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Previous Volume 330:1260-1266 May 5, 1994 Number 18 Next

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ABSTRACT

Background The role of molecular markers in predicting the response to treatment of breast cancer is poorly defined. The Cancer and Leukemia Group B (CALGB) conducted a randomized adjuvant-chemotherapy trial (CALGB 8541) comparing three doses (high, moderate, and low) of cyclophosphamide, doxorubicin, and fluorouracil in 1572 women with node-positive breast cancer. This study (CALGB 8869) was designed to determine whether the DNA index, the S-phase fraction, c-erbB-2 expression, or p53 accumulation could be used as a marker to identify a subgroup of patients more likely than others to benefit from high doses of chemotherapy.

Methods Tissue blocks were obtained from 442 patients randomly selected from the larger CALGB trial. Paraffin sections from the primary lesions were analyzed for DNA content, S-phase fraction, c-erbB-2 expression, and p53 accumulation.

Results Patients randomly assigned to the high-dose regimen of adjuvant chemotherapy had significantly longer disease-free and overall survival if their tumors had c-erbB-2 overexpression. No further information was gained by adding the data on S-phase fraction or p53 accumulation to the analysis. There was no clear evidence of a dose-response effect in patients with minimal or no c-erbB-2 expression.

Conclusions There is a significant dose-response effect of adjuvant chemotherapy with cyclophosphamide, doxorubicin, and fluorouracil in patients with overexpression of c-erbB-2 but not in patients with no c-erbB-2 expression or minimal c-erbB-2 expression. Overexpression of c-erbB-2 may be a useful marker to identify the patients who are most likely to benefit from high doses of adjuvant chemotherapy.

Source Information

From the Bowman Gray School of Medicine, Winston-Salem, N.C. (H.B.M., T.K.); Massachusetts General Hospital, Boston (A.D.T., F.K.); the Statistical Office of the Cancer and Leukemia Group B, Durham, N.C. (D.A.B., C.T.C.); the Department of Medicine, University of North Carolina School of Medicine, Chapel Hill (E.T.L.); North Shore University Hospital (New York Hospital), New York (D.R.B.); Emory University, Atlanta (W.C.W.); the Department of Medicine, Roswell Park Memorial Institute, Buffalo, N.Y. (M.B.); and the University of California, San Francisco (I.C.H.).

Address reprint requests to Dr. Thor at the Department of Pathology, University of Vermont School of Medicine, Medical Alumni Bldg., Burlington, VT 05405.

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Adjuvant Therapy for Breast Cancer
Muller H.-J., Gleiter C. H., Gundert-Remy U., Melnychuk D., Panasci L. C., Coppin C. M.L., Goldie J. H., Sauter C., Garey J., Lehrer S., Farkas D. H., Umek R. M., Morrison B. W., Atkins C. D., Wood W. C., Budman D., Henderson I. C., Muss H. B., Thor A. D., Berry D. A., Goldhirsch A., Gelber R. D.
Extract | Full Text  
N Engl J Med 1994; 331:741-746, Sep 15, 1994. Correspondence

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• Parton, M., Krajewski, S., Smith, I., Krajewska, M., Archer, C., Naito, M., Ahern, R., Reed, J., Dowsett, M. (2002). Coordinate Expression of Apoptosis-associated Proteins in Human Breast Cancer before and during Chemotherapy. Clin. Cancer Res. 8: 2100-2108 [Abstract] [Full Text]  
• Schilsky, R. L., Dressler, L. M., Bucci, D., Monovich, L., Jewell, S., Suster, S., Caligiuri, M. A., Kantoff, P. W., Compton, C. (2002). Cooperative Group Tissue Banks As Research Resources: The Cancer and Leukemia Group B Tissue Repositories. Clin. Cancer Res. 8: 943-948 [Full Text]  
• Park, J. W., Hong, K., Kirpotin, D. B., Colbern, G., Shalaby, R., Baselga, J., Shao, Y., Nielsen, U. B., Marks, J. D., Moore, D., Papahadjopoulos, D., Benz, C. C. (2002). Anti-HER2 Immunoliposomes: Enhanced Efficacy Attributable to Targeted Delivery. Clin. Cancer Res. 8: 1172-1181 [Abstract] [Full Text]  
• Seidman, A., Hudis, C., Pierri, M. K., Shak, S., Paton, V., Ashby, M., Murphy, M., Stewart, S. J., Keefe, D. (2002). Cardiac Dysfunction in the Trastuzumab Clinical Trials Experience. JCO 20: 1215-1221 [Abstract] [Full Text]  
• Barnes, C. J., Li, F., Mandal, M., Yang, Z., Sahin, A. A., Kumar, R. (2002). Heregulin Induces Expression, ATPase Activity, and Nuclear Localization of G3BP, a Ras Signaling Component, in Human Breast Tumors. Cancer Res. 62: 1251-1255 [Abstract] [Full Text]  
• Guidi, A. J., Berry, D. A., Broadwater, G., Helmchen, B., Bleiweiss, I. J., Budman, D. R., Henderson, I. C., Norton, L., Hayes, D. F. (2002). Association of Angiogenesis and Disease Outcome in Node-Positive Breast Cancer Patients Treated With Adjuvant Cyclophosphamide, Doxorubicin, and Fluorouracil: A Cancer and Leukemia Group B Correlative Science Study From Protocols 8541/8869. JCO 20: 732-742 [Abstract] [Full Text]  
• Ravdin, P. M. (2001). Is Her2 of Value in Identifying Patients Who Particularly Benefit From Anthracyclines During Adjuvant Therapy? A Qualified Yes.. J Natl Cancer Inst Monogr 2001: 80-84 [Abstract] [Full Text]  
• Kim, Y. S., Konoplev, S. N., Montemurro, F., Hoy, E., Smith, T. L., Rondon, G., Champlin, R. E., Sahin, A. A., Ueno, N. T. (2001). HER-2/neu Overexpression As a Poor Prognostic Factor for Patients with Metastatic Breast Cancer undergoing High-dose Chemotherapy with Autologous Stem Cell Transplantation. Clin. Cancer Res. 7: 4008-4012 [Abstract] [Full Text]  
• Colleoni, M., Gelber, S., Coates, A. S., Castiglione-Gertsch, M., Gelber, R. D., Price, K., Rudenstam, C.-M., Lindtner, J., Collins, J., Thurlimann, B., Holmberg, S. B., Cortes-Funes, H., Simoncini, E., Murray, E., Fey, M., Goldhirsch, A. (2001). Influence of Endocrine-Related Factors on Response to Perioperative Chemotherapy for Patients With Node-Negative Breast Cancer. JCO 19: 4141-4149 [Abstract] [Full Text]  
• Baron, A. T., Lafky, J. M., Suman, V. J., Hillman, D. W., Buenafe, M. C., Boardman, C. H., Podratz, K. C., Perez, E. A., Maihle, N. J. (2001). A Preliminary Study of Serum Concentrations of Soluble Epidermal Growth Factor Receptor (sErbB1), Gonadotropins, and Steroid Hormones in Healthy Men and Women. Cancer Epidemiol. Biomarkers Prev. 10: 1175-1185 [Abstract] [Full Text]  
• Paradiso, A., Schittulli, F., Cellamare, G., Mangia, A., Marzullo, F., Lorusso, V., De Lena, M. (2001). Randomized Clinical Trial of Adjuvant Fluorouracil, Epirubicin, and Cyclophosphamide Chemotherapy for Patients With Fast-Proliferating, Node-Negative Breast Cancer. JCO 19: 3929-3937 [Abstract] [Full Text]  
• Hait, W. N. (2001). The Prognostic and Predictive Values of ECD-HER-2. Clin. Cancer Res. 7: 2601-2604 [Abstract] [Full Text]  
• Hayes, D. F., Yamauchi, H., Broadwater, G., Cirrincione, C. T., Rodrigue, S. P., Berry, D. A., Younger, J., Panasci, L. L., Millard, F., Duggan, D. B., Norton, L., Henderson, I. C. (2001). Circulating HER-2/erbB-2/c-neu (HER-2) Extracellular Domain as a Prognostic Factor in Patients with Metastatic Breast Cancer: Cancer and Leukemia Group B Study 8662. Clin. Cancer Res. 7: 2703-2711 [Abstract] [Full Text]  
• Simon, R., Nocito, A., Hubscher, T., Bucher, C., Torhorst, J., Schraml, P., Bubendorf, L., Mihatsch, M. M., Moch, H., Wilber, K., Schotzau, A., Kononen, J., Sauter, G. (2001). Patterns of HER-2/neu Amplification and Overexpression in Primary and Metastatic Breast Cancer. JNCI J Natl Cancer Inst 93: 1141-1146 [Abstract] [Full Text]  
• Petit, T., Borel, C., Ghnassia, J.-P., Rodier, J.-F., Escande, A., Mors, R., Haegele, P. (2001). Chemotherapy Response of Breast Cancer Depends on HER-2 Status and Anthracycline Dose Intensity in the Neoadjuvant Setting. Clin. Cancer Res. 7: 1577-1581 [Abstract] [Full Text]  
• Birner, P., Oberhuber, G., Stani, J., Reithofer, C., Samonigg, H., Hausmaninger, H., Kubista, E., Kwasny, W., Kandioler-Eckersberger, D., Gnant, M., Jakesz, R. (2001). Evaluation of the United States Food and Drug Administration-approved Scoring and Test System of HER-2 Protein Expression in Breast Cancer. Clin. Cancer Res. 7: 1669-1675 [Abstract] [Full Text]  
• Liu, S., Edgerton, S. M., Moore, D. H. II, Thor, A. D. (2001). Measures of Cell Turnover (Proliferation and Apoptosis) and Their Association with Survival in Breast Cancer. Clin. Cancer Res. 7: 1716-1723 [Abstract] [Full Text]  
• Akewanlop, C., Watanabe, M., Singh, B., Walker, M., Kufe, D. W., Hayes, D. F. (2001). Phagocytosis of Breast Cancer Cells Mediated by Anti-MUC-1 Monoclonal Antibody, DF3, and Its Bispecific Antibody. Cancer Res. 61: 4061-4065 [Abstract] [Full Text]  
• Yamauchi, H., Stearns, V., Hayes, D. F. (2001). When Is a Tumor Marker Ready for Prime Time? A Case Study of c-erbB-2 as a Predictive Factor in Breast Cancer. JCO 19: 2334-2356 [Abstract] [Full Text]  
• Zhou, Z., Jia, S.-F., Hung, M.-C., Kleinerman, E. S. (2001). E1A Sensitizes HER2/neu-overexpressing Ewing's Sarcoma Cells to Topoisomerase II-targeting Anticancer Drugs. Cancer Res. 61: 3394-3398 [Abstract] [Full Text]  
• Bast, R. C. Jr, Ravdin, P., Hayes, D. F., Bates, S., Fritsche, H. Jr, Jessup, J. M., Kemeny, N., Locker, G. Y., Mennel, R. G., Somerfield, M. R. (2001). 2000 Update of Recommendations for the Use of Tumor Markers in Breast and Colorectal Cancer: Clinical Practice Guidelines of the American Society of Clinical Oncology. JCO 19: 1865-1878 [Abstract] [Full Text]  
• Braun, S., Schlimok, G., Heumos, I., Schaller, G., Riethdorf, L., Riethmüller, G., Pantel, K. (2001). erbB2 Overexpression on Occult Metastatic Cells in Bone Marrow Predicts Poor Clinical Outcome of Stage I-III Breast Cancer Patients. Cancer Res. 61: 1890-1895 [Abstract] [Full Text]  
• Menard, S., Valagussa, P., Pilotti, S., Gianni, L., Biganzoli, E., Boracchi, P., Tomasic, G., Casalini, P., Marubini, E., Colnaghi, M. I., Cascinelli, N., Bonadonna, G. (2001). Response to Cyclophosphamide, Methotrexate, and Fluorouracil in Lymph Node-Positive Breast Cancer According to HER2 Overexpression and Other Tumor Biologic Variables. JCO 19: 329-335 [Abstract] [Full Text]