© 1998 by Oxford University Press
Journal of the National Cancer Institute, Vol. 90, No. 18, 1361-1370,
September 16, 1998
©Copyright 1998 Oxford University Press
ARTICLES |
erB-2 and Response to Doxorubicin in Patients With Axillary Lymph Node-Positive, Hormone Receptor-Negative Breast Cancer
Affiliations of authors: S. Paik, National Surgical Adjuvant Breast and Bowel Project (NSABP) and Department of Human Oncology, Allegheny University of Health Sciences, Pittsburgh, PA, and Lombardi Cancer Center, Georgetown University, Washington, DC; J. Bryant, NSABP and Departments of Statistics and Biostatistics, University of Pittsburgh; C. Park, B. Fisher, E. Tan-Chiu, D. Hyams, E. R. Fisher, D. L. Wickerham, N. Wolmark, NSABP and Department of Human Oncology, Allegheny University of Health Sciences; M. E. Lippman, Lombardi Cancer Center, Georgetown University.
Correspondence to: Soonmyung Paik, M.D., NSABP Pathology Section, East Commons Professional Bldg., Four Allegheny Center—5th Floor, Pittsburgh, PA 15212-5234 (spaik{at}pgh.auhs.edu).
Abstract
Background: Overexpression of the erbB-2 protein by breast cancer cells has been suggested to be a predictor of response to doxorubicin. A retrospective study was designed to test this hypothesis. Methods: In National Surgical Adjuvant Breast and Bowel Project protocol B-11, patients with axillary lymph node-positive, hormone receptor-negative breast cancer were randomly assigned to receive either L-phenylalanine mustard plus 5-fluorouracil (PF) or a combination of L-phenylalanine mustard, 5-fluorouracil, and doxorubicin (PAF). Tumor cell expression of erbB-2 was determined by immunohistochemistry for 638 of 682 eligible patients. Statistical analyses were performed to test for interaction between treatment and erbB-2 status (positive versus negative) with respect to disease-free survival (DFS), survival, recurrence-free survival (RFS), and distant disease-free survival (DDFS). Reported P values are two-sided. Results: Overexpression of erbB-2 (i.e., positive immunohistochemical staining) was observed in 239 (37.5%) of the 638 tumors studied. Overexpression was associated with tumor size (P = .02), lack of estrogen receptors (P = .008), and the number of positive lymph nodes (P = .0001). After a mean time on study of 13.5 years, the clinical benefit from doxorubicin (PAF versus PF) was statistically significant for patients with erbB-2-positive tumors—DFS: relative risk of failure (RR) = 0.60 (95% confidence interval [CI] = 0.44–0.83), P = .001; survival: RR = 0.66 (95% CI = 0.47–0.92), P = .01; RFS: RR = 0.58 (95% CI = 0.42–0.82), P = .002; DDFS: RR = 0.61 (95% CI = 0.44–0.85), P = .003. However, it was not significant for patients with erbB-2-negative tumors—DFS: RR = 0.96 (95% CI = 0.75–1.23), P = .74; survival: RR = 0.90 (95% CI = 0.69–1.19), P = .47; RFS: RR = 0.88 (95% CI = 0.67–1.16), P = .37; DDFS: RR = 1.03 (95% CI = 0.79–1.35), P = .84. Interaction between doxorubicin treatment and erbB-2 overexpression was statistically significant for DFS (P = .02) and DDFS (P = .02) but not for survival (P = .15) or RFS (P = .06). Conclusions: These data support the hypothesis of a preferential benefit from doxorubicin in patients with erbB-2-positive breast cancer. [J Natl Cancer Inst 1998;90:1361–70]
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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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 R. Tubbs, J. Pettay, M. Skacel, R. Powell, M. Stoler, P. Roche, and J. Hainfeld Gold-Facilitated in Situ Hybridization : A Bright-Field Autometallographic Alternative to Fluorescence in Situ Hybridization for Detection of HER-2/neu Gene Amplification Am. J. Pathol., May 1, 2002; 160(5): 1589 - 1595. [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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 National Institutes of Health Consensus Developmen National Institutes of Health Consensus Development Conference Statement: Adjuvant Therapy for Breast Cancer, November 1-3, 2000 J Natl Cancer Inst Monographs, December 1, 2001; 2001(30): 5 - 15. [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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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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 W. K. Funkhouser and K. Kaiser-Rogers Significance of, and Optimal Screening for, HER-2 Gene Amplification and Protein Overexpression in Breast Carcinoma Ann. Clin. Lab. Sci., October 1, 2001; 31(4): 349 - 358. [Abstract] [Full Text] [PDF]
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K. I. Pritchard Use of ErbB-1 and ErbB-2 to Select Endocrine Therapy for Breast Cancer: Will It Play in Peoria? J. Clin. Oncol., September 15, 2001; 19(18): 3795 - 3797. [Full Text] [PDF]
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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. Kataoka, N. Sadanaga, K. Mimori, H. Ueo, G. F. Barnard, K. Sugimachi, D. Auclair, L. B. Chen, and M. Mori Overexpression of HRad17 mRNA in Human Breast Cancer: Correlation with Lymph Node Metastasis Clin. Cancer Res., September 1, 2001; 7(9): 2815 - 2820. [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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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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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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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. Braun, G. Schlimok, I. Heumos, G. Schaller, L. Riethdorf, G. Riethmüller, and K. Pantel erbB2 Overexpression on Occult Metastatic Cells in Bone Marrow Predicts Poor Clinical Outcome of Stage I-III Breast Cancer Patients Cancer Res., March 1, 2001; 61(5): 1890 - 1895. [Abstract] [Full Text]
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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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Benefit of a High-Dose Epirubicin Regimen in Adjuvant Chemotherapy for Node-Positive Breast Cancer Patients With Poor Prognostic Factors: 5-Year Follow-Up Results of French Adjuvant Study Group 05 Randomized Trial J. Clin. Oncol., February 1, 2001; 19(3): 602 - 611. [Abstract] [Full Text] [PDF]
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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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A. Lebeau, D. Deimling, C. Kaltz, A. Sendelhofert, A. Iff, B. Luthardt, M. Untch, and U. Lohrs HER-2/neu Analysis in Archival Tissue Samples of Human Breast Cancer: Comparison of Immunohistochemistry and Fluorescence In Situ Hybridization J. Clin. Oncol., January 15, 2001; 19(2): 354 - 363. [Abstract] [Full Text] [PDF]
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S. Paik, J. Bryant, E. Tan-Chiu, G. Yothers, C. Park, D. L. Wickerham, and N. Wolmark HER2 and Choice of Adjuvant Chemotherapy for Invasive Breast Cancer: National Surgical Adjuvant Breast and Bowel Project Protocol B-15 J Natl Cancer Inst, December 20, 2000; 92(24): 1991 - 1998. [Abstract] [Full Text] [PDF]
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M.-M. Ameyaw, N. Thornton, and H. L. McLeod Re: Population-Based, Case-Control Study of HER2 Genetic Polymorphism and Breast Cancer Risk J Natl Cancer Inst, December 6, 2000; 92(23): 1947 - 1947. [Full Text] [PDF]
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M. Ferrero-Poüs, K. Hacène, C. Bouchet, V. Le Doussal, M. Tubiana-Hulin, and F. Spyratos Relationship between c-erbB-2 and Other Tumor Characteristics in Breast Cancer Prognosis Clin. Cancer Res., December 1, 2000; 6(12): 4745 - 4754. [Abstract] [Full Text]
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G. Pauletti, S. Dandekar, H. Rong, L. Ramos, H. Peng, R. Seshadri, and D. J. Slamon 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 J. Clin. Oncol., November 1, 2000; 18(21): 3651 - 3664. [Abstract] [Full Text] [PDF]
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