© 2002 by Oxford University Press
Journal of the National Cancer Institute, Vol. 94, No. 11, 852-854,
June 5, 2002
© 2002 Oxford University Press
BRIEF COMMUNICATION |
Real-World Performance of HER2 Testing—National Surgical Adjuvant Breast and Bowel Project Experience
Affiliations of authors: S. Paik, E. Tan-Chiu, W. Hiller, K. Park, R. Smith, D. L. Wickerham, N. Wolmark, National Surgical Adjuvant Breast and Bowel Project (NSABP) Operation Center, Pittsburgh, PA; J. Bryant, NSABP Biostatistical Center, Pittsburgh, Departments of Statistics and Biostatistics, University of Pittsburgh, PA; E. Romond, Division of Hematology/Oncology, Markey Cancer Center, University of Kentucky, Lexington; A. Brown, NSABP Biostatistical Center; G. Yothers, NSABP Biostatistical Center, and Department of Statistics, University of Pittsburgh; S. Anderson, Center for Molecular Biology and Pathology, Laboratory Corporation of America Holdings, Research Triangle Park, NC.
Correspondence to: Soonmyung Paik, M.D., Division of Pathology, National Surgical Adjuvant Breast and Bowel Project, Four Allegheny Center 5th Floor, East Commons Professional Bldg., Pittsburgh, PA 15212 (e-mail: soon.paik{at}nsabp.org).
ABSTRACT
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 HercepTestTM 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.
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