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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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• 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]  
• Paik, S., Bryant, J., Tan-Chiu, E., Yothers, G., Park, C., Wickerham, D. L., Wolmark, N. (2000). HER2 and Choice of Adjuvant Chemotherapy for Invasive Breast Cancer: National Surgical Adjuvant Breast and Bowel Project Protocol B-15. JNCI J Natl Cancer Inst 92: 1991-1998 [Abstract] [Full Text]  
• Carr, J. A., Havstad, S., Zarbo, R. J., Divine, G., Mackowiak, P., Velanovich, V. (2000). The Association of HER-2/neu Amplification With Breast Cancer Recurrence. Arch Surg 135: 1469-1474 [Abstract] [Full Text]  
• Ferrero-Poüs, M., Hacène, K., Bouchet, C., Le Doussal, V., Tubiana-Hulin, M., Spyratos, F. (2000). Relationship between c-erbB-2 and Other Tumor Characteristics in Breast Cancer Prognosis. Clin. Cancer Res. 6: 4745-4754 [Abstract] [Full Text]  
• Pauletti, G., Dandekar, S., Rong, H., Ramos, L., Peng, H., Seshadri, R., Slamon, D. J. (2000). Assessment of Methods for Tissue-Based Detection of the HER-2/neu Alteration in Human Breast Cancer: A Direct Comparison of Fluorescence In Situ Hybridization and Immunohistochemistry. JCO 18: 3651-3664 [Abstract] [Full Text]  
• Berry, D. A., Muss, H. B., Thor, A. D., Dressler, L., Liu, E. T., Broadwater, G., Budman, D. R., Henderson, I. C., Barcos, M., Hayes, D., Norton, L. (2000). HER-2/neu and p53 Expression Versus Tamoxifen Resistance in Estrogen Receptor-Positive, Node-Positive Breast Cancer. JCO 18: 3471-3479 [Abstract] [Full Text]  
• Mandler, R., Wu, C., Sausville, E. A., Roettinger, A. J., Newman, D. J., Ho, D. K., King, C. R., Yang, D., Lippman, M. E., Landolfi, N. F., Dadachova, E., Brechbiel, M. W., Waldmann, T. A. (2000). Immunoconjugates of Geldanamycin and Anti-HER2 Monoclonal Antibodies: Antiproliferative Activity on Human Breast Carcinoma Cell Lines. JNCI J Natl Cancer Inst 92: 1573-1581 [Abstract] [Full Text]  
• Amadori, D., Nanni, O., Marangolo, M., Pacini, P., Ravaioli, A., Rossi, A., Gambi, A., Catalano, G., Perroni, D., Scarpi, E., Giunchi, D. C., Tienghi, A., Becciolini, A., Volpi, A. (2000). Disease-Free Survival Advantage of Adjuvant Cyclophosphamide, Methotrexate, and Fluorouracil in Patients With Node-Negative, Rapidly Proliferating Breast Cancer: A Randomized Multicenter Study. JCO 18: 3125-3134 [Abstract] [Full Text]  
• Thor, A. D., Liu, S., Edgerton, S., Moore, D. II, Kasowitz, K. M., Benz, C. C., Stern, D. F., DiGiovanna, M. P. (2000). Activation (Tyrosine Phosphorylation) of ErbB-2 (HER-2/neu): A Study of Incidence and Correlation With Outcome in Breast Cancer. JCO 18: 3230-3239 [Abstract] [Full Text]  
• Kuter, I. (2000). Breast Cancer Update. The Oncologist 5: 285-292 [Abstract] [Full Text]  
• Emilien, G., Ponchon, M., Caldas, C., Isacson, O., Maloteaux, J.-M. (2000). Impact of genomics on drug discovery and clinical medicine. QJM 93: 391-423 [Abstract] [Full Text]  
• Orr, M. S., O'Connor, P. M., Kohn, K. W. (2000). Effects of c-erbB2 Overexpression on the Drug Sensitivities of Normal Human Mammary Epithelial Cells. JNCI J Natl Cancer Inst 92: 987-994 [Abstract] [Full Text]  
• Cantero, R., Torres, A. J., Maestro, M. L., Hernando, F., Sanz, M. T., del Barco, V., Gomez, A., Fernandez, C., Balibrea, J. L. (2000). PROGNOSTIC VALUE OF THE QUANTIFIED EXPRESSION OF P185c-erbB2 IN NON-SMALL CELL LUNG CANCER. J. Thorac. Cardiovasc. Surg. 119: 1119-1125 [Abstract] [Full Text]  
• Colomer, R., Montero, S., Lluch, A., Ojeda, B., Barnadas, A., Casado, A., Massutí, B., Cortés-Funes, H., Lloveras, B. (2000). Circulating HER2 Extracellular Domain and Resistance to Chemotherapy in Advanced Breast Cancer. Clin. Cancer Res. 6: 2356-2362 [Abstract] [Full Text]  
• Simpson, J. F., Gray, R., Dressler, L. G., Cobau, C. D., Falkson, C. I., Gilchrist, K. W., Pandya, K. J., Page, D. L., Robert, N. J. (2000). Prognostic Value of Histologic Grade and Proliferative Activity in Axillary Node-Positive Breast Cancer: Results From the Eastern Cooperative Oncology Group Companion Study, EST 4189. JCO 18: 2059-2069 [Abstract] [Full Text]