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Tytuł:
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Validation of the IHC4 Breast Cancer Prognostic Algorithm Using Multiple Approaches on the Multinational TEAM Clinical Trial.
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Autorzy:
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Bartlett, John M. S.
Christiansen, Jason
Gustavson, Mark
Rimm, David L.
Piper, Tammy
van de Velde, Cornelis J. H.
Hasenburg, Annette
Kieback, Dirk G.
Putter, Hein
Markopoulos, Christos J.
Dirix, Luc Y.
Seynaeve, Caroline
Rea, Daniel W.
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Temat:
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DISEASE relapse
BREAST cancer prognosis
BREAST tumors
CONFIDENCE intervals
FLUORESCENT antibody technique
DIGITAL image processing
IMMUNOHISTOCHEMISTRY
RESEARCH methodology
MULTIVARIATE analysis
ONCOGENES
PROBABILITY theory
RESEARCH funding
STATISTICS
SURVIVAL analysis (Biometry)
TUMOR markers
LOGISTIC regression analysis
DATA analysis
RANDOMIZED controlled trials
PROPORTIONAL hazards models
DATA analysis software
TISSUE arrays
KAPLAN-Meier estimator
LOG-rank test
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Źródło:
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Archives of Pathology & Laboratory Medicine. Jan2016, Vol. 140 Issue 1, p66-74. 9p. 3 Charts, 5 Graphs.
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Context.--Hormone receptors HER2/neu and Ki-67 are markers of residual risk in early breast cancer. An algorithm (IHC4) combining these markers may provide additional information on residual risk of recurrence in patients treated with hormone therapy. Objective.--To independently validate the IHC4 algorithm in the multinational Tamoxifen Versus Exemestane Adjuvant Multicenter Trial (TEAM) cohort, originally developed on the trans-ATAC (Arimidex, Tamoxifen, Alone or in Combination Trial) cohort, by comparing 2 methodologies. Design.--The IHC4 biomarker expression was quantified on TEAM cohort samples (n = 2919) by using 2 independent methodologies (conventional 3,3'-diaminobe-zidine [DAB] immunohistochemistry with image analysis and standardized quantitative immunofluorescence [QIF] by AQUA technology). The IHC4 scores were calculated by using the same previously established coefficients and then compared with recurrence-free and distant recurrence-free survival, using multivariate Cox proportional hazards modeling. Results.--The QIF model was highly significant for prediction of residual risk (P < .001), with continuous model scores showing a hazard ratio (HR) of 1.012 (95% confidence interval [95% CI]: 1.010-1.014), which was significantly higher than that for the DAB model (HR: 1.008, 95% CI: 1.006-1.009); P < .001). Each model added significant prognostic value in addition to recognized clinical prognostic factors, including nodal status, in multivariate analyses. Quantitative immunofluorescence, however, showed more accuracy with respect to overall residual risk assessment than the DAB model. Conclusions.--The use of the IHC4 algorithm was validated on the TEAM trial for predicting residual risk in patients with breast cancer. These data support the use of the IHC4 algorithm clinically, but quantitative and standardized approaches need to be used. [ABSTRACT FROM AUTHOR]
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