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Journal of Clinical Oncology, Vol 16, 2659-2671, Copyright © 1998 by American Society of Clinical Oncology

ARTICLES

Phase II study of receptor-enhanced chemosensitivity using recombinant humanized anti-p185HER2/neu monoclonal antibody plus cisplatin in patients with HER2/neu-overexpressing metastatic breast cancer refractory to chemotherapy treatment

MD Pegram, A Lipton, DF Hayes, BL Weber, JM Baselga, D Tripathy, D Baly, SA Baughman, T Twaddell, JA Glaspy and DJ Slamon
Department of Medical Oncology, The University of California at Los Angeles, USA. mpegram@ucla.edu

PURPOSE: To determine the toxicity, pharmacokinetics, response rate, and response duration of intravenous (i.v.) administration of recombinant, humanized anti-p185HER2 monoclonal antibody (rhuMAb HER2) plus cisplatin (CDDP) in a phase II, open-label, multicenter clinical trial for patients with HER2/neu-overexpressing metastatic breast cancer. PATIENTS AND METHODS: The study population consisted of extensively pretreated advanced breast cancer patients with HER2/neu overexpression and disease progression during standard chemotherapy. Patients received a loading dose of rhuMAb HER2 (250 mg i.v.) on day 0, followed by weekly doses of 100 mg i.v. for 9 weeks. Patients received CDDP (75 mg/m2) on days 1, 29, and 57. RESULTS: Of 37 patients assessable for response, nine (24.3%) achieved a PR, nine (24.3%) had a minor response or stable disease, and disease progression occurred in 19 (51.3%). The median response duration was 5.3 months (range, 1.6- 18). Grade III or IV toxicity was observed in 22 of 39 patients (56%). The toxicity profile reflected that expected from CDDP alone with the most common toxicities being cytopenias (n = 10), nausea/vomiting (n = 9), and asthenia (n = 5). Mean pharmacokinetic parameters of rhuMAb HER2 were unaltered by coadministration of CDDP. CONCLUSION: The use of rhuMAb HER2 in combination with CDDP in patients with HER2/neu- overexpressing metastatic breast cancer results in objective clinical response rates higher than those reported previously for CDDP alone, or rhuMAb HER2 alone. In addition, the combination results in no apparent increase in toxicity. Finally, the pharmacology of rhuMAb HER2 was unaffected by coadministration with CDDP.
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Evaluation of HER-2/neu Gene Amplification and Overexpression: Comparison of Frequently Used Assay Methods in a Molecularly Characterized Cohort of Breast Cancer Specimens
J. Clin. Oncol., July 15, 2002; 20(14): 3095 - 3105.
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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.
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T. Fehm, A. Sagalowsky, E. Clifford, P. Beitsch, H. Saboorian, D. Euhus, S. Meng, L. Morrison, T. Tucker, N. Lane, et al.
Cytogenetic Evidence That Circulating Epithelial Cells in Patients with Carcinoma Are Malignant
Clin. Cancer Res., July 1, 2002; 8(7): 2073 - 2084.
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K. Carles-Kinch, K. E. Kilpatrick, J. C. Stewart, and M. S. Kinch
Antibody Targeting of the EphA2 Tyrosine Kinase Inhibits Malignant Cell Behavior
Cancer Res., May 1, 2002; 62(10): 2840 - 2847.
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A. D. Santin, S. Bellone, M. Gokden, M. Palmieri, D. Dunn, J. Agha, J. J. Roman, L. Hutchins, S. Pecorelli, T. O'Brien, et al.
Overexpression of HER-2/Neu in Uterine Serous Papillary Cancer
Clin. Cancer Res., May 1, 2002; 8(5): 1271 - 1279.
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A. J. da Silva, M. Brickelmaier, G. R. Majeau, Z. Li, L. Su, Y.-M. Hsu, and P. S. Hochman
Alefacept, an Immunomodulatory Recombinant LFA-3/IgG1 Fusion Protein, Induces CD16 Signaling and CD2/CD16-Dependent Apoptosis of CD2+ Cells
J. Immunol., May 1, 2002; 168(9): 4462 - 4471.
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F. J. Esteva, V. Valero, D. Booser, L. T. Guerra, J. L. Murray, L. Pusztai, M. Cristofanilli, B. Arun, B. Esmaeli, H. A. Fritsche, et al.
Phase II Study of Weekly Docetaxel and Trastuzumab for Patients With HER-2-Overexpressing Metastatic Breast Cancer
J. Clin. Oncol., April 1, 2002; 20(7): 1800 - 1808.
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L. B. Michaud and K. L. Jones
Recent Advances in the Systemic Management of Metastatic Breast Cancer
Journal of Pharmacy Practice, February 1, 2002; 15(1): 52 - 61.
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H. Kobayashi, K. Shirakawa, S. Kawamoto, T. Saga, N. Sato, A. Hiraga, I. Watanabe, Y. Heike, K. Togashi, J. Konishi, et al.
Rapid Accumulation and Internalization of Radiolabeled Herceptin in an Inflammatory Breast Cancer Xenograft with Vasculogenic Mimicry Predicted by the Contrast-enhanced Dynamic MRI with the Macromolecular Contrast Agent G6-(1B4M-Gd)256
Cancer Res., February 1, 2002; 62(3): 860 - 866.
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M. A. Molina, R. Saez, E. E. Ramsey, M.-J. Garcia-Barchino, F. Rojo, A. J. Evans, J. Albanell, E. J. Keenan, A. Lluch, J. Garcia-Conde, et al.
NH2-terminal Truncated HER-2 Protein but not Full-Length Receptor Is Associated with Nodal Metastasis in Human Breast Cancer
Clin. Cancer Res., February 1, 2002; 8(2): 347 - 353.
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N. Normanno, M. Campiglio, A. De Luca, G. Somenzi, M. Maiello, F. Ciardiello, L. Gianni, D. S. Salomon, and S. Menard
Cooperative inhibitory effect of ZD1839 (Iressa) in combination with trastuzumab (Herceptin) on human breast cancer cell growth
Ann. Onc., January 19, 2002; 13(1): 65 - 72.
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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.
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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.
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M. Ohta, Y. Tokuda, Y. Suzuki, M. Kubota, T. Watanabe, H. Fujii, Y. Sasaki, T. Niwa, H. Makuuchi, and T. Tajima
A Case with HER2-overexpressing Breast Cancer Completely Responded to Humanized anti-HER2 Monoclonal Antibody
Jpn. J. Clin. Oncol., November 1, 2001; 31(11): 553 - 556.
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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.
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A. M. Scott, F.-T. Lee, W. Hopkins, J. S. Cebon, J. M. Wheatley, Z. Liu, F. E. Smyth, C. Murone, S. Sturrock, D. MacGregor, et al.
Specific Targeting, Biodistribution, and Lack of Immunogenicity of Chimeric Anti-GD3 Monoclonal Antibody KM871 in Patients With Metastatic Melanoma: Results of a Phase I Trial
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S R Lakhani
Molecular genetics of solid tumours: translating research into clinical practice. What we could do now: breast cancer
Mol. Pathol., October 1, 2001; 54(5): 281 - 284.
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R. S. Kerbel
Clinical Trials of Antiangiogenic Drugs: Opportunities, Problems, and Assessment of Initial Results
J. Clin. Oncol., September 15, 2001; 19(90001): 45s - 51.
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A. Yamada, K. Kawano, M. Koga, T. Matsumoto, and K. Itoh
Multidrug Resistance-associated Protein 3 Is a Tumor Rejection Antigen Recognized by HLA-A2402-restricted Cytotoxic T Lymphocytes
Cancer Res., September 1, 2001; 61(17): 6459 - 6466.
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G. Ritter, L. S. Cohen, C. Williams Jr., E. C. Richards, L. J. Old, and S. Welt
Serological Analysis of Human Anti-Human Antibody Responses in Colon Cancer Patients Treated with Repeated Doses of Humanized Monoclonal Antibody A33
Cancer Res., September 1, 2001; 61(18): 6851 - 6859.
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J. Baselga
Is Circulating HER-2 More Than Just a Tumor Marker?
Clin. Cancer Res., September 1, 2001; 7(9): 2605 - 2607.
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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.
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R. E. Jimenez, M. Hussain, F. J. Bianco Jr., U. Vaishampayan, P. Tabazcka, W. A. Sakr, J. E. Pontes, D. P. Wood Jr., and D. J. Grignon
Her-2/neu Overexpression in Muscle-invasive Urothelial Carcinoma of the Bladder: Prognostic Significance and Comparative Analysis in Primary and Metastatic Tumors
Clin. Cancer Res., August 1, 2001; 7(8): 2440 - 2447.
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A. Viloria-Petit, T. Crombet, S. Jothy, D. Hicklin, P. Bohlen, J. M. Schlaeppi, J. Rak, and R. S. Kerbel
Acquired Resistance to the Antitumor Effect of Epidermal Growth Factor Receptor-blocking Antibodies in Vivo: A Role for Altered Tumor Angiogenesis
Cancer Res., July 1, 2001; 61(13): 5090 - 5101.
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I. Bergman, M. A. Barmada, J. A. Griffin, and D. J. Slamon
Treatment of Meningeal Breast Cancer Xenografts in the Rat Using an Anti-P185/HER2 Antibody
Clin. Cancer Res., July 1, 2001; 7(7): 2050 - 2056.
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E. Laughner, P. Taghavi, K. Chiles, P. C. Mahon, and G. L. Semenza
HER2 (neu) Signaling Increases the Rate of Hypoxia-Inducible Factor 1{alpha} (HIF-1{alpha}) Synthesis: Novel Mechanism for HIF-1-Mediated Vascular Endothelial Growth Factor Expression
Mol. Cell. Biol., June 15, 2001; 21(12): 3995 - 4004.
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M. A. Molina, J. Codony-Servat, J. Albanell, F. Rojo, J. Arribas, and J. Baselga
Trastuzumab (Herceptin), a Humanized Anti-HER2 Receptor Monoclonal Antibody, Inhibits Basal and Activated HER2 Ectodomain Cleavage in Breast Cancer Cells
Cancer Res., June 1, 2001; 61(12): 4744 - 4749.
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G. P. Adams, R. Schier, A. M. McCall, H. H. Simmons, E. M. Horak, R. K. Alpaugh, J. D. Marks, and L. M. Weiner
High Affinity Restricts the Localization and Tumor Penetration of Single-Chain Fv Antibody Molecules
Cancer Res., June 1, 2001; 61(12): 4750 - 4755.
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P. Birner, G. Oberhuber, J. Stani, C. Reithofer, H. Samonigg, H. Hausmaninger, E. Kubista, W. Kwasny, D. Kandioler-Eckersberger, M. Gnant, et al.
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., June 1, 2001; 7(6): 1669 - 1675.
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A. D. Seidman, M. N. Fornier, F. J. Esteva, L. Tan, S. Kaptain, A. Bach, K. S. Panageas, C. Arroyo, V. Valero, V. Currie, et al.
Weekly Trastuzumab and Paclitaxel Therapy for Metastatic Breast Cancer With Analysis of Efficacy by HER2 Immunophenotype and Gene Amplification
J. Clin. Oncol., May 15, 2001; 19(10): 2587 - 2595.
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H. J. Burstein, I. Kuter, S. M. Campos, R. S. Gelman, L. Tribou, L. M. Parker, J. Manola, J. Younger, U. Matulonis, C. A. Bunnell, et al.
Clinical Activity of Trastuzumab and Vinorelbine in Women With HER2-Overexpressing Metastatic Breast Cancer
J. Clin. Oncol., May 15, 2001; 19(10): 2722 - 2730.
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J.-P. H. Machiels, R. T. Reilly, L. A. Emens, A. M. Ercolini, R. Y. Lei, D. Weintraub, F. I. Okoye, and E. M. Jaffee
Cyclophosphamide, Doxorubicin, and Paclitaxel Enhance the Antitumor Immune Response of Granulocyte/Macrophage-Colony Stimulating Factor-secreting Whole-Cell Vaccines in HER-2/neu Tolerized Mice
Cancer Res., May 1, 2001; 61(9): 3689 - 3697.
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E. Lyon, A. Millson, M. C. Lowery, R. Woods, and C. T. Wittwer
Quantification of HER2/neu Gene Amplification by Competitive PCR Using Fluorescent Melting Curve Analysis
Clin. Chem., May 1, 2001; 47(5): 844 - 851.
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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.
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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.
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D. J. Slamon, B. Leyland-Jones, S. Shak, H. Fuchs, V. Paton, A. Bajamonde, T. Fleming, W. Eiermann, J. Wolter, M. Pegram, et al.
Use of Chemotherapy plus a Monoclonal Antibody against HER2 for Metastatic Breast Cancer That Overexpresses HER2
N. Engl. J. Med., March 15, 2001; 344(11): 783 - 792.
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M. Summerhayes
Trastuzumab in the treatment of HER2 positive breast cancer
Journal of Oncology Pharmacy Practice, March 1, 2001; 7(1): 9 - 25.
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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.
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