Biomedical Engineering Reference
In-Depth Information
accrediting agency. Preanalytical standardization procedure includes
the time from tumor removal to fixation of ≤ 1 hour, use of 10%
neutral buffered formalin (NBF) as the fixative, and the duration of
fixation from ≥ 6 hours to ≤ 72 hours, and storage of slides of ≤ 6
weeks. The procedure for analytic standardization comprises the
use of ER/PgR antibodies that have been clinically validated, and
optimal testing conditions with acceptable recommended positive
and negative controls on each batch run. Clones 1D5 and 6F11 are
the most widely used and clinically validated mouse monoclonal
antibodies for IHC use (Fig. 5.2). It is recommended that ER and PgR
assays are considered positive if there are at least 1% positive tumor
nuclei in the sample on testing in the presence of expected reactivity
of internal (normal epithelial elements) and external controls.
115
5.7
Conclusions
The prognostic and predictive values of HRs in breast cancer
treatment are established through numerous studies over several
decades. The evolution of hormonal receptor serving as predictive
biomarkers has historical value for future biomarkers studies in
breast cancer and other cancer types. Robust clinical validation
of the molecular factors that predict sensitivity and resistance of
endocrine therapy identified in preclinical and small sample size
clinical studies should be a focus in future investigations. In turn,
more patients could experience response and benefit from endocrine
therapy.
References
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2. Early Breast Cancer Trialists' Collaborative Group (EBCTCG) Effects
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recurrence and 15-year survival: an overview of the randomised trials.
Lancet
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3. Beatson, G.T. On the treatment of inoperable cases of carcinoma of the
mamma: suggestions for a new method of treatment, with illustrative
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