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Recombinant Humanized Anti-HER2 Antibody (Herceptin^TM) Enhances the Antitumor Activity of Paclitaxel and Doxorubicin against HER2/neu Overexpressing Human Breast Cancer Xenografts¹

Laboratory of Receptor Biology and Department of Medicine [J. B., Y-M. K., J. M.] and Breast Cancer Medicine Service [J. B., L. N.], Memorial Sloan-Kettering Cancer Center, New York, New York 10021; and Medical Oncology Service, Vall d'Hebron University Hospital, 08035 Barcelona, Spain [J. B., J. A.]

Recombinant humanized anti-HER2 antibody, rhuMAb HER2, inhibits the growth of breast cancer cells overexpressing HER2 and has clinical activity. We explored in preclinical models its capacity to enhance the tumoricidal effects of paclitaxel and doxorubicin. In cultures of naturally HER2-overexpressing cancer cells, rhuMAb HER2 inhibited growth and enhanced the cytotoxic effects of paclitaxel. Treatment of well established BT-474 breast cancer xenografts overexpressing HER2 in athymic mice with rhuMAb HER2 resulted in a dose-dependent antitumor activity. In combination studies, treatment with paclitaxel and rhuMAb HER2 or doxorubicin and rhuMAb HER2 resulted in greater inhibition of growth than that observed with any agent alone. The combination of paclitaxel and rhuMAb HER2 resulted in the highest tumor growth inhibition and had a significantly superior complete tumor regression rate when compared with either paclitaxel or rhuMAb HER2 alone. Clinical trials that are built on these results are under way.

¹ Supported in part by an American Society of Clinical Oncology Career Development Award (to J. B.), NIH Grant CA65746, and Specialized Programs of Research Excellence Grant p50-CA58207 from The National Cancer Institute.

² To whom requests for reprints should be addressed, at Medical Oncology Service, Vall d'Hebron University Hospital, Paseo Vall d'Hebrón 119–129, Barcelona 08035, Spain. Phone: 011-34-93-2746077; Fax: 011-34-93-2746059; E-mail: baselga@hg.vhebron.es.

³ Present address: U. T. M. D. Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, Texas 77030.

Received 2/ 9/98. Accepted 5/ 1/98.

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				M. Zocher, P. A. Baeuerle, T. Dreier, and A. Iglesias Specific depletion of autoreactive B lymphocytes by a recombinant fusion protein in vitro and in vivo Int. Immunol., July 1, 2003; 15(7): 789 - 796. [Abstract] [Full Text] [PDF]

				S. Palm, R. M. Enmon Jr., C. Matei, K. S. Kolbert, S. Xu, P. B. Zanzonico, R. L. Finn, J. A. Koutcher, S. M. Larson, and G. Sgouros Pharmacokinetics and Biodistribution of 86Y-Trastuzumab for 90Y Dosimetry in an Ovarian Carcinoma Model: Correlative MicroPET and MRI J. Nucl. Med., July 1, 2003; 44(7): 1148 - 1155. [Abstract] [Full Text] [PDF]

				R. Nahta, S. Trent, C. Yang, and E. V. Schmidt Epidermal Growth Factor Receptor Expression Is a Candidate Target of the Synergistic Combination of Trastuzumab and Flavopiridol in Breast Cancer Cancer Res., July 1, 2003; 63(13): 3626 - 3631. [Abstract] [Full Text] [PDF]

				J. Baselga Skin as a Surrogate Tissue for Pharmacodynamic End Points: Is It Deep Enough? Clin. Cancer Res., July 1, 2003; 9(7): 2389 - 2390. [Full Text] [PDF]

				M. X. Yang, B. Shenoy, M. Disttler, R. Patel, M. McGrath, S. Pechenov, and A. L. Margolin Crystalline monoclonal antibodies for subcutaneous delivery PNAS, June 10, 2003; 100(12): 6934 - 6939. [Abstract] [Full Text] [PDF]

				M. Konigshoff, J. Wilhelm, R. M. Bohle, A. Pingoud, and M. Hahn HER-2/neu Gene Copy Number Quantified by Real-Time PCR: Comparison of Gene Amplification, Heterozygosity, and Immunohistochemical Status in Breast Cancer Tissue Clin. Chem., February 1, 2003; 49(2): 219 - 229. [Abstract] [Full Text] [PDF]

				S. A. Pilon, C. Kelly, and W.-Z. Wei Broadening of Epitope Recognition During Immune Rejection of ErbB-2-Positive Tumor Prevents Growth of ErbB-2-Negative Tumor J. Immunol., February 1, 2003; 170(3): 1202 - 1208. [Abstract] [Full Text] [PDF]

				M. Varella-Garcia Molecular Cytogenetics in Solid Tumors: Laboratorial Tool for Diagnosis, Prognosis, and Therapy Oncologist, February 1, 2003; 8(1): 45 - 58. [Abstract] [Full Text] [PDF]

				D. Miles, G. von Minckwitz, and A. D. Seidman Combination Versus Sequential Single-Agent Therapy in Metastatic Breast Cancer Oncologist, December 1, 2002; 7(90006): 13 - 19. [Abstract] [Full Text] [PDF]

				J. Walker-Daniels, D. J. Riese II, and M. S. Kinch c-Cbl-Dependent EphA2 Protein Degradation Is Induced by Ligand Binding Mol. Cancer Res., November 1, 2002; 1(1): 79 - 87. [Abstract] [Full Text] [PDF]

				J.-L. Merlin, M. Barberi-Heyob, and N. Bachmann In vitro comparative evaluation of trastuzumab (Herceptin(R)) combined with paclitaxel (Taxol(R)) or docetaxel (Taxotere(R)) in HER2-expressing human breast cancer cell lines Ann. Onc., November 1, 2002; 13(11): 1743 - 1748. [Abstract] [Full Text] [PDF]

				M. van de Rijn and B. P. Rubin Gene Expression Studies on Soft Tissue Tumors Am. J. Pathol., November 1, 2002; 161(5): 1531 - 1534. [Full Text] [PDF]

				S. Lee, W. Yang, K.-H. Lan, S. Sellappan, K. Klos, G. Hortobagyi, M.-C. Hung, and D. Yu Enhanced Sensitization to Taxol-induced Apoptosis by Herceptin Pretreatment in ErbB2-overexpressing Breast Cancer Cells Cancer Res., October 15, 2002; 62(20): 5703 - 5710. [Abstract] [Full Text] [PDF]

				R. Salcedo, M. Martins-Green, B. Gertz, J. J. Oppenheim, and W. J. Murphy Combined Administration of Antibodies to Human Interleukin 8 and Epidermal Growth Factor Receptor Results in Increased Antimetastatic Effects on Human Breast Carcinoma Xenografts Clin. Cancer Res., August 1, 2002; 8(8): 2655 - 2665. [Abstract] [Full Text] [PDF]

				S. S. W. Ng, M.-S. Tsao, T. Nicklee, and D. W. Hedley Effects of the Epidermal Growth Factor Receptor Inhibitor OSI-774, Tarceva, on Downstream Signaling Pathways and Apoptosis in Human Pancreatic Adenocarcinoma Mol. Cancer Ther., August 1, 2002; 1(10): 777 - 783. [Abstract] [Full Text] [PDF]

				F. M. Yakes, W. Chinratanalab, C. A. Ritter, W. King, S. Seelig, and C. L. Arteaga Herceptin-induced Inhibition of Phosphatidylinositol-3 Kinase and Akt Is Required for Antibody-mediated Effects on p27, Cyclin D1, and Antitumor Action Cancer Res., July 15, 2002; 62(14): 4132 - 4141. [Abstract] [Full Text] [PDF]

				D. Osoba, D. J. Slamon, M. Burchmore, and M. Murphy Effects on Quality of Life of Combined Trastuzumab and Chemotherapy in Women With Metastatic Breast Cancer J. Clin. Oncol., July 15, 2002; 20(14): 3106 - 3113. [Abstract] [Full Text] [PDF]

				M. Zhang, Z. Yao, K. Garmestani, D. B. Axworthy, Z. Zhang, R. W. Mallett, L. J. Theodore, C. K. Goldman, M. W. Brechbiel, J. A. Carrasquillo, et al. Pretargeting radioimmunotherapy of a murine model of adult T-cell leukemia with the alpha -emitting radionuclide, bismuth 213 Blood, June 17, 2002; 100(1): 208 - 216. [Abstract] [Full Text] [PDF]

				K. Subbaramaiah, L. Norton, W. Gerald, and A. J. Dannenberg Cyclooxygenase-2 Is Overexpressed in HER-2/neu-positive Breast Cancer. EVIDENCE FOR INVOLVEMENT OF AP-1 AND PEA3 J. Biol. Chem., May 17, 2002; 277(21): 18649 - 18657. [Abstract] [Full Text] [PDF]

				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]

				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]

				E. Auzenne, N. J. Donato, C. Li, E. Leroux, R. E. Price, D. Farquhar, and J. Klostergaard Superior Therapeutic Profile of Poly-L-Glutamic Acid-Paclitaxel Copolymer Compared with Taxol in Xenogeneic Compartmental Models of Human Ovarian Carcinoma Clin. Cancer Res., February 1, 2002; 8(2): 573 - 581. [Abstract] [Full Text] [PDF]

				E. Waelti, N. Wegmann, R. Schwaninger, A. Wetterwald, C. Wingenfeld, B. Rothen-Rutishauser, and C. D. Gimmi Targeting HER-2/neu with Antirat Neu Virosomes for Cancer Therapy Cancer Res., January 1, 2002; 62(2): 437 - 444. [Abstract] [Full Text] [PDF]

				Y. Lu, X. Zi, Y. Zhao, D. Mascarenhas, and M. Pollak Insulin-Like Growth Factor-I Receptor Signaling and Resistance to Trastuzumab (Herceptin) J Natl Cancer Inst, December 19, 2001; 93(24): 1852 - 1857. [Abstract] [Full Text] [PDF]

				S. L. Moulder, F. M. Yakes, S. K. Muthuswamy, R. Bianco, J. F. Simpson, and C. L. Arteaga Epidermal Growth Factor Receptor (HER1) Tyrosine Kinase Inhibitor ZD1839 (Iressa) Inhibits HER2/neu (erbB2)-overexpressing Breast Cancer Cells in Vitro and in Vivo Cancer Res., December 1, 2001; 61(24): 8887 - 8895. [Abstract] [Full Text] [PDF]