Care For Metastatic Breast Cancer Research Articles

Impact of COVID-19 on patients with metastatic breast cancer: REthink Access to Care and Treatment survey results.

Aim: Patients with metastatic breast cancer (MBC) may be vulnerable to changes in healthcare management, safety standards and protocols that occurred during the COVID-19 pandemic. Materials & methods: The REthink Access to Care & Treatment (REACT) survey assessed USA-based patient perspectives on COVID-19-related impacts to their MBC treatment experience between 27 April 2021 and 17 August 2021. Results: Participants (n=341; 98.5% females, mean age 50.8years) reported that overall oncology treatment quality was maintained during the pandemic. Delayed/canceled diagnostic imaging was reported by 44.9% of participants while telemedicine uptake was high among participants (80%). Conclusion: Overall, MBC care was minimally affected by the pandemic, possibly due to the expanded use of telemedicine, informing MBC management for future public health emergencies.

Seizing the moment: The time for harnessing electronic patient-reported outcome measures for enhanced and sustainable metastatic breast cancer care is now

The sustainability of healthcare systems is under pressure. Unlike care for many other chronic diseases, cancer care has yet to empower patients in effectively self-managing both the medical and emotional consequences of their condition, including adapting to changes in lifestyle and work, which is essential to achieve optimal health and recovery. Although proposed as a potential solution for sustainable healthcare and support for optimal health and recovery already decades ago, practical implementation of digital care lags behind.We believe electronic patient reported outcome measures (ePROMs) could play an important role in creating sustainable healthcare, both to guide complex treatment pathways and to empower survivors to self-manage consequences of diagnosis and treatment. That is, ePROMs can be used for screening and monitoring of symptoms, but also for treatment decision-making and to facilitate communication about quality of life. We therefore see opportunities for improvements in quality of care, quality of life, and survival of cancer patients, as well as research opportunities, as ePROMs collection can lead to better understanding of care needs. The ‘10 Actions for Change report’ of the Advanced Breast Cancer Global Alliance stresses a critical need for improvement of care for metastatic breast cancer (MBC) patients. We therefore in this paper focus on MBC care and research.

Re-imagining metastatic breast cancer care delivery: a patient-partnered qualitative study

PurposeWhile significant progress in metastatic breast cancer (MBC) treatment has prolonged survival and improved prognosis, there remain substantial gaps in providing patient-centered supportive care. The specific care delivery needs for metastatic cancer differ from that of early-stage cancer due to the incurable nature and lifelong duration of the condition. The objective of this study was to assess how patients living with MBC would re-imagine cancer care delivery.MethodsThis qualitative study was conducted in partnership with patient-led organizations Guiding Researchers and Advocates to Scientific Partnerships (GRASP) and Project Life, a nonprofit, online wellness community founded by patients with MBC for patients living with MBC. Virtual semi-structured interviews (n = 36) were conducted with Project Life members purposively sampled from the groups’ overall membership. The interview guide contained items surrounding patients’ lived experiences of MBC, greatest unmet needs related to care, and perspectives on virtual wellness community involvement. Interviews were coded using two-stage deductive and inductive analysis.ResultsThree major themes for re-imagining cancer care delivery were identified, including holistic care, information needs, and conceptual shifts. Within these several subthemes emerged with patients re-imagining referrals to non-oncological services, caregiver support, acceptance of integrative medicine, streamlined clinical trial enrollment, curated quality patient resources, MBC-specific terminology and approaches, long-term life and goal-of-care planning, and patient-centered voice throughout.ConclusionPeople living with metastatic cancers have specific supportive care needs. These findings highlight patient-driven areas for re-imagination that are most salient for individuals with MBC.

Patient-Reported Outcome Measures to Improve the Care Continuum for Patients With Metastatic Breast Cancer: Opportunities and Implications for Nursing Practice

ObjectivesAlbeit treatable, metastatic breast cancer (MBC) remains incurable. To achieve remaining life years lived well, extended survival should be balanced with optimal health-related quality of life (HRQoL) and timely initiated supportive, palliative, and end-of-life care. The Advanced Breast Cancer (ABC) Global Alliance identified 10 urgent and actionable goals for the decade between 2015 and 2025 to achieve substantial improvement in the lives of patients living with ABC, including MBC. Enhancements are needed for HRQoL, research, quality of care, and survival. We explore the potential of patient-reported outcome measures (PROMs) in addressing these gaps and aim to describe opportunities and current initiatives for improving the MBC care continuum through PROMs. Data sourcesNarrative description of recent literature on MBC and PROMs. ConclusionWe believe PROMs can make valuable contributions to seven of the 10 goals described: 1) enhancing the understanding of MBC through high-quality data collection, 2) improving HRQoL and raising consideration of survival versus HRQoL, 2) prolonging survival, 4) increasing referral to nonclinical support services, 5) supporting patient–healthcare provider communication, 6) encouraging improvements in healthcare access, and 7) supporting meeting patients’ informational needs. Implications for Nursing PracticeMaximizing the benefits of PROMs requires effective implementation. Because nurses and nurse practitioners are at the forefront of care, they can offer a comprehensive understanding of patients’ needs and play a crucial role in facilitating the integration of PROMs into routine care for MBC patients and ultimately optimizing patients’ outcomes and life years and months left.

Patient Preferences in Metastatic Breast Cancer Care: A Scoping Review.

People with metastatic breast cancer (MBC) have diverse medical, physical, and psychosocial needs that require multidimensional care. Understanding patient preferences is crucial to tailor treatments, services, and foster patient-centered care. A scoping review was performed to summarize the current evidence on the preferences of people with MBC regarding their care to identify knowledge gaps and key areas for future research. The Embase, MEDLINE, CINAHL and PsycInfo databases were searched. Twenty studies enrolling 3354 patients met the study eligibility criteria. Thirteen quantitative studies, four mixed methods studies, and three qualitative studies were included. Seven studies captured healthcare provider perspectives; thirteen studies evaluated patient preferences relating specifically to cancer treatments; three studies evaluated preferences relating to supportive care; and four studies evaluated communication and decision-making preferences. The current literature evaluating MBC patient preferences is heterogeneous with a focus on cancer treatments. Future research should explore patient preferences relating to multidisciplinary, multi-modal care that aims to improve quality of life. Understanding MBC patient preferences regarding their comprehensive care can help tailor healthcare delivery, enhance the patient experience, and improve outcomes.

A Qualitative Study of the Impact of the COVID-19 Pandemic on Metastatic Breast Cancer Care

A Qualitative Study of the Impact of the COVID-19 Pandemic on Metastatic Breast Cancer Care

European Society of Breast Cancer Specialists/Advanced Breast Cancer Global Alliance quality indicators for metastatic breast cancer care

AimsImprovement in the care of patients with metastatic breast cancer (MBC) can only occur if the adequate quality of care is implemented and verified, including access to multidisciplinary, specialised care given in accordance with high-quality guidelines. To this purpose, European Society of Breast Cancer Specialists and the Advanced Breast Cancer Global Alliance joined efforts to develop the first set of quality indicators (QI) specifically for MBC that should be routinely measured and evaluated to ensure that breast cancer centres meet the required standards. MethodsA working group of multidisciplinary European experts in breast cancer met to discuss each identified QI, reporting the definition, the minimum and target standard for breast cancer centres to achieve, and the motivation for selection. The level of evidence was determined according to the short version of the United States Agency for Healthcare Research and Quality classification. ResultsQI to measure access to and involvement in multidisciplinary and supportive care, appropriate pathological characterisation of disease, systemic therapies and radiotherapy were developed with the consensus of the working group. ConclusionsThis is the first effort of a multistep project that aims to have QI for MBC routinely measured and evaluated to ensure that breast cancer centres achieve mandated standards in the care of patients with metastatic disease.

Abstract P1-13-07: Investigating NF1 Mutations in Circulating Tumor DNA of Patients with Hormone-receptor Positive (HR+) Breast Tumors Resistant to CDK4/6 Inhibition (CDK4/6i): A Retrospective Clinical Analysis

Abstract Background: CDK4/6 inhibitors (CDK4/6i) are standard of care for the management of HR+/HER2- metastatic breast cancer (MBC). Genomic alterations that drive resistance to CDK4/6i are diverse, and while the molecular landscape is heterogeneous, several mechanisms of CDK4/6i resistance converge on the RAS/MAPK and PI3K/AKT/mTOR signaling pathways. NF1 downregulates RAS and dampens cellular proliferation. Laboratory-based models demonstrate that loss of NF1 is associated with resistance to endocrine therapy (ET), and emergence of NF1 mutations (NF1m) are correlated with progressive disease (PD) in circulating tumor DNA (ctDNA). While NF1m may diminish CDK4/6i susceptibility, a clear relationship has not been elucidated. The primary objective of this study was to characterize patient (pt) response to CDK4/6i in NF1m HR+/HER2- MBC. Methods: We identified 47 pts with NF1m via a database with one or more ctDNA samples sequenced at variable time-points as part of routine care for MBC. NF1m were categorized as pathogenic (p)NF1m or variants of uncertain significance (VUS) based on their associated Guardant report. We identified 27 pts with HR+/HER2- MBC and NF1m that received at least 1 line of CDK4/6i in the metastatic setting. Intrinsic resistance was defined as PD < 6 months on a CDK4/6i regimen, and acquired resistance was defined as PD >6 months. Pts with intrinsic resistance or acquired resistance and NF1m detected post-PD were categorized as having a resistance phenotype potentially driven by NF1m. Pts with NF1m detected prior to therapy and >6 months clinical response on a CDK4/6i were categorized as having NF1m tumors sensitive to CDK4/6i. Results: The NF1m cohort (n = 27) had 9 pts with pNF1m, while 18 pts expressed VUS. The median age at MBC diagnosis was 54 years, and 67% had visceral metastasis at ctDNA collection. Pts received a median of 1 prior line (range: 0 - 6) of ET or chemotherapy in the metastatic setting before CDK4/6i. Amongst pts with pathogenic variants (n = 9), we found 3 pts with pNF1m were intrinsically resistant to CDK4/6i. Acquired resistance was seen in 1 pt with pNF1m detected post-PD, and 2 pts had evidence of both acquired and subsequent intrinsic resistance to a later line of CDK4/6i. Overall, 67% (6/9) of pNF1m pts demonstrated a CDK4/6i resistance phenotype; mutant allele fraction (AF) ranged from 0.2% - 29.9%, and the mean maximum allele fraction (MAF) was 6.0%. Pre- and post-treatment samples were available on 3 pts with pNF1m, and 1 of these pts had an AF rise from 2.7% to 12.3% when comparing ctDNA pre- and post-CDK4/6i. ctDNA from 4 of 6 resistant tumors harbored other putative drivers including alterations in FGFR, KRAS, PTEN, and RB. We identified 2 counter-examples of pNF1m tumors sensitive to CDK4/6i. These pts expressed relatively low NF1m AF, ranging 0.1% - 0.5% with a mean MAF 0.3%. Another pNF1m pt had intrinsic resistance to initial CDK4/6i but was sensitive to later-line CDK4/6i. In the subgroup of pts with VUS-NF1m (n = 18), a more mixed picture of resistance and sensitivity was seen. 8 pts had intrinsic or acquired resistance, 8 pts had NF1m tumors sensitive to CDK4/6i, and 1 pt had evidence of both; 61% (n = 11) of pts expressed alterations in other resistance mediating genes. 1 pt stopped therapy due to toxicity rather than PD. Conclusions: Our work demonstrates that tumor expression of pNF1m may be associated with CDK4/6i resistance in pts with HR+/HER2- MBC, and allele fraction could be predictive of drug susceptibility. Tumors harboring VUS had varied sensitivity, suggesting that some of these mutations may not be pathogenic, and counter-examples of pNF1m MBC benefiting from CDK4/6i plus ET highlight the complexities in predicting drug response based on single gene alteration. Future effort is warranted to explore the potential impact of NF1 on CDK4/6i resistance, as well as the potential role for therapies targeting the MAPK pathway in this patient population. Citation Format: Maxwell R. Lloyd, Lianne Ryan, Arielle J. Medford, Jennifer C. Keenan, Laura M. Spring, Neelima Vidula, Beverly Moy, Dejan Juric, Leif Ellisen, Aditya Bardia, Seth A. Wander. Investigating NF1 Mutations in Circulating Tumor DNA of Patients with Hormone-receptor Positive (HR+) Breast Tumors Resistant to CDK4/6 Inhibition (CDK4/6i): A Retrospective Clinical Analysis [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P1-13-07.

A Qualitative Study of the Impact of the COVID-19 Pandemic on Metastatic Breast Cancer Care.

The COVID-19 pandemic substantially impacted the delivery of oncology care, particularly for individuals with metastatic cancers. The objective of this study was to qualitatively evaluate the impacts of COVID-19 on metastatic breast cancer (MBC) care among patients. This study consisted of 36 semi-structured qualitative interviews conducted virtually with people living with MBC, who were members of a patient support organization called Project Life. Project Life is an MBC patient-led, web-based wellness community. Responses were analyzed using Phronetic Iterative Analysis. Interviews were conducted from March 14, 2022, to May 31, 2022. Analysis from 36 individual in-depth qualitative interviews revealed the following themes during COVID-19: (1) variable preferences for telehealth (2) disruptions to care, (3) virtualization of social care. Wide variations existed in preferences surrounding telehealth, centered around ideas of convenience. Disruptions to care included delays to diagnostic care, isolation from caregivers, and interruptions associated with COVID-19 infection. These results call for adaptability in oncology care given wide-ranging preferences on telehealth and the shifting of available support services.

Treatment Sequencing Patterns and Associated Direct Medical Costs of Metastatic Breast Cancer Care in the United States, 2011 to 2021

Advances in treatment of metastatic breast cancer (MBC) led to changes in clinical practice and treatment costs in the US over the past decade. There is limited information on current MBC treatment sequences and associated costs by MBC subtype in the US. To identify treatment patterns by MBC subtype and associated anticancer and supportive drug costs from health care sector and Medicare perspectives. This economic evaluation analyzed data of patients with MBC obtained from the nationwide Flatiron Health database, an electronic health record-derived, deidentified database with data from community and academic practices across the US from 2011 to 2021. Participants included women aged at least 18 years diagnosed with MBC, who had at least 6 months of follow-up data, known hormone receptor (HR) and human epidermal growth factor receptor 2 (ERBB2) receptor status, and at least 1 documented line of therapy. Patients with documented receipt of clinical study drugs were excluded. Data were analyzed from June 2021 to May 2022. Outcomes of interest were frequency of different drug regimens received as a line of therapy by subtype for the first 5 lines and mean medical costs of documented anticancer treatment and supportive care drugs per patient by MBC subtype and years since metastatic diagnosis, indexed to 2021 US dollars. Among 15 215 patients (10 171 patients [66.85%] with HR-positive and ERBB2-negative MBC; 2785 patients [18.30%] with HR-positive and ERBB2-positive MBC; 802 patients [5.27%] with HR-negative and ERBB2-positive MBC; 1457 patients [9.58%] with triple-negative breast cancer [TNBC]) who met eligibility criteria, 1777 (11.68%) were African American, 363 (2.39%) were Asian, and 9800 (64.41%) were White; the median (range) age was 64 (21-84) years. The mean total per-patient treatment and supportive care drug cost using publicly available Medicare prices was $334 812 for patients with HR-positive and ERBB2-positive MBC, $284 609 for patients with HR-negative and ERBB2-positive MBC, $104 774 for patients with HR-positive and ERBB2-negative MBC, and $54 355 for patients with TNBC. From 2011 to 2019 (most recent complete year 1 data are for patients diagnosed in 2019), annual costs in year 1 increased from $12 986 to $80 563 for ERBB2-negative and HR-positive MBC, $99 997 to $156 712 for ERBB2-positive and HR-positive MBC, and $31 397 to $53 775 for TNBC. This economic evaluation found that drug costs related to MBC treatment increased between 2011 and 2021 and differed by tumor subtype. These findings suggest the growing financial burden of MBC treatment in the US and highlights the importance of performing more accurate cost-effectiveness analysis of novel adjuvant therapies that aim to reduce metastatic recurrence rates for early-stage breast cancer.

Reimaging metastatic breast cancer care delivery: A patient-partnered qualitative investigation.

259 Background: Treatment advances for metastatic breast cancer (MBC) have markedly increased survival over the last several decades. Despite the clinical innovation that has occurred, there remains substantial fragmentation of care and lack of focused attention on MBC survivorship care. This study partnered with Project Life, an MBC-survivor led patient wellness community to assess MBC patient experiences with treatment experiences and social support services. Methods: We conducted, virtual, in-depth semi-structured qualitative interviews among people who were members of the Project Life Wellness community. The interview guide and study materials were developed in collaboration with Project Life leadership. A study flyer was distributed by Project Life to members that included a link to an eligibility survey. Participants were eligible if they self-identified as having MBC, were a member of the Project Life community, and could complete the interview in English. As part of the interview, we asked, “How would you re-imagine medical care for people with metastatic breast cancer?” We then systematically processed responses with phronetic iterative analysis, using the mixed-methods research software MAXQDA, to uncover contextually grounded, emergent themes through synthetic coding. Results: We interviewed 36 women with MBC who were members of the Project Life Wellness Community in Spring 2022. In terms of age, 8 (22%) participants were 30-45, 15 (42%) were 46-59, and 13 (36%) were 60+. Overall, 22% of participants identified as people of color (Black, Latina, or Asian). In response to how they would reimagine MBC care delivery, all participants touched upon dimensions of care coordination. Aspects of care coordination that participants specifically raised included 1) Organized referral processes for non-oncology care like mental health services, sexual health care, and palliative care; 2) The need for MBC-specific support services within the care setting; 3)Patient connection to psychosocial aspects of care including social work and patient navigation; 4) Streamlined processes for identifying and enrolling in clinical trials. Conclusions: In our investigation, when asked how they would reimagine MBC care delivery, participants overwhelmingly endorsed the need for more care coordination along several key domains. Responses highlighted the unique needs of care coordination specific to MBC patients. Future care innovations should center patient voices to ensure optimal impact.

Adapting and Developing an Academic and Community Practice Collaborative Care Model for Metastatic Breast Cancer Care (Project ADAPT): Protocol for an Implementation Science-Based Study.

BackgroundMetastatic breast cancer (MBC) remains incurable despite significant treatment advances. Coordinating care for patients with MBC can be challenging given the various treatment options, available clinical trials, and frequent need for ancillary services. To optimize MBC care, we designed a project for adapting and developing an academic and community practice collaborative care model for MBC care (Project ADAPT), based on the Ending Metastatic Breast Cancer for Everyone (EMBRACE) program developed at Dana Farber Cancer Institute.ObjectiveWe aim to describe the implementation science–based study design and innovative components of Project ADAPT.MethodsProject ADAPT uses the Dynamic Adaptation Process informed by the Exploration, Preparation, Implementation, Sustainment framework. Washington University School of Medicine (WUSM) partnered with 3 community hospitals in the St. Louis region covering rural and urban settings. The exploration and preparation phases provide patient and provider feedback on current referral practices to finalize the approach for the implementation phase. At the implementation phase, we will enroll patients with MBC at these 3 community sites to evaluate potential collaborative care at WUSM and assess the impact of this collaborative care model on referral satisfaction and acceptability for patients with MBC and their providers. Patients may then return to their community site for care or continue to receive part of their care at WUSM. We are incorporating virtual and digital health strategies to improve MBC care coordination in order to minimize patient burden.ResultsThe exploration phase is ongoing. As of August 2021, we have recruited 21 patient and provider participants to complete surveys of the current collaborative care process at WUSM. Using a 2-tailed paired t test, 44 patients (including 10 patients from the exploration phase) and 32 oncologists are required to detect an effect size of 0.5 with 80% power at a level of significance of .05. Throughout this phase and in preparation for the implementation phase, we have iteratively updated and refined our surveys for the implementation phase based on testing of our data collection instruments. Our partner sites are in various stages of the single institutional review board (IRB) approval process. We have ongoing engagement with all partner sites, which has helped solidify our participant recruitment strategies and design patient-friendly recruitment materials. In addition, we have included a patient advocate on the research team. Members of the research team have launched a single IRB Support Network at WUSM to create a repository of the single IRB procedures in order to streamline the partner site onboarding process and facilitate enhanced collaboration across institutions.ConclusionsWith this robust model, we expect that patients with MBC will receive optimal care regardless of geographical location and the model will improve patient and provider experiences when navigating the health system.International Registered Report Identifier (IRRID)DERR1-10.2196/35736

Treatment patterns and medical costs of metastatic breast cancer care in the United States.

e18834 Background: Substantial advances in treatment of metastatic breast cancer (mBC) have led to changes in clinical practice and treatment costs in the United States in the past decade. We aimed to identify treatment patterns in mBC patients by subgroup and year after mBC diagnosis and associated costs from payer and societal perspectives. Methods: This study used the nationwide Flatiron Health electronic health record (EHR)-derived de-identified database (1/2011-5/2021). We excluded cases that were male, had < 6 months of follow up, no treatment data, no structured data within 90 days of diagnosis, participated in clinical trials, had non-breast invasive cancers, received therapies not used in mBC, had no data on human epidermal growth factor (HER2) and hormone receptor (HR) status. We classified patients into four subgroups: HER2-HR+, HER2+HR+, HER2+HR-, and Triple Negative (TNBC). We calculated anti-cancer and supportive drug costs at the patient level and mean costs by year after diagnosis for each subgroup. We used average wholesale prices (AWP, from McKesson Corporation) for payer perspective and Medicare prices (part B payment limit data, Part D Drug Spending Dashboard) for societal perspective. We estimated costs up to year 5 after diagnosis of mBC (< 8% received treatment after year 5). Results: 15,215 patients met the criteria (64.41% non-Hispanic White, 66.85% HER2-HR+, 18.30% HER2+HR+, 5.27% HER2+HR-, 9.58% TNBC). AWP and Medicare cost estimates by year after diagnosis and subgroup are shown in Table. 334,812 for HER2+HR+, $284,609 for HER2+HR-, $104,774 for HER2-HR+, and $54,355 for the TNBC. We observed an increase in annual costs between years 2011-2021 in most subgroups. This increase was most substantial for HER2-HR+ patients. From 2011 to 2019 (most recent complete year 1 data is for patients diagnosed in 2019), annual Medicare treatment costs in year 1 increased from $12,986 to $80,563 for HER2-HR+, $99,997 to $156,712 for HER2+HR+, and $31,397 to $53,775 for TNBC. There was no increase in costs of treating HER2+HR- in year 1, but an increase in year 2 (from $90,427 to $129,690 between 2011-2019). Conclusions: mBC treatment costs vary significantly by receptor subtype and years after diagnosis. Annual costs increased over time. Costs were greatest for HER2+ and lowest for TNBC.[Table: see text]

Treatment and Monitoring Variability in US Metastatic Breast Cancer Care.

Treatment and monitoring options for patients with metastatic breast cancer (MBC) are increasing, but little is known about variability in care. We sought to improve understanding of MBC care and its correlates by analyzing real-world claims data using a search engine with a novel query language to enable temporal electronic phenotyping. Using the Advanced Cohort Engine, we identified 6,180 women who met criteria for having estrogen receptor-positive, human epidermal growth factor receptor 2-negative MBC from IBM MarketScan US insurance claims (2007-2014). We characterized treatment, monitoring, and hospice usage, along with clinical and nonclinical factors affecting care. We observed wide variability in treatment modality and monitoring across patients and geography. Most women received first-recorded therapy with endocrine (67%) versus chemotherapy, underwent more computed tomography (CT) (76%) than positron emission tomography-CT, and were monitored using tumor markers (58%). Nearly half (46%) met criteria for aggressive disease, which were associated with receiving chemotherapy first, monitoring primarily with CT, and more frequent imaging. Older age was associated with endocrine therapy first, less frequent imaging, and less use of tumor markers. After controlling for clinical factors, care strategies varied significantly by nonclinical factors (median regional income with first-recorded therapy and imaging type, geographic region with these and with imaging frequency and use of tumor markers; P < .0001). Variability in US MBC care is explained by patient and disease factors and by nonclinical factors such as geographic region, suggesting that treatment decisions are influenced by local practice patterns and/or resources. A search engine designed to express complex electronic phenotypes from longitudinal patient records enables the identification of variability in patient care, helping to define disparities and areas for improvement.

Patient-reported outcomes to assess symptoms in patients with metastatic breast cancer: Pilot implementation project.

177 Background: Use of patient-reported outcomes (PRO) to evaluate symptoms improves clinical outcomes. Best practices for implementing PROs into routine care may vary according to clinical scenario, site-specific resources and programmatic goals. Patients with metastatic breast cancer (MBC) often experience a variety of symptoms. Methods: As a quality improvement project, we are pilot testing incorporation of a battery of PRO measures into routine care for patients with MBC at Johns Hopkins in order to gain experience that will guide future broader implementation of PROs across our program. Participants complete the PROs on paper at baseline (BL), 3, and 6 months (mo). Measures include NCCN Distress Thermometer (BL only), Patient Health Questionnaire-8 (PHQ-8), Generalized Anxiety Disorder-7 (GAD-7), PRO-CTCAE Insomnia questions and a modified version of the revised Edmonton Symptom Assessment System (r-ESAS) questionnaire with 3 extra symptom domains. Project team members alert clinicians by email of scores that exceed severity thresholds as follows – Distress: ≥4, PHQ-8: ≥8, GAD-7: ≥10, any item on r-ESAS: ≥4 and PRO-CTCAE Insomnia: severe/very severe or quite a bit/very much. Results: From May 29, 2020 and April 5, 2021, 67 patients were approached for participation, and 40 (59.7%) completed the BL PROs. Median age was 64 (range 36-85). Most participants were White (70%), non-Hispanic (90%) and had hormone receptor-positive (93%) MBC. At BL, 22 (55%) had visceral disease and most were receiving endocrine-based regimens [21 (53%)] or chemotherapy [16 (40%)]. 27 (68%) participants had ≥1 BL alert. The most common BL alerts were for symptoms on the r-ESAS [23 participants (58%)]. The most frequent items on the r-ESAS for which participants had BL alerts were pain, tiredness, well-being, tingling/numbness and rash. Other BL alerts were: Distress [9 participants (23%)], PRO-CTCAE Insomnia [5 participants (13%)], PHQ-8 [4 participants (10%)] and GAD-7 [2 participants (5%)]. To date, 24 of 35 (69%) and 15 of 28 (54%) participants who have reached the 3 and 6 mo time points have completed the respective follow-up (FU) PROs. Most common FU alerts to date are on the r-ESAS [3 mo: 14 participants (58%), 6 mo: 9 participants (60%)]. The project team has successfully notified providers of all alerts to date. Clinical actions (phone calls, provider visits and/or referrals) have been taken within 30 days of notification for &gt; 75% of alerts. Conclusions: Implementation of a PRO battery for patients receiving routine care for MBC led to detection of a range of symptoms, the majority of which were clinically actionable. Restrictions on in-person interactions during the COVID-19 pandemic may have contributed to low rates of PRO completion in this pilot project. Prior to broader implementation, we will consider strategies such as an electronic platform and a shorter battery to enhance patient engagement.

Evaluating specialty referral, research involvement, and PROs in a CNS-involved metastatic breast cancer care coordination program.

47 Background: Central nervous system (CNS) metastases are associated with decreased survival and quality of life for patients with metastatic breast cancer (MBC). Multi-disciplinary care can optimize outcomes. This project aims to improve access to coordinated care for patients with MBC and CNS metastases while assessing patient-reported outcomes (PROs) in the context of the multidisciplinary care experience. Methods: Patients with MBC and CNS metastases are referred and offered to enroll in our care coordination program. A team of specialists (breast medical oncology, breast cancer genetics, radiation oncology, neurosurgery, neuro-oncology, physical medicine and rehabilitation (PM&amp;R), neuropsychology, and palliative care) supports a dedicated program coordinator who provides navigation, education, specialty referral, and clinical trial screening. A unique intake form developed for the program creates personalized, coordinated, and expedited referrals. PROs and caregiver assessments are collected on a voluntary basis using the following validated questionnaires: PROMIS Cancer Function Brief 3D Profile, MD Anderson Symptom Inventory Brain Tumor (MDASI), and Short Form Zarit Burden Interview (ZBI-12), a screening tool for caregiver burden. Results: Since May 2020, 43 patients were referred and a total of 40 patients (93%) were enrolled – 2 (5%) declined due to perceived burden of participation and 1 (2%) died before enrollment. The majority of patients were White (n = 34, 85%). Median time to program intake was 1 day (range: 0-8 days). Of the 43 patients referred, 17 (40%) consented to research studies in the metastatic setting. 11 were for an interventional trial (65%), while 9 consents were for non-interventional studies (53%). In addition to the initially referred specialty, 56 referrals were made across 7 sub-specialties; 37 patients (66%) were subsequently seen by a sub-specialist, most commonly radiation oncology (n = 9), PM&amp;R (n = 9), neuro-oncology (n = 8), and neuropsychology (n = 8). Of the nine patients seen by PM&amp;R, 5 completed the PROMIS Profile (55%). Similar completion rates were seen for the MDASI (13 of 23 surveys given, 56.5%) and ZBI-12 (13 of 26 surveys given, 50%) questionnaires. Conclusions: Implementation of a care coordination program for patients with MBC and CNS metastases allows for improved access to care across sub-specialties and supports participation in clinical research for a group of cancer patients historically underrepresented in research studies. Though completion of questionnaires is optional in this program, the rate of completion raises the question of whether this patient population faces unique challenges that make it difficult to complete questionnaires that are often required in research studies. Funding source: National Comprehensive Cancer Network Oncology Research Program from financial support from Pfizer.

A mixed-methods study of cyclin-dependent kinase 4 and 6 inhibitor symptom burden and quality of life among metastatic breast cancer patients and providers.

BackgroundCyclin‐dependent kinase 4 and 6 (CDK4/6) inhibitor targeted therapies dramatically improve survival outcomes for metastatic breast cancer (MBC), but they are associated with significant symptom burden that can impact patients’ health‐related quality of life (HRQOL) and treatment outcomes. This study is the first to describe CDK4/6 inhibitor symptoms from the lived perspectives of MBC patients taking CDK4/6 inhibitors and healthcare providers involved in MBC care. This study also explored patients’ symptom management and HRQOL concerns, and gathered feedback about developing supportive interventions for MBC.MethodsMBC patients taking CDK4/6 inhibitors (N = 20) and MBC healthcare providers (N = 12) participated in semi‐structured interviews that were analyzed for qualitative themes. MBC patients completed surveys about HRQOL, symptoms, and unmet needs.ResultsPatient and provider perceptions of CDK4/6 inhibitor symptoms did not align with patients perceiving symptoms as more burdensome. Patients reported that supportive resources (e.g., support groups, blogs) that are not specific to MBC do not adequately meet their needs. Patients and providers were enthusiastic about developing supportive interventions specifically for MBC and offered considerations for designing such interventions.ConclusionsFindings highlight differences in perceptions of CDK4/6 inhibitor symptom burden between MBC patients and providers. Results will inform the development of supportive interventions to assist MBC patients in managing CDK4/6 inhibitor symptom burden and maintaining HRQOL. Such interventions could also improve treatment outcomes.

Real-world practice patterns in treatment of metastatic breast cancer in Washington State.

e13038 Background: Evidence-based, national guidelines for the management of metastatic breast cancer (MBC) recommend numerous treatment options that do not capture the nuances of real-world practice. Disparities may exist across Washington State with financial implications for patients and health systems. The objective of this study was to assess practice patterns around treatment of ER+/HER2- MBC in actual clinical practice. Methods: We collaborated with Hutchinson Institute for Cancer Outcomes Research (HICOR) to link enrollment and insurance claims records with Washington State cancer registries from 2008-2017. Our cohort comprised of women &gt;18 years old with de novo ER+/HER2- MBC who met enrollment criteria in one of four payors (Premera, Regence, Medicare, or Medicaid). We identified receipt of first line treatment, categorized as CDK4/6 inhibitors plus endocrine therapy (CDKi+ET), chemotherapy (CT), or endocrine therapy alone (ET). We examined factors influencing treatment selection using Fisher's and Kruskal-Wallis tests. Total costs (defined as costs from inpatient and outpatient claims one year after diagnosis) was estimated for patients and payors. Results: We identified 140 patients with de novo ER+/HER2- MBC with median age of 64 (range 28-95). The majority of the cohort were Caucasian (90%) with the rest comprising of Asian, Black, American Indian, and Hispanic patients. Based on the Rural Urban Commuting Area (RUCA) classification, patients predominantly lived in metropolitan neighborhoods (96%). Over 20% of patients lived in areas of high deprivation (area of deprivation index, ADI, 8-10). Patients had either Commercial (40.7%), Medicaid/Medicare (43.6%) or multiple (15.7%) insurance. Our data show that 17 patients (12%) received first line therapy with CDKi + ET, 64 patients (46%) with CT, and 59 patients (42%) with ET alone. Factors influencing treatment selection include age, co-morbidity score, and payor type. Older patients (&gt;65 years old) were more likely to receive ET alone compared to younger patients (56% vs 44%, p value &lt;0.001). Patients with high co-morbidity score were more likely to receive ET (30%) compared to CT (5%) or CDKi + ET (23%), p value &lt;0.001. Patients with commercial insurance made up over 50% of patients in our cohort who received CDKi +ET, while Medicare-insured patients were most likely to receive ET alone (p value &lt;0.001). We estimated the mean cost of receiving first line therapy with CDKi +ET ($20,368 and $175,932), CT ($10,624 and $117,847) and ET alone ($13,292 and $60,338) for patients and payors, respectively (costs inflated to December 2019). Conclusions: Our study shows substantial variation across Washington state in treatment selection and costs for patients with metastatic breast cancer in the first-line setting. Our findings demonstrate the need for initiatives to standardize quality of care relative to clinical guidelines in metastatic breast cancer care.

The Quality of End-of-Life Care for Women Deceased From Metastatic Breast Cancer.

Metastatic breast cancer (MBC) carries unique disease burdens with potential for poor-quality end-of-life (EOL) care. It is the purpose of this article to explore the association of poor-quality EOL care indicators according to key tumor, demographic, social, and clinical factors. End-of-life quality indicators were based on Emanuel and Emanuel's good death model in conjunction with Earle et al (2003). A single-institution retrospective chart review of women deceased from MBC between November 2016 and November 2019 with double-verification chart review was completed. Data were analyzed with descriptive, correlative, and comparative statistics. Total sample was N = 167 women, with 14.4% (n = 24) Black and 85.6% (n = 143) White. Mean (SD) age was 55.3 (11.73) years. Overall, MBC survival was 3.12 years (SD, 3.31): White women, 41.2 months (3.4 years), and Black women, 19 months (1.6 years). A total of 64.1% (n = 107) experienced 1 or more indicators of poor-quality EOL care. Patients more likely to experience poor-quality EOL care were older (P = .03), estrogen negative (P = .08), human epidermal growth factor receptor 2 negative (P = .07), from more deprived neighborhoods (P = .02), married (P = .05), and with physical (P = .001) and mental (P = .002) comorbidities. Understanding sociodemographic and clinical factors associated with poor EOL MBC care may be useful for proactive patient navigation.

Abstract PD9-12: Concordance and use patterns of tissue and cell-free based genomic testing in metastatic breast cancer

Abstract Genomic testing has transformed clinical care in metastatic breast cancer. Cell-free DNA (cfDNA) has made sequential testing feasible, however, concordance between tissue and cfDNA, sensitivity of cfDNA, and optimal sampling frequency have not been examined on large data sets with clinical annotation. Of the 648 genes in the tissue NGS Tempus xT assay, 105 genes are also included in the Tempus xF cfDNA plasma-based test. Both platforms are run on Illumina and detect SNVs, indels, CNVs, and rearrangements/fusions with high sensitivity and specificity (&amp;gt;90%). This study used the Tempus Labs LENS™ tool to identify the most recent ~3,300 metastatic breast cancer patients who underwent clinical testing and had either tissue-based testing, cfDNA testing or both. Of the 212 patients with xF and xT testing, 87 had xT before xF, 135 had xF before xT, and 7 had the testing performed at the same time. The most common pathogenic germline versus somatic alterations on tissue-based testing and their concordance will also be reported. In summary, this data suggests a variable amount of concordance between tissue-based and plasma-based assays. Timing of assay performance and inclusion of germline DNA might play an important role in contributing to these differences which need further exploration. Table: Count of Reported Variants and xT/xF Concordance by GeneSomatic GenesxF frequency (n)xT frequency(n)Concordance Between xF and xTTP5313911043%PIK3CA848058%ESR1584141%BRCA238217%ERBB2372629%NF1322113%RB1272416%ATM30165%GATA3213441%FGFR13353%PTEN193036%ARID1A251823% Citation Format: Minetta Liu, Jeff Schaffer, Aneta Piwowarczyk, Nike Beaubier, Kimberly Blackwell, Ben Park. Concordance and use patterns of tissue and cell-free based genomic testing in metastatic 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 PD9-12.