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We sought to understand why some women with early-stage breast cancer decide to forgo or discontinue endocrine therapy (ET), and to identify factors that might lead to greater acceptance of, and long-term adherence to, this treatment. We conducted in-depth interviews with N = 53 stage I-III HR+ women who were either non-initiators of ET, initiators who discontinued or initiators who continued with variable daily patterns of adherence. An inductive content analysis was performed to explore the decision-making process of women prescribed ET. Qualitative analyses revealed 55 themes that drove complex decision making. The initiators generally trusted their physicians and did little research before starting the medication. Non-initiators were more suspicious of the medical system, believing that ET presented more risks than benefits. Most discontinuers stopped ET because of side effects. Both non-initiators and discontinuers indicated that push-back from their physicians could have changed their decision. Stories and social support were important in decision making. Although ET can significantly reduce the risk of breast cancer recurrence, substantial barriers prevent many women from initiating or continuing it. Physicians have powerful influence over patients' decisions to initiate ET and can be important levers for motivating patients to persist. • ET adherence decision making among breast cancer patients is complex and driven by a variety of factors. • Counseling provided by physicians plays a crucial role in the initiation and continuation of ET. • Mistrust in the healthcare system drove non-initiation, while burdensome side-effects drove discontinuation of ET. [ABSTRACT FROM AUTHOR]

Background: Inequities in guideline-concordant treatment receipt contribute to worse survival in Black patients with breast cancer. Inequity-reduction interventions (eg, navigation, bias training, tracking dashboards) can close such treatment gaps. We simulated the population-level impact of statewide implementation of inequity-reduction interventions on racial breast cancer inequities in North Carolina., Methods: Using registry-linked multipayer claims data, we calculated inequities between Black and White patients receiving endocrine therapy (n = 12 033) and chemotherapy (n = 1819). We then built cohort-stratified (endocrine therapy and chemotherapy) and race-stratified Markov models to simulate the potential increase in the proportion of patients receiving endocrine therapy or chemotherapy and subsequent improvements in breast cancer outcomes if inequity-reducing intervention were implemented statewide. We report uncertainty bounds representing 95% of simulation results., Results: In total, 75.6% and 72.1% of Black patients received endocrine therapy and chemotherapy, respectively, over the 2006-2015 and 2004-2015 periods (vs 79.3% and 78.9% of White patients, respectively). Inequity-reduction interventions could increase endocrine therapy and chemotherapy receipt among Black patients to 89.9% (85.3%, 94.6%) and 85.7% (80.7%, 90.9%). Such interventions could also decrease 5-year and 10-year breast cancer mortality gaps from 3.4 to 3.2 (3.0, 3.3) and from 6.7 to 6.1 (5.9, 6.4) percentage points in the endocrine therapy cohorts and from 8.6 to 8.1 (7.7, 8.4) and from 8.2 to 7.8 (7.3, 8.1) percentage points in the chemotherapy cohorts., Conclusions: Inequity-focused interventions could improve cancer outcomes for Black patients, but they would not fully close the racial breast cancer mortality gap. Addressing other inequities along the cancer continuum (eg, screening, pre- and postdiagnosis risk factors) is required to achieve full equity in breast cancer outcomes., (© The Author(s) 2024. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Competing Interests: PMS reports grant funding from Pfizer paid to their institution. KER-H reports grant funding from Pfizer paid to their institution.

Background: Almost half of the patients with cancer report cancer-related financial hardship, termed "financial toxicity" (FT), which affects health-related quality of life, care retention, and, in extreme cases, mortality. This increasingly prevalent hardship warrants urgent intervention. Financial navigation (FN) targets FT by systematically identifying patients at high risk, assessing eligibility for existing resources, clarifying treatment cost expectations, and working with patients and caregivers to develop a plan to cope with cancer costs. This trial seeks to (1) identify FN implementation determinants and implementation outcomes, and (2) evaluate the effectiveness of FN in improving patient outcomes., Methods: The Lessening the Impact of Financial Toxicity (LIFT) study is a multi-site Phase 2 clinical trial. We use a pre-/post- single-arm intervention to examine the effect of FN on FT in adults with cancer. The LIFT trial is being conducted at nine oncology care settings across North Carolina in the United States. Sites vary in geography (five rural, four non-rural), size (21-974 inpatient beds), and ownership structure (governmental, non-profit). The study will enroll 780 patients total over approximately 2 years. Eligible patients must be 18 years or older, have a confirmed cancer diagnosis (any type) within the past 5 years or be living with advanced disease, and screen positive for cancer-related financial distress. LIFT will be delivered by full- or part-time financial navigators and consists of 3 components: (1) systematic FT screening identification and comprehensive intake assessment; (2) connecting patients experiencing FT to financial support resources via trained oncology financial navigators; and (3) ongoing check-ins and electronic tracking of patients' progress and outcomes by financial navigators. We will measure intervention effectiveness by evaluating change in FT (via the validated Comprehensive Score of Financial Toxicity, or COST instrument) (primary outcome), as well as health-related quality of life (PROMIS Global Health Questionnaire), and patient-reported delayed or forgone care due to cost. We also assess patient- and stakeholder-reported implementation and service outcomes post-intervention, including uptake, fidelity, acceptability, cost, patient-centeredness, and timeliness., Discussion: This study adds to the growing evidence on FN by evaluating its implementation and effectiveness across diverse oncology care settings., Trial Registration: ClinicalTrials.gov NCT04931251. Registered on June 18, 2021., (© 2022. The Author(s).)

Identifying patients at higher risk of chemotherapy-induced peripheral neuropathy (CIPN) is a major unmet need given its high incidence, persistence, and detrimental effect on quality of life. We determined if the expression of p16, a biomarker of aging and cellular senescence, predicts CIPN in a prospective, multi-center study of 152 participants enrolled between 2014 and 2018. Any women with newly diagnosed Stage I-III breast cancer scheduled to receive taxane-containing chemotherapy was eligible. The primary outcome was development of grade 2 or higher CIPN during chemotherapy graded by the clinician before each chemotherapy cycle (NCI-CTCAE v5 criteria). We measured p16 expression in peripheral blood T cells by qPCR before and at the end of chemotherapy. A multivariate model identified risk factors for CIPN and included taxane regimen type, p16Age Gap, a measure of discordance between chronological age and p16 expression, and p16 expression before chemotherapy. Participants with higher p16Age Gap-higher chronological age but lower p16 expression prior to chemotherapy - were at the highest risk. In addition, higher levels of p16 before treatment, regardless of patient age, conferred an increased risk of CIPN. Incidence of CIPN positively correlated with chemotherapy-induced increase in p16 expression, with the largest increase seen in participants with the lowest p16 expression before treatment. We have shown that p16 expression levels before treatment can identify patients at high risk for taxane-induced CIPN. If confirmed, p16 might help guide chemotherapy selection in early breast cancer., (© 2022. The Author(s).)

Purpose: To examine trends in the surgical treatment of breast cancer by age, rurality, and among Black women in a populous, racially diverse, state in the Southeastern United States of America., Methods: We identified women diagnosed with localized or regional breast cancer between 2003 and 2016 in the North Carolina Central Cancer Registry (n = 86,776). Using Joinpoint regression we evaluated the average annual percentage change in proportion of women treated with mastectomy versus breast-conserving surgery overall, by age group, among Black women, and for women residing in rural areas., Results: Overall, the rate of mastectomy usage in the population declined 2.5% per year between 2003 and 2016 (95% CI - 3.2, - 1.7). Over this same time interval, breast-conserving surgery increased by 1.6% per year (95% CI 0.9, 2.2). These temporal trends in surgery were also observed among Black women and rural residing women. Trends in surgery type varied by age group: mastectomy declined over time among women > 50 years, but not among women aged 18-49 at diagnosis., Discussion: In contrast to national studies that reported increasing use of mastectomy, we found declining mastectomy rates in the early 2000s in a Southern US state with a racially and geographically diverse population. These decreasing trends were consistent among key subgroups affected by cancer inequities, including Black and White rural women., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: The optimal treatment strategy for small node-negative human epidermal growth factor receptor 2-positive (HER2+) breast cancer remains controversial. Neoadjuvant chemotherapy may risk overtreatment, whereas surgery first fails to identify patients with residual disease in need of escalated adjuvant systemic therapy. We investigated patient characteristics associated with receipt of neoadjuvant chemotherapy., Methods: Adult women with cT1-T2/N0, HER2+ breast cancer between 2013 and 2017 in the National Cancer Database who underwent surgery within 8 months of diagnosis were included. Patients were classified as receiving neoadjuvant chemotherapy versus a surgery-first approach. We assessed the sociodemographic and clinical predictors of neoadjuvant chemotherapy versus surgery first and associations between neoadjuvant chemotherapy and breast cancer treatments using multivariable regression models., Results: We identified 56,784 women, of whom 12,758 (22%) received neoadjuvant chemotherapy, 29,139 (53%) received adjuvant chemotherapy, 12,907 (24%) received no chemotherapy, and 1980 were missing chemotherapy information. After adjustment, cT2 stage was the strongest predictor of neoadjuvant chemotherapy compared with surgery first. Younger age and later diagnosis year were positively associated with receipt of neoadjuvant chemotherapy. In contrast, hormone receptor positivity, Black race, rural county, and government-funded or no health insurance were inversely associated with neoadjuvant chemotherapy. In multivariable analyses, patients who received neoadjuvant chemotherapy were more likely to have a mastectomy (vs. lumpectomy) and sentinel lymph node biopsy or no nodal surgery (vs. axillary lymph node dissection). Patients who received neoadjuvant chemotherapy were more likely to receive multi-agent (vs. single-agent) chemotherapy than those who received adjuvant chemotherapy., Conclusions: Substantial differences in the utilization of neoadjuvant chemotherapy exist in women with HER2+ breast cancer, which reflect both clinical parameters and disparities. Optimal treatment strategies should be implemented equitably across sociodemographic groups., (© 2021. Society of Surgical Oncology.)

Purpose: To describe breast cancer treatment patterns among premenopausal women by age and time since last pregnancy., Methods: Data were analyzed from 1179 women diagnosed with premenopausal breast cancer in the Carolina Breast Cancer Study. Of these, 160 had a recent pregnancy (within 5 years of cancer diagnosis). Relative frequency differences (RFDs) and 95% confidence intervals (CIs) were used to compare cancer stage, treatment modality received, treatment initiation delay (> 30 days), and prolonged treatment duration (> 2 to > 8 months depending on the treatment received) by age and recency of pregnancy., Results: Recently postpartum women were significantly more likely to have stage III disease [RFD (95% CI) 12.2% (3.6%, 20.8%)] and to receive more aggressive treatment compared to nulliparous women. After adjustment for age, race and standard clinical tumor characteristics, recently postpartum women were significantly less likely to have delayed treatment initiation [RFD (95% CI) - 11.2% (- 21.4%, - 1.0%)] and prolonged treatment duration [RFD (95% CI) - 17.5% (- 28.0%, - 7.1%)] and were more likely to have mastectomy [RFD (95% CI) 14.9% (4.8%, 25.0%)] compared to nulliparous. Similarly, younger women (< 40 years of age) were significantly less likely to experience prolonged treatment duration [RFD (95% CI) - 5.6% (- 11.1%, - 0.0%)] and more likely to undergo mastectomy [RFD (95% CI) 10.6% (5.2%, 16.0%)] compared to the study population as a whole., Conclusion: These results suggest that recently postpartum and younger women often received prompt and aggressive breast cancer treatment. Higher mortality and recurrence among recently pregnant women are unlikely to be related to undertreatment., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Purpose: Surgery is an important part of early stage breast cancer treatment that affects overall survival. Many studies of surgical treatment of breast cancer rely on data sources that condition on continuous insurance coverage or treatment at specified facilities and thus under-sample populations especially affected by cancer care inequities including the uninsured and rural populations. Statewide cancer registries contain data on first course of cancer treatment for all patients diagnosed with cancer but the accuracy of these data are uncertain., Methods: Patients diagnosed with stage I-III breast cancer between 2003 and 2016 were identified using the North Carolina Central Cancer Registry and linked to Medicaid, Medicare, and private insurance claims. We calculated the sensitivity, specificity, positive predictive value, negative predictive value, and Kappa statistics for receipt of surgery and type of surgery (breast conserving surgery or mastectomy) using the insurance claims as the presumed gold standard. Analyses were stratified by race, insurance type, and rurality., Results: Of 26,819 patients who met eligibility criteria, 23,125 were identified as having surgery in both the claims and registry for a sensitivity of 97.9% (95% CI 97.8%, 98.1%). There was also strong agreement for surgery type between the cancer registry and the insurance claims (Kappa: 0.91). Registry treatment data validity was lower for Medicaid insured patients than for Medicare and commercially insured patients., Conclusions: Cancer registry treatment data reliably identified receipt and type of breast cancer surgery. Cancer registries are an important source of data for understanding cancer care in underrepresented populations., (© 2021. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Purpose: Chemotherapy-related amenorrhea (CRA) is a surrogate for ovarian toxicity and associated risk of infertility and premature menopause. Here, we compare CRA rate with paclitaxel (T)-trastuzumab (H) to that with ado-trastuzumab emtansine (T-DM1)., Methods: Patients with T1N0 HER2 + early-stage breast cancer (eBC) enrolled on the ATEMPT trial and were randomized 3:1 to T-DM1 3.6 mg/kg IV every (q) 3 weeks (w) × 17 vs. T 80 mg/m 2 with H IV qw × 12 (4 mg/kg load → 2 mg/kg), followed by H (6 mg/kg IV q3w × 13). Enrollees who self-reported as premenopausal were asked to complete menstrual surveys at baseline and every 6-12 months for 60 months. 18-month CRA (no periods reported during prior 6 months on 18-month survey) was the primary endpoint of this analysis., Results: Of 512 ATEMPT enrollees, 123 who began protocol therapy and answered baseline and at least one follow-up menstrual survey were premenopausal at enrollment. 76 had menstrual data available at 18 months without having received a gonadotropin-releasing hormone agonist or undergone hysterectomy and/or oophorectomy. Median age was 45 (range 23-53) among 18 who had received TH and 46 (range 34-54) among 58 who had received T-DM1. The 18-month rate of CRA was 50% after TH and 24% after T-DM1 (p = 0.045)., Conclusion: Amenorrhea at 18 months was less likely in recipients of adjuvant T-DM1 than TH. Future studies are needed to understand how T-DM1 impacts risk of infertility and permanent menopause, and to assess amenorrhea rates when T-DM1 is administered after standard HER2-directed chemotherapy regimens., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Purpose: To evaluate the cost-effectiveness of endocrine therapy (ET), radiation therapy (XRT), and combination ET + XRT as post-surgical treatment for older women with early-stage breast cancer from the societal perspective., Methods: We constructed a Markov state-transition model consisting of three mutually exclusive health-states: Disease-Free, Recurrence, or Death. Osteoporotic fracture, radiation-induced breast fibrosis, and radiation pneumonitis were modeled as treatment-related adverse events (AEs). Cancer registry-linked-Medicare data were used to assess probability of recurrence and total costs, after propensity adjustment to account for treatment selection, among women aged >65 years diagnosed with estrogen receptor positive or progesterone receptor positive (ER+/PR+) breast cancer receiving ET, XRT, or ET + XRT in 2007-2011. Following randomized controlled trials, overall survival was assumed equivalent, but locoregional recurrence varied. Indirect costs and health-state utilities were literature-driven and varied in sensitivity analyses. Costs and outcomes were discounted at 3% annually., Results: In a cohort of 10,000 women over ten years, we estimated 1620 total recurrences in the ET-only group, 1296 in the XRT-only group, and 1076 with ET + XRT. Compared to ET-only, the base-case incremental cost-effectiveness ratio (ICER) was $10,826 per quality-adjusted life-year (QALY)-gained for XRT-only and $26,834/QALY-gained for ET + XRT. Similarities in cost and effectiveness between treatments led to highly sensitive results. We also present clinically-relevant patient preference scenarios for recurrence risk-averse patients and near-term AE risk-averse patients., Conclusions: The cost-effectiveness of regimens including ET and/or XRT in older women with early-stage breast cancer is sensitive to small differences in costs, as well as risk of, and utilities associated with, locoregional recurrence, suggesting that patient preferences concerning treatment benefits and risks should be considered by physicians., Competing Interests: Declaration of Competing Interest SBW received unrelated grant funding to her institution from Pfizer. JR is currently employed by Mathematica, Inc.; his work on this manuscript was done as an employee of UNC Chapel Hill., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Purpose: Recent clinical trials support de-escalation of adjuvant radiation therapy following lumpectomy in some older women with low-risk HR+ breast cancers planning to take endocrine therapy. The adoption of these findings into clinical practice, and the effectiveness of de-escalated therapy in real-world populations, remain under investigation., Materials and Methods: We evaluated use of adjuvant radiation therapy and/or endocrine therapy among older women with T1-2 node-negative, HR+ breast cancer in the United States between 2007 and 2011. The study included patients from the Surveillance, Epidemiology and End Results-Medicare linked database and the North Carolina Cancer Information and Population Health Resource database., Results: Radiation therapy was received by 65.5% of patients, with no decrease over time. Older women and those with T2 (compared to T1) tumors were less likely to receive radiation therapy. In propensity-adjusted analyses, both radiation therapy alone (HR 0.75, 95% CI 0.67-0.84) and radiation + endocrine therapy (HR 0.62, 95% CI 0.54-0.69) were associated with significantly lower recurrence risk compared to endocrine therapy alone. Non-adherence to endocrine therapy was common (37%) and similar across groups. With a median follow-up of 48 months (range 13-84), we were not able to detect an association of non-adherence with recurrence risk in endocrine therapy-containing treatment arms., Conclusion: Most older women with stage I HR+ breast cancers continue to receive radiation, at higher rates than patients with node-negative stage II tumors. These findings suggest that while multiple evidence-based treatment options exist in these patients, improvements are needed to ensure that radiation therapy is applied equitably and rationally., Competing Interests: Declaration of Competing Interest Dr. Meyer is currently employed by Roche, Inc. in a non-development role; Dr. Meng is founder and owner of the contract research company Element Stat Inc.; Jason Rotter is currently employed by Mathematica, Inc. Their work on this manuscript was done as employees of UNC Chapel Hill. The other authors have no current or past conflicts of interest to report., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objectives: A cancer diagnosis can influence medication adherence for chronic conditions by shifting care priorities or reinforcing disease prevention. This study describes changes in adherence to medications for treating three common chronic conditions - diabetes, hyperlipidemia, and hypertension - among older adults newly diagnosed with non-metastatic breast, colorectal, lung, or prostate cancer., Methods: We identified Medicare beneficiaries aged ≥66 years newly diagnosed with cancer and using medication for at least one chronic condition, and similar cohorts of matched individuals without cancer. To assess medication adherence, proportion of days covered (PDC) was measured in six-month windows starting six-months before through 24 months following cancer diagnosis or matched index date. Generalized estimating equations were used to estimate difference-in-differences (DID) comparing changes in PDCs across cohorts using the pre-diagnosis window as the referent. Analyses were run separately for each cancer type-chronic condition combination., Results: Across cancer types and non-cancer cohorts, adherence was highest for anti-hypertensives (90-92%) and lowest for statins (77-79%). In older adults with colorectal and lung cancer, adherence to anti-diabetics and statins declined post-diagnosis compared with the matched non-cancer cohorts, with estimates ranging from a DID of -2 to -4%. In older adults with breast and prostate cancer cohorts, changes in adherence for all medications were similar to non-cancer cohorts., Conclusion: Our findings highlight variation in medication adherence by cancer type and chronic condition. As many older adults with early stage cancer eventually die from non-cancer causes, it is imperative that cancer survivorship interventions emphasize medication adherence for other chronic conditions., Competing Interests: Declaration of Competing Interest Dr. Lund's spouse is a full-time, paid employee of GlaxoSmithKline who also holds stock in the amount of approximately $42,000. Dr. Lund also receives unrelated grant funding paid to her institution from AbbVie. Dr. Wheeler receives unrelated grant funding paid to her institution from Pfizer. All other co-authors have no potential conflicts of interest to report., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Purpose of Review: To review research on breast cancer mortality disparities, emphasizing research conducted in the Carolina Breast Cancer Study, with a focus on challenges and opportunities for integration of tumor biology and access characteristics across the cancer care continuum., Recent Findings: Black women experience higher mortality following breast cancer diagnosis, despite lower incidence compared to white women. Biological factors, such as stage at diagnosis and breast cancer subtypes, play a role in these disparities. Simultaneously, social, behavioral, environmental, and access to care factors are important. However, integrated studies of biology and access are challenging and it is uncommon to have both data types available in the same study population. The central emphasis of Phase 3 of the Carolina Breast Cancer Study, initiated in 2008, was to collect rich data on biology (including germline and tumor genomics and pathology) and health care access in a diverse study population, with the long term goal of defining intervention opportunities to reduce disparities across the cancer care continuum., Summary: Early and ongoing research from CBCS has identified important interactions between biology and access, leading to opportunities to build greater equity. However, sample size, population-specific relationships among variables, and complexities of treatment paths along the care continuum pose important research challenges. Interdisciplinary teams, including experts in novel data integration and causal inference, are needed to address gaps in our understanding of breast cancer disparities., Competing Interests: Conflict of Interest Marc A. Emerson, Katherine E. Reeder-Hayes, Heather J. Tipaldos, Mary E. Bell, Marina R. Sweeney, Lisa A. Carey, H. Shelton Earp, Andrew F. Olshan and Melissa A. Troester declare no conflicts of interest relevant to this manuscript.

Guidelines recommend using caution in co-prescribing opioids with benzodiazepines, yet, in practice, the extent of concurrent prescribing is poorly understood. Notably, no population-based studies, to our knowledge, have investigated concurrent prescribing among patients with cancer. We conducted a retrospective cohort study using data from the Surveillance, Epidemiology, and End Results (SEER) database linked with Medicare claims (2012-2016) for women diagnosed with breast cancer. We used modified Poisson regression to examine predictors of any concurrent prescriptions in the year post-diagnosis and Poisson regression to examine predictors of the number of overlapping days. We found that 13.0% of the 19 267 women in our sample had concurrent prescriptions. Women who underwent more extensive treatment and those with previous use of opioids or benzodiazepines were at increased risk for concurrent prescriptions (adjusted risk ratio of previous benzodiazepine use vs no previous use = 15.05, 95% confidence interval = 13.19 to 17.19). Among women with concurrent prescriptions, overlap was most pronounced among low-income, rural, and Hispanic women (adjusted incidence rate ratio of Hispanic vs non-Hispanic white = 1.25, 95% confidence interval = 1.20 to 1.30). Our results highlight opportunities to reduce patients' unnecessary exposure to this combination., (© The Author(s) 2019. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: Some breast tumors expressing greater than 1% and less than 10% estrogen receptor (ER) positivity (ER-borderline) are clinically aggressive; others exhibit luminal biology. Prior ER-borderline studies included few black participants., Methods: Using the Carolina Breast Cancer Study (phase I: 1993-1996; 2: 1996-2001; 3: 2008-2013), a population-based study that oversampled black women, we compared ER-borderline (n = 217) to ER-positive (n = 1885) and ER-negative (n = 757) tumors. PAM50 subtype and risk of recurrence score (ROR-PT, incorporates subtype, proliferation, tumor size) were measured. Relative frequency differences (RFD) were estimated using multivariable linear regression. Disease-free interval (DFI) was evaluated by ER category and endocrine therapy receipt, overall and by race, using Kaplan Meier and Cox models. Statistical tests were two-sided., Results: ER-borderlines were more frequently basal-like (RFD = +37.7%, 95% confidence interval [CI] = 27.1% to 48.4%) and high ROR-PT (RFD = +52.4%, 95% CI = 36.8% to 68.0%) relative to ER-positives. Having a high ROR-PT ER-borderline tumor was statistically significantly associated with black race (RFD = +26.2%, 95% CI = 9.0% to 43.3%). Compared to ER-positives, DFI of ER-borderlines treated with endocrine therapy was poorer but not statistically significantly different (hazard ratio [HR] = 2.03, 95% CI = 0.89% to 4.65%), whereas DFI was statistically significantly worse for ER-borderlines without endocrine therapy (HR = 3.33, 95% CI = 1.84% to 6.02%). However, black women with ER-borderline had worse DFI compared to ER-positives, even when treated with endocrine therapy (HR = 2.77, 95% CI = 1.09% to 7.04%)., Conclusions: ER-borderline tumors were genomically heterogeneous, with survival outcomes that differed by endocrine therapy receipt and race. Black race predicted high-risk ER-borderlines and may be associated with poorer endocrine therapy response., (© The Author(s) 2019. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Purpose: We estimated average medical costs due to metastatic breast cancer (mBC) among younger (aged 18-44), midlife (aged 45-64), and older women (aged 65 and older) by phase of care: initial, continuing, and terminal., Methods: We used 2003-2014 North Carolina cancer registry data linked with administrative claims from public and private payers. We developed a claims-based algorithm to identify breast cancer patients who progressed to metastatic disease. We matched breast cancer patients (mBC and earlier stage) to non-cancer patients on age group, county of residence, and insurance plan. Outcomes were average monthly medical expenditures and expected medical expenditures by phase. We used regression to estimate excess costs attributed to mBC as the difference in mean payments between patients with mBC (N = 4806) and patients with each earlier-stage breast cancer (stage 1, stage 2, stage 3, and unknown stage; N = 21,772) and non-cancer controls (N = 109,631) by treatment phase and age group., Results: Adjusted monthly costs for women with mBC were significantly higher than for women with earlier-stage breast cancer and non-cancer controls for all age groups and treatment phases except the initial treatment among women with stage 3 breast cancer at diagnosis. The largest expected total costs were for women aged 18-44 with mBC during the continuing phase ($209,961 95% Confidence Interval $165,736-254,186)., Conclusions: We found substantial excess costs for mBC among younger women and during the continuing and terminal phases of survivorship. It is important to assess whether this care is high value for these women.

Purpose: Understanding breast cancer mortality disparities by race and age is complex due to disease heterogeneity, comorbid disease, and the range of factors influencing access to care. It is important to understand how these factors group together within patients., Methods: We compared socioeconomic status (SES) and comorbidity factors in the Carolina Breast Cancer Study Phase 3 (CBCS3, 2008-2013) to those for North Carolina using the 2010 Behavioral Risk Factor Surveillance Study. In addition, we used latent class analysis of CBCS3 data to identify covariate patterns by SES/comorbidities, barriers to care, and tumor characteristics and examined their associations with race and age using multinomial logistic regression., Results: Major SES and comorbidity patterns in CBCS3 participants were generally similar to patterns in the state. Latent classes were identified for SES/comorbidities, barriers to care, and tumor characteristics that varied by race and age. Compared to white women, black women had lower SES (odds ratio (OR)  6.3, 95% confidence interval (CI) 5.2, 7.8), more barriers to care (OR 5.6, 95% CI 3.9, 8.1) and several aggregated tumor aggressiveness features. Compared to older women, younger women had higher SES (OR 0.5, 95% CI 0.4, 0.6), more barriers to care (OR 2.1, 95% CI 1.6, 2.9) and aggregated tumor aggressiveness features., Conclusions: CBCS3 is representative of North Carolina on comparable factors. Patterns of access to care and tumor characteristics are intertwined with race and age, suggesting that interventions to address disparities will need to target both access and biology.

Purpose: Little is known about racial variations in the financial impact of cancer care. Using data from a national survey of racially diverse patients with metastatic breast cancer, we examined racial/ethnic patterns in employment and cost-management (i.e., financial coping) behaviors., Methods: We conducted an online survey of patients with metastatic breast cancer. Participants reported on socio-demographic characteristics, employment, and financial coping behaviors. We employed adjusted modified Poisson regressions to evaluate racial/ethnic differences in changes in work for pay and financial coping., Results: Our analysis included 1052 respondents from 41 states, including Non-Hispanic Blacks (NHB, 9%), Hispanics (7%), Asians/Pacific Islanders/Native Hawaiians (API/NH, 10%), American Indians/Alaskan Natives (AI/AN, 8%), and Non-Hispanic Whites (NHW, 66%). In adjusted analyses comparing NHWs with patients of color, patients of color were more likely to take unpaid leave (NHB Adjusted Risk Ratio [ARR] = 2.27; 95% CI 1.54, 3.34), take paid leave (Hispanic ARR = 2.27; 95% CI 1.54, 1.29), stop work (AI/AN ARR = 1.22; 95% CI 1.05, 1.41), and reduce work hours (AI/AN ARR = 1.33; 95% CI 1.14, 1.57). Patients of color were more likely than NHWs to stop treatment (NHB ARR = 1.22; 95% CI 1.08, 1.39), borrow money from friends/family (Hispanic ARR = 1.75; 95% CI 1.25, 2.44), skip other medical bills (API/NH ARR = 2.02; 95% CI 1.54, 2.63), and skip non-medical bills (AI/AN ARR = 1.67 95% CI 1.06, 2.63). Non-Hispanic Whites more commonly reported using savings or skipping a vacation to help manage costs., Conclusions: Racial/ethnic differences exist in employment changes and financial coping among metastatic breast cancer patients, with patients of color experiencing worse consequences. Equity must be a guiding principle in strategies addressing financial burden during cancer care.

Background: Compared to non-Hispanic Whites, Hispanic women are more likely to report pain, depression, and other mental health concerns. However, little is known about Hispanic women's use of supportive medications, and whether use differs depending on nativity (US- vs. foreign-born). This study's objectives were to examine patterns of supportive medication use and investigate potential differences by ethnicity/nativity among women with breast cancer., Methods: We used the Surveillance, Epidemiology, and End Results data linked with Medicare claims to identify women diagnosed with incident breast cancer between July 1, 2007, and December 31, 2011. Supportive medication use (opioid pain and non-opioid psychotropic medications) in the 90 days after diagnosis was the primary outcome. We categorized ethnicity/nativity as US-Born non-Hispanic, US-born Hispanic, foreign-born non-Hispanic, and foreign-born Hispanic. Modified Poisson models examined associations between ethnicity/nativity and medication use, adjusting for tumor, treatment, and demographic characteristics., Results: We included 23,091 women, of whom 88% were US-born non-Hispanics, 4% US-born Hispanics, 6% foreign-born non-Hispanics, and 2% foreign-born Hispanics. Supportive medication use varied by ethnicity/nativity. Compared to US-born non-Hispanics, foreign-born Hispanics and non-Hispanics were 5% (95% CI 0.92-0.98) and 10% (95% CI 0.85-0.96) less likely to receive supportive medications, respectively. US-born Hispanics were 5% (95% CI 1.02-1.09) more likely to receive supportive medications. Observed differences persisted when analyses were limited to stage I-III breast cancer cases., Conclusions: This work highlights potential disparities in the pharmacologic treatment of psychosocial needs of foreign-born breast cancer patients. Future studies should explore if differences observed here are reflective of health disparities or differential patient preferences.

Background: Differential use of endocrine therapy (ET) by race may contribute to breast cancer outcome disparities, but racial differences in ET behaviors are poorly understood., Methods: Women aged 20-74 years with a first primary, stage I-III, hormone receptor-positive (HR+) breast cancer were included. At 2 years postdiagnosis, we assessed nonadherence, defined as not taking ET every day or missing more than two pills in the past 14 days, discontinuation, and a composite measure of underuse, defined as either missing pills or discontinuing completely. Using logistic regression, we evaluated the relationship between race and nonadherence, discontinuation, and overall underuse in unadjusted, clinically adjusted, and socioeconomically adjusted models., Results: A total of 1280 women were included; 43.2% self-identified as black. Compared to white women, black women more often reported nonadherence (13.7% vs 5.2%) but not discontinuation (10.0% vs 10.7%). Black women also more often reported the following: hot flashes, night sweats, breast sensitivity, and joint pain; believing that their recurrence risk would not change if they stopped ET; forgetting to take ET; and cost-related barriers. In multivariable analysis, black race remained statistically significantly associated with nonadherence after adjusting for clinical characteristics (adjusted odds ratio = 2.72, 95% confidence interval = 1.75 to 4.24) and after adding socioeconomic to clinical characteristics (adjusted odds ratio = 2.44, 95% confidence interval = 1.50 to 3.97) but was not independently associated with discontinuation after adjustment. Low recurrence risk perception and lack of a shared decision making were strongly predictive of ET underuse across races., Conclusions: Our results highlight important racial differences in ET-adherence behaviors, perceptions of benefits/harms, and shared decision making that may be targeted with culturally tailored interventions., (© The Author(s) 2018. Published by Oxford University Press.)

Purpose: The goal of this systematic review is to provide an update to the review by Pouwels et al. by conducting a systematic review and an assessment of the reporting quality of the economic analyses conducted since 2014., Methods: This systematic review identified published articles focused on metastatic breast cancer treatment using the Medline/PubMed and Scopus databases and the following search criteria: (((cost effectiveness[MeSH Terms]) OR (cost effectiveness) OR (cost-effectiveness) OR (cost utility) OR (cost-utility) OR (economic evaluation)) AND (("metastatic breast cancer") OR ("advanced breast cancer"))). The reporting quality of the included articles was evaluated using the International Society of Pharmacoeconomics and Outcomes Research (ISPOR) Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist., Results: Of the 256 identified articles, 67 of the articles were published after October 2014 when the prior systematic review stopped its assessment (Pouwels et al. in Breast Cancer Res Treat 165:485-498, 2017). From the 67 articles, we narrowed down to include 17 original health economic analyses specific to metastatic or advanced breast cancer. These articles were diverse with respect to methods employed and interventions included., Conclusion: Although each of the articles contributed their own analytic strengths and limitations, the overall quality of the studies was moderate. The review demonstrated that the vast majority of the reported incremental cost-effectiveness ratios exceeded the typically employed willingness to pay thresholds used in each country of analysis. Only three of the reviewed articles studied chemotherapies rather than treatments targeting either HER2 or hormone receptors, demonstrating a gap in the literature.

Introduction: As the cost of cancer treatment continues to rise, many patients are faced with significant emotional and financial burden. Oncology navigators guide patients through many aspects of care and therefore may be especially aware of patients' financial distress. Our objective was to explore navigators' perception of their patients' financial burden and their role in addressing financial needs., Materials and Methods: We conducted a real-time online survey of attendees at an oncology navigators' association conference. Participants included lay navigators, oncology nurse navigators, community health workers, and social workers. Questions assessed perceived burden in their patient population and their role in helping navigate patients through financial resources. Answers to open-ended questions are reported using identified themes., Results: Seventy-eight respondents participated in the survey, reporting that on average 75% of their patients experienced some degree of financial toxicity related to their cancer. Only 45% of navigators felt the majority of these patients were able to get some financial assistance, most often through assistance with medical costs (73%), subsidized insurance (36%), or non-medical expenses (31%). Commonly identified barriers for patients obtaining assistance included lack of resources (50%), lack of knowledge about resources (46%), and complex/duplicative paperwork (20%)., Conclusion: Oncology navigators reported a high burden of financial toxicity among their patients but insufficient knowledge or resources to address this need. This study underscores the importance of improved training and coordination for addressing financial burden, and the need to address community and system-level barriers.

Background: African American breast cancer patients have lower frequency of hormone receptor-positive (HR+)/human epidermal growth factor receptor 2 (HER2)-negative disease and higher subtype-specific mortality. Racial differences in molecular subtype within clinically defined subgroups are not well understood., Methods: Using data and biospecimens from the population-based Carolina Breast Cancer Study (CBCS) Phase 3 (2008-2013), we classified 980 invasive breast cancers using RNA expression-based PAM50 subtype and recurrence (ROR) score that reflects proliferation and tumor size. Molecular subtypes (Luminal A, Luminal B, HER2-enriched, and Basal-like) and ROR scores (high vs low/medium) were compared by race (blacks vs whites) and age (≤50 years vs > 50 years) using chi-square tests and analysis of variance tests., Results: Black women of all ages had a statistically significantly lower frequency of Luminal A breast cancer (25.4% and 33.6% in blacks vs 42.8% and 52.1% in whites; younger and older, respectively). All other subtype frequencies were higher in black women (case-only odds ratio [OR] = 3.11, 95% confidence interval [CI] = 2.22 to 4.37, for Basal-like; OR = 1.45, 95% CI = 1.02 to 2.06, for Luminal B; OR = 2.04, 95% CI = 1.33 to 3.13, for HER2-enriched). Among clinically HR+/HER2- cases, Luminal A subtype was less common and ROR scores were statistically significantly higher among black women., Conclusions: Multigene assays highlight racial disparities in tumor subtype distribution that persist even in clinically defined subgroups. Differences in tumor biology (eg, HER2-enriched status) may be targetable to reduce disparities among clinically ER+/HER2- cases., (© The Author 2017. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com)

Purpose: The incidence of treatment-related toxicity for adjuvant chemotherapy in breast cancer is well documented in clinical trials. However, the effect of chemotherapy on functional outcomes in older patients is less well known. We identified a cohort of older women diagnosed with early stage breast cancer to examine the association between exposure to chemotherapy and a claims-based measure of function-related adverse events (FAE)., Methods: Using the Surveillance, Epidemiology, and End Results (SEER)-Medicare dataset, we identified women aged ≥66 diagnosed with stage I or II breast cancer from 2004 to 2011. FAE were defined as one or more claims suggestive of functional impairment within 24months following chemotherapy including claims for durable medical equipment and skilled care. Women who did not receive chemotherapy were weighted to reflect the covariate distribution of chemotherapy recipients using propensity score weighting for age, stage, baseline healthcare utilization, and comorbidities., Results: The cohort included 44,626 patients, 6892 (15%) received chemotherapy. 19% of the population experienced ≥1 FAE. After propensity weighting, chemotherapy was associated with a small increased risk of FAEs (HR 1.12, 95% confidence interval: 1.04, 1.20). Results were similar in patients 75years and older versus younger patients. In the chemotherapy group, the highest risk of FAE occurred in the first 3months, but persisted through follow-up., Conclusions: Exposure to chemotherapy was associated with a small increased risk of FAE which did not vary by age. These data can be used to inform treatment decision making for older patients with breast cancer who are eligible for adjuvant chemotherapy., (Copyright © 2017 Elsevier Ltd. All rights reserved.)

Purpose: We aimed to identify subgroups of women with breast cancer who experience different health-related quality of life (HRQOL) patterns during active treatment and survivorship and determine characteristics associated with subgroup membership., Methods: We used data from the third phase of the population-based Carolina Breast Cancer Study and included 2142 women diagnosed with breast cancer from 2008 to 2013. HRQOL was measured, on average, 5 and 25 months post diagnosis. Latent profile analysis was used to identify HRQOL latent profiles (LPs) at each time point. Latent transition analysis was used to determine probabilities of women transitioning profiles from 5 to 25 months. Multinomial logit models estimated adjusted odds ratios (aORs) and 95% confidence intervals for associations between patient characteristics and LP membership at each time point., Results: We identified four HRQOL LPs at 5 and 25 months. LP1 had the poorest HRQOL and LP4 the best. Membership in the poorest profile at 5 months was associated with younger age aOR 0.95; 0.93-0.96, White race aOR 1.48; 1.25-1.65, being unmarried aOR 1.50; 1.28-1.65 and having public aOR 3.09; 1.96-4.83 or no insurance aOR 6.51; 2.12-20.10. At 25 months, Black race aOR 1.75; 1.18-1.82 was associated with the poorest profile membership. Black race and smoking were predictors of deteriorating to a worse profile from 5 to 25 months., Conclusions: Our results suggest patient-level characteristics including age at diagnosis and race may identify women at risk for experiencing poor HRQOL patterns. If women are identified and offered targeted HRQOL support, we may see improvements in long-term HRQOL and better breast cancer outcomes.

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

Purpose: Compared with young White women, young Black women are more likely to present with aggressive breast cancer (BC) subtypes that are potentially linked to worse health-related quality of life (HRQOL); however, there is limited consensus regarding HRQOL needs among young Black BC survivors. Employing Ferrell's framework on QOL in BC (i.e., physical, psychological, social, and spiritual well-being), we conducted a systematic review on HRQOL among Black BC survivors aged <50 years and proposed recommendations for advancing HRQOL research and care for this population., Methods: Literature searches were conducted in MEDLINE/PubMed, EMBASE, CINAHL, and PsycINFO to identify relevant articles published from 1995 to 2015. Abstracts and full-text articles were screened using predetermined inclusion/exclusion criteria and evaluated for quality., Results: A total of 2533 articles were identified, but six met eligibility criteria. Most studies examined multiple HRQOL domains, with the psychological domain most represented. Compared with their older, White, and BC-free counterparts, young Black BC survivors reported greater fear of dying, unmet supportive care needs, financial distress, and lower physical/functional well-being. However, spiritual well-being appeared favorable for young Black survivors. Research gaps include the absence of longitudinal studies and under-representation of studies examining physical, social, and particularly, spiritual HRQOL in young Black BC survivors., Conclusions: Young Black BC survivors generally experience suboptimal HRQOL after BC diagnosis. As few studies have reported on HRQOL among this group, future research and oncology care should prioritize young Black women in ways that recognize their unique concerns, in order to ensure better HRQOL outcomes both during and after treatment., Competing Interests: All other authors have no conflicts of interest to disclose.

Purpose: Although racial disparities in health-related quality of life (HRQOL) among women with breast cancer (BC) are well documented, less is known about HRQOL changes over time among women of different races. Our objective was to assess racial differences in HRQOL during active treatment and survivorship phases of BC care., Methods: We used data from the third phase of the Carolina Breast Cancer Study (CBCS-III). CBCS-III enrolled 3000 women in North Carolina aged 20-74 years diagnosed with BC between 2008 and 2013. HRQOL assessments occurred 5 and 25 months post diagnosis, representing distinct phases of care. HRQOL measures included the Functional Assessment of Cancer Therapy for BC and Functional Assessment of Chronic Illness Therapy for Spiritual Well-Being. Analysis of covariance models were employed to assess racial differences in changes in HRQOL., Results: The cohort included 2142 Non-Hispanic White (n = 1105) and Black women (n = 1037) who completed both HRQOL assessments. During active treatment, Whites reported physical and functional scores 2-2.5 points higher than Blacks (p < 0.0001). Spiritual HRQOL was 2.1 points higher for Blacks (p < 0.0001). During survivorship, differences persisted. After adjusting for demographic, socioeconomic, tumor, and treatment characteristics, physical and functional HRQOL gaps narrowed, but spiritual HRQOL gaps widened., Conclusions: Racial differences in physical and functional HRQOL during active treatment and survivorship may be largely mediated by socioeconomic factors. However, our results suggest that among Black women, spiritual HRQOL is well supported throughout the BC care continuum. These results inform opportunities for improving the quality and equity of supportive services for women with BC.

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

Objectives: To provide a brief overview of disparities across the spectrum of breast cancer incidence, treatment, and long-term care during the survivorship period., Data Sources: Review of the literature including research reports, review articles, and clinically based articles available through PubMed and CINAHL., Conclusion: Minority women generally experience worse breast cancer outcomes despite a lower incidence of breast cancer than whites. A variety of factors contribute to this disparity, including advanced stage at diagnosis, higher rates of aggressive breast cancer subtypes, and lower receipt of appropriate therapies including surgery, chemotherapy, and radiation. Disparities in breast cancer care also extend into the survivorship trajectory, including lower rates of endocrine therapy use among some minority groups, as well as differences in follow-up and survivorship care., Implications for Nursing Practice: Breast cancer research should include improved minority representation and analyses by race, ethnicity, and socioeconomic status. While we cannot yet change the biology of this disease, we can encourage adherence to screening and treatment and help address the many physical, psychological, spiritual, and social issues minority women face in a culturally sensitive manner., (Copyright © 2015 Elsevier Inc. All rights reserved.)

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