Cost-Utility Analysis of Multigene Assays to Guide Treatment Decisions for Node-Negative Early Breast Cancer.

Introduction: Clinicopathologic and patient factors, such as tumor grade, size, age, and menopausal status, provide limited prognostic and predictive information in hormone receptor positive (HR +), human epidermal growth receptor 2 negative (HER2-), node-negative early-stage breast cancer, leading to potential over- or under-treatment. Multigene expression profile tests used in clinical practice in the USA, including the 21-gene assay, 70-gene assay, 12-gene assay, and 50-gene assay, offer prognostic information beyond traditional clinicopathologic features to improve treatment decisions. This study aimed to estimate the cost-effectiveness of these four multigene assays compared with clinicopathologic risk assessment alone.

Cost-Effectiveness Analysis of the Oncotype DX Breast Recurrence Score Test from a US Societal Perspective.

Background And Objectives: The 21-gene assay (the Oncotype DX Breast Recurrence Score test) estimates the 10-year risk of distant recurrence in hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) early-stage breast cancer to inform adjuvant chemotherapy decisions. The cost-effectiveness of the 21-gene assay compared against standard clinical-pathological risk tools alone for HR+/HER2- early-stage breast cancer was assessed using an economic model informed by evidence from randomized controlled trials.

Materials And Methods: A cost-effectiveness model consisted of a decision-tree to stratify patients according to their Recurrence Score (RS) results and the use of adjuvant chemotherapy, followed by a Markov component to estimate the long-term costs and outcomes of the chosen treatment.

The budget impact of utilizing the Oncotype DX Breast Recurrence Score test from a US healthcare payer perspective.

Background And Objectives: The Oncotype DX Breast Recurrence Score test is used to estimate distant recurrence risk of hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) early-stage breast cancer and inform decisions on the use of adjuvant chemotherapy. A model-based budget impact analysis compared the Oncotype DX test in combination with clinical-pathological risk against using clinical-pathological risk alone for HR+/HER2- node-negative (N0) and node-positive (N1; 1-3 axillary lymph nodes) early-stage breast cancer patients.

Materials And Methods: Test and medical costs associated with treatment of breast cancer were assessed through a US healthcare payer perspective.

Using Oncotype DX breast recurrence score® assay to define the role of neoadjuvant endocrine therapy in early-stage hormone receptor-positive breast cancer.

Purpose: The role of neoadjuvant endocrine therapy in the treatment of patients with early-stage, hormone receptor-positive (HR +) breast cancer is not well defined. Tools to better determine which patients may benefit from neoadjuvant endocrine therapy versus chemotherapy or upfront surgery remain an unmet need.

Methods: We assessed the rate of clinical and pathologic complete response (cCR, pCR) among a pooled cohort of patients with early-stage HR + breast cancer who had been randomized to neoadjuvant endocrine therapy or neoadjuvant chemotherapy in two earlier studies to understand better how outcomes varied by Oncotype DX Breast Recurrence Score® assay.

Population-based estimate for the correlation of the Oncotype Dx Breast Recurrence Score® result and Ki-67 IHC MIB-1 pharmDx in HR+, HER2-, node-positive early breast cancer.

Background: The United States Food and Drug Administration recently approved a Ki-67 immunohistochemistry (IHC) assay to identify patients with early breast cancer at high disease recurrence risk. The Oncotype Dx Breast Recurrence Score® assay has been validated in hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) invasive breast cancer (IBC) to predict chemotherapy benefit and distant recurrence risk, regardless of nodal status. This study assessed the correlation between Recurrence Score® (RS) results and the Ki-67 IHC MIB-1 pharmDx assay.

Expanding the Staging Criteria for T1-2N0 Hormone-Receptor Positive Breast Cancer Patients Enrolled in TAILORx.

Background: The American Joint Committee on Cancer (AJCC) 8th edition pathologic prognostic staging (PPS) incorporates anatomic and biologic factors. The OncotypeDX Breast Recurrence Score (RS) was included based on the initial report of the TAILORx trial, with T1-2N0 hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer patients who had a RS < 11 staged as PPS 1A. This study examined whether the RS criteria for PPS 1A can be further expanded using patients enrolled in the TAILORx trial.

Discordance in Oncotype DX Breast Recurrence Score Results for Bilateral Breast Cancer.

Background: The Oncotype DX Breast Recurrence Score assay is a clinically useful tool to determine the benefit of chemotherapy in the treatment of early-stage, hormone-receptor-positive breast cancer. Bilateral breast cancer (BBC) is found in ~ 5% of patients with breast cancer, and data regarding discordance of Oncotype DX results between BBC defined by current TAILORx subgroups are limited. Our goals are to study the rate of Oncotype DX discordance between BBC and investigate whether such differences can affect chemotherapy treatment discussions.

Expanding Criteria for Prognostic Stage IA in Hormone Receptor-Positive Breast Cancer.

Background: The prognostic significance of patients with low-risk recurrence score (RS) results in the context of the American Joint Committee on Cancer (AJCC) eighth edition pathologic prognostic staging has not been investigated. We evaluated if expanded RS criteria can be considered for downstaging in AJCC pathologic prognostic staging.

Methods: Using Surveillance, Epidemiology, and End Results data, we identified patients with T1-3N0-3M0 hormone receptor-positive, HER2-negative breast cancer treated from 2010 to 2015 with follow-up data through 2016.

Response to neoadjuvant chemotherapy and the 21-gene Breast Recurrence Score test in young women with estrogen receptor-positive early breast cancer.

Purpose: The 21-gene Breast Recurrence Score test predicts benefit from adjuvant chemotherapy in estrogen receptor-positive, HER2-negative (ER+/HER2-) breast cancer (BC). We examined whether the 21-gene assay predicts response to neoadjuvant chemotherapy (NCT).

Methods: We identified patients with stage I-III ER+/HER2- BC treated with NCT from the Young Women's Breast Cancer Study, a prospective cohort of women diagnosed with BC at age ≤40 years.

Young-Onset Colon Cancer and Recurrence Risk by Gene Expression.

The incidence and mortality from colorectal cancer in younger adults (younger than 55 years) is increasing. We reviewed the complete database of a gene-expression test, Oncotype DX Colon Recurrence Score test, to determine age-related differences in recurrence score (RS) and single-gene results (7 cancer-related of the 12-gene assay). We included 20 478 stage II and III A and B colon cancer patients submitted to Genomic Health.

Factors associated with MRI detection of occult lesions in newly diagnosed breast cancers.

Background: The use of preoperative magnetic resonance imaging (MRI) for newly diagnosed breast cancer remains controversial. We examined factors associated with detection of occult multicentric, multifocal, and contralateral malignant lesions only seen by MRI.

Methods: We performed a retrospective analysis of consecutive patients undergoing preoperative MRI for breast cancer.

Prognostic Impact of the 21-Gene Recurrence Score Assay Among Young Women With Node-Negative and Node-Positive ER-Positive/HER2-Negative Breast Cancer.

Purpose: The 21-gene recurrence score (RS) assay is prognostic among women with early-stage estrogen receptor-positive (ER+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer and is used to inform recommendations for chemotherapy. Women ≤ 40 years of age represent a minority of patients studied using gene expression profiles.

Methods: The Young Women's Breast Cancer Study is a prospective cohort of women diagnosed with breast cancer at age ≤ 40 years and enrolled patients between 2006 and 2016 (N = 1,302).

Clinical relevance of the 21-gene Recurrence Score assay in treatment decisions for patients with node-positive breast cancer in the genomic era.

In contemporary management of early-stage breast cancer, clinical decisions regarding adjuvant systemic therapy are increasingly made after considering both genomic assay results and clinico-pathologic features. Genomic information augments the prognostic information gleaned from clinico-pathologic features by providing risk estimates for distant recurrence and/or breast cancer-specific survival based on individual tumor biology. The 21-gene Oncotype DX Breast Recurrence Score (RS) assay is validated to be prognostic and predictive of chemotherapy benefit in patients with hormone receptor-positive (HR+), HER2-negative early-stage breast cancer, regardless of nodal status.

Correction to: Lymph Node Status in Breast Cancer Does Not Predict Tumor Biology.

In the "Results" section third paragraph, second sentence, there is an error. The corrected sentence is as follows.

Lymph Node Status in Breast Cancer Does Not Predict Tumor Biology.

Background/objective: The 21-gene Oncotype DX Breast Recurrence Score (RS) assay has been prospectively validated as prognostic and predictive in node-negative, estrogen receptor-positive (ER+)/HER2- breast cancer patients. Less is known about its prognostic role in node-positive breast cancer. We compared RS results among patients with lymph node-negative (N0), micrometastatic (N1mi), and macrometastatic (N+) breast cancer to determine if nodal metastases are associated with more aggressive biology, as determined by RS.

The effect of nurse-led group discussions by race on depressive symptoms in patients with heart failure.

Background: African Americans with heart failure (HF) have the highest rates of depression among all ethnicities in the USA.

Objectives: To compare the effects by race on depressive symptoms and topics discussed in the first clinic appointment after HF hospitalization.

Methods: This study is a secondary analysis of data from a randomized clinical trial testing a patient group discussion of HF self-management with 93 Caucasians and 77 African Americans.

Neratinib Efficacy and Circulating Tumor DNA Detection of Mutations in Nonamplified Metastatic Breast Cancer.

Based on promising preclinical data, we conducted a single-arm phase II trial to assess the clinical benefit rate (CBR) of neratinib, defined as complete/partial response (CR/PR) or stable disease (SD) ≥24 weeks, in nonamplified metastatic breast cancer (MBC). Secondary endpoints included progression-free survival (PFS), toxicity, and circulating tumor DNA (ctDNA) detection. Tumor tissue positive for was required for eligibility.

Value of routine staging imaging studies for patients with stage III breast cancer.

Background And Objectives: Routine staging imaging studies (RSIS) are optional in stage III breast cancer (BC). The impact of RSIS on treatment decisions and patient outcomes has not been extensively studied. The goal of this study was to determine whether RSIS in stage III BC affected treatment or patient outcomes.

The tipping point: Tamoxifen toxicity, central serous chorioretinopathy, and the role of estrogen and its receptors.

Purpose: To describe a case of tamoxifen toxicity superimposed on central serous chorioretinopathy (CSCR). We review the role of estrogen and the effect of tamoxifen on ocular tissues.

Observations: A 32-year-old Hispanic female with infiltrating ductal carcinoma of the left breast (T2N1M0, triple-positive), status post chemotherapy and bilateral mastectomy, presented with complaint of a floater and decreased central vision of the right eye (OD).

Double-Blind Phase III Randomized Trial of the Antiprogestin Agent Mifepristone in the Treatment of Unresectable Meningioma: SWOG S9005.

Purpose: Progesterone receptors are expressed in approximately 70% of meningiomas. Mifepristone is an oral antiprogestational agent reported to have modest activity in a phase II study. This multicenter, prospective, randomized, placebo-controlled phase III trial conducted by SWOG was planned to define the role of mifepristone in the treatment of unresectable meningioma.

Caregiver coaching program effect: Reducing heart failure patient rehospitalizations and improving caregiver outcomes among African Americans.

Objectives: (1) Test whether FamHFcare intervention could reduce patients' heart failure (HF)-related rehospitalizations and improve family caregiver outcomes; (2) calculate effect size on caregiver outcomes; and (3) evaluate the FamHFcare.

Background: Few interventions target family caregivers for HF home care.

Methods: This study was a mixed method design with stratification and random assignment of 20 African American HF patient/caregiver dyads.

Double-Blind Randomized 12-Month Soy Intervention Had No Effects on Breast MRI Fibroglandular Tissue Density or Mammographic Density.

Soy supplementation by patients with breast cancer remains controversial. No controlled intervention studies have investigated the effects of soy supplementation on mammographic density in patients with breast cancer. We conducted a double-blind, randomized, placebo-controlled intervention study in previously treated patients with breast cancer (n = 66) and high-risk women (n = 29).

Lymph node status in inflammatory breast cancer.

Positive lymph node status in breast cancer is known to be an adverse prognostic factor, but the effect of lymph node (LN) status in inflammatory breast cancer (IBC) has not been evaluated. This study was designed to investigate the association between lymph node status and overall survival (OS) in individuals with IBC. Using the Surveillance, Epidemiology, and End Results (SEER) 18 registry, we collected data on 761 patients diagnosed with non-metastatic IBC from 2004 to 2008.

Nurse-Led Multidisciplinary Heart Failure Group Clinic Appointments: Methods, Materials, and Outcomes Used in the Clinical Trial.

Background: The Self-management and Care of Heart Failure through Group Clinics Trial evaluated the effects of multidisciplinary group clinic appointments on self-care skills and rehospitalizations in high-risk heart failure (HF) patients.

Objective: The purpose of this article is to (1) describe key Self-management and Care of Heart Failure through Group Clinics Trial group clinic interactive learning strategies, (2) describe resources and materials used in the group clinic appointment, and (3) present results supporting this patient-centered group intervention.

Methods: This clinical trial included 198 HF patients (randomized to either group clinical appointments or to standard care).