity, are willing to enroll in trials if asked to participate by their treating clinician. Prospective and longitudinal data and metrics at the site- and clinician-level are necessary to understand whether patients are equitably considered for clinical trials. Methods: ASCO and Association of Community Cancer Centers (ACCC) developed a self-assessment for trial sites to record and gauge the number of patients across races and ethnicities screened, offered, and enrolled into clinical trials. Research sites, from across the US, were recruited through an open call to apply to participate in the ASCO-ACCC Pilot Project. There were 65 sites assigned to this pilot study, which tested the feasibility and utility of the site assessment. Sites were asked to enter 2019 and 2020 aggregate data for each step along the clinical trial enrollment continuum by select races and ethnicities (Black, Hispanic/Latinx, White) and overall. Results: 62 of 65 sites completed the study and represented a range of settings and practice types (61% academic, 26% hospital/health system, 13% independent). Only 2 sites (3%) were able to provide the data requested at each enrollment step in the assessment (table). Sites that collected the data did not do so routinely (table) and most had to compile data through multiple sources and/or manual extraction (40-100% across enrollment steps). Sites with missing data reported they did not collect data at all (36-64% across enrollment steps), did not collect data in a systematic way (0-29% across enrollment steps), or stated it would be too burdensome to manually review charts to extract data (12-29% across enrollment steps). Conclusions: Data collection and routine evaluation of participation metrics, by race and ethnicity, are necessary to assess and monitor equity and diversity in clinical trials. Most sites in this study did not collect, or routinely collect, data for screening, offering, and consenting patients to clinical trials. Without these data, sites are unable to evaluate and monitor whether their patients have equitable access to clinical trials or establish strategies to address any inequities. ASCO and ACCC will continue to partner with sites to better understand their processes and the feasibility of collecting such data in a systematic and automated way, such as through electronic health record systems. [Table: see text]

Background Precision medicine in advanced non-small cell lung cancer (NSCLC) requires molecular biomarker testing in patients with nonsquamous and select patients with squamous histologies, and programmed death-ligand 1 (PD-L1) testing in both. Research Question What are rates of molecular and PD-L1 biomarker testing in patients with advanced NSCLC in community practices, and do rates vary by sociodemographic factors? What is the prevalence of molecular biomarker mutations and PD-L1 expression levels? Study Design and Methods From 389 stage IV NSCLC pathology reports obtained through the University of North Carolina Lineberger Comprehensive Cancer Center’s Rapid Case Ascertainment Program from 38 community hospitals across North Carolina, we abstracted demographics, histology, molecular biomarker testing and results, and PD-L1 testing and expression. We geocoded patient and hospital addresses to determine travel time, distance to care, and census block level contextual variables. We compared molecular biomarker and PD-L1 testing rates, the prevalence of molecular biomarkers, and PD-L1 expression levels by race and sex, using χ2 tests. We determined predictors of testing, using multivariable logistic regression and report adjusted ORs and 95%CI. Results Among patients with nonsquamous NSCLC, 64.4% were tested for molecular biomarkers, and among all NSCLC patients 53.2% were tested for PD-L1 expression. Differences in biomarker testing rates by sociodemographic factors were not statistically significant in univariate or adjusted analyses. Adjusted analyses showed that patients living in areas with higher household internet access were more likely to undergo PD-L1 testing (adjusted OR = 1.66, 95% CI, 1.02-2.71). Sociodemographic differences in molecular biomarker prevalence and PD-L1 expression levels were not statistically significant, except for human epidermal growth factor receptor 2 (HER2) mutations, which occurred in 16.7% of males vs 0% in females, P = .05. Interpretation Biomarker testing remains underused in NSCLC. Future work should include larger populations and evaluate hospital-specific testing protocols to identify and address barriers to guideline-recommended testing.

The emergence of oral targeted therapy in the management of non-small cell lung cancer with targetable oncogenes has led to significant improvements in progression-free survival, toxicity profile, and quality of life compared to intravenous chemotherapy. However, patients unable to swallow or with exclusive enteral feeding are left without alternative formulations for these targeted therapies given their availability only in tablet or capsule formulations. We report a case of a woman with metastatic anaplastic lymphoma kinase-positive non-small cell lung cancer who was unable to swallow and was successfully treated with an oil-based alectinib liquid suspension.

Background Safety net hospitals provide care mostly to low-income, uninsured, and vulnerable populations, in whom delays in cancer screening are established barriers. Socioeconomic barriers might pose important challenges to the success of a lung cancer screening program at a safety net hospital. We aimed to determine screening follow-up compliance, rates of diagnostic and treatment procedures, and the rate of cancer diagnosis in patients classified as category 4 by the Lung CT Screening Reporting and Data System (Lung-RADS 4). Methods We conducted a retrospective review of all patients enrolled in our multidisciplinary lung cancer screening program between March 2015 and July 2016. Demographics, smoking status, Lung-RADS score, and number of diagnostic and therapeutic interventions and cancer diagnoses were captured. Results A total of 554 patients were screened over a 16-month period. The mean patient age was 63 years (range, 47-85 years), and 60% were male. The majority (92%; 512 of 554) were classified as Lung-RADS 1 to 3, and 8% (42 of 554) were classified as Lung-RADS 4. Among the Lung-RADS 4 patients, 98% (41 of 42) completed their recommended follow-up; 29% (12 of 42) underwent a diagnostic procedure, for an overall diagnostic intervention rate of 2% (12 of 554). Eleven of these 12 patients had cancer, and 1 patient had sarcoidosis. The overall rate of surgical resection was 0.9% (5 of 554), and the rate of diagnostic intervention for noncancer diagnosis was 0.1% (1 of 554). Conclusions Implementation of a multidisciplinary lung cancer screening program at a safety net hospital is feasible. Compliance with follow-up and interventional recommendations in Lung-RADS 4 patients was high despite anticipated social challenges. Overall diagnostic and surgical resection rates and interventions for noncancer diagnosis were low in our initial experience.

Participatory research approaches can help ensure research is culturally relevant and aligned with stakeholder priorities, but barriers exist between researchers and community stakeholders, particularly in communities of color. We developed a measurement tool for assessing oncology researcher and provider readiness to undertake patient-engaged research, and piloted this measurement tool among oncology researchers and providers at the hospital's cancer care center. A survey was developed by drawing from existing PCORI assessments as well as creating original questions, in an effort to develop an evidence-based survey tailored to this project. A total of 23 researchers and providers responded to the survey. The majority of respondents indicated that they were moderately or very familiar with the concept of patient-centered outcomes research. Most respondents had little to no experience engaging in participatory research and endorsed several barriers to engaging patients in the research process, including lack of experience and time. A mechanism for preparing and supporting researchers and providers is needed if cancer centers are to implement patient-powered research agendas as recommended by PCORI.

101 Background: Racial disparities are well described in the management of early-stage lung cancer, with Black patients less likely to receive potentially curative surgery than non-Hispanic Whites. A multi-site pragmatic trial entitled Accountability for Cancer Care through Undoing Racism and Equity (ACCURE), designed in collaboration with community partners, eliminated racial disparities in lung cancer surgery through a multi-component intervention. The study involved real-time electronic health record (EHR) monitoring to identify patients not receiving recommended care, a nurse navigator who reviewed and addressed EHR alerts daily, and race-specific feedback provided to clinical teams. Timeliness of cancer care is an important quality metric. Delays can lead to disease progression, upstaging, and worse survival, and Black patients are more likely to experience longer wait times to lung cancer surgery. Yet interventions to reduce racial disparities in timely delivery of lung cancer surgery have not been well studied. We evaluated the effect of ACCURE on timely receipt of lung cancer surgery. Methods: We analyzed data of a retrospective cohort at five cancer centers gathered prior to the ACCURE intervention and compared results with prospective data collected during the intervention. We calculated mean time from clinical suspicion of lung cancer to surgery and evaluated the proportion of patients who received surgery within 60 days stratified by race. We performed a t-test to compare mean days to surgery and chi2 for the delivery of surgery within 60 days. Results: 1320 patients underwent surgery in the retrospective arm, 160 were Black. 254 patients received surgery in the intervention arm, 85 were Black. Results are summarized in Table. Mean time to surgery in the retrospective cohort was 41.8 days, compared with 25.5 days in the intervention cohort (p

e18540 Background: Multiple myeloma (MM) is a disease of aging, associated with one of the greatest black-white disparities in incidence and mortality among all US cancer types. Clinical trials provide the critical evidence-base to inform clinical management in all cancers, including MM. However, clinical trial participants are often younger (age < 65 years) and white, limiting the generalizability of published data to real-world MM care. Although geographical and financial barriers to clinical trial participation are well recognized, less is known about the association of county-level social vulnerability with MM trial availability. We examined county-level variation in the number of registered myeloma trials per 10,000 North Carolina (NC) residents age ≥ 65 years as a function of social vulnerability and the presence of a National Cancer Institute Comprehensive Cancer Center (CCC). Methods: We conducted a cross-sectional study using data from ClinicalTrials.gov to identify all registered interventional myeloma trials involving adults age ≥ 65 years with sites in NC. Records were downloaded on January 24th, 2021. This strategy yielded 456 non-unique NC sites for 223 trials. We obtained county locations for all trial sites by matching city, zip code, or institution name. We obtained NC population data for residents age ≥ 65 years (in 2019) from the American Community Survey. The four themes (socioeconomic status, household composition, ethnic and racial minority status/language, housing/transportation) within the Centers for Disease Control Social Vulnerability Index (CDC SVI) (composite score: 0-1, with a higher number indicating more vulnerability) were used to characterize county-level social vulnerability. We performed negative binomial regression and tabulations using R, version 3.6.1. A p-value < 0.05 was considered statistically significant. Results: Across 100 counties in NC, trial site counts by county per 10,000 residents age ≥ 65 years ranged from 0 to 23.2 (mean: 1.5, median: 0; IQR, 0-0.7). Controlling for the 4 SVI themes, counties with CCCs (Durham, Forsyth, Orange) had 77% more trials than those without CCCs [Incidence Rate Ratio (IRR): 7.74; p = 0.05]. We observed a 3.3% reduction in trial counts with each percentile increase in socioeconomic vulnerability (IRR: 0.97; p = 0.008). Counties with higher representation by racial and ethnic minorities had similar trial site counts to counties with lower minority populations (IRR: 1.01; p = 0.08). Sub-group analyses of early-stage studies (phase 1/2 and phase 2; n = 268) and late-stage studies (phase 2/3 and phase 3; n = 168) were similar. Conclusions: Our preliminary results suggest county-level socioeconomic status is associated with the distribution of MM clinical trial sites across NC. Further work is planned to explore whether additional variances in trial distribution could be explained by site- and study-specific characteristics.

Breast cancer mortality is higher in Black women than in White women. The prevalence of type 2 diabetes mellitus is also higher, yet data on whether diabetes affects breast cancer mortality in this population are lacking. We investigated the relation of diabetes at the time of breast cancer diagnosis to breast cancer mortality in the Black Women's Health Study, a prospective cohort study.1,621 Black women with invasive breast cancer diagnosed in 1995-2013 were followed by mailed questionnaires and searches of the National Death Index. Multivariable Cox regression analysis was used to compute hazard ratios (HRs) for diabetes in relation to breast cancer mortality and all-cause mortality, with adjustment for age, stage, treatment modality, estrogen receptor (ER) status, and body mass index.There were 368 deaths during follow-up, of which 273 were due to breast cancer. Breast cancer mortality was significantly increased in women who had been diagnosed with diabetes at least 5 years before breast cancer occurrence, HR 1.86 (95% CI 1.20-2.89), with elevations observed for both ER+ and ER- breast cancer. All-cause mortality was also higher in diabetics, with HRs of 1.54 (95% CI 1.12-2.07) overall and 2.26 (95% CI 1.62-3.15) for ≥5-year duration of diabetes relative to non-diabetics.Our results present the first solid evidence of a positive association of type 2 diabetes with breast cancer mortality in Black women. Given the higher prevalence and earlier onset of type 2 diabetes in Black women, it is likely that diabetes contributes to racial disparities in breast cancer mortality.

Background Racial disparities in patient-reported outcomes (PROs; e.g., symptoms, financial burden) among patients with cancer are well documented. Prior studies have attributed such disparities to patient- and provider-level factors, but less is known about the contribution of practice-level factors. Hospital racial composition of patients has been linked to disparities in care quality and outcomes, but questions remain regarding whether oncology practice racial composition mediates racial disparities. Using 2017-2020 data from the Patient-Reported Outcomes to Enhance Cancer Treatment (PRO-TECT) trial (ClinicalTrials.gov NCT03249090), we examined racial disparities in PROs among patients with metastatic cancer, and whether oncology practice racial composition accounted for observed disparities. Methods Our sample included 1099 patients (n=198 Black; n=901 White) from 51 community oncology practices across the US. Predictors of interest were patient race (Black vs. White) and practice-reported racial composition (Black patient population >20% vs. ≤20%). Patient-reported outcome metrics included pain, appetite loss, fatigue, nausea, dyspnea, insomnia, constipation, diarrhea, and financial burden, measured at baseline and at 1- and 3-month follow-up using the EORTC Quality of Life Core Questionnaire (QLQ-C30). Raw EORTC QLQ-C30 scores were standardized to range from 0 (best) to 100 (worst). We estimated multilevel linear mixed models predicting each PRO as a function of patient race, adjusting for clinical and sociodemographic factors, followed by further adjustment for practice racial composition. Results Twelve out of fifty-one (23.5%) practices reported a Black racial composition of >20%, with 41.6% of Blacks and 14.5% Whites receiving care at these practices. Across all practices, Blacks reported worse pain (β=5.5, p=0.02), nausea (β=2.5, p=0.04) and financial burden (β=7.6, p20% reported more pain (β=5.5, p=0.01), appetite loss (β=8.1, p Citation Format: Cleo A. Samuel, Olive Mbah, Wendi Elkins, Marjory Charlot, Amylou Dueck, Brenda F. Ginos, Jennifer Jansen, Deborah Schrag, Patty Spears, Angela Stover, Ethan Basch. Separate and unequal: Examining the role of race and site of care on patient-reported outcomes among patients with metastatic cancer (AFT-39) [abstract]. In: Proceedings of the AACR Virtual Conference: Thirteenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2020 Oct 2-4. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(12 Suppl):Abstract nr PO-119.

BACKGROUND Patient navigation improves the timely diagnosis of cancer among minorities, but little is known about the effects of patient and navigator race and language concordance on health outcomes. METHODS The authors investigated the effects of patient and navigator race and language concordance on the time to diagnosis of cancer screening abnormalities among participants in the Boston Patient Navigation Research Program, a clinical effectiveness trial for women who had breast or cervical cancer screening abnormalities identified from January 1, 2007 to December 31, 2008. Hazard ratios and 95% confidence intervals were estimated using proportional hazards regression adjusting for clinical and demographic factors. RESULTS In total, 1257 women had breast cancer screening abnormalities (n = 655) or cervical cancer screening abnormalities (n = 602) identified, and 56% were nonwhite. Language concordance was associated with timelier resolution for all patients in the cervical cancer screening abnormalities group during the first 90 days (adjusted hazard ratio, 1.46; 95% confidence interval, 1.18-1.80), and specifically for Spanish speakers during the first 90 days (adjusted hazard ratio, 1.43; 95% confidence interval, 1.10-1.84), but no difference was observed after 90 days for women who had cervical cancer screening abnormalities or at any time for those who had breast cancer screening abnormalities. Race concordance was associated with significant decreases in the time to diagnosis for minority women with breast and cervical cancer screening abnormalities in analyses stratified by race, but no differences were observed in analyses that included all women. CONCLUSIONS Patient navigator race and language concordance improved the timeliness of care in a minority population. Patient navigators who are racially/ethnically diverse and multilingual may help address barriers to care and improve cancer outcomes for low-income minorities. Cancer 2015;121:1477–1483. © 2015 American Cancer Society.

Background While racial disparity in colorectal cancer survival have previously been studied, whether this disparity exists in patients with metastatic colorectal cancer receiving care at safety net hospitals (and therefore of similar socioeconomic status) is poorly understood. Methods We examined racial differences in survival in a cohort of patients with stage IV colorectal cancer treated at the largest safety net hospital in the New England region, which serves a population with a majority (65%) of non-Caucasian patients. Data was extracted from the hospital’s electronic medical record. Survival differences among different racial and ethnic groups were examined graphically using Kaplan-Meier analysis. A univariate cox proportional hazards model and a multivariable adjusted model were generated. Results Black patients had significantly lower overall survival compared to White patients, with median overall survival of 1.9 years and 2.5 years respectively. In a multivariate analysis, Black race posed a significant hazard (HR 1.70, CI 1.01–2.90, p = 0.0467) for death. Though response to therapy emerged as a strong predictor of survival (HR = 0.4, CI = 0.2-0.7, p = 0.0021), it was comparable between Blacks and Whites. Conclusions Despite presumed equal access to healthcare and socioeconomic status within a safety-net hospital system, our results reinforce findings from previous studies showing lower colorectal cancer survival in Black patients, and also point to the importance of investigating other factors such as genetic and pathologic differences.

MicroRNAs (miRNAs) have been shown to be reliable early biomarkers in a variety of cancers including that of lung. We ascertained whether the biomarker potential of miRNAs could be validated in microscopically normal and easily accessible buccal epithelial brushings from cigarette smokers as a consequence of lung cancer linked ‘field carcinogenesis’. We found that compared to neoplasia-free subjects, a panel of 68 miRNAs were upregulated and 3 downregulated in the normal appearing buccal mucosal cells collected from patients harboring lung cancer (n=76). The performance characteristics of selected miRNAs (with ≥1-fold change) were excellent with an average under the receiver operator characteristic curve (AUROC) of >0.80. Several miRNAs also displayed gender specificity between the groups. These results provide the first proof-of-concept scenario in which minimally intrusive cheek brushings could provide an initial screening tool in a large at-risk population.

Although a number of studies have found an inverse association between body mass index (BMI) and risk of lung cancer, there is little information on this relation in African Americans, who experience a higher incidence of lung cancer.We assessed the relation of BMI to incidence of lung cancer in the Black Women's Health Study, an ongoing prospective follow-up of 59,000 women in the USA. Cox proportional hazard models were used to estimate hazard ratios for various levels of BMI relative to BMI 18.5-24.9 kg/m2 ("normal weight") with adjustment for age, education, pack-years of smoking, and other covariates. Two other anthropometric measures, waist circumference (WC) and waist/hip ratio (WHR), were also assessed. A total of 323 primary lung cancer cases were identified from 1995 to 2011.The hazard ratio (HR) for BMI ≥ 30 relative to BMI 18.5-24.9 was 0.69 (95% CI 0.51-0.92). As expected, cigarette smoking was strongly associated with increased risk of lung cancer. In analyses stratified by smoking status, the HR for BMI ≥ 30 relative to BMI 18.5-24.9 was 0.62 (0.38-1.00) among current smokers, 0.90 (0.56-1.42) among former smokers, and 0.83 (0.41-1.70) among never smokers (p for interaction = 0.28). Control for pack-years of smoking or age started smoking had little effect on the hazard ratios. WC and WHR were not materially associated with lung cancer risk.Our results indicate that high BMI is associated with a lower risk of lung cancer in African American women, particularly among current smokers.

We report on the clinical presentation and histopathology of a series of seven patients with localized amyloidosis of the breast. These patients were diagnosed by biopsy performed to rule out malignancy because of calcifications seen by mammography, and represented 0.5% of patients referred to the Amyloid Treatment and Research Program at Boston University Medical Campus in an 18-year period. The patients ranged in age from 35 to 75, median 63 years. None of these seven patients had evidence of a systemic plasma cell dyscrasia or amyloidosis in other organs, nor did systemic disease develop with a median follow-up of 6 years. Thus, other than excisional biopsy to exclude malignancy, no systemic therapy is indicated for this disorder.

Background: The evidence on the relation of family history of cancers other than breast cancer to breast cancer risk is conflicting, and most studies have not assessed specific breast cancer subtypes. Methods: We assessed the relation of first-degree family history of breast, prostate, lung, colorectal, ovarian, and cervical cancer and lymphoma or leukemia, to the risk of estrogen receptor–positive (ER+), ER−, and triple-negative breast cancer in data from the African American Breast Cancer Epidemiology and Risk Consortium. Multivariable logistic regression models were used to calculate ORs and 95% confidence intervals (CI). Results: There were 3,023 ER+ and 1,497 ER− breast cancer cases (including 696 triple-negative cases) and 17,420 controls. First-degree family history of breast cancer was associated with increased risk of each subtype: OR = 1.76 (95% CI, 1.57–1.97) for ER+, 1.67 (1.42–1.95) for ER−, and 1.72 (1.38–2.13) for triple-negative breast cancer. Family history of cervical cancer was associated with increased risk of ER− (OR = 2.39; 95% CI, 1.36–4.20), but not ER+ cancer. Family history of both breast and prostate cancer was associated with increased risk of ER+ (3.40; 2.42–4.79) and ER− (2.09; 1.21–3.63) cancer, but family history of both breast and lung cancer was associated only with ER− cancer (2.11; 1.29–3.46). Conclusions: A family history of cancers other than breast may influence the risk of breast cancer, and associations may differ by subtype. Impact: Greater surveillance and counseling for additional screening may be warranted for women with a family history of cancer. Cancer Epidemiol Biomarkers Prev; 25(2); 366–73. ©2015 AACR.

Introduction: Family history of breast cancer has been shown to be a strong risk factor for breast cancer in all populations studied. However, there are limited data related to risk of estrogen receptor negative (ER-) breast cancer in African American women, who have a disproportionately high incidence of ER- and triple negative (ER-, progesterone receptor negative, and HER2 receptor negative; TN) breast cancer. Even less information is available on whether a family history of other cancers also affects risk of ER- and TN breast cancer. Methods: Questionnaire data from the Black Women's Health Study, the Carolina Breast Cancer Study, the Multiethnic Cohort Study, and the Women's Circle of Health Study were pooled as part of the African American Breast Cancer Epidemiology and Risk (AMBER) Consortium. Breast cancer cases were classified as ER+, ER-, and TN based on pathology data from medical records and/or state cancer registries. Participants were asked about first degree relatives with a breast cancer diagnosis and the age at which the relative was diagnosed. Participants were also asked about first degree relatives with prostate, lung, colorectal, ovarian, or cervical cancer or with lymphoma or leukemia. Polytomous logistic regression models were used to calculate odds ratios (ORs) and 95% confidence intervals (CIs) for various categories of positive family history relative to no first degree relative with breast cancer or no first degree relative with any of the cancers. Multivariable analyses controlled for age, study, time period, and other potential confounders. Results: The analysis included 3,023 African American women with ER+, 1,497 with ER-, and 696 with TN breast cancer and 17,420 controls. First degree family history of breast cancer, regardless of whether first degree relatives had cancers other than breast cancer, was associated with a 70% increased risk of ER+, ER- and TN breast cancer; the ORs were 1.7 (95% CI 1.6-2.0) for ER+, 1.7 (95% CI 1.4-1.9) for ER-, and 1.7 (95% CI 1.4-2.1) for TN breast cancer. The ORs were somewhat higher if the relative was diagnosed before age 50 (2.0 for ER+, 1.9 for ER-, and 1.8 for TN). Among the six other cancer sites examined, only family history of cervical cancer was significantly associated with risk; the ORs were 2.4 (1.4-4.2) for ER- and 2.9 (1.5-5.5) for TN breast cancer and there was no association with ER+ breast cancer. The OR for family history of ovarian cancer in relation to TN breast cancer was 1.6 (0.9-2.7), which is of interest because findings from The Cancer Genome Atlas (TCGA) indicate that serous ovarian cancers and basal-like breast cancers, which are mostly triple negative, have many molecular commonalities. The ORs for a family history of both breast and prostate cancer versus no family history of any of the cancers were 3.4 (2.4-4.7) for ER+ cancer, as compared with 1.6 for breast alone (p-interaction=0.01), and 2.1 (1.2-3.7) for ER- cancer, as compared with 1.5 for breast alone (p-interaction=0.08). The OR for a family history of both breast and lung cancer was 3.3 (1.9-5.9) for TN breast cancer, compared to 1.5 for breast alone (p-interaction=0.10). The ORs for family history of breast plus two other cancers were 2.4 (1.6-3.6) for ER+, 2.8 (1.6-4.7) for ER-, and 2.7 (1.3-5.7) for TN breast cancer. Conclusion: Our results confirm that having a first degree family history of breast cancer is a strong risk factor for ER+, ER-, and TN breast cancer. The findings also suggest that having relatives with other cancers in addition to a relative with breast cancer may further increase risk. Consideration of family history of other cancers may improve risk prediction models. The association observed for family history of cervical cancer and increased risk of ER- and TN breast cancer was unexpected and needs to be replicated by other studies. Citation Format: Traci N. Bethea, Lynn Rosenberg, Nelsy Castro-Webb, Kathryn L. Lunetta, Lara E. Sucheston, Edward A. Ruiz-Narvaez, Marjory Charlot, Song Y. Park, Elisa V. Bandera, Melissa A. Troester, Christine B. Ambrosone, Julie R. Palmer. Relation of family history of cancer to risk of ER+, ER-, and triple-negative breast cancer in African American women. [abstract]. In: Proceedings of the Eighth AACR Conference on The Science of Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; Nov 13-16, 2015; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2016;25(3 Suppl):Abstract nr C49.

A number of studies have found that obesity, as measured by body mass index (BMI), is inversely related to lung cancer incidence among current and former smokers. The findings may be due to uncontrolled confounding by cigarette smoking, as smokers tend to be thinner on average than non-smokers and have a greatly increased risk of lung cancer. Recent results from the NIH-AARP Diet and Health Study, with a very large sample size, suggest that the observed association may be independent of smoking effects. The study also found the association to be stronger among women than men. Limited data are available on the relation of BMI to lung cancer incidence in African Americans. We assessed this question in the Black Women's Health Study, an ongoing prospective follow-up of 59,000 women from all regions of the U.S. Participants enrolled in the study by completing mailed questionnaires in 1995 and have been followed by biennial questionnaire since then. Self-reported weight and height at baseline were used to calculate BMI (weight in kilograms divided by height in meters2). Detailed information on cigarette smoking was ascertained on each questionnaire. Incident cases of lung cancer were ascertained by study questionnaire, cancer registry, or National Death Index. Pathology reports and/or cancer registry data were reviewed by a study oncologist to identify primary cancers. Cox proportional hazard models were used to estimate hazard ratios for the association of various levels of BMI relative to BMI 18.5-24.9 (“lean” women) in relation to lung cancer incidence. Multivariate models included adjustment for pack-years of cigarette smoking and current smoking status, as well as other variables. Among 331 incident primary lung cancer cases that occurred from 1995 to 2011, cigarette smoking, as measured by pack-years, cigarettes per day, or age started smoking, was strongly associated with increased risk of lung cancer, as expected. Baseline BMI was inversely associated with lung cancer risk: the hazard ratio for obese women (BMI ≥30) relative to lean women was 0.74 (95% confidence interval (CI) 0.55-0.99). In analyses stratified by smoking status, the HR for obese women relative to lean women was 0.60 (0.37-0.97) among current smokers, 0.88 (0.55-1.39) among former smokers, and 0.86 (95% CI 0.43-1.73) among never smokers. Of note, controlling for pack-years or age started smoking had little effect on the hazard ratios among current and former smokers. Our results suggest that obesity may be associated with a lower risk of lung cancer. These findings, from a study of African American women, confirm recent findings from the predominantly Caucasian NIH-AARP Study. Residual confounding by cigarette smoking did not appear to explain the association. Potential mechanisms will be discussed. Citation Format: Traci N. Bethea, Lynn Rosenberg, Marjory Charlot, Lucille L. Adams-Campbell, Julie R. Palmer. Body mass index in relation to incident lung cancer in African American women. [abstract]. In: Proceedings of the Fifth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2012 Oct 27-30; San Diego, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2012;21(10 Suppl):Abstract nr A57.

6097 Background: Patient navigators have been shown to reduce cancer disparities among racial/ethnic minorities by improving timely diagnosis and treatment of cancer. For a group of navigators who received cultural competency training, we sought to determine if racial/ ethnic concordance of the navigator and patient improved time to diagnostic resolution of cancer screening abnormalities. Methods: Demographic data on 1466 patients and their 23 navigators from the Boston Patient Navigation Research Program were used to assess concordance by race and ethnicity. All participants with either breast (n=751) or cervical (n=715) screening abnormalities were followed up to one year. Kaplan-Meier survival curves and proportional hazards regression models examined the effect of race/ethnicity concordance on time to definitive diagnosis, adjusting for age, race, language, economic status, insurance status, and severity of screening abnormality. Analyses were performed separately for the breast and cervical groups. Results: Of the 1466 patients, 32% were White, 27% Black, 31% Hispanic, and 10% Asian. Navigators were 61% White, 17% Black, 13% Hispanic and 9% Asian. Fifty eight percent of patient-navigator pairs were concordant by race/ethnicity. Overall rate of diagnostic resolution of cancer screening abnormalities within 365 days was high at 90%. In both the breast and cervical cancer screening groups, racial/ethnic concordance was not associated with time to diagnostic resolution, with an aHR 1.03 (95% CI: 0.85, 1.25) for breast patients and HR 1.02 (95% CI: 0.85, 1.21) for cervical patients. Conclusions: Patient-navigator racial/ethnic concordance is not associated with time to diagnostic resolution of cancer screening abnormalities, in part because overall rates of diagnostic resolution were high. Our data suggest that with cultural competency training, navigators can be equally effective with patients from different ethnic and cultural backgrounds.

Abstract 4906 AL amyloidosis is characterized by widespread, progressive deposition of fibrillar amyloid protein derived from monoclonal immunoglobulin light chains, leading to organ failure and death. This disease is typically systemic, however, it can occur as a localized form. In localized amyloidosis, the deposits occur near the site of synthesis of the precursor protein and in some cases, plasma cells have been demonstrated histologically adjacent to the deposits. For unknown reasons, the tracheobronchial tree is the most common site for localized AL amyloidosis. Localized AL amyloidosis of the breast is a rare entity that has been described in the literature in isolated case reports. It can present as a palpable mass or as calcifications on routine screening mammography. We report here a case series of seven women (median age 63 years, range 46 to75) seen and evaluated at Boston University Medical Center from 1990-2008. We evaluated 1502 new patients with AL amyloidosis in this time period, making the incidence of localized AL amyloidosis of the breast to be 0.5% at a single referral center. All seven patients had abnormal screening mammography with calcifications, and biopsies that revealed Congo red positive amyloid deposits. Histologically, the amyloid deposits appeared as amorphous material in the stroma around the ducts and lobules in most patients; one patient had amyloid deposits in the ducts only, but not in the stroma. None of the patients had clinical or laboratory evidence of other organ involvement, all had negative Congo red staining of an abdominal fat pad aspirate, and all had a negative work up for a plasma cell dyscrasia or circulating paraprotein. The patients were treated with local excision of the regions of calcification or lumpectomy. Three out of seven patients underwent routine follow up within 6-12 months from the time of diagnosis with no evidence of disease recurrence or progression to systemic AL amyloidosis. One out of seven patients had bilateral and recurrent amyloidosis of the breasts and was found to have an associated stage I invasive ductal adenocarcinoma that was treated with lumpectomy and radiation. In summary, breast amyloidosis is rare, is not associated with a systemic plasma cell dyscrasia or amyloidosis in other organs, and can be treated surgically. Disclosures No relevant conflicts of interest to declare.

Introduction We investigated clinical and pathologic features of breast cancers (BC) in an unselected series of patients diagnosed in a tertiary care hospital serving a diverse population. We focused on triple-negative (Tneg) tumours (oestrogen receptor (ER), progesterone receptor (PR) and HER2 negative), which are associated with poor prognosis. Methods We identified female patients with invasive BC diagnosed between 1998 and 2006, with data available on tumor grade, stage, ER, PR and HER2 status, and patient age, body mass index (BMI) and self-identified racial/ethnic group. We determined associations between patient and tumour characteristics using contingency tables and multivariate logistic regression. Results 415 cases were identified. Patients were racially and ethnically diverse (born in 44 countries, 36% white, 43% black, 10% Hispanic and 11% other). 47% were obese (BMI > 30 kg/m2). 72% of tumours were ER+ and/or PR+, 20% were Tneg and 13% were HER2+. The odds of having a Tneg tumour were 3-fold higher (95% CI 1.6, 5.5; p = 0.0001) in black compared with white women. Tneg tumours were equally common in black women diagnosed before and after age 50 (31% vs 29%; p = NS), and who were obese and non-obese (29% vs 31%; p = NS). Considering all patients, as BMI increased, the proportion of Tneg tumours decreased (p = 0.08). Conclusions Black women of diverse background have 3-fold more Tneg tumours than non-black women, regardless of age and BMI. Other factors must determine tumour subtype. The higher prevalence of Tneg tumours in black women in all age and weight categories likely contributes to black women's unfavorable breast cancer prognosis.