Phase II Study of Weekly Intravenous Recombinant Humanized Anti-p185HER2 Monoclonal Antibody in Patients with HER2/neu-Overexpressing Metastatic Breast Cancer

Journal of Clinical Oncology

Volumn 14, Issue 3, 1996, Pages 737-744

  Baselga, José ^a   Tripathy, Debasish ^b   Mendelsohn, John ^b   Baughman, Sharon ^b   Benz, Christopher C ^b   Dantis, Lucy ^b   Sklarin, Nancy T ^b   Seidman, Andrew D ^b   Hudis, Clifford A ^b   Moore, Jackie ^b   Rosen, Paul P ^b   Twaddell, Thomas ^b   Henderson, I Craig ^b   Norton, Larry ^b  

^a MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

GROWTH FACTOR RECEPTOR; MONOCLONAL ANTIBODY; MONOCLONAL ANTIBODY HER2; UNCLASSIFIED DRUG;

ADULT; ARTICLE; BREAST CANCER; CANCER INHIBITION; CHILL; CLINICAL ARTICLE; CLINICAL TRIAL; DIARRHEA; DRUG EFFICACY; FEMALE; FEVER; GENE EXPRESSION REGULATION; HUMAN; HUMAN CELL; HUMAN TISSUE; INTRAVENOUS DRUG ADMINISTRATION; METASTASIS; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROTO ONCOGENE; REMISSION; TREATMENT OUTCOME;

ADULT; ANTIBODIES, MONOCLONAL; BREAST NEOPLASMS; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; INFUSIONS, INTRAVENOUS; MIDDLE AGED; NEOPLASM METASTASIS; RECEPTOR, ERBB-2;

EID: 0029991439     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.1996.14.3.737     Document Type: Article

References (38)

1. Aaronson SA: Growth factors and cancer. Science 254:1146-1153, 1991
2. Coussens L, Yang-Feng TL, Liao Y-C, et al: Tyrosine kinase receptor with extensive homology to EGF receptor shares chromosomal location with neu oncogene. Science 230:1132-1139, 1985
3. Akiyama T, Sudo C, Ogawara H, et al: The product of the human c-erbB-2 gene: A 185-kilodalton glycoprotein with tyrosine kinase activity. Science 232:1644-1646, 1986
4. Stern DF, Hefferman PA, Weinberg RA: p185, a product of the neu proto-oncogene, is a receptorlike protein associated with tyrosine kinase activity. Mol Cell Biol 6:1729-1740, 1986
5. Slamon DJ, Godolphin W, Jones LA, et al: Studies of the HER-2/neu proto-oncogene in human breast and ovarian cancer. Science 244:707-712, 1989
6. Slamon DJ, Clark GM, Wong SG, et al: Human breast cancer: Correlation of relapse and survival with amplification of the HER2/neu oncogene. Science 235:177-182, 1987
7. Ravdin PV, Chamness GC: The c-erbB-2 proto-oncogene as a prognostic and predictive marker in breast cancer: A paradigm for the development of other macromolecular markers - A review. Gene 159:19-27, 1995
8. Hynes NE, Stern DF: The biology of erB-2/neu/HER-2 and its role in cancer. Biochim Biophys Acta 1198:165-184, 1994
9. HER2 causes transformation and tumorigenesis of NIH 3T3 cells. Proc Natl Acad Sci USA 84:7159-7163, 1987
10. Di Fiore PP, Pierce JH, Kraus MH, et al: erbB-2 is a potent oncogene when overexpressed in NIH-3T3 cells. Science 237:178-182, 1987
11. Guy CT, Webster MA, Schaller M, et al: Expression of the neu protooncogene in the mammary epithelium of transgenic mice induces metastatic disease. Proc Natl Acad Sci USA 89:10578-10582, 1992
12. Gusterson BA, Machin LG, Gullick WJ, et al: Immunohistochemical distribution of c-erbB-2 in infiltrating and in situ breast cancer. Int J Cancer 42:842-845, 1988
13. van de Vijver MJ, Peterse JL, Mooi WJ, et al: NEU-protein overexpression in breast cancer - Association with comedo-type ductal carcinoma in situ and limited prognostic value in stage II breast cancer. N Engl J Med 319:1239-1245, 1988
14. Drebin JA, Link VC, Stern DF, et al: Down-modulation of an oncogene protein product and reversion of the transformed phenotype by monoclonal antibodies. Cell 41:695-706, 1985
15. McKenzie SJ, Marks PJ, Lam T, et al: Generation and characterization of monoclonal antibodies specific for the human neu oncogene product, p185. Oncogene 4:543-548, 1989
16. Stancovski I, Hurwitz E, Leitner D, et al: Mechanistic aspects of the opposing effects of monoclonal antibodies to the erbB-2 receptor on tumor growth. Proc Natl Acad Sci USA 88:8691-8695, 1991
17. Hancock MC, Langton BC, Chan T, et al: A monoclonal antibody against the c-erbB-2 protein enhances the cytotoxicity of cis-diamminedichloroplatinum against human breast and ovarian tumor cell lines. Cancer Res 51:4575-4580, 1991
18. Harwerth IM, Wels W, Schlegel J, et al: Monoclonal antibodies directed to the erbB-2 receptor inhibit in vivo tumour cell growth. Br J Cancer 68:1140-1145, 1993
19. HER2 monoclonal antibody has antiproliferative effects in vitro and sensitizes human breast tumor cells to tumor necrosis factor. Mol Cell Biol 9:1165-1172, 1989
20. HER2 monoclonal antibodies. Cancer Immunol Immunother 37:255-263, 1993
21. Shepard HM, Lewis GD, Sarup JC, et al: Monoclonal antibody therapy of human cancer: Taking the HER2 protooncogene to the clinic (review). J Clin Immunol 11:117-127, 1991
22. Carter P, Presta L, Gorman CM, et al: Humanization of an anti-p185HER2 antibody for human cancer therapy. Proc Natl Acad Sci USA 89:4285-4289, 1992
23. Baselga J, Norton L, Coplan K, et al: Anti-HER2 humanized monoclonal antibody alone and in combination with chemotherapy against human breast carcinoma xenografts. Proc Am Soc Clin Oncol 13:63, 1994 (abstr 53)
24. HER2 in biological fluids. J Immunol Methods 132:73-80, 1990
25. D'Argenio DZ, Schumitzky A: ADAPT II User's Guide (ed 2). Los Angeles, CA, Biomedical Simulations Resource, University of Southern California, 1990
26. Fleiss JL: Statistical Methods for Rates and Proportions (ed 2). New York, NY, Wiley, 1981, pp 13-17
27. Hayes DF, Kaplan WD: Evaluation of patients following primary therapy, in Harris JR, Hellman S, Kinne DW (eds): Breast Diseases (ed 2). Philadelphia, PA, Lippincott, 1991, pp 505-525
28. Fan Z, Baselga J, Masui H, et al: Antitumor effect of anti-epidermal growth factor receptor monoclonal antibodies plus cis-diamminedichloroplatinum on well established A431 cell xenografts. Cancer Res 53:4637-4642, 1993
29. Norton L: Salvage chemotherapy of breast cancer. Semin Oncol 21:19-24, 1994
30. Zabrecky JR, Lam T, McKenzie SJ, et al: The extracellular domain of p185/neu is released from the surface of human breast carcinoma cells, SK-BR-3. J Biol Chem 266:1716-1720, 1991
31. Pupa SM, Menard S, Morelli D, et al: The extracellular domain of the c-erbB-2 oncoprotein is released from tumor cells by proteolytic cleavage. Oncogene 8:2917-2923, 1993
32. Lin YJ, Clinton GM: A soluble protein related to the HER-2 proto-oncogene product is released from human breast carcinoma cells. Oncogene 6:639-643, 1991
33. Hayes DF, Cirrincione C, Carney W, et al: Elevated circulating HER2/neu related protein (NRP) is associated with poor survival in patients with metastatic breast cancer. Proc Am Soc Clin Oncol 12:58, 1993 (abstr 35)
34. Kandl H, Seymour L, Bezwoda WR: Soluble c-erbB-2 fragment in serum correlates with disease stage and predicts for shortened survival in patients with early-stage and advanced breast cancer. Br J Cancer 70:739-742, 1994
35. Scott GK, Dodson JM, Montgomery PA, et al: p185HER2 signal transduction in breast cancer cells. J Biol Chem 266:14300-14305, 1991
36. Scott GK, Robles R, Park JW, et al: A truncated intracellular HER2/neu receptor produced by alternative RNA processing affects growth of human carcinoma cells. Mol Cell Biol 13:2247-2257, 1993
37. Riethmuller G, Schneider-Gadicke E, Schlimok G, et al: Randomised trial of monoclonal antibody for adjuvant therapy of resected Dukes' C colorectal carcinoma. Lancet 343:1177-1183, 1994
38. Pietras RJ, Fendly BM, Chazin VR, et al: Antibody to HER-2/neu receptor blocks DNA repair after cisplatin in human breast and ovarian cancer cells. Oncogene 9:1829-1838, 1994