Introduction: Prognostic gene expression signatures can be used in combination with classical clinicopathological factors to guide adjuvant chemotherapy decisions in ER-positive, HER2-negative breast cancer. However, long-term outcome data after introduction of genomic testing in the treatment decision-making process are limited.
Methods: In the prospective RASTER study, the tumours of 427 patients with cTanyN0M0 breast cancer were tested to assess the 70-gene signature (MammaPrint).
Hypothermia is a potentially fatal adverse effect of antipsychotic drug (APD) use. With only 69 cases described in the literature, the condition is considered rare. We describe five new cases, in which we estimated the role of clozapine, haloperidol, olanzapine, penfluridol, risperidone, and zuclopentixol with the aid of two structured assessment tools.
View Article and Find Full Text PDFBackground: Hypothermia is a rare, but potentially fatal adverse effect of antipsychotic drug (APD) use. Although the opposite condition, thermia, has been researched extensively in the context of the malignant antipsychotic syndrome, little is known about thermia due to APDs.
Objective: This study aimed to review the literature on hypothermia in the context of APD use, and formulate implications for research and clinical care.
Multigene assays have been developed and validated to determine the prognosis of breast cancer. In this study, we assessed the additional predictive value of the 70-gene MammaPrint signature for chemotherapy (CT) benefit in addition to endocrine therapy (ET) from pooled study series. For 541 patients who received either ET (n = 315) or ET + CT (n = 226), breast cancer-specific survival (BCSS) and distant disease-free survival (DDFS) at 5 years were assessed separately for the 70-gene high and low risk groups.
View Article and Find Full Text PDFBackground: Mammographic screening and increased awareness has led to an increase in the detection of T1 breast tumors that are generally estimated as having low risk of recurrence after locoregional treatment. However, even small tumors can metastasize, which leaves us with the question for the necessity of adjuvant treatment. Therefore, additional prognostic markers are needed to tailor adjuvant systemic treatment for these relatively low-risk patients.
View Article and Find Full Text PDFPurpose: The level of estrogen receptor (ER), progesterone receptor (PR), and HER2 aids in the determination of prognosis and treatment of breast cancer. Immunohistochemistry is currently the predominant method for assessment, but differences in methods and interpretation can substantially affect the accuracy, resulting in misclassification. Here, we investigated the association of microarray-based mRNA expression levels compared with immunohistochemistry.
View Article and Find Full Text PDFInt J Technol Assess Health Care
January 2009
Objectives: Constructive Technology Assessment (CTA) is a means to guide early implementation of new developments in society, and can be used as an evaluation tool for Coverage with Evidence Development (CED). We used CTA for the introduction of a new diagnostic test in the Netherlands, the 70-gene prognosis signature (MammaPrint) for node-negative breast cancer patients.
Methods: Studied aspects were (organizational) efficiency, patient-centeredness and diffusion scenarios.
Background: A microarray-based 70-gene prognosis signature might improve the selection of patients with node-negative breast cancer for adjuvant systemic treatment. The main aims of this MicroarRAy PrognoSTics in Breast CancER (RASTER) study were to assess prospectively the feasibility of implementation of the 70-gene prognosis signature in community-based settings and its effect on adjuvant systemic treatment decisions when considered with treatment advice formulated from the Dutch Institute for Healthcare Improvement (CBO) and other guidelines.
Methods: Between January, 2004 and December, 2006, 812 women aged under 61 years with primary breast carcinoma (clinical T1-4N0M0) were enrolled.
Int J Technol Assess Health Care
June 2007
Objectives: Technologies in health care are evolving quickly, with new findings in the area of biotechnological and genetic research being published regularly. A health technology assessment (HTA) is often used to answer the question of whether the new technology should be implemented into clinical practice. International evidence confirms that the results of HTA research sometimes have limited impact on practical implementation and on coverage decisions; the study design is commonly based on the paradigm of stability of both the technology and the environment, which is often not the case.
View Article and Find Full Text PDFScientific advances in the field of genetics and gene-expression profiling have revolutionized the concept of patient-tailored treatment. Analysis of differential gene-expression patterns across thousands of biological samples in a single experiment (as opposed to hundreds to thousands of experiments measuring the expression of one gene at a time), and extrapolation of these data to answer clinically pertinent questions such as those relating to tumor metastatic potential, can help define the best therapeutic regimens for particular patient subgroups. The use of microarrays provides a powerful technology, allowing in-depth analysis of gene-expression profiles.
View Article and Find Full Text PDFObjectives: Pain exposure during early infancy affects the pain perception beyond infancy into childhood. The objective of this study was to examine whether major surgery within the first 3 months of life in combination with preemptive analgesia alters pain responses to immunization at 14 or 45 months and to assess whether these alterations are greater in toddlers with a larger number of negative hospital experiences.
Methods: Two groups of 50 toddlers each were compared: index group and control group.