erbB-2, p53, and Efficacy of Adjuvant Therapy in Lymph Node-Positive Breast Cancer (original) (raw)

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Revision received:

06 June 1998

Published:

16 September 1998

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Ann D. Thor, Donald A. Berry, Daniel R. Budman, Hyman B. Muss, Timothy Kute, I. Craig Henderson, Maurice Barcos, Constance Cirrincione, Susan Edgerton, Craig Allred, Larry Norton, Edison T. Liu, erbB-2, p53, and Efficacy of Adjuvant Therapy in Lymph Node-Positive Breast Cancer, JNCI: Journal of the National Cancer Institute, Volume 90, Issue 18, 16 September 1998, Pages 1346–1360, https://doi.org/10.1093/jnci/90.18.1346
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Abstract

Background: We have previously reported that high expression of the erbB-2 gene (also known as HER-2/neu and ERBB2) in breast cancer is associated with patient response to dose-intensive treatment with cyclophosphamide, doxorubicin (Adriamycin), and 5-flurouracil (CAF) on the basis of short-term follow-up of 397 patients (set A) with axillary lymph node-positive tumors who were enrolled in Cancer and Leukemia Group B (CALGB) protocol 8541. Methods: To validate those findings, we conducted immunohistochemical analyses of erbB-2 and p53 protein expression in an additional cohort of 595 patients (set B) from CALGB 8541, as well as a molecular analysis of erbB-2 gene amplification in tumors from all patients (sets A and B). Marker data were compared with clinical, histologic, treatment, and outcome data. Results: Updated analyses of data from set A (median follow-up, 10.4 years) showed an even stronger interaction between erbB-2 expression and CAF dose, by use of either immunohistochemical or molecular data. A similar interaction between erbB-2 expression and CAF dose was observed in all 992 patients, analyzed as a single group. However, for set B alone (median follow-up, 8.2 years), results varied with the method of statistical analysis. By use of a proportional hazards model, the erbB-2 expression-CAF dose interaction was not significant for all patients. However, in the subgroups of patients randomly assigned to the high- or the moderate-dose arms, significance was achieved. When patient data were adjusted for differences by use of a prognostic index (to balance an apparent failure of randomization in the low-dose arm), the erbB-2 expression-CAF dose interaction was significant in all patients from the validation set B as well. An interaction was also observed between p53 immunopositivity and CAF dose. Conclusions: The hypothesis that patients whose breast tumors exhibit high erbB-2 expression benefit from dose-intensive CAF should be further validated before clinical implementation. Interactions between erbB-2 expression, p53 expression, and CAF dose underscore the complexities of predictive markers where multiple interactions may confound the outcome. [J Natl Cancer Inst 1998;90:1346-60]

© 1998 Oxford University Press

Topic:

• doxorubicin
• cancer
• cyclophosphamide
• axilla
• breast neoplasms
• follow-up
• genes, erbb-2
• lymph
• protein p53
• receptor, erbb-2
• arm
• neoplasms
• patient prognosis
• breast cancer
• adjuvant therapy
• amplification
• predictive marker
• cancer and leukemia group b

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