Early-stage Breast Research Articles

Abstract OT1-10-01: The Breast Cancer Index registry study: A prospective multi-center observational study to evaluate patient outcome, clinical impact, and medication adherence in HR+ breast cancer patients considering treatment with extended endocrine therapy

Abstract Background: Hormone receptor-positive (HR+) is the most common molecular subtype of breast cancer accounting for approximately 2 out of every 3 patients. Adjuvant anti-estrogen therapy is the cornerstone of systemic therapy, underscoring the critical role of endocrine treatment which affects the majority of women with breast cancer. Furthering efforts to better understand endocrine response and resistance and implementing genomic tools to help individualize patient selection for endocrine therapy are of ongoing importance to improve outcomes. Breast Cancer Index (BCI) is a gene expression signature composed of the Molecular Grade Index (MGI) and HOXB13/IL17BR (H/I) that predicts the likelihood of extended endocrine benefit and quantifies the risk of both late (5-10 years) and overall (0-10 years) distant recurrence. BCI has recently been incorporated into the NCCN clinical practice guideline as a biomarker for prediction of benefit from extended endocrine therapy in patients with early-stage, HR+ breast cancer. The objective of the BCI Registry Study is to collect real-world evidence at a national level aimed at advancing patient care and optimizing duration of endocrine treatment and will be conducted in two phases. First, long-term patient outcomes and the impact of BCI on decision-making based on physician and patient reported outcomes as well as medication adherence to extended endocrine therapy will be assessed. Secondly, individual patient data on over 40 clinical variables will be collected and partnered with molecular profiling and genomic data for each patient to enable correlative analysis and novel biomarker research of endocrine sensitivity and resistance. Study Description: The BCI Registry Study is a prospective, multi-center, observational data registry and biospecimen repository for stage I-III HR+ breast cancer patients. The main objective of the Registry Study is prospective characterization of BCI predictive and prognostic performance. The primary endpoint is time to distant recurrence (TTDR), defined as the interval between the time of BCI testing and the first metastasis at distant organs. Secondary endpoints include time to any recurrences and medication adherence score over time. Eligibility criteria includes confirmed diagnosis of HR+ early-stage invasive breast carcinoma (ductal, lobular, or mixed ductal/lobular), either HER2 negative or positive and either node-negative or node-positive tumors with 1-3 positive lymph nodes (N1). Patients must have completed 4 to 7 years of primary adjuvant endocrine therapy and have pre-treatment tumor tissue available from a previous breast surgery or biopsy. Both physicians and patients will complete a pre- and post-test Decision Impact Questionnaire to assess the impact of BCI results on extended endocrine therapy decision-making. Patients who elect to complete 10 years of endocrine therapy will answer a Medication Adherence Questionnaire during annual follow-up visits. Follow-up of patients will end 10 years from initial breast cancer diagnosis. The Registry plans to enroll approximately 3,000 patients across approximately 40 study sites in the United States. Enrollment for the study began in Q2 2021, and 324 patients have been enrolled as of July 2021. For more information, please visit the ClinicalTrials.gov registration: NCT04875351. Citation Format: Joyce A O'Shaughnessy, Jenny R Fox, Carlos A Encarnación, Brandon O'Neal, Kai Treuner, Tara Sanft, Rachel C Jankowitz, Mark D Pegram, Catherine A Schnabel, Sami G Diab. The Breast Cancer Index registry study: A prospective multi-center observational study to evaluate patient outcome, clinical impact, and medication adherence in HR+ breast cancer patients considering treatment with extended endocrine therapy [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr OT1-10-01.

Social Disparities of Pain and Pain Intensity Among Women Diagnosed With Early Stage Breast Cancer.

BackgroundBreast cancer is one of the most commonly diagnosed cancers among women in the United States and pain is the most common side effect of breast cancer and its treatment. Yet, the relationships between social determinants of pain and pain experience/intensity remain under-investigated. We examined the associations between social determinants of pain both at the individual level and the neighborhood level to understand how social conditions are associated with pain perception among early stage breast cancer patients.MethodsWe conducted integrated statistical analysis of 1,191 women with early stage breast cancer treated at a large cancer center in Memphis, Tennessee. Combining electronic health records, patient-reported data and census data regarding residential address at the time of first diagnosis, we evaluated the relationships between social determinants and pain perception. Pain responses were self-reported by a patient as a numerical rating scale score at the patient’s initial diagnosis and follow-up clinical visits. We implemented two sets of statistical analyses of the zero-inflated Poisson model and estimated the associations between neighborhood poverty prevalence and breast cancer pain intensity. After adjustment for demographic characteristics, cancer stage, and chemotherapy, pain perception was significantly associated with poverty and blight level of the neighborhood.ResultsAmong women living in the highest-poverty areas, the odds of reporting pain were 2.48 times higher than those in the lowest-poverty area. Women living in the highest-blight area had 5.43 times higher odds of reporting pain than those in the lowest-blight area. Neighborhood-level social determinants were significantly associated with pain intensity among women diagnosed with early-stage breast cancer.ConclusionsDistressed neighborhood conditions are significantly associated with higher pain perception. Breast cancer patients living in socio-economically disadvantaged neighborhoods and in poor environmental conditions reported higher pain severity compared to patients from less distressed neighborhoods. Therefore, post-diagnosis pain treatment design needs to be tailored to the social determinants of the breast cancer patients.

Tumor infiltrating lymphocyte stratification of prognostic staging of early-stage triple negative breast cancer

The importance of integrating biomarkers into the TNM staging has been emphasized in the 8th Edition of the American Joint Committee on Cancer (AJCC) Staging system. In a pooled analysis of 2148 TNBC-patients in the adjuvant setting, TILs are found to strongly up and downstage traditional pathological-staging in the Pathological and Clinical Prognostic Stage Groups from the AJJC 8th edition Cancer Staging System. This suggest that clinical and research studies on TNBC should take TILs into account in addition to stage, as for example patients with stage II TNBC and high TILs have a better outcome than patients with stage I and low TILs.

Survival Outcomes among Human Epidermal Growth Factor Receptor 2- (HER2-) Positive Breast Cancer Patients at Kenyatta National Hospital.

Introduction HER2-positive breast cancer is associated with poor outcomes and higher mortality rates than other breast cancer subtypes. The advent of trastuzumab has significantly changed the natural history of HER2-positive breast cancer. However, it is not an affordable treatment option in sub-Saharan African countries. Because of the expense, most patients in our setting do not receive trastuzumab for the optimal control of their disease. Additionally, there is a lack of comprehensive data about the survival outcomes of HER2-positive breast cancer patients in our setting. The present study was aimed at determining the survival outcomes among HER2-positive breast cancer patients at the Oncology Department of Kenyatta National Hospital. Methods A hospital-based retrospective cohort design was used to evaluate the survival outcomes among patients with HER2-positive breast cancer treated from 1st January 2015 to 31st December 2019 at Kenyatta National Hospital. A total of 50 eligible HER2-positive breast cancer patients were included in the study. In the predesigned data abstraction tool, data were collected by reviewing the medical records of the patients. The data were entered and analyzed using the Statistical Package for the Social Sciences version 27 software. The mean survival time was estimated using Kaplan-Meier survival analysis. Results The mean age was 45.44 ± 12.218 years, with a majority (80%) of the patients being below 60 years. Most patients (64%) had advanced-stage disease. The median follow-up time for patients with curative stages of breast cancer was 41 months, while the median follow-up time for those with the advanced incurable disease was 8.5 months. The 4-year survival rate was 62.5% for those curable-stage HER2-positive breast cancer compared to 5.6% for those with metastatic disease at presentation. Conclusion The 4-year survival rate for both early-stage and advanced-stage HER2-positive breast cancer in our setting is suboptimal when compared to existing outcome data from health care systems where trastuzumab is more widely available.

Variation in chemotherapy prescribing rates and mortality in early breast cancer over two decades: a national data linkage study

BackgroundRegional variation in clinical practice may identify differences in care, reveal inequity in access, and explain inequality in outcomes. The study aim was to measure geographical variation in Scotland for adjuvant chemotherapy use and mortality in early-stage breast cancer.Patients and methodsIn this retrospective cohort study using population cancer registry-based data linkage, patients with surgically treated early breast cancer between 2001 and 2018 were identified from the Scottish Cancer Registry. Geographical regions considered were based on NHS Scotland organisational structure including 14 territorial Health Boards as well as three regional Cancer Networks. Regional variation in the proportion receiving chemotherapy, breast cancer mortality and all-cause mortality was investigated. Inter-regional comparisons of chemotherapy use were adjusted for differences in case mix using logistic regression. Comparison of breast cancer-specific mortality and all-cause mortality used regression with a parametric survival model. Time trends were assessed using moving average plots.ResultsChemotherapy use ranged from 35% to 46% of patients across Health Boards without adjustment. Variation reduced between 2001 and 2018. Following adjustment for clinical case mix, variation between cancer networks was within 3 percentage points, but up to 10 percentage points from the national average in some Health Boards. Differences in breast cancer mortality and all-cause mortality between cancer networks were modest, with hazard ratios of between 0.933 (95% confidence interval 0.893-0.975) and 1.041 (1.002-1.082) compared with the national average. Survival improved over the time period studied.ConclusionWith adequate case mix adjustment, variation in adjuvant chemotherapy use for early breast cancer in Scotland is small, with a trend towards greater convergence in practice and improved mortality outcomes in more recent cohorts. This suggests very limited regional inequity in access and convergence of clinical practice towards risk-stratified treatment recommendations. Outliers require assessment to understand the reasons for variance.

Impact of the EndoPredict genomic assay on treatment decisions for oestrogen receptor-positive early breast cancer patients: benefits of physician selective testing.

Genomic tests improve accuracy of risk prediction for early breast cancers but these are expensive. This study evaluated the clinical utility of EndoPredict®, in terms of impact on adjuvant therapy recommendations and identification of parameters to guide selective application. Patients with ER-positive, HER2-negative, and early-stage invasive breast cancer were tested with EndoPredict®. Two cohorts were recruited: one consecutively and another at clinical team discretion. Systemic treatment recommendations were recorded before and after EndoPredict® results were revealed to the multidisciplinary team. 233 patients were recruited across five sites: 123 consecutive and 110 at clinical team discretion. In the consecutive cohort 50.6% (62/123) cases were classified high risk of recurrence by EndoPredict®, compared with 62.7% (69/110) in the selective cohort. A change in treatment recommendation was significantly more likely (p < 0.0001) in the selective cohort (43/110, 39.1%) compared to the consecutive group (11/123, 8.9%). The strongest driver of selective recruitment was intermediate grade histology, whilst logistic regression modelling demonstrated that nodal status (p < 0.001), proliferative rate (p = 0.001), and progesterone receptor positivity (p < 0.001) were the strongest discriminators of risk. Whilst molecular risk can be predicted by traditional variables in a high proportion of cases, EndoPredict® had a greater impact on treatment decisions in those cases selected for testing at team discretion. This is indicative of the robust ability of the clinical team to identify cases most likely to benefit from testing, underscoring the value of genomic tests in the oncologists' tool kit.

Axillary metastasis from occult breast cancer and synchronous contralateral breast cancer initially suspected to be cancer with contralateral axillary metastasis: a case report

BackgroundInitial detection of axillary metastasis without known ipsilateral breast cancer could be a challenging diagnostic problem. Four options could be considered for the primary site of the malignancy: ipsilateral occult breast cancer, contralateral breast cancer, tumors in other distant organs, and primary axillary malignancy itself. Although breast cancer is known as the most common primary cancer of axillary metastasis, both occult breast cancer and breast cancer with contralateral axillary metastasis (CAM) are rare.Case presentationA 63-year-old woman presented with palpable right axillary metastasis, and a tiny contralateral breast cancer was detected by breast magnetic resonance imaging. No lesion was found in the ipsilateral right breast and contralateral left axillary region. Both right axillary metastasis and contralateral breast cancer were positive for estrogen receptor. The diagnostic issue was to determine whether the axillary metastasis was derived from the contralateral breast cancer or not. Right axillary dissection and left breast conserving surgery were performed. The final diagnosis was occult breast cancer that presented with axillary lymph node metastasis and early-stage synchronous contralateral breast cancer, based on clinical evidence and postoperative pathologic results. After surgery, systemic treatment and whole breast irradiation were administered. No recurrence or metastasis was observed 15 months postoperatively.ConclusionFor accurate diagnosis of axillary metastasis without detectable ipsilateral breast cancer, multifaceted diagnostic approach considering clinical, radiological, and pathological evidences is required.

Abstract 10797: Applying Cardiotoxicity Risk Prediction Scores in Women with Early-Stage Breast

Background: Cardiotoxicity is a common complication of anthracyclines and HER2-targeted therapies in breast cancer patients. Despite recognized risk factors, accurate prediction of cardiotoxicity risk remains a challenge. We applied 3 published risk prediction scores (Table) to a cohort of women with HER2+ breast cancer treated with anthracycline and trastuzumab and described their predictive accuracy. Methods: Women with stage I-III HER2+ breast cancer treated at the Princess Margaret Cancer Centre (Toronto) between 2006-2019 were identified retrospectively. Those with a pre-therapy MUGA scan or 2D echocardiography and ≥ 3 follow up scans using the same modality were included. CREC criteria were applied to define cardiotoxicity. Three risk prediction scores (Ezaz et al., Romond et al., and HFA-ICOS proformas) were used to classify patients into low/medium/high cardiotoxicity risk according to pretreatment characteristics. The proportion of patients who developed cardiotoxicity across risk categories were compared within each score using chi-square test. Results: Of 629 women (mean age 52.4 ± 10.9 years), 151 (24%) met CREC cardiotoxicity criteria. With the Ezaz et al. score , proportion of patients that developed cardiotoxicity was 24.4% (n = 141/577), 20% (n = 9/45) and 14.3% (n =1/7), in the low, medium, and high predicted risk groups, respectively (p = 0.665). With Romond et al. score , this was 17.9% (n = 40/223), 24.5% (n = 50/204) and 30.5% (n = 61/200), respectively (p = 0.01). HFA-ICOS was 15.5% (n = 30/193), 26.9% (n = 109/404), and 37.5% (n = 12/32), respectively (p = 0.002). Conclusion: In women with early stage HER2+ breast cancer receiving trastuzumab therapy, risk scores by Romond et al., and the HFA-ICOS proformas predict cardiotoxicity risk. However, for both these scores the incidence of cardiotoxicity in the “low” predicted risk group remains high (15.5%-17.9%). Therefore, there remains a need to develop more accurate risk prediction scores.

A Novel Prognostic Model Based on the Serum Iron Level for Patients With Early-Stage Triple-Negative Breast Cancer.

The dysregulation of iron homeostasis has been explored in malignancies. However, studies focusing on the association between the serum iron level and prognosis of patients with early-stage triple-negative breast cancer (TNBC) are scarce. Accordingly, in current study, 272 patients with early-stage TNBC treated at Sun Yat-sen University Cancer Center (SYSUCC) between September 2005 and October 2016 were included as a training cohort, another 86 patients from a previous randomized trial, SYSUCC-001, were analyzed as a validation cohort (SYSUCC-001 cohort). We retrospectively collected their clinicopathological data and tested the serum iron level using blood samples at the diagnosis. In the training cohort, patients were divided into low-iron and high-iron groups according to the serum iron level cut-off of 17.84 μmol/L determined by maximally selected rank statistics. After a median follow-up of 87.10 months, patients with a low iron had a significantly longer median disease-free survival (DFS) of 89.13 [interquartile range (IQR): 66.88–117.38] months and median overall survival (OS) of 92.85 (IQR: 68.83–117.38) months than those in the high-iron group (median DFS: 75.25, IQR: 39.76–105.70 months, P = 0.015; median OS: 77.17, IQR: 59.38–110.28 months, P = 0.015). Univariate and multivariate Cox analysis demonstrated the serum iron level to be an independent predictor for DFS and OS. Then, a prognostic nomogram incorporating the serum iron level, T stage and N stage was developed for individualized prognosis predictions. It had good discriminative ability with a C-index of DFS (0.729; 95% CI 0.666–0.792) and OS (0.739; 95% CI 0.666–0.812), respectively. Furtherly, we validated the predictive model in the SYSUCC-001 cohort, which also showed excellent predictive performance with a C-index of DFS (0.735; 95% CI 0.614–0.855) and OS (0.722; 95% CI 0.577–0.867), respectively. All these suggested that the serum iron level might be a potential prognostic biomarker for patients with early-stage TNBC, the predictive model based on it might be served as a practical tool for individualized survival predictions.

Overall Survival From a Prospective Multi-Institutional Trial to Resolve Black-White Disparities in the Treatment of Early Stage Breast and Lung Cancer

Black patients with curable lung or breast cancer complete treatment less often than similar white patients contributing to worse survival. ACCURE was a system-based intervention trial shown to eliminate black-white disparities in treatment completion and improved completion for all. The current study investigates how the ACCURE intervention influenced survival disparity.We previously reported a prospective multi-institutional trial using a system-based intervention. Patients diagnosed with early-stage breast and lung cancer, aged 18 to 85 were eligible. Enrollment spanned from 2013 until 2015. Intervention components included: (1) a real time warning system derived from electronic health records, (2) feedback to clinical teams on cancer treatment according to race, and (3) a nurse navigator. Consented patients were compared to retrospective and concurrent controls. The primary study outcome was receipt of curative treatment. The current study compares 5-year survival according to race for eligible patients from the tumor registry during the study period with comparison to historical controls. The ACCURE study treatment for early-stage lung cancer included resection or stereotactic body radiotherapy (SBRT) and survivals are now reported separately.There were a total of 1,413 patients with stages 0, I & II lung and breast cancer diagnosed in 2013-2015 who were compared to 2,016 patients treated in 2007-2011. The table shows statistically significant improved survival for black and white breast cancer patients and white lung cancer patients over time, while the racial gap in survival was reduced for lung and breast cancer. The 5-year observed survivals for white (2150) versus black (644) breast patients increased from 91% vs. 89% (P = NS) to 94% for both. The 5-year observed survival for white (510) and black (125) lung narrowed from 43% and 37% (P = NS) to 56% and 54%. Subgroup analysis of lung cancer patients showed 5-year survival for surgery was 78.5% and 70.1% for white and black patients (P = NS) while survival for SBRT was 41.9% and 50% for white and black patients (P = NS).A systems-based intervention reduced racial gaps in treatment completion and improved care for all. This study suggests that equity in treatment may be associated with elimination of survival disparities during the ACCURE study. In the lung cancer sub-group, the higher survival of white lung cancer patients undergoing surgery and black patients undergoing SBRT may suggest some continued disparity in patient selection for lung resection. Further analysis of comorbid conditions and other important factors will shed light on the full survival impact of the intervention.

Deep learning from HE slides predicts the clinical benefit from adjuvant chemotherapy in hormone receptor-positive breast cancer patients

We hypothesized that a deep-learning algorithm using HE images might be capable of predicting the benefits of adjuvant chemotherapy in cancer patients. HE slides were retrospectively collected from 1343 de-identified breast cancer patients at the Samsung Medical Center and used to develop the Lunit SCOPE algorithm. Lunit SCOPE was trained to predict the recurrence using the 21-gene assay (Oncotype DX) and histological parameters. The risk prediction model predicted the Oncotype DX score > 25 and the recurrence survival of the prognosis validation cohort and TCGA cohorts. The most important predictive variable was the mitotic cells in the cancer epithelium. Of the 363 patients who did not receive adjuvant therapy, 104 predicted high risk had a significantly lower survival rate. The top-300 genes highly correlated with the predicted risk were enriched for cell cycle, nuclear division, and cell division. From the Oncotype DX genes, the predicted risk was positively correlated with proliferation-associated genes and negatively correlated with prognostic genes from the estrogen category. An integrative analysis using Lunit SCOPE predicted the risk of cancer recurrence and the early-stage hormone receptor-positive breast cancer patients who would benefit from adjuvant chemotherapy.

Yoga versus massage in the treatment of aromatase inhibitor-associated knee joint pain in breast cancer survivors: a randomized controlled trial

Aromatase inhibitors (AIs) are standard adjuvant therapy for postmenopausal women with oestrogen receptor-positive, early-stage, and metastatic breast cancer. Although effective, the risk of falls due to AI-associated knee joint pain significantly increased. The aim of this study was to evaluate the therapeutic effects of yoga and massage on AI-associated knee joint pain. Breast cancer survivors were randomly assigned to a 6-week yoga intervention-2-week rest-6-week massage exposure (Yoga first, n = 30) or a 6-week massage intervention-2-week rest-6-week yoga exposure (Massage first, n = 30). Evaluations of the treatment efficacy were made at baseline, post-intervention, and post-exposure using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale, plasma cytokine levels, and changes in meridian energy. The results showed that yoga, superior to massage intervention, significantly reduced AI-associated knee joint pain, as demonstrated by the WOMAC pain score. The yoga intervention improvements were also associated with changes in plasma cytokine levels and meridian energy changes. In conclusion, this study provides scientific evidence that yoga was more effective than massage for reducing AI-associated knee joint pain. Meridian energy changes may provide another scientific, objective, non-invasive way to monitor the therapeutic effects of yoga and investigate another alternative, complementary medicine.

ASO Visual Abstract: Cancer in the Shadow of COVID: Early-Stage Breast and Prostate Cancer Patient Perspectives on Surgical Delays Due to COVID-19

ASO Visual Abstract: Cancer in the Shadow of COVID: Early-Stage Breast and Prostate Cancer Patient Perspectives on Surgical Delays Due to COVID-19

Influence of Ile655Val polymorphism on trastuzumab-induced cardiotoxicity in early-stage HER2 positive breast cancer

Trastuzumab has improved the prognosis of HER2 positive breast cancer, but cardiotoxicity remains a concern. We aimed to identify risk factors for trastuzumab-induced cardiotoxicity, with an emphasis on the HER2 Ile655Val single nucleotide polymorphism. This single-center case–control study included 1056 patients with early-stage HER2 positive breast cancer that received adjuvant trastuzumab. Cardiotoxicity was defined as a decline in left ventricular ejection fraction (LVEF) > 15% in patients without previous cardiomyopathy, or > 10% in patients with baseline LVEF of < 50%. Patient characteristics and cardiac parameters were compared in 78 (7.38%) cases and 99 randomly assigned controls, and the polymorphism was genotyped using real-time polymerase chain reaction. Cardiotoxicity was independently associated with advanced age (P = 0.024), lower body mass index (P = 0.023), left breast involvement (P = 0.001), N3 status (P = 0.004), diabetes (P = 0.016), and a family history of coronary artery disease (P = 0.019). Genotype distribution was as follows: A/A (Ile/Ile) was found in 111 (62.7%) patients, A/G (Ile/Val) in 60 (33.9%) patients, and G/G (Val/Val) in 6 (3.4%) patients. The genotype was not associated with cardiotoxicity or the severity of heart failure, reversibility, and recovery time. We found no association between the HER2 Ile655Val polymorphism and trastuzumab-induced cardiotoxicity; therefore, we do not recommend routine cardiotoxicity-risk stratification using this polymorphism.

Abstract 2617: Factors associated with utilization of post-mastectomy adjuvant therapies in privately insured female patients with early-stage invasive breast cancer

Abstract Background: In a commercially insured cohort of female patients with early-stage invasive breast cancer we examined geographic and clinical factors associated with variation in uptake of post-mastectomy adjuvant endocrine therapy (AET), cytotoxic chemotherapy (ACT) and biologic therapy (ABT). Methods: Retrospective observational study of the IBM® MarketScan® claims data from 01/01/2012-03/31/2018. Eligibility criteria included: 1) diagnosis of non-metastatic invasive breast cancer in female patients 18 years old or older, 2) mastectomy within 6 months of initial diagnosis. Patients with breast carcinoma in situ only and those who received neoadjuvant therapies were excluded. Multivariate logistic regression was used to identify factors associated with receipt of adjuvant therapy, including: 1) age, insurance plan type, and select chronic comorbid conditions, 2) sociodemographic, community-level (ZIP3) measures obtained from the 2019 Area Health Resource Files, and 3) time effects. Analyses were conducted at the patient level with standard errors clustered by ZIP3. Results: Of the 16,680 patients identified, 5,341 (32%) received AET only, 2,290 (14%) received ACT only and 729 (4%) received ABT. 7,911 (47%) did not have any claims for adjuvant therapy. 3% received adjuvant combinations, mostly post-radiation treatment (2%). We observed the following statistically significant associations (p&amp;lt;.001 to p&amp;lt;.05) between selected variables and adjuvant therapy use:- Increasing age and higher likelihood of AET (1.2-1.8) but decreased likelihood of ACT (.8-.03) and ABT (.98-.24).- Primary health policy holders were 13% more likely to receive ACT compared to a spouse or other dependent.- Patients residing in the Midwest and higher likelihood of receiving AET (OR=1.15), ACT (OR=1.14), and ABT (OR=1.44) compared to those in the Northeast whereas those in the West and South had higher likelihood of receiving ACT (OR=1.31; OR=1.21), and ABT (OR=1.66; OR=1.36).- Patients residing in areas with increased Black resident density (ZIP3 level) and lower likelihood of receiving AET (OR=.58), ACT (OR=.61), and ABT (OR=.45).- Percentage population with a 4-year college degree and decreased likelihood of ACT (OR=.33).- Genetic testing and increased likelihood of AET (OR=1.92), ACT (OR=2.72), and ABT (OR=1.91).- Breast carcinoma in situ diagnosis preceding invasive disease diagnosis and decreased likelihood of receiving AET (OR=.56), ACT (OR=.2) and ABT (OR=.65). Conclusions: In a large cohort of commercially insured patients with early-stage invasive breast cancer, uptake of post-mastectomy adjuvant therapies varied and was influenced by several non-clinical factors. Results of real-world evidence cancer studies may support treatment-decision making, guide adoption of value-based care models and reduce treatment disparities. Citation Format: Yull Arriaga, Joseph Tkacz, M Christopher Roebuck, Judy George, Van Willis, Irene Dankwa-mullan. Factors associated with utilization of post-mastectomy adjuvant therapies in privately insured female patients with early-stage invasive breast cancer [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2021; 2021 Apr 10-15 and May 17-21. Philadelphia (PA): AACR; Cancer Res 2021;81(13_Suppl):Abstract nr 2617.

Cancer in the Shadow of COVID: Early-Stage Breast and Prostate Cancer Patient Perspectives on Surgical Delays Due to COVID-19.

BackgroundDuring the height of the coronavirus disease 2019 (COVID-19) pandemic, elective surgeries, including oncologic surgeries, were delayed. Little prospective data existed to guide practice, and professional surgical societies issued recommendations grounded mainly in common sense and expert consensus, such as medical therapy for early-stage breast and prostate cancer patients. To understand the patient experience of delay in cancer surgery during the pandemic, we interviewed breast and prostate cancer patients whose surgeries were delayed due to the pandemic.Patients and MethodsPatients with early-stage breast or prostate cancer who suffered surgical postponement at Brigham and Women’s Hospital (BWH) were invited to participate. Semi-structured telephone interviews were conducted with 21 breast and prostate cancer patients. Interviews were transcribed, and qualitative analysis using ground-theory approach was performed.ResultsMost patients reported significant distress due to cancer and COVID. Key themes that emerged included the lack of surprise and acceptance of the surgical delays but endorsed persistent cancer- and delay-related worries. Satisfaction with patient–physician communication and the availability of a delay strategy were key factors in patients’ acceptance of the situation; perceived lack of communication prompted a few patients to seek care elsewhere.DiscussionThe clinical effect of delay in cancer surgery will take years to fully understand, but there are immediate steps that can be taken to improve the patient experience of delays in care, including elicitation of individual patient perspectives and ongoing communication. More work is needed to understand the wider experiences of patients, especially minority, socioeconomically disadvantaged, and uninsured patients, who encounter delays in oncologic care.Graphical Supplementary InformationThe online version contains supplementary material available at 10.1245/s10434-021-10319-0.

Long-term outcomes and predictors of recurrence in patients with early-stage node negative breast cancer.

e12597 Background: In this study, we aimed to assess the outcomes, and predictors of recurrence in patients with early-stage node-negative breast cancer. Methods: We evaluated data of the patients who were treated between 1988 and 2018 years retrospectively. Demographical, clinical, pathological, and treatment features of the patients were recorded. SPSS 25 version was used for statistical analysis. We used Kaplan-Meier and Cox regression analysis to assess survival analysis. Also, we performed logistic regression and ROC analysis for recurrence predictors. Results: In total, 347 patients were included in the study.The median age was 50 (range, 18-81) at diagnosis. The percent of the patients who had stage 1 and 2 were 86.6% and 13.4%, respectively. The most common histopathological type was invasive ductal carcinoma (71.6%). Estrogen receptor and progesterone receptor positivity were 80.3% and 62.1%, respectively. Her2 receptor positivity was 15.9%. The number of patients who had undergone lumpectomy and mastectomy was 85.5% and 14.5%, respectively. Sentinel lymph node biopsy was performed on 78.7% of the patients, and axillary lymph node dissection 21.3%. Also, the patients received adjuvant radiotherapy (88.7%), adjuvant chemotherapy (48.5%), and adjuvant hormonotherapy (82.1%). Tumor recurrence was occurred in 31 (8.7%) patients (local recurrence-45.2% and metastasis-54.8%). Five-, ten- and twenty-years recurrence ratios were 4.3%, 8%, and 23%. Also, contralateral breast cancer has occurred in 19 (5.3%) patients. During the study period, 30 (8.4%) patients died. Ten-years and twenty-years survival ratios were 91.6% and 76.6%, respectively. In univariate analysis, aged over 65 years (p = 0.004), nuclear pleomorphism (p = 0.049), mitosis (p = 0.003), and necrosis (p = 0.002) were statistically significant for recurrence. In ROC analysis, the tumor's longest size was not statistically significant for recurrence (for over 1.45 cm, p = 0.07). Conclusions: In this study, we determined thirty-years outcomes in patients with early-stage node-negative breast cancer. In the follow-up, we detected the recurrences ratios, between ten and twenty years, were more common than the first ten-years. Despite a small number of patients who had a recurrence, we showed that being age over 65 years and pathological features (nuclear pleomorphism, mitosis, and necrosis) were statistically significant for disease recurrence in univariate analysis.

The moderating role of informal caregiver’s involvement on the relationship between patient activation and adherence to treatment: Implications for self-management intervention in cancer care.

12083 Background: With increasing demands for a more active role on the part of individuals with cancer and their families in cancer care, patient activation (PA) is emerging as a key factor to promote self-management, adherence to treatment, and satisfaction with treatment planning. The present work investigated the relationship between patient activation and treatment decision making. Given the role informal caregivers play on patient-reported outcomes, it was additionally assessed whether caregiver involvement acted as a moderator of this relationship. Methods: Survey data collected from 504 cancer survivors recruited through online consumer panels were utilized. The survey contained questions concerning treatment options, quality of life, adherence to treatment, next to presence and involvement of informal caregivers. Additionally, the Patient Activation Measure (PAM), sociodemographic and clinical questions were included. A path analysis Structural Equation Modeling (SEM) controlling for covariates was used to examine the relationship between Patient Activation Measure (PAM), caregiver involvement, and the identified outcomes. Moderator analysis was conducted using multiple group SEM. Results: Respondents were mostly women (57.1%), non-Hispanic white (72.9%), middle aged or older adults (68% ≥ 55 y.o.) The four largest cancer type groups were prostate (16.3%), early stage breast (9.7%), gynecological (8.9%), and colorectal cancer (8.3%). Most of the respondents were diagnosed more than 4 years earlier (52.0%). Participants were evenly split between those who received care at an academic cancer center (29.4%) and those treated at community hospital (31.7%). Patient activation was significantly associated with treatment planning being reflective of survivors ’goals and values ( p &lt; 0.001); adherence to treatment ( p = 0.011); and satisfaction ( p &lt; 0.001). Caregiver’s involvement significantly moderated the association between activation and adherence to treatment. Conclusions: Patient activation was positively associated with all three selected outcomes. However, for cancer survivors reporting low rates of caregiver involvement, patient activation was not associated with treatment adherence. Research is needed to deliver and test patient activation interventions inclusive of informal caregivers to improve self-management.

Anlotinib plus chemotherapy as neoadjuvant treatment of high-risk, early-stage triple-negative breast cancer: A prospective, single-arm, single-center, phase II clinical study.

e12585 Background: Anlotinib is an oral multi-targeted tyrosine kinase inhibitor (TKI) that strongly inhibits VEGFR, PDGFR, FGFR, and c-kit. Combining anti-angiogenesis with chemotherapy yielded increased response rates in patients with early-stage triple-negative breast cancer (TNBC). This phase II study aims to evaluate the efficacy and safety of adding anlotinib to standard neoadjuvant chemotherapy in primary TNBC. Methods: Patients aged 18 years or older with previously untreated stage ⅡB-IIIA histologically documented TNBC were assigned to receive chemotherapy plus oral Anlotinib (12 mg qd, d1-14; 21 days per cycle; total 8 cycles). Chemotherapy comprised of epirubicin at 90 mg/m2 and cyclophosphamide at 600 mg/m2 followed by docetaxel at 100 mg/m2, (21 days per cycle; both total 4 cycles), which was then followed by surgery. The primary endpoint was pathologic complete response (pCR) (no invasive carcinoma in breast or axilla). Stratification was based on the clinical breast cancer stage. This study is registered on Chinese Clinical Trials.gov (ChiCTR2000038174), and still ongoing. Results: Between July 2019 to June 2020, 18 patients (female) with pathological stage ⅡB (83.3%), and IIIA (16.7%) were enrolled with a median age of 46 years (range: 32-72). Overall pCR rate was 44.4% (8/18, CI 95%: 24.6%-66.3%). The pCR rate of pathological stage IIB patients was 46.7%(CI 95%: 26.7%-69.9%), which is tend to be better than the pCR rate of 33.3%(CI 95%: 6.2%-79.2%) for patients with pathological stage IIIA. There are 21 kind of AEs were observed, all including 56 times grade 1 AEs and 34 times grade 2 AEs, no grade 3 or higher AE was observed. The most common AEs included hand-foot syndrome(55.6% in total with 33.3% grade 2 and 22.2% grade 1), oral mucositis(50.00% in total with 33.3% grade 2 and 16.67% grade 1), fatigue(61.1%, all grade 1), hoarse voice(33.3%, all grade 1), nasal bleeding(27.8%, all grade 1), hypertension(22.2% with 5.6% grade 2) and diarrhea(22.2% with 5.6% grade 2). Neither unexpected safety signals nor treatment-related death occurred. Conclusions: The addition of anlotinib to neoadjuvant chemotherapy showed manageable toxicity and promising antitumor activity for patients with high-risk, early-stage TNBC. Clinical trial information: ChiCTR2000038174.

The impact of the COVID-19 pandemic on stage at diagnosis of breast and colorectal cancers.

6501 Background: Effective cancer screening leads to a substantial increase in the detection of earlier stages of cancer, while decreasing the incidence of later stage cancer diagnoses. Timely screening programs are critical in reducing cancer-related mortality in both breast and colorectal cancer by detecting tumors at an early, curable stage. The COVID-19 pandemic resulted in the postponement or cancellation of many screening procedures, due to both patient fears of exposures within the healthcare system as well as the cancellation of some elective procedures. We sought to identify how the COVID-19 pandemic has impacted the incidence of early and late stage breast and colorectal cancer diagnoses at our institution. Methods: We examined staging for all patients presenting to UCSD at first presentation for a new diagnosis of malignancy or second opinion in 2019 and 2020. Treating clinicians determined the stage at presentation for all patients using an AJCC staging module (8th edition) in the electronic medical record (Epic). We compared stage distribution at presentation in 2019 vs 2020, both for cancers overall and for colorectal and breast cancer, because these cancers are frequently detected by screening. Results: Total numbers of new patient visits for malignancy were similar in 2019 and 2020 (1894 vs 1915 pts), and stage distribution for all cancer patients was similar (stage I 32% in 2019 vs 29% in 2020; stage IV 26% in both 2019 and 2020). For patients with breast cancer, we saw a lower number of patients presenting with stage I disease (64% in 2019 vs 51% in 2020) and a higher number presenting with stage IV (2% vs 6%). Similar findings were seen in colorectal cancer (stage I: 22% vs 16%; stage IV: 6% vs 18%). Conclusions: Since the COVID-19 pandemic, there has been an increase in incidence of late stage presentation of colorectal and breast cancer, corresponding with a decrease in early stage presentation of these cancers at our institution. Cancer screening is integral to cancer prevention and control, specifically in colorectal and breast cancers which are often detected by screening, and the disruption of screening services has had a significant impact on our patients. We plan to continue following these numbers closely, and will present data from the first half of 2021 as it becomes available.