External Quality Assessment (EQA) program for the preanalytical and analytical immunohistochemical determination of HER2 in breast cancer

An experience on a regional scale

Irene Terrenato, Vincenzo Arena, Sara Pizzamiglio, Ilaria Pennacchia, Letizia Perracchio, Simonetta Buglioni, Cristiana Ercolani, Francesca Sperati, Leopoldo Costarelli, Elena Bonanno, Daniela Baldini, Silvia Candia, Anna Crescenzi, Antonella Dal Mas, Claudio Di Cristofano, Vito Gomes, Lucia Rosalba Grillo, Paola Pasquini, Maria Nicoletta Pericoli, Maria Teresa Ramieri & 8 others Domenica Di Stefano, Luigi Ruco, Stefania Scarpino, Domenico Vitolo, Giulia D'Amati, Angelo Paradiso, Paolo Verderio, Marcella Mottolese

Research output: Contribution to journalArticle

9 Citations (Scopus)

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 languageEnglish
Article number58
JournalJournal of Experimental and Clinical Cancer Research
Volume32
Issue number1
DOIs
Publication statusPublished - 2013

Fingerprint

Breast Neoplasms
Italy
Confidence Intervals
Pathology
Staining and Labeling

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 journalArticle

Terrenato, I, Arena, V, Pizzamiglio, S, Pennacchia, I, Perracchio, L, Buglioni, S, Ercolani, C, Sperati, F, Costarelli, L, Bonanno, E, Baldini, D, Candia, S, Crescenzi, A, Dal Mas, A, Di Cristofano, C, Gomes, V, Grillo, LR, Pasquini, P, Pericoli, MN, Ramieri, MT, Di Stefano, D, Ruco, L, Scarpino, S, Vitolo, D, D'Amati, G, Paradiso, A, Verderio, P & Mottolese, M 2013, 'External Quality Assessment (EQA) program for the preanalytical and analytical immunohistochemical determination of HER2 in breast cancer: An experience on a regional scale', Journal of Experimental and Clinical Cancer Research, vol. 32, no. 1, 58. https://doi.org/10.1186/1756-9966-32-58
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. / External Quality Assessment (EQA) program for the preanalytical and analytical immunohistochemical determination of HER2 in breast cancer : An experience on a regional scale. In: Journal of Experimental and Clinical Cancer Research. 2013 ; Vol. 32, No. 1.
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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.",
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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.

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KW - Breast Neoplasm/drug therapy

KW - Immunohistochemistry/ methods

KW - Quality control

KW - Receptor erbB-2/analysis

KW - Reproducibility of results

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