External Quality Assessment (EQA) program for the preanalytical and analytical immunohistochemical determination of HER2 in breast cancer: an experience on a regional scale

Abstract

BackgroundAn External Quality Assessment (EQA) program was developed to investigate the state of the art of HER2 immunohistochemical determination in breast cancer (BC) in 16 Pathology Departments in the Lazio Region (Italy). This program was implemented through two specific steps to evaluate HER2 staining (step 1) and interpretation (step 2) reproducibility among participants.MethodsThe management activities of this EQA program were assigned to the Coordinating Center (CC), the Revising Centers (RCs) and the Participating Centers (PCs). In step 1, 4 BC sections, selected by RCs, were stained by each PC using their own procedures. In step 2, each PC interpreted HER2 score in 10 BC sections stained by the CC. The concordance pattern was evaluated by using the kappa category-specific statistic and/or the weighted kappa statistic with the corresponding 95% Jackknife confidence interval.ResultsIn step 1, a substantial/almost perfect agreement was reached between the PCs for scores 0 and 3+ whereas a moderate and fair agreement was observed for scores 1+ and 2+, respectively.In step 2, a fully satisfactory agreement was observed for 6 out of the 16 PCs and a quite satisfactory agreement was obtained for the remaining 10 PCs.ConclusionsOur findings highlight that in the whole HER2 evaluation process the two intermediate categories, scores 1+ and 2+, are less reproducible than scores 0 and 3+. These findings are relevant in clinical practice where the choice of treatment is based on HER2 positivity, suggesting the need to share evaluation procedures within laboratories and implement educational programs.

Moving from Discovery to Validation in Circulating microRNA Research

“…To investigate the technical reproducibility between the Megaplex and the customized cards, we computed as measure of agreement the concordance correlation coefficient (CCC) and its 95% confidence interval (95% CI) (13) starting from the log 2 RQ values of the 7 miRNAs of interest, evaluated in the same 60 samples with the 2 methods. In line with our previous experience (14, 15), the observed value of CCC was considered fully satisfactory only when the lower limit of the 95% CI was equal to or greater than 0.80. The statistical analyses were carried out with SAS software (version 9.2; SAS Institute Inc., Cary, NC, USA).…”

The novel desmopressin analogue [V4Q5]dDAVP inhibits angiogenesis, tumour growth and metastases in vasopressin type 2 receptor-expressing breast cancer models

“…Triple-negative breast cancer is defined by a lack of expression of both PR and ER, as well as a low expression of (HER2)/neu ( 35 ). There have been significant improvements in the outcome of other subtypes of breast cancer, including ER-positive/HER2 overexpressed tumours, attributed to the addition of targeted therapy, including hormonal agents and trastuzumab/pertuzumab ( 36 , 37 ). However, no targeted therapies are available for the treatment of triple-negative breast cancer, and frontline treatments are limited to surgical approaches and chemotherapeutics ( 38 ).…”

HER2 Status Determination

“…Furthermore, pathology laboratories that handle a limited number of cases a year are likely to benefit from the experience of RCs that should take a leading role in the initiation of such quality control studies. The creation of the Breast Units and the participation in regional/interregional and/or national quality control programs, 13 in our opinion, could be of help to ensure the correct preanalytical standardization 14 , 15 that, to date, is essential in BC as in other tumor pathology. However, even in the absence of Breast Units, we believe that an effective collaboration between the various professionals involved in BC diagnosis, it will certainly be of help to reduce these kinds of problems.…”