Real-world performance of HER2 testing--National Surgical Adjuvant Breast and Bowel Project experience.
Trastuzumab (Herceptin) provides clinical benefits for patients diagnosed with advanced breast cancers that have overexpressed the HER2 protein or have amplified the HER2 gene. The National Surgical Adjuvant Breast and Bowel Project (NSABP) Protocol B-31 is designed to test the advantage of adding Herceptin to the adjuvant chemotherapeutic regimen of doxorubicin and cyclophosphamide followed by paclitaxel (Taxol) in the treatment of stage II breast cancer with HER2 overexpression or gene amplification. Eligibility is based on HER2 assay results submitted by the accruing institutions. We conducted a central review of the first 104 cases entered in this trial on the basis of immunohistochemistry (IHC) results. We found that 18% of the community-based assays, which were used to establish the eligibility of patients to participate in the B-31 study, could not be confirmed by HercepTest IHC or fluorescence in situ hybridization (FISH) by a central testing facility. This report provides a snapshot of the quality of HER2 assays performed in laboratories nationwide.
Paik
Soonmyung
S
National Surgical Adjuvant Breast and Bowel Project (NSABP) Operation Center, Pittsburgh, PA 15212, USA. soon.paik@nsabp.org
Bryant
John
J
Tan-Chiu
Elizabeth
E
Romond
Edward
E
Hiller
William
W
Park
Kyeongmee
K
Brown
Ann
A
Yothers
Greg
G
Anderson
Steve
S
Smith
Roy
R
Wickerham
D Lawrence
DL
Wolmark
Norman
N
D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000378:metabolism* / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D002986:Clinical Trials as Topic / Q000379:methods; D000075202:Contraindications; D003951:Diagnostic Errors; D005784:Gene Amplification; D006801:Humans; D007150:Immunohistochemistry; D017404:In Situ Hybridization, Fluorescence; D018579:Patient Selection; D011785:Quality Assurance, Health Care; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000032:analysis* / Q000235:genetics / Q000378:metabolism; D015203:Reproducibility of Results; D000068878:Trastuzumab
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab