Iterative Development of an Interactive Website to Support Shared Decision-Making in Metastatic Breast Cancer.

Recent treatment advances have resulted in significantly increased survival times following metastatic breast cancer (MBC) diagnosis. Novel treatment approaches-and their related side effects-have changed the landscape of MBC treatment decision-making. We developed a prototype of an online educational tool to prepare patients with MBC for shared decision-making with their oncologists. We describe the five phases of tool development: (1) in-depth, semi-structured qualitative interviews and (2) feedback on storyboards of initial content with patients with MBC and oncology providers. This was followed by three phases of iterative feedback with patients in which they responded to (3) initial, non-navigable website content and (4) a beta version of the full website. In the final phase (5), patients newly diagnosed with MBC (N = 6) used the website prototype for 1 week and completed surveys assessing acceptability, feasibility, treatment knowledge, preparation for decision-making, and self-efficacy for decision-making. Participants in Phase 1 characterized a cyclical process of MBC treatment decision-making and identified key information needs. Website content and structure was iteratively developed in Phases 2-4. Most participants in Phase 5 (n = 4) accessed the website 2-5 times. All participants who accessed the website at least once (n = 5) felt they learned new information from the website prototype and would recommend it to others newly-diagnosed with MBC. After using the website prototype, participants reported high preparation and self-efficacy for decision-making. This multiphase, iterative process resulted in a prototype intervention designed to support decision-making for MBC patients.

Design and pilot implementation of the Achieving Cancer Equity through Identification, Testing, and Screening (ACE-ITS) program in an urban underresourced population.

INTRODUCTION: The Achieving Cancer Equity through Identification, Testing, and Screening (ACE-ITS) program is a community-engaged framework to improve mammography maintenance and rates of genetic risk assessment, counseling, and testing using a multilevel approach that enhances patient navigation through mobile health and community education. METHODS: The ACE-ITS program is based on the National Institute of Minority Health and Health Disparities research framework focused on the individual (genetic testing, screening navigation) and community (community-based breast health education) levels and targeted to the biological- (genetic risk), behavioral- (mammography screening), sociocultural- (underserved Black and Hispanic women), and the health care system (patient navigation, automated text messages)-related domains. We further integrate the Practical Robust Implementation and Sustainability Model to describe our program implementation. RESULTS: In collaboration with genetic counselors and community partners, we created educational modules on mammography maintenance and genetic counseling/testing that have been incorporated into the navigator-led community education sessions. We also implemented a universal genetic risk assessment tool and automated text message reminders for repeat mammograms into our mammography navigation workflow. Through the ACE-ITS program implementation, we have collaboratively conducted 22 educational sessions and navigated 585 women to mammography screening over the 2020-2021 calendar years. From January to December 2021, we have also conducted genetic risk assessment on 292 women, of whom 7 have received genetic counseling/testing. CONCLUSIONS: We describe a multilevel, community-engaged quality improvement program designed to reduce screening-related disparities in Black and Hispanic women in our catchment area.

Self-reported barriers to screening breast MRI among women at high risk for breast cancer.

BACKGROUND: Annual screening breast MRI is recommended for women at high (≥ 20% lifetime) breast cancer risk, but is underutilized. Guided by the Health Services Utilization Model (HSUM), we assessed factors associated with screening breast MRI among high-risk women. METHODS: From August 2020-January 2021, we recruited an online convenience sample of high-risk women ages 25-85 (N = 232). High-risk was defined as: pathogenic genetic mutation in self or first-degree relative; history of lobular carcinoma in situ; history of thoracic radiation; or estimated lifetime risk ≥ 20%. Participants self-reported predisposing factors (breast cancer knowledge, health locus of control), enabling factors (health insurance type, social support), need factors (perceived risk, screening-supportive social norms, provider recommendation), and prior receipt of screening breast MRI. Multivariable logistic regression analysis with backward selection identified HSUM factors associated with receipt of screening breast MRI. RESULTS: About half (51%) of participants had received a provider recommendation for screening breast MRI; only 32% had ever received a breast MRI. Breast cancer knowledge (OR = 1.15, 95% CI = 1.04-1.27) and screening-supportive social norms (OR = 2.21, 95% CI = 1.64-2.97) were positively related to breast MRI receipt. No other HSUM variables were associated with breast MRI receipt (all p's > 0.1). CONCLUSIONS: High-risk women reported low uptake of screening breast MRI, indicating a gap in guideline-concordant care. Breast cancer knowledge and screening-supportive social norms are two key areas to target in future interventions. Data were collected during the COVID-19 pandemic and generalizability of results is unclear. Future studies with larger, more heterogeneous samples are needed to replicate these findings.

Scientific uncertainty and perceived mammography benefits in women screened for breast cancer.

PURPOSE: Personal aversion to scientific uncertainty may influence how women perceive the benefits of mammography, a breast cancer screening practice with conflicting scientific opinions and guidelines. Such associations may even exist among women who participate in screening. METHODS: We evaluated the distribution of aversion to ambiguous medical information (AA-Med), using a 6-item scale capturing the level of agreement with statements about obtaining a cancer screening test with conflicting medical recommendations in 665 women (aged 40-60 years; 79.5% Hispanic) recruited during screening mammography appointments in New York City. We assessed the association of AA-Med with perceptions of benefits of mammography (breast cancer mortality reduction, worry reduction, early detection, treatment improvement) using multivariable logistic regression. RESULTS: Over a quarter of participants expressed negative reactions to medical ambiguity about a cancer screening test (e.g., fear, lower trust in experts), but a majority endorsed intention to undergo screening. AA-Med was higher in women who were U.S.-born, non-Hispanic black, and had marginal to adequate health literacy, but there were no differences by clinical factors or screening experiences (e.g., family history, prior breast biopsy). Women with higher AA-Med were more likely to perceive treatment benefits from mammography (OR = 1.37, 95% CI = 0.99-1.90), but AA-Med was not associated with other perceived mammography benefits. CONCLUSIONS: Aversion to uncertainty regarding cancer screening varies by sociodemographic characteristics but has limited associations with perceived mammography benefits in women who already participate in screening.

Using Protection Motivation Theory to Predict Intentions for Breast Cancer Risk Management: Intervention Mechanisms from a Randomized Controlled Trial.

The purpose of this study is to evaluate the direct and indirect effects of a web-based, Protection Motivation Theory (PMT)-informed breast cancer education and decision support tool on intentions for risk-reducing medication and breast MRI among high-risk women. Women with ≥ 1.67% 5-year breast cancer risk (N = 995) were randomized to (1) control or (2) the PMT-informed intervention. Six weeks post-intervention, 924 (93% retention) self-reported PMT constructs and behavioral intentions. Bootstrapped mediations evaluated the direct effect of the intervention on behavioral intentions and the mediating role of PMT constructs. There was no direct intervention effect on intentions for risk-reducing medication or MRI (p's ≥ 0.12). There were significant indirect effects on risk-reducing medication intentions via perceived risk, self-efficacy, and response efficacy, and on MRI intentions via perceived risk and response efficacy (p's ≤ 0.04). The PMT-informed intervention effected behavioral intentions via perceived breast cancer risk, self-efficacy, and response efficacy. Future research should extend these findings from intentions to behavior. ClinicalTrials.gov Identifier: NCT03029286 (date of registration: January 24, 2017).

Barriers and facilitators to taking CDK4/6 inhibitors among patients with metastatic breast cancer: a qualitative study.

PURPOSE: Most studies of adherence to treatment for breast cancer have focused on early-stage patients. Findings from these studies may not generalize to patients with metastatic breast cancer (MBC). The objective of this study was to identify barriers and facilitators of adherence to cyclin-dependent kinase 4/6 (CDK4/6) inhibitors among patients with MBC, guided by the social ecologic model (SEM). METHODS: Patients with MBC (N = 25), their caregivers (N = 9), and oncology providers (N = 13) completed semi-structured qualitative interviews exploring their experiences with CDK4/6 inhibitors. Interviews were audio-recorded, transcribed verbatim, and analyzed by three raters using a combined deductive and inductive approach. RESULTS: Qualitative analysis identified barriers and facilitators of adherence at each SEM level. Intrapersonal and interpersonal factors were most frequently discussed. Intrapersonal factors included knowledge/beliefs about CDK4/6 inhibitors, side effects, and establishing a routine. Interpersonal factors included effective communication with/coordination by the care team, support from family and friends, and information from other patients with MBC. Although less frequently discussed, policy factors (i.e., cost of CDK4/6 inhibitors) were of great concern to patients, caregivers, and providers. CONCLUSION: Barriers to adherence to CDK4/6 inhibitors exist at multiple levels. Our results underscore the potential value of a multilevel intervention (e.g., patient education, evidence-based strategies for symptom management, tips for open and assertive communication with providers, information about financial resources/support available, and so on) to support adherence in this population.

Affect regulation as a moderator of intentions for breast cancer chemoprevention.

Women at high risk for breast cancer (BC) may consider chemoprevention for risk reduction, but uptake is low. This study examined the role of affect regulation (the attempt to alter or control one's emotions) in decision-making about BC chemoprevention. A cross-sectional, single group design was used. High-risk women (N = 81) were surveyed. Moderation analyses specified cancer-specific distress as the independent variable, affect regulation (cognitive reappraisal or expressive suppression) as the moderator, and chemoprevention intentions (yes = 1, unsure = 0, no = -1) as the dependent variable. Cognitive reappraisal significantly moderated the relationship between cancer-specific distress and chemoprevention intentions (p = 0.03), but expressive suppression did not (p = 0.31). For the 44% of participants who were highest on reappraisal, higher cancer-specific distress was associated with greater intentions for chemoprevention. For the remaining 56%, there was no relationship between cancer-specific distress and chemoprevention intentions. Cognitive reappraisal may play an important role in decisions regarding uptake of chemoprevention.

Improving our model of cascade testing for hereditary cancer risk by leveraging patient peer support: a concept report.

Consensus and evidence suggest that cascade testing is critical to achieve the promise of cancer genetic testing. However, barriers to cascade testing include effective family communication of genetic risk information and family members' ability to cope with genetic risk. These barriers are further complicated by the developmental needs of unaffected family members during critical windows for family communication and adaptation. Peer support could address these barriers. We provide two illustrative examples of ongoing BRCA1/2-related clinical trials that apply a peer support model to improve family communication and functioning. Peer support can augment currently available genetic services to facilitate adjustment to and effective use of cancer genetic risk information. Importantly, this scalable approach can address the presence of cancer risk within families across multiple developmental stages. This applies a family-centered perspective that accommodates all potentially at-risk relatives. This peer support model can be further applied to emerging topics in clinical genetics to expand reach and impact.

The Genetic Education for Men (GEM) Trial: Development of Web-Based Education for Untested Men in BRCA1/2-Positive Families.

Cascade testing for hereditary breast/ovarian cancer is an important public health priority. Increasing attention has been paid to the relevance of testing for men within BRCA1/2-positive families given that such testing may provide important information about their cancer risks, particularly for prostate cancer, and risks to their offspring. However, men are much less likely to seek genetic counseling and testing than their at-risk female relatives. To facilitate access to pre-test information and testing, we developed a web-based intervention (WI) for men that we are evaluating in a pilot randomized controlled trial (RCT). This paper describes three phases of research in the development of the WI: (1) formative (qualitative) research among men from BRCA1/2 families to assess needs and preferences for education; (2) a detailed description of the organization, format, and content of the WI; and (3) usability testing. We discuss the aims and hypotheses of the pilot RCT in which the WI is being compared with an enhanced usual care condition among at-risk men. We expect that the WI described here will foster informed decisions and lead to increased use of BRCA1/2 counseling and testing, potentially yielding improved cancer control outcomes for this understudied group, and for their at-risk relatives.

Prior breast density awareness, knowledge, and communication in a health system-embedded behavioral intervention trial.

BACKGROUND: Breast density is an important breast cancer risk factor and a focus of recent national and state health policy efforts. This article describes breast density awareness, knowledge, and communication among participants in a health system-embedded trial with clinically elevated breast cancer risk 1 year before state-mandated density disclosure. METHODS: Trial participants' demographics and prior health history were ascertained from electronic health records. The proportions of women reporting prior breast density awareness, knowledge of density's masking effect, and communication with a provider about their own breast density were calculated using baseline interview data collected from 2017 to 2018. Multiple logistic regression was used to estimate associations between women's characteristics and density awareness, knowledge, and communication. RESULTS: Although the overwhelming majority of participants had heard of breast density (91%) and were aware of breast density's masking effect (87%), only 60% had ever discussed their breast density with a provider. Annual mammography screening was associated with prior breast density awareness (odds ratio [OR], 2.97; 95% confidence interval [CI], 1.29-6.81), knowledge (OR, 2.83; 95% CI, 1.20-6.66), and communication (OR, 2.87; 95% CI, 1.34-6.16) compared with an infrequent or unknown screening interval. Receipt of breast biopsy was also associated with prior knowledge (OR, 1.60; 95% CI, 1.04-2.45) and communication (OR, 1.36; 95% CI, 1.00-1.85). CONCLUSIONS: Breast density awareness and knowledge are high among insured women participating in clinical research, even in the absence of mandated density disclosure. Patient-provider communication about personal density status is less common, particularly among women with fewer interactions with breast health specialists.

Predictors of contralateral prophylactic mastectomy in genetically high risk newly diagnosed breast cancer patients.

PURPOSE: Recent trends indicate increased use of contralateral prophylactic mastectomy (CPM) among newly diagnosed breast cancer patients, particularly those who test positive for a pathogenic variant in the BRCA1/2 genes. However, the rate of CPM among patients who test negative or choose not to be tested is surprisingly high. We aimed to identify patient predictors of CPM following breast cancer diagnosis among such patients. METHODS: As part of a randomized controlled trial of rapid genetic counseling and testing vs. usual care, breast cancer patients completed a baseline survey within 6 weeks of diagnosis and before definitive surgery. Analyses focused on patients who opted against testing (n = 136) or who received negative BRCA1/2 test results (n = 149). We used multivariable logistic regression to assess the associations between sociodemographic, clinical- and patient-reported factors with use of CPM. RESULTS: Among patients who were untested or who received negative test results, having discussed CPM with one's surgeon at the time of diagnosis predicted subsequent CPM. Patients who were not candidates for breast-conserving surgery and those with higher levels of cancer-specific intrusive thoughts were also more likely to obtain a CPM. CONCLUSION: The strongest predictors of CPM in this population were objective clinical factors and discussion with providers. However, baseline psychosocial factors were also independently related to the receipt of CPM. Thus, although CPM decisions are largely guided by relevant clinical factors, it is important to attend to psychosocial factors when counseling newly diagnosed breast cancer patients about treatment options.

Patient-centered care and genomic medicine: A qualitative provider study in the military health system.

The diagnostic and predictive information produced by genomic sequencing may impact medical management, and it is critical that providers and institutions are able to use this information appropriately for patient care. Guided by the patient-centered care model, we investigated provider perspectives of patient, provider, and system-level factors that could influence the implementation of genomic medicine within the integrated healthcare system of the US Department of Defense (DOD). The purpose of this study was to explore patient-centered care elements related to the application of genomic sequencing in a military healthcare facility to understand the current capability and key gaps for patient-centered genomic medicine. Twenty DOD healthcare providers were interviewed regarding their past experiences and future expectations of genetics and genomics. These semi-structured interviews were recorded, transcribed and analyzed. All providers interviewed had some experience with genetics, but the level of experience varied greatly. Providers reported widely differing degrees of knowledge and confidence regarding genetics and about military-specific policies regarding genetics which varied by specialty. In addition, most providers stated that their department did not currently have the infrastructure to allow for the care of patients with secondary genetic findings, defined as genetic findings which are intentionally examined because of their importance to healthcare management, but are unrelated to the reason the individual underwent sequencing. This study reveals gaps in key elements of patient-centered care related to genomic medicine that may be helpful to address in future implementation efforts.

Underuse of exon mutational analysis for gastrointestinal stromal tumors.

BACKGROUND: Tyrosine kinase inhibitors (TKI) have become the guideline-recommended therapy for high-risk resected and advanced gastrointestinal stromal tumors (GISTs). Exon mutational analysis (EMA) is used to inform pretherapy response to TKI and may predict overall prognosis. Despite these benefits, EMA remains underused, and its impact on TKI therapy decision-making remains unexplored. MATERIALS AND METHODS: A retrospective cohort was established from 104 patients receiving treatment for GISTs from 2006 to 2017. Current National Comprehensive Cancer Network guidelines indicate that EMA should be considered for all patients undergoing TKI therapy to identify genotypes that are likely, or unlikely, to respond to treatment. We first tracked guideline-considered EMA use and subsequent impact on treatment decision-making. A questionnaire was then administered to gastrointestinal medical oncologists to assess EMA perception. RESULTS: Among 104 GIST patients, 54 (52%) received TKI therapy. Of these, only 22 (41%) received EMA. Informed by EMA, treatment decisions included 59% who continued with original TKI therapy, 32% who switched to an alternative TKI, and 9% who discontinued or received no TKI. Although 92% of physicians indicated EMA was a valuable tool, only 62% indicated they used it "frequently" or "always" to inform treatment decisions. CONCLUSIONS: Less than half of patients receiving TKI therapy for GISTs received EMA at a comprehensive cancer center. Despite this low uptake, when it was performed, EMA guided alternative treatment decision in 41% of patients. Physician survey responses indicated that interventions targeting physician education and an electronic medical record reminder may improve EMA uptake.

Multilevel Influences on Patient-Oncologist Communication about Genomic Test Results: Oncologist Perspectives.

Thousands of women with early-stage breast cancer receive gene-expression profile (GEP) tests to guide chemotherapy decisions. However, many patients report a poor understanding of how their test results inform treatment decision-making. We applied models of patient-centered communication and informed decision-making to assess which variables oncologists' perceive as most influential to effective communication with their patients about GEP results and intervention modalities and approaches that could support more effective conversations about treatment decisions in routine clinical care. Medical oncologists who were part of a practice group in the mid-Atlantic US completed an online, cross-sectional survey in 2016. These data were merged with de-identified electronic patient and practice data. Of the 83 oncologists contacted, 29 completed the survey (35% response rate, representing 52% of the test-eligible patients in the practice network). There were no significant differences between survey responders and nonresponders. Oncologists reported patient-related variables as most influential, including performance status (65.5%), pretesting preferences for chemotherapy (55.2%), and comprehension of complex test results (55.2%). Oncologists endorsed their experience with testing (58.6%) and their own confidence in using the test results (48.3%) as influential as well. They indicated that a clinical decision support tool incorporating patient comorbidities, age, and potential benefits from chemotherapy would support their own practice and that they could share these results and other means of communication support using print materials (79.3%) with their patients in clinic (72.4%). These preferred intervention characteristics could be integrated into routine care, ultimately facilitating more effective communication about genomic testing (such as GEP) and its role in treatment selection.

Endocrine therapy initiation, discontinuation and adherence and breast imaging among 21-gene recurrence score assay-eligible women under age 65.

BACKGROUND: Aside from chemotherapy utilization, limited data are available on the relationship between gene expression profiling (GEP) testing and breast cancer care. We assessed the relationship between GEP testing and additional variables and the outcomes of endocrine therapy initiation, discontinuation and adherence, and breast imaging exams in women under age 65 years. METHODS: Data from five state cancer registries were linked with claims data and GEP results. We assessed variables associated with survivorship care outcomes in an incident cohort of 5014 commercially insured women under age 65 years, newly diagnosed with stage I or II hormone-receptor-positive, human epidermal growth factor receptor 2 (HER2) non-positive breast cancer from 2006 to 2010. RESULTS: Among tested women, those with high Oncotype DX® Breast Recurrence Score® (RS) were significantly less likely to initiate endocrine therapy than women with low RS tumors (OR 0.40 (95% CI 0.20 to 0.81); P = 0.01). Among all test-eligible women, receipt of Oncotype DX testing was associated with a greater likelihood of endocrine therapy initiation (OR 2.48 (95% CI 2.03 to 3.04); P <0.0001). The odds of initiation were also significantly higher for tested vs. untested women among women who did not initiate chemotherapy within six months of diagnosis (OR 3.25 (95% CI 2.53 to 4.16)), with no effect in women who received chemotherapy. Discontinuation and adherence and breast imaging exams were unrelated to tested status or RS. CONCLUSIONS: Lower endocrine therapy initiation rates among women with high RS tumors and among untested women not receiving chemotherapy are concerning, given its established efficacy. Additional research is needed to suggest mechanisms to close this gap.

Initiation of Trastuzumab by Women Younger Than 64 Years for Adjuvant Treatment of Stage I-III Breast Cancer.

Purpose: Studies have reported disparities by age and race in the initiation of adjuvant trastuzumab for the initial treatment of older women with early-stage breast cancer, but less is known about its initiation in younger patients. Therefore, we assessed temporal trends and clinical and demographic factors associated with trastuzumab initiation in a large, population-based cohort of patients aged <64 years in 5 states. Methods: Using a cancer registry and claims-linked data set of 13,398 women with incident invasive breast cancer from 2006 to 2011, we identified 934 patients aged <64 years with HER2-positive stage I-III breast cancer. We assessed trastuzumab initiation within the first 9 months after diagnosis and conducted logistic regression analyses to assess sociodemographic and clinical factors associated with trastuzumab initiation. Results: From 2006 to 2011, trastuzumab initiation steadily increased in patients with node-positive (from 65% to 91%) and node-negative (from 39% to 75%) breast cancers. Several tumor-related factors were associated with trastuzumab initiation, including high histologic grades (adjusted odds ratio [aOR], 6.43; 95% CI, 3.27-12.65; and aOR, 3.25; 95% CI, 1.66-6.36, for grades 3 and 2, respectively), node-positive status (aOR, 1.88; 95% CI, 1.28-2.78; P=.001), tumor size >2 cm (aOR, 1.50; 95% CI, 1.04-2.16; P=.03), and hormone receptor-negative status (aOR, 1.51; 95% CI, 1.01-2.26; P=.04). We found a null effect of race. Conclusions: Adjuvant trastuzumab therapy for early-stage breast cancer has been widely disseminated among women aged <64 years. The initiation of this targeted therapy was associated with higher-risk features, consistent with practice guidelines.

Impact of genomic testing and patient-reported outcomes on receipt of adjuvant chemotherapy.

Practice guidelines incorporate genomic tumor profiling, using results such as the Oncotype DX Recurrence Score (RS), to refine recurrence risk estimates for the large proportion of breast cancer patients with early-stage, estrogen receptor-positive disease. We sought to understand the impact of receiving genomic recurrence risk estimates on breast cancer patients' well-being and the impact of these patient-reported outcomes on receipt of adjuvant chemotherapy. Participants were 193 women (mean age 57) newly diagnosed with early-stage breast cancer. Women were interviewed before and 2-3 weeks after receiving the RS result between 2011 and 2015. We assessed subsequent receipt of chemotherapy from chart review. After receiving their RS, perceived pros (t = 4.27, P < .001) and cons (t = 8.54, P < .001) of chemotherapy increased from pre-test to post-test, while perceived risk of breast cancer recurrence decreased (t = 2.90, P = .004). Women with high RS tumors were more likely to receive chemotherapy than women with low RS tumors (88 vs. 5 %, OR 0.01, 0.00-0.02, P < .001). Higher distress (OR 2.19, 95 % CI 1.05-4.57, P < .05) and lower perceived cons of chemotherapy (OR 0.50, 95 % CI 0.26-0.97, P < .05) also predicted receipt of chemotherapy. Distressed patients who saw few downsides of chemotherapy received this treatment. Clinicians should consider these factors when discussing chemotherapy with breast cancer patients.

Population-based study of the effect of gene expression profiling on adjuvant chemotherapy use in breast cancer patients under the age of 65 years.

BACKGROUND: Gene expression profiling (GEP) testing can help to predict the risk of cancer recurrence and guide decisions about adjuvant chemotherapy for breast cancer (BC). However, no prior US studies have evaluated the relation between GEP testing and the use of adjuvant chemotherapy by women treated in a general oncology practice. METHODS: Eligible patients were women under the age 65 of years who were newly diagnosed with their first stage I or II, hormone receptor-positive BC between 2006 and 2011 (n = 9405). This retrospective study was conducted with a data set consisting of registry data, health claims data, and GEP testing results. The distribution of GEP test results was reported in terms of the risk of recurrence predicted, and logistic regression was used to assess the association of test results with chemotherapy use, with adjustments made for multiple patient characteristics. RESULTS: The proportions of tested women with low, intermediate, and high recurrence score results were 51%, 39%, and 10%, respectively. Among these women, 11%, 47%, and 88%, respectively, received adjuvant chemotherapy. There was a significant, positive linear relation of assay scores with chemotherapy use within the low and intermediate subgroups after adjustments for all other factors (adjusted odds ratios, 1.17 and 1.20, respectively). CONCLUSIONS: Adjuvant chemotherapy use after GEP testing is generally consistent with the recommended test interpretation for women with a high or low predicted risk of recurrence. Chemotherapy use in the intermediate-risk group increased with Recurrence Score values, and evidence from ongoing randomized trials may help to clarify whether this finding reflects optimal interpretation of GEP test results. These results demonstrate the principle that genomic testing, on the basis of research establishing its utility, can be applied appropriately in general practice in accordance with guideline recommendations.

Adoption of Gene Expression Profiling for Breast Cancer in US Oncology Practice for Women Younger Than 65 Years.

BACKGROUND: A number of practice guidelines incorporate the use of gene expression profiling (GEP) tests for early-stage, hormone receptor-positive, HER2-negative breast tumors. Few studies describe factors associated with GEP testing in US oncology practice. We assessed the relationship between clinical, demographic, and group-level socioeconomic variables and test use in women younger than 65 years. PATIENTS AND METHODS: Data from 5 state cancer registries were linked with insurance claims data and GEP test results. We assessed rates of testing and variables associated with test use in an incident cohort of 9,444 commercially insured women younger than 65 years, newly diagnosed with stage I or II hormone receptor-positive breast cancer from 2006 through 2012. RESULTS: Rates of testing for women with N0 disease increased from 20.4% in 2006 to 35.2% in 2011. Variables associated with higher rates of testing, beyond clinical factors such as nodal status (P<.001), included being diagnosed from 2008 through 2012 versus 2006 through 2007 (adjusted odds ratio [OR], 1.67; 95% CI, 1.47-1.90), having preexisting comorbidities (adjusted OR, 1.35; 95% CI, 1.14-1.59), and higher out-of-pocket pharmacy costs (adjusted OR, 1.66; 95% CI, 1.40-1.97). Women younger than 50 years were more likely to be tested if they had stage I versus stage II disease (P<.0001). CONCLUSIONS: In an insured population of women younger than 65 years, GEP testing increased after its inclusion in clinical practice guidelines and mounting evidence. Additional research is needed to better understand oncologists' decision not to order GEP testing for their patients who are otherwise eligible.

Contemplating genetic feedback regarding lung cancer susceptibility.

BACKGROUND AND PURPOSE: We examined three theoretical models (self-enhancement theory, consistency theory, and a combined model) for understanding how expectations and test result favorability influence smokers' desire for a retest following hypothetical genetic test results. METHOD: College smokers (N = 128) read a brochure describing a biomarker for lung cancer (the GSTM1 gene) then reported whether they thought they had the gene (indicating lower lung cancer risk) or were missing the gene (indicating higher lung cancer risk). Participants then reported whether they would get retested if they received favorable GSTM1 results versus unfavorable GSTM1 results. RESULTS: Participants were most likely to want a retest, suggesting rejection of the results, if they expected favorable news yet received unfavorable news. CONCLUSION: The findings supported the combined model such that smokers expressed greatest interest in a retest when they imagined genetic risk feedback that challenges both enhancement and consistency motives.