OS-1. Are conventional clinical markers outperformed by microarray gene expression profilers in breast cancer prognosis?

2005 ◽  
Vol 3 (1) ◽  
pp. 40
2015 ◽  
Vol 31 (1-2) ◽  
pp. 36-50 ◽  
Author(s):  
Sarah E. Ali-Khan ◽  
Lee Black ◽  
Nicole Palmour ◽  
Michael T. Hallett ◽  
Denise Avard

Objectives: There have been multiple calls for explicit integration of ethical, legal, and social issues (ELSI) in health technology assessment (HTA) and addressing ELSI has been highlighted as key in optimizing benefits in the Omics/Personalized Medicine field. This study examines HTAs of an early clinical example of Personalized Medicine (gene expression profile tests [GEP] for breast cancer prognosis) aiming to: (i) identify ELSI; (ii) assess whether ELSIs are implicitly or explicitly addressed; and (iii) report methodology used for ELSI integration.Methods: A systematic search for HTAs (January 2004 to September 2012), followed by descriptive and qualitative content analysis.Results: Seventeen HTAs for GEP were retrieved. Only three (18%) explicitly presented ELSI, and only one reported methodology. However, all of the HTAs included implicit ELSI. Eight themes of implicit and explicit ELSI were identified. “Classical” ELSI including privacy, informed consent, and concerns about limited patient/clinician genetic literacy were always presented explicitly. Some ELSI, including the need to understand how individual patients’ risk tolerances affect clinical decision-making after reception of GEP results, were presented both explicitly and implicitly in HTAs. Others, such as concern about evidentiary deficiencies for clinical utility of GEP tests, occurred only implicitly.Conclusions: Despite a wide variety of important ELSI raised, these were rarely explicitly addressed in HTAs. Explicit treatment would increase their accessibility to decision-makers, and may augment HTA efficiency maximizing their utility. This is particularly important where complex Personalized Medicine applications are rapidly expanding choices for patients, clinicians and healthcare systems.


The Breast ◽  
2011 ◽  
Vol 20 (4) ◽  
pp. 309-313 ◽  
Author(s):  
Lars C. Hanker ◽  
Thomas Karn ◽  
Loreta Mavrova-Risteska ◽  
Eugen Ruckhäberle ◽  
Regine Gaetje ◽  
...  

2018 ◽  
Vol 2018 ◽  
pp. 1-6 ◽  
Author(s):  
Ghina B. Fakhri ◽  
Reem S. Akel ◽  
Maya K. Khalil ◽  
Deborah A. Mukherji ◽  
Fouad I. Boulos ◽  
...  

Introduction. Accurate evaluation of estrogen and progesterone receptors and HER2 is critical when diagnosing invasive breast cancer for optimal treatment. The current evaluation method is via immunohistochemistry (IHC). In this paper, we compared results of ER, PR, and HER2 from microarray gene expression to IHC in 81 fresh breast cancer specimens. Methods. Gene expression profiling was performed using the GeneChip Human Genome U133 Plus 2.0 arrays (Affymetrix Inc). Immunohistochemical staining for estrogen receptor, progesterone receptor, and HER2 status was performed using standard methods at a CAP-accredited pathology laboratory. Concordance rates, agreement measures, and kappa scores were calculated for both methods. Results. For ER, Kappa score was 0.918 (95% CI, 0.77.3–1.000) and concordance rate was 97.5% (95% CI, 91.4%–99.7%). For PR, Kappa score was 0.652 (95% CI, 0.405–0.849) and concordance rate was 86.4% (95% CI, 77%–93%). For HER2, Kappa score was 0.709 (95% CI, 0.428–0.916) and concordance rate was 97.5% (95% CI, 91.4%–99.7%). Conclusion. Our results are in line with the available evidence with the concordance rate being the lowest for the progesterone receptor. In general, microarray gene expression and IHC proved to have high concordance rates. Several factors can increase the discordance rate such as differences in sample processing.


Sign in / Sign up

Export Citation Format

Share Document