© 1998 by Oxford University Press
Journal of the National Cancer Institute, Vol. 90, No. 18, 1346-1360,
September , 1998
©Copyright 1998 Oxford University Press
ARTICLES |
erbB-2, p53, and Efficacy of Adjuvant Therapy in Lymph Node-Positive Breast Cancer
Affiliations of authors: A. D. Thor, S. Edgerton, Evanston Hospital and Northwestern University, Evanston, IL; D. A. Berry, C. Cirrincione, Cancer and Leukemia Group B Statistical Office, Durham, NC; D. R. Budman, North Shore University Hospital, Manhasset, NY; H. B. Muss, Vermont Cancer Center, Burlington; T. Kute, Bowman Gray School of Medicine, Winston-Salem, NC; I. C. Henderson, University of California, San Francisco; M. Barcos, Roswell Park Cancer Center, Buffalo, NY; C. Allred, University of Texas at San Antonio; L. Norton, Memorial Sloan-Kettering Cancer Center, New York, NY; E. T. Liu, University of North Carolina at Chapel Hill.
Present address: E. T. Liu, Division of Clinical Sciences, National Cancer Institute, National Institutes of Health, Bethesda, MD.
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]
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C. Van Poznak, L. Tan, K. S. Panageas, C. D. Arroyo, C. Hudis, L. Norton, and A. D. Seidman Assessment of Molecular Markers of Clinical Sensitivity to Single-Agent Taxane Therapy for Metastatic Breast Cancer J. Clin. Oncol., May 1, 2002; 20(9): 2319 - 2326. [Abstract] [Full Text] [PDF]
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R. L. Schilsky, L. M. Dressler, D. Bucci, L. Monovich, S. Jewell, S. Suster, M. A. Caligiuri, P. W. Kantoff, and C. Compton Cooperative Group Tissue Banks As Research Resources: The Cancer and Leukemia Group B Tissue Repositories Clin. Cancer Res., May 1, 2002; 8(5): 943 - 948. [Full Text] [PDF]
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A. Di Leo, D. Gancberg, D. Larsimont, M. Tanner, T. Jarvinen, G. Rouas, S. Dolci, J.-Y. Leroy, M. Paesmans, J. Isola, et al. HER-2 Amplification and Topoisomerase II{alpha} Gene Aberrations as Predictive Markers in Node-positive Breast Cancer Patients Randomly Treated Either with an Anthracycline-based Therapy or with Cyclophosphamide, Methotrexate, and 5-Fluorouracil Clin. Cancer Res., May 1, 2002; 8(5): 1107 - 1116. [Abstract] [Full Text] [PDF]
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J. S. Coon, E. Marcus, S. Gupta-Burt, S. Seelig, K. Jacobson, S. Chen, V. Renta, G. Fronda, and H. D. Preisler Amplification and Overexpression of Topoisomerase II{alpha} Predict Response to Anthracycline-based Therapy in Locally Advanced Breast Cancer Clin. Cancer Res., April 1, 2002; 8(4): 1061 - 1067. [Abstract] [Full Text] [PDF]
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J. W. Park, K. Hong, D. B. Kirpotin, G. Colbern, R. Shalaby, J. Baselga, Y. Shao, U. B. Nielsen, J. D. Marks, D. Moore, et al. Anti-HER2 Immunoliposomes: Enhanced Efficacy Attributable to Targeted Delivery Clin. Cancer Res., April 1, 2002; 8(4): 1172 - 1181. [Abstract] [Full Text] [PDF]
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A. Seidman, C. Hudis, M. K. Pierri, S. Shak, V. Paton, M. Ashby, M. Murphy, S. J. Stewart, and D. Keefe Cardiac Dysfunction in the Trastuzumab Clinical Trials Experience J. Clin. Oncol., March 1, 2002; 20(5): 1215 - 1221. [Abstract] [Full Text] [PDF]
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A. J. Guidi, D. A. Berry, G. Broadwater, B. Helmchen, I. J. Bleiweiss, D. R. Budman, I. C. Henderson, L. Norton, and D. F. Hayes 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 J. Clin. Oncol., February 1, 2002; 20(3): 732 - 742. [Abstract] [Full Text] [PDF]
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S. Menard, A. Balsari, P. Casalini, E. Tagliabue, M. Campiglio, R. Bufalino, and N. Cascinelli HER-2-positive Breast Carcinomas As a Particular Subset with Peculiar Clinical Behaviors Clin. Cancer Res., February 1, 2002; 8(2): 520 - 525. [Abstract] [Full Text] [PDF]
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P. M. Ravdin Is Her2 of Value in Identifying Patients Who Particularly Benefit From Anthracyclines During Adjuvant Therapy? A Qualified Yes. J Natl Cancer Inst Monographs, December 1, 2001; 2001(30): 80 - 84. [Abstract] [Full Text] [PDF]
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G. W. Sledge Jr. Is HER-2/neu a Predictor of Anthracycline Utility? No. J Natl Cancer Inst Monographs, December 1, 2001; 2001(30): 85 - 87. [Abstract] [Full Text] [PDF]
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M. N. Fornier, A. D. Seidman, M. Theodoulou, M. E. Moynahan, V. Currie, M. Moasser, N. Sklarin, T. Gilewski, G. D'Andrea, R. Salvaggio, et al. Doxorubicin Followed by Sequential Paclitaxel and Cyclophosphamide versus Concurrent Paclitaxel and Cyclophosphamide: 5-Year Results of a Phase II Randomized Trial of Adjuvant Dose-dense Chemotherapy for Women with Node-positive Breast Carcinoma Clin. Cancer Res., December 1, 2001; 7(12): 3934 - 3941. [Abstract] [Full Text] [PDF]
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Y. S. Kim, S. N. Konoplev, F. Montemurro, E. Hoy, T. L. Smith, G. Rondon, R. E. Champlin, A. A. Sahin, and N. T. Ueno 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., December 1, 2001; 7(12): 4008 - 4012. [Abstract] [Full Text] [PDF]
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A. Paradiso, F. Schittulli, G. Cellamare, A. Mangia, F. Marzullo, V. Lorusso, and M. De Lena Randomized Clinical Trial of Adjuvant Fluorouracil, Epirubicin, and Cyclophosphamide Chemotherapy for Patients With Fast-Proliferating, Node-Negative Breast Cancer J. Clin. Oncol., October 1, 2001; 19(19): 3929 - 3937. [Abstract] [Full Text]
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W. N. Hait The Prognostic and Predictive Values of ECD-HER-2 Clin. Cancer Res., September 1, 2001; 7(9): 2601 - 2604. [Abstract] [Full Text] [PDF]
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D. F. Hayes, H. Yamauchi, G. Broadwater, C. T. Cirrincione, S. P. Rodrigue, D. A. Berry, J. Younger, L. L. Panasci, F. Millard, D. B. Duggan, et al. 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., September 1, 2001; 7(9): 2703 - 2711. [Abstract] [Full Text] [PDF]
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A. Thor Are Patterns of HER-2/neu Amplification and Expression Among Primary Tumors and Regional Metastases Indicative of Those in Distant Metastases and Predictive of Herceptin Response? J Natl Cancer Inst, August 1, 2001; 93(15): 1120 - 1121. [Full Text] [PDF]
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R. Simon, A. Nocito, T. Hubscher, C. Bucher, J. Torhorst, P. Schraml, L. Bubendorf, M. M. Mihatsch, H. Moch, K. Wilber, et al. Patterns of HER-2/neu Amplification and Overexpression in Primary and Metastatic Breast Cancer J Natl Cancer Inst, August 1, 2001; 93(15): 1141 - 1146. [Abstract] [Full Text] [PDF]
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W. Zhang, P. M. Laborde, K. R. Coombes, D. A. Berry, and S. R. Hamilton Cancer Genomics: Promises and Complexities Clin. Cancer Res., August 1, 2001; 7(8): 2159 - 2167. [Abstract] [Full Text] [PDF]
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A. D. Thor, S. M. Edgerton, S. Liu, D. H. Moore II, and D. J. Kwiatkowski Gelsolin as a Negative Prognostic Factor and Effector of Motility in erbB-2-positive Epidermal Growth Factor Receptor-positive Breast Cancers Clin. Cancer Res., August 1, 2001; 7(8): 2415 - 2424. [Abstract] [Full Text] [PDF]
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National Institutes of Health Consensus Development Conference Statement: Adjuvant Therapy for Breast Cancer, November 1-3, 2000 J Natl Cancer Inst, July 4, 2001; 93(13): 979 - 989. [Abstract] [Full Text] [PDF]
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N.-H. Chow, S.-H. Chan, T.-S. Tzai, C.-L. Ho, and H.-S. Liu Expression Profiles of ErbB Family Receptors and Prognosis in Primary Transitional Cell Carcinoma of the Urinary Bladder Clin. Cancer Res., July 1, 2001; 7(7): 1957 - 1962. [Abstract] [Full Text] [PDF]
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M. J. Piccart, A. Di Leo, M. Beauduin, A. Vindevoghel, J. Michel, C. Focan, A. Tagnon, F. Ries, P. Gobert, C. Finet, et al. Phase III Trial Comparing Two Dose Levels of Epirubicin Combined With Cyclophosphamide With Cyclophosphamide, Methotrexate, and Fluorouracil in Node-Positive Breast Cancer J. Clin. Oncol., June 15, 2001; 19(12): 3103 - 3110. [Abstract] [Full Text] [PDF]
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L. N. Harris, L. Yang, V. Liotcheva, S. Pauli, J. D. Iglehart, O. M. Colvin, and T. S. Hsieh Induction of Topoisomerase II Activity after ErbB2 Activation Is Associated with a Differential Response to Breast Cancer Chemotherapy Clin. Cancer Res., June 1, 2001; 7(6): 1497 - 1504. [Abstract] [Full Text] [PDF]
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T. Petit, C. Borel, J.-P. Ghnassia, J.-F. Rodier, A. Escande, R. Mors, and P. Haegele Chemotherapy Response of Breast Cancer Depends on HER-2 Status and Anthracycline Dose Intensity in the Neoadjuvant Setting Clin. Cancer Res., June 1, 2001; 7(6): 1577 - 1581. [Abstract] [Full Text] [PDF]
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S. Liu, S. M. Edgerton, D. H. Moore II, and A. D. Thor Measures of Cell Turnover (Proliferation and Apoptosis) and Their Association with Survival in Breast Cancer Clin. Cancer Res., June 1, 2001; 7(6): 1716 - 1723. [Abstract] [Full Text] [PDF]
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R.R. Tubbs, J.D. Pettay, P.C. Roche, M.H. Stoler, R.B. Jenkins, and T.M. Grogan Discrepancies in Clinical Laboratory Testing of Eligibility for Trastuzumab Therapy: Apparent Immunohistochemical False-Positives Do Not Get the Message J. Clin. Oncol., May 15, 2001; 19(10): 2714 - 2721. [Abstract] [Full Text] [PDF]
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H. Yamauchi, V. Stearns, and D. F. Hayes When Is a Tumor Marker Ready for Prime Time? A Case Study of c-erbB-2 as a Predictive Factor in Breast Cancer J. Clin. Oncol., April 15, 2001; 19(8): 2334 - 2356. [Abstract] [Full Text] [PDF]
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L. N. Harris, V. Liotcheva, G. Broadwater, M. J. Ramirez, P. Maimonis, S. Anderson, T. Everett, D. Harpole, M. B. Moore, D. A. Berry, et al. Comparison of Methods of Measuring HER-2 in Metastatic Breast Cancer Patients Treated With High-Dose Chemotherapy J. Clin. Oncol., March 15, 2001; 19(6): 1698 - 1706. [Abstract] [Full Text] [PDF]
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R. C. Bast Jr, P. Ravdin, D. F. Hayes, S. Bates, H. Fritsche Jr, J. M. Jessup, N. Kemeny, G. Y. Locker, R. G. Mennel, and M. R. Somerfield 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 J. Clin. Oncol., March 15, 2001; 19(6): 1865 - 1878. [Abstract] [Full Text] [PDF]
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E. A. Eisenhauer From the Molecule to the Clinic -- Inhibiting HER2 to Treat Breast Cancer N. Engl. J. Med., March 15, 2001; 344(11): 841 - 842. [Full Text] [PDF]
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S. Geisler, P. E. Lønning, T. Aas, H. Johnsen, O. Fluge, D. F. Haugen, J. R. Lillehaug, L. A. Akslen, and A.-L. Børresen-Dale Influence of TP53 Gene Alterations and c-erbB-2 Expression on the Response to Treatment with Doxorubicin in Locally Advanced Breast Cancer Cancer Res., March 1, 2001; 61(6): 2505 - 2512. [Abstract] [Full Text]
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S. Menard, P. Valagussa, S. Pilotti, L. Gianni, E. Biganzoli, P. Boracchi, G. Tomasic, P. Casalini, E. Marubini, M. I. Colnaghi, et al. Response to Cyclophosphamide, Methotrexate, and Fluorouracil in Lymph Node-Positive Breast Cancer According to HER2 Overexpression and Other Tumor Biologic Variables J. Clin. Oncol., January 15, 2001; 19(2): 329 - 335. [Abstract] [Full Text] [PDF]
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