Guidelines for HER2 testing in breast cancer: a national consensus of the Spanish Society of Pathology (SEAP) and the Spanish Society of Medical Oncology (SEOM).
Identifying breast cancers with HER2 overexpression or amplification is critical as these usually imply the use of HER2-targeted therapies. DNA (amplification) and protein (overexpression) HER2 abnormalities usually occur simultaneously and both in situ hybridisation and immunohistochemistry may be accurate methods for the evaluation of these abnormalities. However, recent studies, including those conducted by the Association for Quality Assurance of the Spanish Society of Pathology, as well as the experience of a number of HER2 testing National Reference Centres have suggested the existence of serious reproducibility issues with both techniques. To address this issue, a joint committee from the Spanish Society of Pathology (SEAP) and the Spanish Society of Medical Oncology (SEOM) was established to review the HER2 testing guidelines. Consensus recommendations are based not only on the panellists' experience, but also on previous consensus guidelines from several countries, including the USA, the UK and Canada. These guidelines include the minimal requirements that pathology departments should fulfil in order to guarantee proper HER2 testing in breast cancer. Pathology laboratories not fulfilling these standards should make an effort to meet them and, until then, are highly encouraged to submit to reference laboratories breast cancer samples for which HER2 determination has clinical implications for the patients.
Albanell
Joan
J
Medical Oncology Department, Hospital del Mar-IMAS & Cancer Research Program, ES-08003 Barcelona, Spain. jalbanel@hospitaldelmar.cat
Andreu
Xavier
X
Calasanz
María José
MJ
Concha
Angel
A
Corominas
José María
JM
García-Caballero
Tomás
T
López
José Antonio
JA
López-Ríos
Fernando
F
Ramón y Cajal
Santiago
S
Vera-Sempere
Francisco J
FJ
Colomer
Ramón
R
Martín
Miguel
M
Alba
Emilio
E
González-Martín
Antonio
A
Llombart
Antonio
A
Lluch
Ana
A
Palacios
José
J
D000465:Algorithms; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy / Q000235:genetics* / Q000473:pathology; D018270:Carcinoma, Ductal, Breast / Q000188:drug therapy / Q000235:genetics* / Q000473:pathology; D017326:Clinical Trials, Phase III as Topic / Q000706:statistics & numerical data; D004273:DNA, Neoplasm / Q000032:analysis*; D005260:Female; D005568:Forms and Records Control / Q000592:standards; D018734:Genes, erbB-2; D006801:Humans; D007150:Immunohistochemistry / Q000379:methods* / Q000592:standards; D017403:In Situ Hybridization / Q000379:methods* / Q000592:standards; D015337:Multicenter Studies as Topic; D010337:Pathology Department, Hospital / Q000458:organization & administration / Q000592:standards* / Q000706:statistics & numerical data; D011785:Quality Assurance, Health Care / Q000458:organization & administration; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D013030:Spain; D013048:Specimen Handling / Q000379:methods* / Q000592:standards; D000068878:Trastuzumab
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D004273:DNA, Neoplasm; D011933:Reagent Kits, Diagnostic; D000068878:Trastuzumab