17 research outputs found
Cardiac Outcomes of Patients Receiving Adjuvant Weekly Paclitaxel and Trastuzumab for Node-Negative, ERBB2-Positive Breast Cancer
Trastuzumab is life-saving but is associated with symptomatic and asymptomatic left ventricular ejection fraction (LVEF) decline. Here we report the low cardiac toxicity of a non-anthracycline and trastuzumab based treatment for patients with early stage HER2-positive breast cancer (BCA)
Phase II Study of Lapatinib in Combination With Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer: Clinical Outcomes and Predictive Value of Early [ 18 F]Fluorodeoxyglucose Positron Emission Tomography Imaging (TBCRC 003)
Lapatinib plus trastuzumab improves outcomes relative to lapatinib alone in heavily pretreated, human epidermal growth factor receptor 2–positive metastatic breast cancer (MBC). We tested the combination in the earlier-line setting and explored the predictive value of [18F]fluorodeoxyglucose positron emission tomography ([18F]FDG-PET) for clinical outcomes
A novel application of a bivariate regression model for binary and continuous outcomes to studies of fetal toxicity
Public health concerns over the occurrence of birth defects and developmental abnormalities that may occur as a result of prenatal exposure to drugs, chemicals and other environmental factors has led to an increasing number of developmental toxicity studies. Because fetal pups are commonly evaluated for multiple outcomes, data analysis frequently involves a joint modelling approach. We focus on modelling clustered binary and continuous outcomes in the setting where both outcomes are potentially observable in all offspring but, owing to practical limitations, the continuous outcome is only observed in a subset of offspring. The subset is not a simple random sample but is selected by the experimenter under a prespecified probability model. Although joint models for binary and continuous outcomes have been developed when both outcomes are available for every fetus, many existing approaches are not directly applicable when the continuous outcome is not observed in a simple random sample. We adapt a likelihood-based approach for jointly modelling clustered binary and continuous outcomes when the continuous response is missing by design and missingness depends on the binary trait. The approach takes into account the probability that a fetus is selected in the subset. Through the use of a partial likelihood, valid estimates can be obtained by a simple modification to the partial likelihood score. Data involving the herbicide 2,4,5-trichlorophenoxyacetic-acid are analysed. Simulation results confirm the approach. Copyright (c) 2009 Royal Statistical Society.
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Analysis of background distributions of metals in the soil at Lawrence Berkeley National Laboratory
As part of its Resource Conservation and Recovery Act (RCRA) Corrective Action Program (CAP), the Lawrence Berkeley National Laboratory (LBNL) Environmental Restoration Program conducted an evaluation of naturally occurring metals in soils at the facility. The purpose of the evaluation was to provide a basis for determining if soils at specific locations contained elevated concentrations of metals relative to ambient conditions. Ambient conditions (sometimes referred to as 'local background') are defined as concentrations of metals in the vicinity of a site, but which are unaffected by site-related activities (Cal-EPA 1997). Local background concentrations of 17 metals were initially estimated by LBNL using data from 498 soil samples collected from borings made during the construction of 71 groundwater monitoring wells (LBNL 1995). These concentration values were estimated using the United States Environmental Protection Agency's (USEPA's) guidance that was available at that time (USEPA 1989). Since that time, many more soil samples were collected and analyzed for metals by the Environmental Restoration Program. In addition, the California Environmental Protection Agency (Cal-EPA) subsequently published a recommended approach for calculating background concentrations of metals at hazardous waste sites and permitted facilities (Cal-EPA 1997). This more recent approach differs from that recommended by the USEPA and used initially by LBNL (LBNL 2002). The purpose of the 2002 report was to apply the recommended Cal-EPA procedure to the expanded data set for metals that was available at LBNL. This revision to the 2002 report has been updated to include more rigorous tests of normality, revisions to the statistical methods used for some metals based on the results of the normality tests, and consideration of the depth-dependence of some sample results. As a result of these modifications, estimated background concentrations for some metals have been slightly revised from those presented in the original 2002 report. In cases where estimated background concentrations were reduced, site data were reviewed to assess whether significant changes to results of the RCRA CAP findings would result. This assessment indicated that no significant changes in RCRA CAP findings would result from the revisions
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Oncologists' and Cancer Patients' Views on Whole-Exome Sequencing and Incidental Findings: Results from The CanSeq Study
Purpose While targeted sequencing improves outcomes for many cancer patients, how somatic and germline whole-exome sequencing (WES) will integrate into care remains uncertain. Methods: We conducted surveys and interviews, within a study of WES integration at an academic center, to determine oncologists' attitudes about WES and to identify lung and colorectal cancer patients' preferences for learning WES findings. Results: 167 patients (85% white, 58% female, mean age 60) and 27 oncologists (22% female) participated. Although oncologists had extensive experience ordering somatic tests (median 100/year), they had little experience ordering germline tests. Oncologists intended to disclose most WES results to patients but anticipated numerous challenges in using WES. Patients had moderately low levels of genetic knowledge (mean 4 correct of 7). Most patients chose to learn results that could help select a clinical trial, pharmacogenetic and positive prognostic results, and results suggesting inherited predisposition to cancer and treatable non-cancer conditions (all ≥95%). Fewer chose to receive negative prognostic results (84%) and results suggesting predisposition to untreatable non-cancer conditions (85%). Conclusion: The majority of patients want most cancer-related and incidental WES results. Patients' low levels of genetic knowledge and oncologists' inexperience with large-scale sequencing presage challenges to implementing paired WES in practice