Care For Metastatic Breast Cancer Research Articles

Investigating the Salience of Clinical Meaningfulness and Clinically Meaningful Outcomes in Metastatic Breast Cancer Care Delivery

PURPOSE As metastatic breast cancer (mBC) treatment evolves, there is a need to understand how clinical meaningfulness, or a meaningful change in a patient's daily life, and clinically meaningful outcomes inform patient-centered care. Partnering with key stakeholders ensures patient-centered research incorporates the knowledge and expertise of advisors with lived experience. We describe a multistakeholder engagement approach to examine how people living with mBC (PLWmBC), caregivers, and health care providers interpret clinical meaningfulness and clinically meaningful outcomes and their influence on mBC treatment decision making and care. METHODS Qualitative focus groups with PLWmBC, caregivers, and health care providers were conducted and analyzed along three overarching themes: interpretations of clinical meaningfulness and clinically meaningful outcomes; treatment recommendations, preferences, and decisions; and implications for clinical practice. Patient-led and professional organizations served as research partners in study design, implementation, and interpretation of findings. RESULTS Partnerships were established with four patient-led and three professional organizations representing diverse constituencies throughout the United States. Twenty-two focus groups were conducted with 50 PLWmBC, 24 caregivers, and 41 health care providers (oncologists, n = 11; advanced practice providers, n = 13; oncology nurses, n = 17) between March and June 2023. PLWmBC and caregivers were unfamiliar with the concepts of clinical meaningfulness and clinically meaningful outcomes. Although health care providers were familiar, they did not use the terms when discussing treatment with PLWmBC. Across groups, participants emphasized the importance of meaningful outcomes beyond overall survival, including quality of life and improvement in symptoms and functioning. Participants noted that outcomes considered meaningful are individualized and dynamic. CONCLUSION This study offers insight into how partnering with patient advocacy and professional organizations can enhance research quality and aid translation of findings to clinical practice, thereby supporting patient-centered care.

Exercise as part of survivorship care in metastatic breast cancer: protocol for the randomized EMBody trial

BackgroundExercise is associated with improved survival, physical functioning, treatment tolerability, and quality of life in early-stage breast cancer. These same endpoints matter in metastatic breast cancer (MBC). Prior trials in MBC have found exercise to be not feasible or of limited benefit, possibly due to inclusion of patients with heterogeneous disease trajectories. Patients with MBC have variable disease trajectories and supportive care needs; those with indolent MBC have longer life expectancy, lower symptom burden and distinct priorities, and are well-positioned to participate in and benefit from an exercise program. The EMBody trial aims to determine the impact of a multimodal exercise intervention on cardiorespiratory fitness, physical function, body composition, and patient-reported outcomes, specifically in patients with stable, indolent MBC.MethodsEligible patients have MBC with no evidence of disease progression on current therapy in the prior 12 months and cannot be receiving cytotoxic chemotherapy. The trial aims to enroll 100 patients, randomized 1:1 to the exercise intervention versus usual care, stratified by baseline function. The virtually-delivered exercise intervention arm achieves moderate intensity exercise with exercise physiologists 3 days/week for 16 weeks. The 60-minute sessions include aerobic, resistance, balance and stretching exercises. The exercise arm receives informational sessions on the role of exercise in cancer and principles of habit and self-efficacy. The primary endpoint is 16 week change in fitness on a ramp treadmill test between the exercise and control arms. Secondary endpoints include change in a physical function, muscle mass assessed by CT scans, and PROs of fatigue and quality of life. Exploratory analysis includes behavioral modifiers of exercise adherence and effectiveness and serologic measures of inflammatory, metabolic, and immune pathway biomarkers.DiscussionThe EMBody trial evaluates exercise in a unique patient population with indolent, non-progressive MBC. Patients living with MBC experience similar symptom burden to those undergoing therapy for early-stage disease and the benefits achieved with exercise could be similarly impactful. This trial will contribute evidence to support expansion of exercise recommendations, among other survivorship care efforts, to those living with metastatic disease. Clinical trial information: NCT05468034.Trial registrationNCT05468034. Date of registration: 7/12/2022.

Cost-effectiveness of early vs delayed use of abemaciclib combination therapy for patients with high-risk hormone receptor-positive/human epidermal growth factor receptor 2-negative early breast cancer.

Abemaciclib was newly approved for hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) high-risk early breast cancer (EBC). Clinical guidelines recommended abemaciclib as the first-line treatment for HR+/ HER2- EBC (early use) or HR+/ HER2- metastatic breast cancer (MBC) (delayed use). To compare the cost-effectiveness of early vs delayed use of abemaciclib for treatment of HR+/HER2- high-risk EBC. Early use was defined as combined abemaciclib and endocrine therapy as first-line therapy for EBC, followed by treatment with fulvestrant for MBC. Delayed use was defined as endocrine therapy for EBC, followed by combined abemaciclib and fulvestrant therapy for MBC. A 5-state model was developed to estimate lifetime costs, life-years (LYs), and quality-adjusted life-years (QALYs) of hypothetical patients with HR+/ HER2- EBC from a third-party US payer's perspective. Key clinical and safety data were derived from the monarchE and MONARCH 2 clinical trials. Costs, utilities, and disutility values of adverse events were obtained from the literature. We calculated the incremental cost-effectiveness ratio (ICER) of early vs delayed abemaciclib use and compared it with a willingness-to-pay (WTP) threshold of $100,000 per LY or QALY. Deterministic and probabilistic sensitivity analyses (PSAs) were performed to test the robustness of the base-case model. Base-case analysis showed early use yielded 21.08 LYs and 17.93 QALYs for $586,213 and delayed use yielded 11.14 LYs and 9.38 QALYs for $157,576. The ICER of early vs delayed use was $43,136/LY and $50,104/QALY, which was cost-effective at the WTP threshold of $100,000. The PSA result indicated that a 94.6% likelihood of early use (vs delayed use) was cost-effective at the WTP threshold of $100,000 per QALY. This study suggests that giving abemaciclib in the early stage rather than waiting until patients develop metastatic disease (current standard of care in MBC) is a cost-effective strategy.

Activating HR+/HER2- and triple-negative breast cancer care teams and their patients in shared decision-making.

1547 Background: In the rapidly evolving treatment landscape of metastatic breast cancer (MBC), shared decision-making (SDM) is critical to individualize care and improve patient outcomes. To help facilitate improved SDM, we developed an educational toolkit for health care providers (HCPs) to use with HR+/HER2- and triple negative breast cancer (TNBC) patients (pts) and evaluated the implementation of this toolkit at 5 community oncology clinics. Methods: In May-June 2022, pts (N=94) and HCPs (N=18) completed surveys assessing attitudes, confidence, goals, and barriers to SDM in MBC care. HCPs then led collaborative learning sessions with their pts using the SDM toolkit to provide education regarding treatment options and side effects, and to better align on shared goals and treatment plans. Results: In surveys, only 50% of pts reported that they decide on a treatment plan together with their HCPs , 38% reported being asked about treatment preferences, and 34% reported discussing supportive care, such as mental health care or pain relief. Additionally, very few pts reported high knowledge of BC treatments and side effects. HCPs and pts were misaligned on patient goals and barriers to SDM. For example, 56% of HCPs thought pts were too overwhelmed/anxious/fatigued to make treatment decisions, but only 21% of pts agreed that was a top challenge. While pts and HCPs were aligned on top treatment decision factors of effectiveness and quality-of-life, HCPs underestimated the importance of concerns about side effects (HCPs 11% vs pts 32%), and the cost and duration of treatment (17% vs 30%, and 22% vs 30%, respectively). HCPs correctly identified survival (56%) as a top goal for pts but were less likely to identify progression/recurrence as important to pts (39%). Additionally, 28% of pts reported their top challenge was worrying about being unable to work or meet responsibilities at home; however, only 19% of HCPs recognized this as a top challenge. Following pt-HCPs collaborative education sessions, in which HCPs used the SDM toolkit to facilitate pt education and SDM, HCPs and pts reported improved confidence in pt-HCP communication. Additionally, 46% of pts reported discussing treatment goals with their HCPs and 46% reported taking a more active role in their care following the learning session. Conclusions: These findings reveal misalignments between HCPs and patients with BC regarding treatment decision-making. The gaps identified are critical to address as they are pre-requisites for SDM. The downloadable shared decision-making toolkit developed as part of this implementation science initiative can be adopted by breast cancer clinical teams to help facilitate patient education and SDM, empowering patients to be active participants in their care.

Self-expressed needs and gaps in our care of metastatic breast cancer (MBC): An all-Ireland patient-led online survey (CTRIAL-IE 23-05).

12058 Background: Therapeutic advances have improved MBC survival rates, but patient self-expressed information needs have not been evaluated in Ireland to date. Heretofore, the patient’s voice has not been central to such an assessment, potentially leading to incorrect assumptions about MBC care. Methods: An anonymous online survey was designed by a cohort of 30 patients with MBC facilitated by a multidisciplinary breast cancer specialist taskforce. A questionnaire asked individuals to report their experience across three domains: credible information sources, palliative care access, and mental health. Patients with MBC 18 years or older living on the Island of Ireland were eligible to participate. The survey was publicised in the media and in oncology clinics nationally and was available for 10 weeks. The survey consisted of a mixture of open and closed questions and results were summarized by means of counts and percentages for categorical variables and by means of mean, standard deviation, median and range for continuous variables. Results: Between July-October 2023, 246 patients completed the survey. The median age of responders was 52.5. 99.4% of patients wished to have access to their personal medical records. Over 95% sought information about metastatic breast cancer outside of the clinic. The go-to information source varied (mostly online). No dedicated comprehensive information source on MBC was identified. Over 83% of patients with MBC were amenable to early palliative care referral but oncology teams did not raise this to the majority. Over 87% of patients reported mental health issues and the majority did seek support (88.4%). Living with uncertainty while awaiting scan results commonly led to feelings of anxiousness (79.5%), fearfulness (54.1%) and depression (15.2%). Conclusions: Patient-led research demonstrates that the patients’ voice is imperative to identify meaningful health interventions. System change including rapid streamlined access to personal medical records and the provision of a credible online information source dedicated to MBC may empower patients to enable them to live well for as long as possible. Routine discussion around early palliative care referral and an opt out approach may be of benefit. Acknowledging the high burden of mental health issues among this patient group and ongoing development of support services is crucial. Minimising the time patients live with uncertainty waiting for scan results should be prioritised.

“Let’s talk about sex, fertility and menopause”: The Irish experience for those diagnosed with metastatic breast cancer (MBC)—An all-Ireland patient-led survey (CTRIAL-IE 23-05).

12057 Background: Therapeutic advances have improved MBC survival rates, but patient expressed needs such as sexual wellness have not been evaluated in Ireland to date. Heretofore, the patient’s voice has not been central to such an assessment, compromising MBC care. Methods: An anonymous online survey was designed by a cohort of 30 patients with MBC facilitated by a multidisciplinary breast cancer specialist taskforce. A questionnaire asked individuals to report their experience across three domains: sexual wellness, fertility and menopause. Patients with MBC 18 years or older living on the island of Ireland were eligible to participate. The survey was publicised in the media and in oncology clinics nationally and was available for 10 weeks. The survey consisted of a mixture of open and closed questions and results were summarised by means of counts and percentages for categorical variables and by means of mean, standard deviation, median and range for continuous variables. Results: Between July-October 2023, 246 patients completed the survey. The median age was 52.5 and 98% of responders were female. Over 75% of patients were not offered advice or support on the effects of MBC and the side effects of treatment on sexual wellness. This is despite over 60% of patients experiencing changes in their sex lives, with only 22.8% of those seeking medical advice. Those who did not seek advice stated fear of being dismissed or misunderstood (26.9%) and being uncomfortable discussing the topic (44.4%) as their reasoning. Less than half of patients < 50 years considered that sufficient information was provided on the impact of treatment on fertility. Over 95% of patients were menopausal or experienced permanent changes to their menstrual cycle but 29.3% of patients who sought support reported that they did not receive it. Participants who did not seek support, were asked what supports could have been provided (Table). Conclusions: Patient-led research demonstrates that the patients’ voice is imperative to identify meaningful health interventions. MBC impacts sexual wellness for the majority of patients, a minority of whom seek medical advice, and a majority of whom are uncomfortable discussing the topic. The majority of participants <50 years felt oncofertility advice was insufficient, suggesting that improvements are needed in the information and support given to younger cancer patients regarding their fertility. Support with menopausal symptoms was commonly sought but resources were limited. The majority of patients would welcome availability of a complex menopause clinic and access to improved curated information resources on sexual wellness and fertility. [Table: see text]

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.