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Type 2 Diabetes (T2D) is a chronic inflammatory disease characterized by inflamed adipose tissue. Patients with triple negative breast cancer (TNBC) and comorbid T2D have higher risk of metastasis and shorter survival. However, mechanisms that couple T2D to TNBC outcomes are unknown. Here we hypothesize that exosomes, small vesicles secreted by tumor microenvironment breast adipocytes, drive epithelial-to-mesenchymal transition (EMT) in TNBC, immune exhaustion and metastasis via Ampk-Akt signaling.Methods: Exosomes were purified from conditioned media of 3T3-L1 mature adipocytes that were insulin-sensitive (IS) or insulin-resistant (IR), then characterized and quantified by NanoSight and surface markers, CD63. Murine 4T1 cells, a TNBC model, were treated with exosomes in vitro (3 days). To establish 3D organoids, 4T1 spheroids were treated with exosomes and embedded in Matrigel. For in vivo models, mammary fat pads of BALB/c mice were injected with 4T1 cells treated with IS vs IR exosomes. 4T1 tumors were harvested and mRNA extracted for qPCR, RNAseq, and Ingenuity Pathway Analysis. Metastatic sites in lung and liver were visualized by H&E staining and clonogenic assay. Immune exhaustion markers of tumor infiltrated lymphocytes (TILs) were measured by flow cytometry. Results: In 4T1 cells treated with IR exosomes, EMT was upregulated and PD-L1 expression increased. Tumor-bearing mice exhibited metastasis in exosome-treated groups, visualized by microscopy and clonogenic assay. Immune exhaustion markers showed modified expression in TILs from exosome-treated groups. RNA-seq analysis revealed differences among exosome-treated groups that suggest dysregulated Ampk-Akt pathways.Conclusion: Exosomes from IR adipocytes modify the tumor microenvironment, increase EMT and immune exhaustion markers on tumor cells and TILs, and promote metastasis to distant organs through Ampk-Akt. Metabolic diseases such as T2D reshape the TNBC tumor microenvironment, promoting metastasis and decreasing survival. Clearly, TNBC patients with T2D should be more closely monitored for metastasis than metabolically normal patients, with metabolic medications considered. Citation Format: Yuhan Qiu, Conor Ross, Naser Jafari, Manohar Kolla, Pablo Llevenes, Christina Ennis, Carla S Mazzeo, Kiana Mahdaviani, Naomi Y Ko, Gerald V Denis. Exosomes produced by adipocytes induce EMT, immune exhaustion and tumor metastasis, in both in vivo and in vitro models of TNBC [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P3-06-02.

PURPOSE Frailty is assessed when making treatment decisions among older women with breast cancer (BC), which in turn impacts survival. We evaluated associations between frailty and risks of BC-specific and all-cause mortality in older women. METHODS We conducted a retrospective cohort study of Medicare beneficiaries ages ≥65 years with stage I-III BC using the Surveillance, Epidemiology and End Results Medicare Health Outcome Survey Data Resource. Frailty was measured using the deficit-accumulation frailty index, categorized as robust, pre-frail or frail, at baseline and during follow-up. Fine and Gray competing risk and Cox proportional hazards models were used to estimate sub-distribution hazard ratios (SHR) and hazard ratios (HR) with 95% confidence intervals (CI) for BC-specific and all-cause mortality, respectively. RESULTS Among 2,411 women with a median age of 75 years at BC diagnosis, 50% were categorized as robust, 29% were pre-frail and 21% were frail. Compared to robust women, fewer frail women received breast-conserving surgery (52% vs. 63%) and radiation (44% vs. 52%). In multivariable analyses, frail women had higher risks of all-cause mortality compared to robust women (HR 2.16, 95% CI 1.80-2.60). CONCLUSION Frail women in our study had a higher cumulative hazard of BC-specific death, but this observed higher risk was not significant after accounting for differences in treatment and competing risks of other-cause death. Measuring frailty may help determine overall life expectancy but not BC-specific death. Table. Risk of Breast Cancer-Specific and All-cause Mortality, using time-varying DAFI measureEventsCrude SHRRobust 95%CIP-valueMinimally Adjusted SHRaRobust 95%CIP-valueFully Adjusted SHRbRobust 95%CIP-valueBreast Cancer-Specific MortalityDAFI CategoriesRobust891.001.001.00Pre-frail691.250.91 – 1.700.161.150.84 – 1.590.381.060.77 – 1.480.72Frail621.531.11 – 2.110.011.371.00 – 1.900.051.190.85 – 1.660.31All-Cause MortalityDAFI CategoriesRobust2721.001.001.00Pre-frail2241.551.30 – 1.84 Citation Format: Connie H Yan, Chandler Coleman, Nadia A Nabulsi, Brian Chiu, Naomi Y Ko, Kent Hoskins, Gregory S Calip. Associations between frailty and cancer-specific mortality among older women with breast cancer [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS7-13.

Introduction Oral chemotherapy agents have become increasingly common for the treatment of various malignancies, specifically in the metastatic setting. In metastatic breast cancer, oral chemotherapy is now considered the standard of care for first-line treatment due to progression-free survival and overall survival benefits. Oral agents are also considered to be a convenient and less toxic therapy option, improving quality of life. However, these benefits are offset by challenges in the delay to initiation of therapy, adherence, and toxicity management which may lead to high co-pays, delays in treatment, increased clinic visits, and non-adherence. These issues can be augmented at a safety net hospital charged to care for the most vulnerable patients. Close monitoring and follow-up are critical but can be complex and pose an additional burden on the treating oncologist. Pharmacists can serve as an extender to the oncologist and may help mitigate many of these clinical and operational barriers through adherence strategies, toxicity management, care coordination, and optimization of dosing schedules and regimens. Methods/Materials We conducted a quality improvement (QI) initiative aimed to decrease the average number of treatment day delays experienced by patients receiving oral chemotherapy for the treatment of MBC during the first six cycles of chemotherapy. A secondary aim was to improve adherence and patient-provider satisfaction. A protocol was designed and implemented utilizing pharmacists to provide assistance with obtaining the medications through a specialty pharmacy, oral chemotherapy counseling, toxicity assessments, and strategies to help optimize oral adherence (OPTIMAL protocol). Pharmacists conducted live in-person visits and telemedicine visits at weekly to monthly intervals to supplement the ongoing routine care of the oncology provider. All treatment and supportive care recommendations, in addition to any identified barriers, were communicated to the provider. Results A baseline assessment of 63 patients receiving oral oncolytic therapy from December 1st, 2018 through November 26th, 2019 was completed. Patients experienced most delays during cycle 1, with an average of 14.5 days of delay (range 1 - 34 days). The most common reasons for delay throughout the first six cycles of therapy were toxicity development, receipt of medication from the pharmacy, and patient adherence. A separate analysis of patients on CDK4/6 inhibitors (n=8) identified an average treatment day delay of 7.7 days (range 3.2 - 15.3 days) during the first six cycles of chemotherapy. Over a 7-month period, fifteen patients were enrolled in the OPTIMAL protocol and experienced an average treatment day delay of 2.9 days (range 0 - 6.8 days) during the first six cycles. Pharmacists made 206 documented interventions amongst the patients on the protocol, encompassing medication reconciliations, therapy counseling, and clinical recommendations. Eleven patients reported treatment-related toxicities, resulting in six therapy modifications and two-dose modifications. Four patients experienced progression on oral oncolytic therapy and subsequently went on to other treatment options. Conclusion Our protocol to incorporate pharmacists in initial and follow-up clinic visits at an outpatient breast cancer clinic within a safety net hospital was associated with decreased treatment day delays. Pharmacists performed a large number of meaningful clinical and operational interventions to facilitate medication treatment in a, particularly vulnerable population. This intervention supports the valuable and versatile role pharmacists can play in co-managing patients with the rest of the healthcare team. Citation Format: Jasmine Patel, David Michael Hughes, Kathryn Quinn, Tsion Fikre, Naomi Ko. Effect of an outpatient pharmacy team to improve management and adherence to oral chemotherapy [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS13-26.

Background: Hepatitis C virus (HCV) infection is a major health problem in the United States and breast cancer is the second most common cancer in US women. Despite these prevalent diseases, there is limited information available on the effects of a concurrent HCV infection among breast cancer patients receiving chemotherapy and the problems they face during their treatment. There are limited guidelines for chemotherapy treatment in HCV positive breast cancer patients. Methods: We performed a retrospective 2:1 matched case control analysis on breast cancer patients with a confirmed active HCV infection who received chemotherapy at Boston Medical Center between January 2000 and April 2015. Cases with HCV infection (n=6) were matched with controls (n=12) who were HCV negative. The controls were matched on age (decade) of diagnosis, stage of breast cancer, and intended chemotherapy regimen. We investigated dose delays, dose changes, hospitalization, hematologic reasons for dose delays, and variation in blood counts during the treatment period in these patients from their medical records. Statistical analysis was done using R version 3.4.0 to compare these outcomes of interest between the two groups. Fisher’s exact and Wilcoxon rank sum tests were used to compare the categorical and continuous variables respectively. Results: The HCV positive group was at a significantly higher risk of dose delays (100% vs. 33%, p = 0.01), dose changes (67% vs. 8%, p = 0.02), and hospitalization during chemotherapy (83% vs. 25%, p = 0.04) than their HCV matched controls. The risk of getting a dose delay due to hematotoxicity was significantly higher in the HCV positive group than the HCV negative group (83% vs. 8%, p = 0.003). The HCV positive patients took longer time to complete their treatment cycles than the HCV negative group. Conclusions: Chronic HCV infection in breast cancer patients receiving chemotherapy may be complicated by their active HCV infection. Treatment challenges due to dose changes, dose delays and hospitalizations were significantly more common when compared to controls. Chemotherapy delays and dose changes during breast cancer treatment has a negative consequence. In the era of curative treatment for HCV, future studies focused on the effect and treatment of concurrent HCV and breast cancer treatment is warranted. Citation Format: Saptaparni Ghosh, Minghua L Chen, Janice Weinberg, Naomi Y Ko. Effects of hepatitis C virus infection on the safety of chemotherapy for breast cancer patients: A retrospective chart analysis [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P4-14-12.

Background & Objectives Breast cancer outcome disparities for racial and ethnic minorities continues to be a problem in the United States. Genomic testing in early stage hormone positive breast cancer is the current standard of care given the useful predictive and prognostic value of testing. However, chemotherapy treatment decisions based on genomic testing results are predicated on the assumption that patient adhere to adjuvant endocrine treatment. Factors that could contribute to ongoing disparities for racial and ethnic minorities include both the utilization of genomic testing and adherence to hormonal therapy. Understanding these patterns of care across the United States with a large dataset has not yet been done. Methods We analyzed a cohort from the National Cancer Database (NCDB) of 387,008 female patients diagnosed with Stage I-II, ER+ breast cancer between 2010 and 2014. Demographic variables included age, race, ethnicity, insurance status, income, education, Charlson-Deyo comorbidity score. Clinicopathologic and treatment variables included tumor grade, histology, receptor status, facility type, delivery of treatment at >1 facility and receipt of genomic testing. Descriptive statistics using chi-square testing were computed to describe patient, tumor and treatment characteristics. Logistic regression analysis was used to calculate odds of genomic testing and receipt of hormone therapy among patients who did or did not receive genomic testing. Results Among a total sample size of 387,008, median age was 63 years old, majority white (87%), non-Hispanic (95.4%), without co-morbidities (88%). A total of 147,863 (38.2%) patients underwent genomic testing. Compared to patients with ages 18- Citation Format: Naomi Y Ko, Mustafa Q Muhammad, Michael R Cassidy, Lauren Oshry, Ariel E Hirsch. Socio-demographic differences in utilization of genomic testing and receipt of endocrine therapy in the National Cancer Database [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P5-12-03.

Introduction: Breast cancer survivors have an increased risk of contralateral breast cancer (CBC), among whom minority breast cancer patients are at increased risk of this adverse outcome. Studies evaluating CBC risk by race/ethnicity frequently aggregate Asian/Pacific Islanders (API) into a single group or exclude them. The purpose of this study was to determine the impact of socioeconomic status (SES) on the risk of CBC among subgroups of API breast cancer survivors. Method: We conducted a population-based retrospective cohort study of women ages 18+ years diagnosed with unilateral Stage I-III breast cancer using the Surveillance, Epidemiology and End Results Census Tract-level SES and Rurality Database (2000-2016). Women included in the study received cancer-directed surgery and the primary outcome of interest was asynchronous CBC occurring. SES was classified using the Yost index, a validated time-dependent composite score with the 1st quintile representing the lowest and 5th quintile being the highest SES. API women were categorized into Chinese, Japanese, Filipina, Hawaiian, Korean, Vietnamese, Indian/Pakistani, and other Asian/Pacific Islanders. We determined overall associations between SES and the risk of CBC using Fine and Gray regression models accounting for competing risks comparing API women to Non-Hispanic White (NHW) women. Multivariable adjusted subdistribution hazard ratios (SHR) and 95% confidence intervals (CI) were estimated and stratified by API subgroups. Results: From a cohort of 44,362 API female breast cancer patients included, one quarter of the cohort were Filipina (25%), 18% were Chinese, 14% were Japanese, 8% were Indian/Pakistani, and 17% were other API. API women living in the lowest SES areas were more likely to be uninsured or have Medicaid coverage (21% vs. 6%) and have Stage lll first primary breast cancer (14% vs. 10%) compared to API women living in the highest SES areas. Overall, API breast cancer patients as an aggregate group did not have significantly increased risk of CBC compared to NHW patients. In stratified subgroups, risk estimates for CBC were higher among Chinese women (SHR 1.24, 95% CI 1.08-1.41), Filipina (SHR 1.37, 95% CI 1.23-1.52), and Hawaiian women (SHR 1.67, 95% CI 1.37-2.08) when compared to NHW women after adjusting for demographics and baseline clinical characteristics. Lower SES was not associated with increased CBC risk among API women overall. However, the risk of CBC is significantly lower among Chinese and Vietnamese women and higher among Filipina women who lived in areas lower SES quintile compared to women who lived in area with the highest SES quintile when examining impact of SES within API subgroups. Conclusion: Chinese, Filipina, and Hawaiian women have higher risk of CBC when compared to NHW. When disaggregated API women into subgroups, the impact of SES on the risk of CBC differs significantly across API subgroups. Citation Format: Hsiao- Ching Huang, Jenny S. Guadamuz, Kent F. Hoskins, Naomi Y. Ko, Gregory S. Calip. Impact of socioeconomic status on the risk of contralateral breast cancer among Asian/Pacific Islander subgroups [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 3630.

Purpose and Objectives: Although systemic therapy is the standard treatment for metastatic breast cancer, the value of locoregional treatment (LRT) to the primary tumor and its impact on survival is controversial. This study evaluates survival outcomes in patients with metastatic breast cancer after receiving LRT (surgery and/or radiation therapy) to the primary tumor. Materials and Methods: The National Cancer Database (NCDB) identified 16,128 qualifying cases of stage IV breast cancer (M1, 2004-2013) who received systemic therapy with or without local therapy. Treatment modality was divided into surgery, radiation therapy (RT), surgery with RT (Sx+RT), and no LRT. Median survival and three-year actuarial survival rates (OS) were analyzed for each treatment group. On multivariate analyses, adjusted hazard ratios (HR) with 95% confidence interval were computed using Cox regression modeling to adjust for patient characteristics, year of diagnosis, clinical T and N staging, and facility type. Additionally, survival outcomes for each treatment group were analyzed by metastasis groups (bone, visceral, multiple). Results: A temporal trend of each treatment modality used in years 2004 – 2013 illustrated that the relative use of LRT decreased from 47.2% to 36.2% (p for trend = 0.041). Overall, the median follow-up was 28.3 months and median survival for all patients was 37.2 months. With 9,761 deaths reported, the estimated 3-year survival rate for all patients was 51.3%. The Sx+RT group (n = 2,166) had the highest 3-year survival rate of 69.4%, followed by the surgery group (n = 4,293) with 57.6%, no LRT group (n = 8,955) with 44.3%, and RT group (n = 714) with 41.5% (p < 0.0001). On multivariate analysis, a decreased hazard of death (adjusted HR, 95% CI) was noted in radiation patients compared to no LRT group but without statistical significance (0.91, 0.81-1.0, p = 0.057). Patients receiving surgery (0.68, 0.65-0.71, p < 0.0001) and Sx+RT group (0.46, 0.43-0.49, p < 0.0001) reported statistically significant improved survival compared to the no LRT group. Additionally, later year of diagnosis, low Charlson-Deyo score, high income, private insurance, white race, age 18 - Conclusion: Patients with metastatic breast cancer have a large range of survival rates. Locoregional treatment, especially surgery followed by RT, in addition to systemic therapy was associated with improved survival in metastatic breast cancer patients. When survival rates for each treatment modality was stratified by metastasis location, the most favorable survival was observed for the surgery with follow-up radiation group, which is consistent with the overall analysis. Citation Format: Kim KN, Huang D, Qureshi MM, Ko NY, Hirsch AE. The impact of locoregional treatment on survival in patients with metastatic breast cancer: A national cancer database analysis [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P1-16-02.

Introduction: Disparities in breast cancer (BC) incidence and outcomes exist across racial/ethnic groups in the U.S. and by socioeconomic status (SES). The extent to which lower SES independently impacts breast cancer outcomes in different racial/ethnic groups is not fully described. Our purpose was to determine the impact of SES on cancer-specific mortality among women with metastatic breast cancer. Method: We conducted a large, population-based retrospective cohort study of women ages 18+ years diagnosed with de novo metastatic breast cancer using the Surveillance, Epidemiology and End Results Census Tract-level SES and Rurality Database (2000-2015). SES was described using the Yost index, a validated time-dependent composite score that reflects SES based on several components including education and income, with the 1st quintile representing the lowest and 5th quintile being the highest SES. Information on demographic and clinical characteristics, including hormone receptor (HR) status, cancer treatment, survival and cause of death were collected from cancer registry data. We determined associations between SES and BC-specific mortality in Fine and Gray regression models. Multivariable adjusted subdistribution hazard ratios (SHR) and 95% confidence intervals (CI) were calculated accounting for competing risks of death. We determined associations between SES and BC mortality overall and calculated stratum specific SHR estimates by racial/ethnic groups and HR status. Results: In an overall cohort of 33,976 women with de novo metastatic BC, the majority were non-Hispanic white (67%), 17% were Black, 0.4% were American Indian/Alaskan Native, 6% were Asian/Pacific Islander and 10% were Hispanic. Compared to women in the highest SES quintile, women in the lowest SES were more likely to be uninsured or on Medicaid (25% vs. 7%) and have HR-negative disease (24% vs. 18%) but were similar with respect to treatment with surgery, radiation and chemotherapy. Overall, metastatic BC patients in the lowest SES quintile had a significantly increased risk of BC mortality compared to the highest SES quintile (adjusted SHR 1.27, 95% CI 1.22-1.32); however, these impacts of SES differed across racial/ethnic groups and by HR status. Risk estimates for the association between low SES (1st quintile) and BC mortality were lower among HR-positive white women (SHR 1.19, 95% CI 1.12-1.26) and minimal among Asian/Pacific Islander women (SHR 1.05, 95% CI 0.88-1.25). The greatest increased risk was observed among HR-negative Black women (SHR 1.38, 95% CI 1.00-1.90) with metastatic BC. Conclusion: Independent of race/ethnicity, lower SES is significantly associated with BC-specific mortality among women with de novo metastatic disease. However, when stratifying these effects by racial/ethnic groups and HR status, the impact of SES appears to be greater among Black women with HR-negative metastatic BC. Citation Format: Hsiao- Ching Huang, Mary H. Smart, Huiwen Deng, Ashwini Zolekar, Colin C. Hubbard, Kent F. Hoskins, Naomi Y. Ko, Gregory S. Calip. Differences in impact of socioeconomic status on cancer: Specific survival in metastatic breast cancer by race/ethnicity [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2021; 2021 Apr 10-15 and May 17-21. Philadelphia (PA): AACR; Cancer Res 2021;81(13_Suppl):Abstract nr 776.

Background: The interaction of racial/ethnic and geographic disparities in determining breast cancer (BC) outcomes is not fully understood. Our purpose was to examine racial and ethnic differences in and the impact of rurality on breast cancer specific mortality among women diagnosed with metastatic BC in the U.S. Methods: We conducted a large, population-based cohort study using the Surveillance, Epidemiology, and End Results rurality database of women ages 18+ years diagnosed with de novo metastatic BC between 2000 and 2015. Our main exposure of interest was U.S. Department of Agriculture Rural Urban Commuting Area categories, and our outcome of interest was BC-specific mortality. We collected information on demographic and clinical characteristics, including molecular subtypes, treatment, survival and cause of death. We determined associations between rurality and BC-specific mortality in Fine and Gray regression models and calculated subdistribution hazard ratios (SHR) and 95% confidence intervals (CI) accounting for competing risks of death and with adjustment for age, year of diagnosis, hormone receptor (HR) status, treatment, marital status and insurance status. We calculated overall and race specific SHR estimates to understand racial/ethnic differences in impacts of rurality on BC mortality and performed stratified analyses by HR status. Results: From an overall cohort of 31,991 de novo metastatic BC patients with a median age of 60 years, there were 29,069 patients in urban commuting areas vs. 2,922 in rural areas. Compared to rural areas, lower proportions of non-Hispanic white (65% vs. 81%) and Asian/Pacific islander (0.3% vs. 0.9%) patients, and higher proportions of Black (17% vs. 10%) and Hispanic (10% vs. 5%) patients lived in urban areas. Metastatic BC patients living in urban commuting areas were more likely to receive surgery compared to rural (56% vs. 48%) and have a positive joint HR status (12% vs. 9%), but were similar with respect to radiation (33% vs. 33%) and chemotherapy (53% vs. 51%). Overall, women living in rural areas had a modestly higher risk of BC-specific mortality (adjusted SHR 1.01, 95% CI 1.00-1.02); however, the impact of rurality differed by race/ethnicity and HR status. Among white women with HR-positive metastatic BC, rurality was associated with an increased risk of BC mortality (SHR 1.09, 95% CI 1.03-1.15). Among Black women with HR-negative metastatic BC, we observed the greatest increased risk of BC mortality associated with rurality (SHR 1.27, 95% CI 1.01-1.59). Conclusion: BC-specific survival among women with de novo metastatic disease differs by race/ethnicity and geography with the greatest adverse impacts of rurality affecting Black women with HR-negative BC. Citation Format: Mary H. Smart, Hsiao-Ching Huang, Ashwini Zolekar, Huiwen Deng, Colin C. Hubbard, Kent Hoskins, Naomi Y. Ko, Gregory S. Calip. Racial and ethnic differences in the impacts of rurality on cancer-specific survival among women with de novo metastatic breast cancer [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2021; 2021 Apr 10-15 and May 17-21. Philadelphia (PA): AACR; Cancer Res 2021;81(13_Suppl):Abstract nr 775.

Background: Racial and ethnic disparity in breast cancer outcomes is a long-standing problem that continues to worsen. Recent evidence has underscored the importance of timely care, as delays in treatment can lead to decreased survival. We sought to understand predictors of delay to first treatment among a racially diverse cancer population. Methods: This is a retrospective study of breast cancer cases diagnosed between the years 2000 to 2014. Data was extracted from the cancer registry at Boston Medical Center (BMC), an urban safety net hospital. Inclusion criteria were any breast cancer diagnosis from 2000-2014, receiving first treatment at BMC, and disease stage 0-III. Cox Proportional Hazards regression analysis was performed to identify predictors of time to first treatment, defined as days from date of diagnosis to date of first treatment with surgery or neo-adjuvant chemotherapy. Covariates included age, sex, race, type of insurance, marital status, US birth, disease stage and year of diagnosis. Results: Patients were 99% female and with a mean age of 58 years (range 23-96). Among a sample of 1545 breast cancer cases, 1372 (89%) had surgery as first treatment and 173 (11%) had neoadjuvant chemotherapy. Median days to treatment was 45 days (IQR 27, 71). In the multi-variable adjusted models for both treatment groups, race, and insurance were significantly associated with delay. In the surgical group, Black race, public or no insurance, non-US born, later stage and unmarried status were associated with increased risk of delay. For example, Blacks were at higher risk for delay (HR= 1.2; 95% CI 1.37-1.04) compared to the Hispanic or White (reference) groups. Public insurance (HR = 1.19; 95%CI 1.37-1.04) and no insurance (HR = 1.43; 95%CI 1.85-1.09) was significantly associated with increased delay when compared to private insurance (reference). In patients with neoadjuvant chemotherapy as first treatment, additional significant predictors of delay were age and year of diagnosis. Conclusion: Race and insurance status were significant predictors of delay to first treatment in a population of diverse breast cancer patients seeking care at a safety net hospital. Intervention efforts need to target patients at greatest risk for treatment delays. Citation Format: Ko NY, Patts G, Battaglia TA, Wang C, Denis GV, Hirsch A, Weinberg J. Socio-demographic predictors for delay of treatment among a racially diverse, urban breast cancer population [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P3-10-08.

Background: Disparities in breast cancer care are a worsening problem, requiring effective interventions that seek to address the delivery of high quality cancer care. Evidence from interventions designed to improve timeliness of care routinely identify lack of social support as one of the biggest barriers to care. And, social support is associated with adherence to treatment and survival. This study explores predictors of social support in a diverse population of cancer patients. Patients and Methods: This is a secondary analysis of baseline preliminary data from participants enrolled in Project SUPPORT, a randomized controlled comparative effectiveness trial designed to evaluate the impact of patient navigation with or without legal support and services, among women diagnosed with Stages 0-4 breast cancer between 2014-2016. Upon enrollment (within one month of a cancer diagnosis) we administered the Medical Outcomes Survey (MOS) of social support to all participants. This validated survey tool addresses functional support, including an overall score (range 0-95) and 4 distinct domains: Emotional/Informational, Tangible, Affectionate and Positive Social Interaction. Using chi-squared and t-tests we compared MOS scores across socio-demographic variables: age, race, language, insurance, health literacy and marital status. Results: Of the 103 participants, mean age is 54.5 (SD = 10.6); 56% Hispanic, 19% Black, and 22% White and 2% identified as other; the majority had public insurance 76%; 66% speak English, 21% Spanish and 13% Haitian Creole. Only 36% have adequate health literacy as measured by the BRIEF. Only 32% are currently partnered. The overall mean total score for social support is 75.8 (+/- 23.6), median of 78.9 (range 60.5 – 98.7). Participants scored lowest in tangible support (mean score 67.7 +/- 33.1) and highest in affective support (83.5 +/- 25.8). Non-White participants scored significantly lower across all domains (mean overall MOS score 73.3 +/- 2.6) when compared with Whites (mean overall MOS score 84.5 +/- 4.8, p value = 0.04). There were no differences in MOS scores by language, insurance, literacy or marital status. Conclusion: This is the first study to describe social support scores (overall and specific domains) from the validated MOS survey tool among a racially diverse, urban cancer patient population. We found significant differences by race. Studies to identify risks for low social support can help inform future targeted interventions. Citation Format: Ko NY, Festa K, Gunn C, Bak S, Wang N, Nelson K, Flacks J, Morton S, Battaglia TA. Predictors of social support among newly diagnosed breast cancer patients seeking care at an urban safety net academic medical center [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P3-10-09.

Background: Physical limitations and disability among older cancer patients can lead to suboptimal treatment and surveillance for secondary cancers. Our objective was to evaluate the effects of poor physical health-related quality of life (PQOL) and physical functioning (PF) on contralateral breast cancer (CBC) risk among older women diagnosed with unilateral breast cancer (UBC). Methods: We performed a nested case-control study within a cohort from the Surveillance, Epidemiology and End Results Medicare Health Outcomes Survey (MHOS) database. Women were required to have first primary UBC without prophylactic contralateral mastectomy. Among 2,938 women ages 65 years and older with stages I-III UBC between 1997 and 2011, we identified 100 subsequent CBC cases and 915 controls using incidence density sampling without replacement matched on age, race, and quarter-year of diagnosis. PQOL and PF were determined from survey responses to the Medical Outcomes Trust Short Form 36 component scores. Conditional logistic regression models were used to estimate relative risks (RR) and 95% confidence intervals (CI) for metachronous CBC. Results: Cases and controls were similar with respect to comorbidities, stage, surgery and radiation treatments but differed by hormone receptor status (ER/PR-negative, cases 23% and controls 11%). Cases had lower mean PQOL (-1.8; 95% CI -4.3, 0.7) and PF (-2.2, 95% CI -4.9, 0.5) component scores, but these differences were not statistically significant. In multivariable models, estimates suggest increased CBC risk for women in the lowest quartile of PQOL compared to those in the upper quartile (RR=1.8; 95% CI 0.8, 4.3). Compared to women in the upper quartile of physical functioning scores, women in the lower three quartiles had a 2.6-fold (95% CI 1.2, 5.9) increased risk of CBC. Conclusions: Our findings indicate that low physical health-related quality of life is common among older women diagnosed with breast cancer, and poor physical functioning is related to risk of CBC. Efforts to understand and minimize declines in physical functioning post-breast cancer diagnosis may help optimize treatment strategies to reduce the risk of this adverse outcome. Citation Format: Nita Mukand, Nadia Nabulsi, Ali Alobaidi, Alemseged Asfaw, Brian C. Chiu, Naomi Y. Ko, Gregory S. Calip. The association between physical health-related quality of life, physical functioning and risk of contralateral breast cancer [abstract]. In: Proceedings of the Annual Meeting of the American Association for Cancer Research 2020; 2020 Apr 27-28 and Jun 22-24. Philadelphia (PA): AACR; Cancer Res 2020;80(16 Suppl):Abstract nr 5749.

Background: Elimination of disparities is critically important for lessening the burden of cancer. Patient navigator programs (PNPs) assist with all aspects of care, including access, cancer prevention, screening, post-diagnosis care, and survivorship care. Little is known about the effect of PNPs on patient care and outcomes following the diagnosis of breast cancer (BC). We examined quality measures (QMs) of breast cancer care among women participating in the Massachusetts General Hospital Avon Breast Care Patient Navigator Program (MABCP), which provides patient navigation services to disadvantaged minority communities in the greater Boston area. Methods: Women diagnosed with BC who participated in the MABCP from 2001 to 2011 were followed to determine the proportion whose care was concordant with American Society of Clinical Oncology/National Comprehensive Cancer Network (ASCO/NCCN) QMs. QMs included 1) hormonal therapy (HT) within 1 year of diagnosis for HR+ tumors > 1 cm; 2)chemotherapy within 120 days of diagnosis of HR- >1cm tumors for women Results: Of the 186 MABCP patients diagnosed with BC, some treatment data was available on 158 (85%) and race/stage information was available on 149 (80%) [Table 1]. Among the MABCP patients, concordant care was received by 70/74 (95%) for the HT QM, 15/17 (88%) for the chemotherapy QM, and 65/71 (92%) for the XRT QM. In comparison, available benchmark concordance rates of BC patients treated at 8 NCCN centers from 2003–6 are: 340/382 (89%) for the HT QM, 156/179 (87%) for the chemotherapy QM, and 141/148 (95%) for the XRT QM. Conclusions: Overall, breast cancer care in the MABCP PNP is concordant with published ASCO/NCCN quality measures. At present, the sample is insufficient to compare concordance rates with NCCN patients but preliminarily, it appears that the quality of care is comparable. Future research should include prospective analyses of quality metrics to assess the process and outcomes of patient navigation in diverse settings, compared with control populations. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P1-11-10.