© 2002 by Oxford University Press
Journal of the National Cancer Institute, Vol. 94, No. 11, 855-857,
June 5, 2002
© 2002 Oxford University Press
BRIEF COMMUNICATION |
Concordance Between Local and Central Laboratory HER2 Testing in the Breast Intergroup Trial N9831
Affiliations of authors: P. C. Roche, V. J. Suman, R. B. Jenkins, J. N. Ingle, Mayo Clinic and Mayo Foundation, Rochester, MN; N. E. Davidson, Eastern Cooperative Oncology Group Data Management Office, Brookline, MA; S. Martino, Southwest Oncology Group Operations Office, San Antonio, TX; P. A. Kaufman, Cancer and Leukemia Group B Data Management Center, Durham, NC; F. K. Addo, Medcenter One Health Systems, and Mid Dakota Clinic, Bismarck, ND; B. Murphy, Metro-Minnesota Community Oncology Program, St. Louis Park, MN; E. A. Perez, Mayo Clinic and Mayo Foundation, Jacksonville, FL.
Correspondence to: Edith A. Perez, M.D., Mayo Clinic, Division of Hematology/Oncology, 4500 San Pablo Rd., Jacksonville, FL 32224 (e-mail: perez.edith{at}mayo.edu).
ABSTRACT
The efficacy of trastuzumab for metastases coupled with the relatively poor prognosis of patients with node-positive, HER2-positive breast cancer has led to the evaluation of trastuzumab as an adjuvant therapy. A prospective, randomized, three-arm, phase III trial is being conducted by the Breast Intergroup (N9831) for women with primary, operable, histologically confirmed, node-positive breast carcinoma that strongly overexpresses (3+) HER2 protein and/or displays HER2/neu gene amplification, as determined by local laboratory testing. The protocol requires confirmatory central testing of HER2 status using the HercepTestTM immunohistochemistry and the Vysis PathVysionTM fluorescence in situ hybridization (FISH) assays. Tumor specimens from the first 119 patients enrolled in N9831 were centrally tested; 74% were found to be HercepTestTM 3+ and 66% were found to have HER2 gene amplification. Only six of nine (67%) of the specimens submitted by local laboratories as FISH positive could be confirmed by central assays. The concordance for central HercepTestTM and central FISH assays was 92%. The poor concordance (74%) between local and central testing for HER2 status has led to modifications in the eligibility criteria for N9831.
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