Information de reference pour ce titreAccession Number: | 00005042-200206050-00010.
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Author: | Roche, Patrick C. 1; Suman, Vera J. 1; Jenkins, Robert B. 1; Davidson, Nancy E. 2; Martino, Silvana 3; Kaufman, Peter A. 4; Addo, Ferdinand K. 5; Murphy, Bronagh 6; Ingle, James N. 1; Perez, Edith A. 7
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Institution: | (1)Mayo Clinic and Mayo Foundation, Rochester, MN (2)Eastern Cooperative Oncology Group Data Management Office, Brookline, MA (3)Southwest Oncology Group Operations Office, San Antonio, TX (4)Cancer and Leukemia Group B Data Management Center, Durham, NC (5)Medcenter One Health Systems, and Mid Dakota Clinic, Bismarck, ND (6)Metro-Minnesota Community Oncology Program, St. Louis Park, MN (7)Mayo Clinic and Mayo Foundation, Jacksonville, FL.
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Title: | |
Source: | Journal of the National Cancer Institute. 94(11):855-857, June 5, 2002.
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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.
(C) Copyright Oxford University Press 2002.
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References: | (1) Slamon DJ, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 2001;344:783-92.
(2) Cobleigh MA, Vogel CL, Tripathy D, Robert NJ, Scholl S, Fehrenbacher L, et al. Multinational study of the efficacy and safety of humanized anti-HER2 monoclonal antibody in women who have HER2-overexpressing metastatic breast cancer that has progressed after chemotherapy for metastatic disease. J Clin Oncol 1999;17:2639-48.
(3) Perez EA, Comis RL, Kaufman PA, Martino S. Phase III randomized study of doxorubicin plus cyclophosphamide followed by paclitaxel with or without trastuzumab (Herceptin) in patients with HER-2-overexpressing breast cancer. [Accessed 04/30/02.] Available from: http://www.cancer.gov/clinical_t...- ouverture dans une nouvelle fenêtre.
(4) Perez EA, Roche PC, Jenkins RB, Reynolds CA, Halling KC, Ingle JN, et al. HER2 testing in patients with breast cancer: poor correlation between weak positivity by immunohistochemistry and gene amplification by fluorescence in situ hybridization. Mayo Clin Proc 2002;77:148-54.
(5) Mass RD, Sanders C, Charlene K, Johnson L, Everett T, Anderson S. The concordance between the clinical trials assay (CTA) and fluorescence in situ hybridization (FISH) in the Herceptin pivotal trials [abstract 291]. Proc ASCO 2000;19:75a.
(6) Mass RD, Press M, Anderson S, Murphy M, Slamon D. Improved survival benefit from Herceptin (trastuzumab) in patients selected by fluorescence in situ hybridization (FISH) [abstract 85]. Proc ASCO 2001;20:22a.
(7) Vogel CL, Cobleigh M, Tripathy D, Mass R, Murphy M, Stewart SJ, et al. Superior outcomes with Herceptin (trastuzumab) (H) in fluorescence in situ hybridization (FISH)-selected patients [abstract 86]. Proc ASCO 2001;20:22a.
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Language: | English.
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Document Type: | BRIEF COMMUNICATION.
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Journal Subset: | Clinical Medicine.
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ISSN: | 0027-8874
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NLM Journal Code: | j9j, 7503089
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