Abstract
Background: An 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. Methods. The 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. Results: In 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. Conclusions: Our 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.
| Original language | English |
|---|---|
| Article number | 58 |
| Journal | Journal of Experimental and Clinical Cancer Research |
| Volume | 32 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 2013 |
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Keywords
- Breast Neoplasm/drug therapy
- Immunohistochemistry/ methods
- Quality control
- Receptor erbB-2/analysis
- Reproducibility of results
ASJC Scopus subject areas
- Cancer Research
- Oncology
Cite this
External Quality Assessment (EQA) program for the preanalytical and analytical immunohistochemical determination of HER2 in breast cancer : An experience on a regional scale. / Terrenato, Irene; Arena, Vincenzo; Pizzamiglio, Sara; Pennacchia, Ilaria; Perracchio, Letizia; Buglioni, Simonetta; Ercolani, Cristiana; Sperati, Francesca; Costarelli, Leopoldo; Bonanno, Elena; Baldini, Daniela; Candia, Silvia; Crescenzi, Anna; Dal Mas, Antonella; Di Cristofano, Claudio; Gomes, Vito; Grillo, Lucia Rosalba; Pasquini, Paola; Pericoli, Maria Nicoletta; Ramieri, Maria Teresa; Di Stefano, Domenica; Ruco, Luigi; Scarpino, Stefania; Vitolo, Domenico; D'Amati, Giulia; Paradiso, Angelo; Verderio, Paolo; Mottolese, Marcella.
In: Journal of Experimental and Clinical Cancer Research, Vol. 32, No. 1, 58, 2013.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - External Quality Assessment (EQA) program for the preanalytical and analytical immunohistochemical determination of HER2 in breast cancer
T2 - An experience on a regional scale
AU - Terrenato, Irene
AU - Arena, Vincenzo
AU - Pizzamiglio, Sara
AU - Pennacchia, Ilaria
AU - Perracchio, Letizia
AU - Buglioni, Simonetta
AU - Ercolani, Cristiana
AU - Sperati, Francesca
AU - Costarelli, Leopoldo
AU - Bonanno, Elena
AU - Baldini, Daniela
AU - Candia, Silvia
AU - Crescenzi, Anna
AU - Dal Mas, Antonella
AU - Di Cristofano, Claudio
AU - Gomes, Vito
AU - Grillo, Lucia Rosalba
AU - Pasquini, Paola
AU - Pericoli, Maria Nicoletta
AU - Ramieri, Maria Teresa
AU - Di Stefano, Domenica
AU - Ruco, Luigi
AU - Scarpino, Stefania
AU - Vitolo, Domenico
AU - D'Amati, Giulia
AU - Paradiso, Angelo
AU - Verderio, Paolo
AU - Mottolese, Marcella
PY - 2013
Y1 - 2013
N2 - Background: An 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. Methods. The 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. Results: In 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. Conclusions: Our 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.
AB - Background: An 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. Methods. The 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. Results: In 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. Conclusions: Our 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.
KW - Breast Neoplasm/drug therapy
KW - Immunohistochemistry/ methods
KW - Quality control
KW - Receptor erbB-2/analysis
KW - Reproducibility of results
UR - http://www.scopus.com/inward/record.url?scp=84882351787&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84882351787&partnerID=8YFLogxK
U2 - 10.1186/1756-9966-32-58
DO - 10.1186/1756-9966-32-58
M3 - Article
VL - 32
JO - Journal of Experimental and Clinical Cancer Research
JF - Journal of Experimental and Clinical Cancer Research
SN - 0392-9078
IS - 1
M1 - 58
ER -