Metastatic Breast
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2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 176-176
Author(s):  
Shruti Sinkar ◽  
Faith Too ◽  
Kelly Carr ◽  
Jessica Jelinek ◽  
Elizabeth Saylor ◽  
...  

176 Background: Assessment of financial toxicity (FTox) is recommended as a component of comprehensive supportive care for patients with metastatic cancer. FTox is common in patients with metastatic breast cancer (MBC) and is associated with poor quality of life. Available data suggest many patients with cancer have faced financial hardship during the COVID-19 pandemic. Methods: We evaluated FTox using the COmprehensive Score for Financial Toxicity (COST) measure in patients with MBC at Johns Hopkins clinical sites. Respondents were patients with MBC who completed the COST measure as part of the baseline assessment for one of two IRB-approved quality improvement projects initiated during the COVID-19 pandemic: 1) a pilot project evaluating incorporation of patient-reported outcome (PRO) measures into routine care (RC), and 2) a needs assessment prior to attending a multi-disciplinary clinic (MultiD-C) focusing on supportive care. COST scores range from 0-44 with higher scores indicating better financial well-being. FTox was graded as: Grade 0 (G0): >26, Grade 1 (G1): >14-26, Grade 2 (G2): >0-14 and Grade 3 (G3): 0. Results: 40 patients with MBC completed the COST measure May 2020 through April 2021 as a component of RC and 17 patients with MBC completed the COST measure September 2020 through May 2021 in advance of anticipated attendance at the MultiD-C. Median age (range) for RC and MultiD-C respondents was 64 (36-85) and 55 (37-75) years, respectively. 4 (10%) and 4 (24%) of RC and MultiD-C respondents respectively reported household income < $50,000. The majority of respondents in both groups were White [RC: 28 (70%), MultiD-C: 14 (82%)], non-Hispanic [RC: 36 (90%), MultiD-C: 16 (94%)], had more than high school education [RC: 37 (93%), MultiD-C: 17 (100%)] and all were insured. 27 (68%) of RC respondents and 11 (65%) of MultiD-C respondents were receiving oral cancer therapies. COST scores and grading are shown in the Table. Approximately half of the respondents in each group reported their illness has been at least “a little bit” of a financial hardship [RC: 22 (55%), Multi-D: 8 (47%)]. Conclusions: Patients with MBC receiving care during the COVID-19 pandemic frequently report FTox. Implementation of routine assessment for FTox via PRO measures and identification of strategies to support patients with MBC experiencing FTox are priorities both during the pandemic and beyond.[Table: see text]


2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 231-231
Author(s):  
Molly Mendenhall ◽  
Andrew Guinigundo ◽  
Elizabeth Burneka ◽  
Hannah Kolish ◽  
Sarah Mancini ◽  
...  

231 Background: Despite consensus driven recommendations, data suggests significant non-compliance in breast cancer genetic screening and testing. In the US nearly 300,000 patients are diagnosed with breast cancer annually, of whom approximately one-third are estimated to be BRCA-testing eligible by NCCN guidelines. Of this cohort of patients eligible for testing, it is estimated that again only one-third are ultimately being referred for genetic counseling and testing. Ideally, every patient who is guideline-eligible for testing should be tested, if they consent. The purpose of this project was to integrate and universally apply NCCN genetic breast cancer testing guidelines, building off current OCM processes, to all new breast and/or metastatic breast cancer patients within a large multi-site community oncology practice setting. Methods: Providers utilized directed EHR templates in the setting of an initial diagnosis visit or a treatment planning “OCM visit”. Discreet data fields were created in the EHR to streamline, prompt, and automate this process. Following provider education and uniform physician pre-approval, appropriate patients were reflexively referred to the genetics team for further evaluation and BRCA testing. Adherence to the plan was maintained and measured using data analytic reports and chart audits. Results: OHC’s pre-project eligible patient testing rate (2018) was found to be 20%. Between 1/2019 to 1/2021 1,203 new breast and/or metastatic breast cancer patients were seen and deemed eligible for inclusion, fully 1,200 were screened using NCCN guidelines (99%). Of those screened, 631 patients met the NCCN testing criteria (52.5%). 585 of the 631 were referred to a genetic specialist (92.7%), of those 449 patients were tested (76.7%), 136 patients refused (30%). 22 patients were found to have a BRCA 1 or 2 mutation (5.3%). An additional “halo” effect on other cancer diagnoses was also observed. Screening newly diagnosed breast cancer and metastatic breast cancer patients resulted in a 163% increase in genetic referrals aside from those with breast cancer. Conclusions: Our results suggest a significant overall improvement in breast cancer genetic testing rates. Implemented methods of provider education and awareness of NCCN guidelines imbedded within provider notes, together with discreet data fields in the EHR, proved to be highly effective at screening appropriate patients and ordering subsequent genetic testing; ensuring nearly 100% compliance with current NCCN guidelines for genetic testing. The workflow also resulted in a favorable increase in genetic referrals and testing across other cancers. The patient refusal rate for testing merits further investigation. This structured workflow with reflex genetics referral was effective, scalable, and financially viable to overall genetic and practice growth.


2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 47-47
Author(s):  
Nicole Margo Grogan ◽  
Donna Pierce-Gjeldum ◽  
Leigh Klaus Swartz ◽  
Kait Verbal ◽  
Sofia Merajver ◽  
...  

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&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&R (n = 9), neuro-oncology (n = 8), and neuropsychology (n = 8). Of the nine patients seen by PM&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.


2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 122-122
Author(s):  
Julia Song ◽  
Elizabeth A. Mittendorf ◽  
Tari A. King ◽  
Christina Ahn Minami

122 Background: Almost 60% of breast cancer in the U.S. occur in women aged >65, but these women are less likely to receive guideline-concordant care. Given existing treatment disparities by race/ethnicity, older minority women may be especially prone to potential gaps in breast cancer care. Hospitals serving higher proportions of minority patients are at risk to deliver suboptimal care, but how site of care impacts aging patients with breast cancer is not well defined. We sought to evaluate the association between race/ethnicity and breast cancer treatment delays in older women treated at minority-serving hospitals (MSH) vs non-MSHs. Methods: Women >65 years old with non-metastatic breast cancer diagnosed from 2010-2017 were identified in the National Cancer Database using data from Commission on Cancer (CoC)-accredited hospitals. Treatment delay was defined as >90 days from diagnosis to first treatment (surgery, chemotherapy, endocrine therapy). MSHs were defined as the top decile of hospitals serving predominantly Black or Hispanic patients. Multivariable logistic regression models adjusted for patient, disease, and hospital characteristics were used to determine the odds of treatment delay for women at MSHs vs non-MSHs across racial/ethnic groups. Results: 529,128 women (84.5% non-Hispanic White, 3.3% Hispanic White, 9.6% non-Hispanic Black, 0.1% Hispanic Black, 0.2% Native American, 2.5% Asian/Pacific Islander) were identified among 41 MSHs and 1,146 non-MSHs. Overall, time to treatment was <90 days in >95% of women (mean 33.4 days; standard deviation 26.4 days). Older women regardless of race at MSHs were more likely to suffer treatment delays than those at non-MSHs (odds ratio 1.31; 95% confidence interval 1.22-1.41). Compared to non-Hispanic White women, all minority groups had a higher likelihood of treatment delay regardless of MSH status (Table). Conclusions: Although most older women with non-metastatic breast cancer treated at CoC hospitals received care in a timely fashion, minorities and those treated at MSHs were more likely to experience treatment delays. Effective interventions addressing barriers to timely care at MSHs and among racial/ethnic minorities are needed. [Table: see text]


2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 275-275
Author(s):  
Emily Miller Ray ◽  
Xinyi Zhang ◽  
Lisette Dunham ◽  
Xianming Tan ◽  
Jennifer Elston Lafata ◽  
...  

275 Background: Oncologists often struggle to know which patients are near end of life to enable a timely transition to supportive care. We developed a breast cancer-specific prognostic tool, using electronic health record data from CancerLinQ Discovery (CLQD), to help identify patients at high risk of near-term death. We created multiple candidate models with varying thresholds for defining high risk that will be considered for future clinical use. Methods: We included patients with breast cancer diagnosed between 1/1/2000 to 6/1/2020 who had at least one encounter with vital signs and evidence of metastatic breast cancer (MBC). All encounters from 1/1/2000 to 7/5/2020 were included. We used multiple imputation (MI) to impute missing numeric variables and treated missing values as a new level for categorical variables. We sampled one encounter per patient and oversampled within 30 days of death, so that the event rate (death within 30 days of encounter) was about 10%. We randomly divided these patients into training (70%) and test datasets (30%). We evaluated candidate predictors of the event using logistic regression with forward variable selection. Candidate predictors included age, vital signs, laboratory values, performance status, pain score, time since chemotherapy, and ER/PR/HER2 receptor status, and change from baseline and change rate of numeric variables. We obtained a single final model by combining resulted logistic regression model from 10 MI training sets. We evaluated this final model on the MI test sets. We varied the alert threshold (i.e., high-risk proportion) from 5% to 40%. Results: We identified 9,270 patients, representing 586,801 encounters. Significant predictors of mortality were: increased age, decreased age at diagnosis, negative change in body mass index, low albumin, high ALP, high AST, high WBC, low sodium, high creatinine, worse performance status, low pulse oximetry, increased age with increased creatinine, high pain score with no opiates, increased pulse rate, unknown/missing PR, opiate use in past 3 months, and prior chemotherapy in past 1 year but not past 30 days. Candidate models had prediction accuracy of 70-89% and positive predictive value of 31-77%. Conclusions: Demographic and clinical variables can be used to predict risk of death within 30 days of a clinical encounter for patients with MBC. Next steps include selection of a preferred model for clinical use, balancing performance characteristics and acceptability, followed by implementation and evaluation of the prognostic tool in the clinic. Candidate models, varying by threshold or percentage of patients assumed to be at high risk, for the outcome of death within 30 days among patients with metastatic breast cancer.[Table: see text]


2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 177-177
Author(s):  
Shruti Sinkar ◽  
Faith Too ◽  
Kelly Carr ◽  
Jessica Jelinek ◽  
Elizabeth Saylor ◽  
...  

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 > 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.


2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Andrea Gombos ◽  
David Venet ◽  
Lieveke Ameye ◽  
Peter Vuylsteke ◽  
Patrick Neven ◽  
...  

AbstractBiomarkers to identify patients without benefit from adding everolimus to endocrine treatment in metastatic breast cancer (MBC) are needed. We report the results of the Pearl trial conducted in five Belgian centers assessing 18F-FDG-PET/CT non-response (n = 45) and ctDNA detection (n = 46) after 14 days of exemestane-everolimus (EXE-EVE) to identify MBC patients who will not benefit. The metabolic non-response rate was 66.6%. Median PFS in non-responding patients (using as cut-off 25% for SUVmax decrease) was 3.1 months compared to 6.0 months in those showing response (HR: 0.77, 95% CI: 0.40–1.50, p = 0.44). The difference was significant when using a “post-hoc” cut-off of 15% (PFS 2.2 months vs 6.4 months). ctDNA detection at D14 was associated with PFS: 2.1 months vs 5.0 months (HR-2.5, 95% CI: 1.3–5.0, p = 0.012). Detection of ctDNA and/or the absence of 18F-FDG-PET/CT response after 14 days of EXE-EVE identifies patients with a low probability of benefiting from treatment. Independent validation is needed.


2021 ◽  
Vol 17 (2) ◽  
pp. 58-67
Author(s):  
I. V. Kolyadina

The luminal HER2-negative subtype is the dominant variant of metastatic breast cancer; modern combined endocrine therapy with CDK4/6 inhibitors due to significantly change the prognosis of the disease, not only for increasing progression free survival, but also for significantly prolonging the life expectancy of patients. This review presents the features of the mechanism of action of CDK4/6 inhibitors, the most significant and updated results of large, randomized trials with ribociclib (MONALEESA-2, MONALEESA-3, and MONALEESA-7) assessing the efficacy and safety of combined endocrine therapy with various endocrine partners in a population of premenopausal women and menopausal patients. The prospects for the use of CDK4/6 inhibitors for therapy patients with visceral crisis are shown.


2021 ◽  
Vol 11 ◽  
Author(s):  
Haochen Mou ◽  
Zhan Wang ◽  
Wenkan Zhang ◽  
Guoqi Li ◽  
Hao Zhou ◽  
...  

BackgroundSurgical therapy of breast cancer and bone metastasis can effectively improve the prognosis of breast cancer. However, after the first operation, the relationship between preoperative indicators and outcomes in patients who underwent metastatic bone surgery remained to be studied. Purpose 1. Recognize clinical and laboratory prognosis factors available to clinical doctors before the operation for bone metastatic breast cancer patients. 2. Develop a risk prediction model for 3-year postoperative survival in patients with breast cancer bone metastasis.MethodsFrom 2014 to 2020, patients who suffered from breast cancer bone metastasis and received therapeutic procedures in our institution were included for analyses (n=145). For patients who underwent both breast cancer radical surgery and bone metastasis surgery, comprehensive datasets of the parameters of interest (clinical features, laboratory factors, and patient prognoses) were collected (n=69). We performed Multivariate Cox regression to identify factors that were associated with postoperative outcome. 3-year survival prediction model and nomograms were established by 100 bootstrapping. Its benefit was evaluated by calibration plot, C-index, and decision curve analysis. The Surveillance, Epidemiology, and End Results database was also used for external validation.ResultsRadiotherapy for primary cancer, pathological type of metastatic breast cancer, lymph node metastasis, elevated serum alkaline phosphatase, lactate dehydrogenase were associated with postoperative prognosis. Pathological types of metastatic breast cancer, multiple bone metastasis, organ metastases, and elevated serum lactate dehydrogenase were associated with 3-year survival. Then those significant variables and serum alkaline phosphatase counts were integrated to construct nomograms for 3-year survival. The C-statistic of the established predictive model was 0.83. The calibration plot presents a graphical representation of calibration. In the decision curve analysis, the benefits are higher than those of the extreme curve. The receiver operating characteristic of the external validation of the model was 0.82, indicating a favored fitting degree of the two models.ConclusionOur study suggests that several clinical features and serological markers can predict the overall survival among the patients who are about to receive bone metastasis surgery after breast cancer surgery. The model can guide the preoperative evaluation and clinical decision-making for patients. Level of evidence Level III, prognostic study.


2021 ◽  
Vol 87 ◽  
pp. 106408
Author(s):  
Sandeep Maharajh ◽  
Kavi Capildeo ◽  
Mickhaiel Barrow ◽  
Shariful Islam ◽  
Vijay Naraynsingh

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