Background Triple-negative breast cancer (TNBC) accounts for 10-20% of all breast cancers (BCs) and a significant proportion of all BC deaths. Eribulin is approved for the treatment of metastatic BC (MBC) after treatment with two prior regimens. A pooled analysis of two phase III studies of eribulin in women with TNBC patients found a 26% reduction in the risk of death vs. controls. Treatment patterns of eribulin and clinical outcomes associated with early vs. late use among TNBC patients treated in community oncology practices have not been evaluated. Methods Physicians from the Cardinal Health Oncology Research Network completed an electronic case report form (CRF) on up to 7 TNBC patients treated with eribulin between 01/01/11 and 12/31/13. Adult female patients with pathologically confirmed metastatic disease and not participating in any interventional clinical trial were included. Providers indicated the usage of chemotherapy, either alone or in combination, by line of therapy (LOT) up to the LOT of eribulin initiation. Reported data points include: clinical parameters (eg, site of metastases, ECOG performance status, and comorbidities), treatment events (eg, LOT start/end date and rationale for discontinuation), and outcomes (eg, clinical response and date of death). Dosing, adverse events, use of supportive care medications, and hospitalization were also captured during eribulin treatment. Use of eribulin in LOT 1/LOT 2 was considered early; LOT 3+ was considered late. All comparisons are univariate. Results An interim analysis was performed on 123 TNBC patients (planned sample size of 250) collected from 26 providers. Patient mean age at eribulin treatment initiation was 55.0 years. Mean follow-up duration was 27 mo (SD = 11.9) from initiation of first line metastatic treatment until date of last visit, death, or loss to follow-up. Overall, 74.0% were deceased, 85.4% had received at least 3 LOTs in the metastatic setting, and 45.4% were stage IV at diagnosis. Most women were prescribed eribulin in a later LOT (61.8%), 3 (2.4%) patients received eribulin in LOT1 and 44 in LOT2 (36.7%). Among patients with known treatment start and end dates (87.0%), mean duration of treatment (DOT) was 6.2 mo (SD = 3.3), median 5.8 mo among early recipients and 5.5 mo (SD = 5.7), median 4.1 mo, among later recipients (p = 0.39). Early users were more likely (p = 0.05) to have a complete/partial response (71.1% vs. 47.7%) and less likely to have progressive disease (7.1% vs. 12.3%). In comparing eribulin users to all other therapies, eribulin users had a significantly longer DOT in LOT2 (5.9 vs. 4.7 mo, p = 0.01) and LOT3 (5.8 vs. 3.6 mo, p = 0.03). In LOT3, eribulin users were significantly more likely to have complete/partial response (54.2% vs. 18.8%) and less likely to have to have progressive disease (4.2% vs. 37.5%) compared to all other observed LOT3 therapies. Conclusions This interim analysis indicates longer DOT for patients treated with eribulin for TNBC in LOT2 and LOT3 and a more favorable response rate compared to all other agents used in each LOT, respectively, among patients treated in community oncology practices. Full results will be available at the conference. Citation Format: Kish JK, Mougalian SS, Copher R, McAllister L, Zhixiao W, Broscious M. Utilization and outcomes of eribulin in triple negative metastatic breast cancer: Real-world findings [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 P5-15-16.

Background Eribulin mesylate is approved for the treatment of metastatic breast cancer (mBC) after two prior chemotherapy regimens including an anthracycline or a taxane in either the metastatic or adjuvant setting. Eribulin in combination with trastuzumab (E+T) has demonstrated tolerability and anti-tumor activity in phase I and II trials but is not FDA-approved for the treatment of HER2-positive mBC. Case series and retrospective research have noted the use of E+T in clinical practice. We sought to describe patient characteristics and long-term outcomes of treatment with E+T for HER2-positive mBC patients treated outside of clinical trials in the US. Methods US-based community oncologists from an open network of over 7,000 oncologists, hematologists, and urologists were invited to participate in identifying HER2-positive mBC patients treated with E+T between 01/01/11 and 12/31/13 outside of clinical trials. Data were collected from 03/18/2016 until 09/01/2016. Providers completed an electronic case report form (CRF) by abstracting data on disease characteristics, treatment patterns, disease response (per provider assessment), adverse events (Aes), and date of death. Duration of treatment and overall survival (OS) were calculated from the initiation of the E+T regimen. The target sample size was 60 patients and patients were selected according to resource available for chart data abstraction. Results Twenty-three providers submitted CRFs for 62 total patients. After data collection, 59 of 62 submitted records were validated for analysis. At mBC diagnosis, 69.4% of patients were ER/PR negative and 42.4% of patient had de novo stage IV disease. At initiation of E+T, the median age was 57 years and 81.4% were ECOG-OS 0/1. Mean length of follow-up from the initiation of any therapy was 33.6 months. Twenty-two (37.3%) patients initiated E+T as their first- or second-line of treatment; those remaining were in third-line or greater. At initiation of E+T, 72.8% of patients had prior treatment with trastuzumab in combination with chemotherapy, 25.4% had prior trastuzumab in combination with pertuzumab and chemotherapy, and 16.9% had received TDM-1. Mean duration of E+T treatment was 5.2 months (SD=2.4). A response (complete [CR] or partial [PR]) was recorded by the providers for 64.4% of patients (not independently verified). The most common Aes reported were fatigue (67.8%), weakness (50.8%), decreased appetite (28.8%), decreased hemoglobin (27.1%), peripheral neuropathy (25.4%), and neutropenia (18.6%). At the end of the study period, 34 patients (57.6%) were deceased; the median OS from the initiation of E+T was 23.9 months (95% CI: 17.8-30.4). Conclusions In a small cohort of patients treated with E+T in the community setting, the observed response rate of 64.4% (CR+PR) was comparable to that of a prior phase II trial of E+T which reported an ORR with first-line E+T of 71.2% overall, 77.4% among T-naïve and 61.9% in T-pretreated patients. Further research is warranted to examine the tolerability and efficacy of E+T for metastatic HER2-positive breast cancer patients in different treatment settings. Citation Format: Mougalian SS, Copher R, McAllister L, Radtchenko J, Wang EC, Broscious M, Yu H-T, Kish J. Outcomes of real-world use of eribulin plus trastuzumab for HER2-positive metastatic breast cancer [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 P6-17-28.

Introduction: Approximately 75% of stage I-III breast cancers are hormone receptor (HR) positive for which the standard of care is 5-10 years of adjuvant endocrine therapy, which has been shown to reduce recurrences and improve survival. Unfortunately, up to 40% of patients may not take the prescribed medication daily or may discontinue it early. Mobile health technology provides an opportunity to develop new innovative tools to identify women who are not taking medication as prescribed, to understand their barriers for adherence and to facilitate communication with providers to improve adherence. Methods: The objective of the BETA study was to develop a new bi-directional text messaging application that simultaneously assesses patient adherence to endocrine therapy and provides direct communication to the provider team. Our primary endpoint was to assess feasibility of the application and the secondary endpoints included adherence, side effects and their severity, and quality of life (QOL). The intervention consisted of 3 types of text messages to which patients responded: 1) daily, evaluating adherence, 2) weekly, evaluating medication-related side effects and their severity, and 3) monthly, evaluating barriers to taking the medication. After 3 months of participation, patients completed surveys assessing the tolerability and financial burden of the intervention and adherence to medication. Patients were eligible if they had stage I-III, HR-positive breast cancer, owned a cell phone, and were initiating endocrine therapy. Target enrollment is 100 patients. For comparison, 100 consecutive patients meeting the above criteria were identified retrospectively as historical controls; adherence was assessed via chart review. Results: Between November 2014 and May 2015, 62 patients (mean age 53.5 years) were enrolled and 25 had completed the study. Of those approached, 66% participated. Of those who completed the study, the application was found to be helpful by 63%; specifically, 76% felt the intervention was a reminder to take the medication, 96% felt it was easy to use, and 71% wanted to continue receiving text messages after the study ended. On average, patients spent 12 minutes with the application per week, 0% felt it took up too much time, and only 1 patient incurred text messaging fees. No patients withdrew from the study and only 1 patient did not adhere to treatment (as defined by ≥ 80% adherence). None of the enrolled patients discontinued endocrine therapy, compared to 9% of historical controls. Side effects were common: hot flashes/night sweats (61% of patients), joint aches/pains (56%), and vaginal symptoms (29%) were reported. Severe side effects (reported by 29% of patients) prompted a return phone call to the patient. The study is ongoing and final results will be available by December 2015. Conclusion: We developed a new bi-directional text messaging intervention to assess adherence to endocrine therapy that provides real-time feedback to providers. Patients found the application helpful, easy to use, and not time consuming. Our tool is scalable for large population-based trials. Citation Format: Epstein LN, Jhaveri AP, Han G, Abu-Khalaf MM, Hofstatter EW, Sanft TB, DiGiovanna MP, Silber AL, Adelson KB, Chung GG, Pusztai L, Gross CP, Mougalian SS. Development of an interactive text messaging tool to improve adherence with adjuvant endocrine therapy: Breast cancer endocrine therapy adherence (BETA) pilot study. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P5-11-03.

Introduction: An emphasis on patient-centered care has led to a growing interest in collecting patient-reported outcomes (PROs) in the setting of cancer care. Routine collection of actionable PROs has been shown to improve patient satisfaction with care and even prolong survival. However, completion rates of PROs outside of the research setting are low, which may be due to an incomplete understanding of the outcomes patients value most. Prior work has focused primarily on symptom burden, but patients are also affected by disease and treatment across multiple domains (e.g. physical, psychological, social, and financial). To address this knowledge gap, we conducted a qualitative study among women with metastatic breast cancer (MBC) to identify the optimal patient-centered approach to collecting PRO data. Methods: We conducted 1-on-1 interviews with patients who had started a treatment regimen for MBC within the past 6 weeks at the Breast Center at Smilow Cancer Hospital of Yale New Haven Hospital to determine which PROs were most personally relevant. We assessed heterogeneity across patients in their prioritization. Patients were asked which of a list of six PRO domains they would like their provider to have information about and then ranked the domains by order of importance (from most to least important). The following domains were created from the NCCN Distress Thermometer: physical well-being, emotional well-being, treatment burden, functional status, financial concerns, and social well-being. For each ranked domain, patients were asked to rank items within the domain using a card sorting exercise where the number of items ranged from 5 to 15. Patients were then asked where and how often they preferred to report PROs. Results: Ten women with MBC completed the card sorting exercise: mean age was 58 years (+/- 12), 7 were white, 2 African American and 1 Asian; 1 identified as Hispanic. After 10 interviews, it was apparent that no single set of domain rankings was common across patients. Patient prioritization of PRO domains was unique and varied. Selection and prioritization of PRO domains and items within each domain were unique and varied. Five women reported “physical well-being” as the most important domain; treatment burden and emotional well-being were also selected as most important or ranked as highly important. Participants preferred reporting MBC PROs while in the waiting room for all domains except emotional well-being (from home was the preference). However, participants were willing to complete PRO assessment in the waiting room for about ten minutes and at home for twenty minutes. Conclusion: Substantial variation exists in how women with MBC rate the importance of specific PRO domains and items within each domain. Importantly, “physical symptoms” was not the top concern for half of the interviewed patients. This is an important finding, given that previous published studies of patient-reported outcomes have focused on one domain, such as symptoms and side effects or the financial burden of treatment. Our findings support the development of multi-dimensional tools for the collection of PROs. Although toxicity and physical symptoms are of utmost concern, clinicians should not neglect other dimensions of quality of life in women with MBC. Citation Format: Mougalian SS, Aminawung JA, Presley C, Canavan ME, Holland ML, Hu X, Gross CP. Prioritization of patient reported outcomes by women with metastatic breast cancer [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 P5-14-06.

Background: Breast cancer care imposes a significant financial burden to U.S. healthcare systems and has become a key focus in the health care debate. Therapies for breast cancer are expensive, and the economic burden of these therapies may be rising due to the rapid introduction of pricey new drugs and techniques. There are limited data on the health care costs of individuals with breast cancer after initial diagnosis and how these costs have changed over time. Methods: We conducted a retrospective analysis of commercially insured adult women with newly diagnosed non-metastatic breast cancer (identified via previously published claims-based algorithms) using 2007-2016 data from a large US health plan available in OptumLabs® Data Warehouse. We included patients with continuous health plan coverage for at least 2 years after initial diagnosis 2007-2014 and assessed how total health care spending and out-of-pocket costs (paid amounts) changed over this time. Costs were adjusted to 2016 US dollars using the general Consumer Price Index. Inpatient, outpatient, and outpatient pharmacy costs were evaluated. A multivariable logistic regression model was used to examine predictors of above average cost (cost > mean for that year of diagnosis). Results: A total of 12,446 newly diagnosed breast cancer patients were identified (mean age, 51.6 years). Forty percent had undergone mastectomy, 38% chemotherapy, and 63% radiation. After adjustment for inflation, total healthcare costs increased 29.7% from 2007 to 2014 (Table 1), with increases primarily observed during the first year after diagnosis. Out-of-pocket costs remained relatively stable, and accounted for 5.3% of the total spending. Approximately 80% of the total costs were related to care received in the outpatient setting. Factors independently associated with above average spending included treatment with mastectomy [OR 1.78 (95% CI 1.5-2.1)], reconstruction [OR 3.0 (95% CI 2.6-3.5)], radiation [OR 4.0 (95% CI 3.4-4.7)] and chemotherapy [OR 18.4 (95% CI 16.6-20.3]. Table 1.Average healthcare spending over time Mean cost during first year after diagnosisMean cost during second year after diagnosisYear of diagnosistotalout-of-pockettotalout-of-pocket2007$80,296.17$4,271.25$16,559.21$1,907.012008$84,126.70$4,445.78$16,785.43$2,205.982009$88,331.45$4,728.42$17,005.68$2,214.932010$91,502.58$5,067.78$17,243.91$2,126.192011$93,826.40$5,089.45$16,862.45$2,027.962012$96,690.06$5,449.91$17,814.09$2,179.262013$104,064.93$5,678.19$17,087.47$2,115.972014$104,169.74$5,620.51$16,714.12$1,590.67 Conclusions: Breast cancer care is increasingly expensive during the first year after diagnosis, and costs are greatest for the recipients of more aggressive treatments. Costs during the second year after diagnosis have remained relatively stable. Citation Format: Ruddy KJ, Sangaralingham LR, Freedman RA, Jemal A, Mougalian SS, Keegan T, Loprinzi CL, Gross CP, Henk HJ, Shah N. Trends in the cost of care for breast cancer among women with commercial insurance [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 PD6-07.