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"Levine, Julia"
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Reporting on invasive lobular breast cancer in clinical trials: a systematic review
Invasive lobular breast cancer (ILC) differs from invasive breast cancer of no special type in many ways. Evidence on treatment efficacy for ILC is, however, lacking. We studied the degree of documentation and representation of ILC in phase III/IV clinical trials for novel breast cancer treatments. Trials were identified on Pubmed and clinicaltrials.gov. Inclusion/exclusion criteria were reviewed for requirements on histological subtype and tumor measurability. Documentation of ILC was assessed and ILC inclusion rate, central pathology and subgroup analyses were evaluated. Inclusion restrictions concerning tumor measurability were found in 39/93 manuscripts. Inclusion rates for ILC were documented in 13/93 manuscripts and varied between 2.0 and 26.0%. No central pathology for ILC was reported and 3/13 manuscripts had ILC sub-analyses. ILC is largely disregarded in most trials with poor representation and documentation. The current inclusion criteria using RECIST v1.1, fall short in recognizing the unique non-measurable metastatic infiltration of ILC.
Journal Article
Decreased enrollment in breast cancer trials by histologic subtype: does invasive lobular carcinoma resist RECIST?
Enrollment in metastatic breast cancer trials usually requires measurable lesions, but patients with invasive lobular carcinoma (ILC) tend to form diffuse disease. We found that the proportion of patients with metastatic ILC enrolled in clinical trials at our institution was significantly lower than that of patients with invasive ductal carcinoma (IDC). Possible links between requiring measurable disease and decreased enrollment of ILC patients require further study to ensure equitable trial access.
Journal Article
53 The development of a multi-institutional prospective registry for patients with metastatic invasive lobular carcinoma: identifying new markers of disease progression
OBJECTIVES/GOALS: We are launching a multi-center prospective registry for patients with metastatic invasive lobular carcinoma (ILC), the second most common type of breast cancer, to better understand patterns of progression, imaging features of metastatic sites, and if serial cell free DNA measurements can serve as a surrogate marker of disease progression. METHODS/STUDY POPULATION: Patients with biopsy proven metastatic ILC of any receptor subtype will be included in the registry. We will exclude patients with ductal histology only or those with multiple primary malignancies. Patients will be enrolled at four large academic medical centers across the country. Cell free DNA measurements using a tumor informed assay will be obtained every 3 months concurrent with regular clinical imaging. Disease status will be determined by the patient’s medical oncologist by taking into account imaging, tumor markers, symptoms, and cell free DNA measurement. At each time point, patients will be surveyed on their quality of life and their medical oncologists will be asked to rate the clinical utility of the cell free DNA value. Patients will be followed indefinitely. RESULTS/ANTICIPATED RESULTS: We will explore whether the use of serial cell free DNA or a combination of blood-based biomarkers and clinical endpoints can reliably identify treatment response and disease progression in patients with metastatic ILC. Many patients with metastatic ILC have unmeasurable disease on imaging and are thereby excluded from clinical trials. The end goal of this registry is to determine if blood-based biomarkers can be used as a proxy for measurable disease in ILC patients and therefore increase clinical trial enrollment for this subgroup of patients. DISCUSSION/SIGNIFICANCE: The creation of this prospective registry will open the door for future studies of blood-based markers that reflect disease stability and progression, which is an unmet need specifically in ILC. Identification of such markers could lead to a novel treatment response endpoint, changing the way patients are enrolled in trials and managed clinically.
Journal Article
State Dependence in Brand, Store, and Category Choice
Across a wide variety of contexts, people who have experienced an event are more likely to experience that event in the future. This empirical regularity, hereafter referred to as state dependence, has two explanations, each with its own set of policy and managerial implications. One explanation, known as structural state dependence, is that the experience of an event alters the preferences or constraints that an individual would hold for that event in the future. A second explanation, spurious state dependence, is that people differ along some unobservable propensity to experience an event. For example, people that become unemployed once are more likely to be unemployed in the future. The structural explanation for this phenomenon is that unemployment has a sustained effect on the probability of future unemployment, while the spurious explanation argues that individuals vary on some unobservable variable, such as work ethic or skill set, that affects their probability of becoming unemployed at any time. These explanations have different implications: if state dependence is structural, short-term policies reducing unemployment can have large long-run effects. This dissertation aims to explore the effects of structural state dependence in three contexts: brand choice, store choice, and category consumption.Using techniques in causal inference and structural modeling, and a rich database of transaction data, I find that structural state dependence 1) has no effect on brand choice in consumer packaged goods, 2) has a strong effect on where people shop for groceries, impacting nutritional intake, and 3) drives consumption in addictive categories to varying extents. These findings give us a better understanding of why brand choice persists over time, why nutritional intake varies drastically across demographic groups, and how cigarette types vary in their addictive and habit-forming properties.
Dissertation
Erratum: 53 The development of a multi-institutional prospective registry for patients with metastatic invasive lobular carcinoma: identifying new markers of disease progression - CORRIGENDUM
[This corrects the article DOI: 10.1017/cts.2023.142.].
Journal Article