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Journal of Clinical Oncology, Vol 14, 737-744, Copyright © 1996 by American Society of Clinical Oncology

ARTICLES

Phase II study of weekly intravenous recombinant humanized anti- p185HER2 monoclonal antibody in patients with HER2/neu-overexpressing metastatic breast cancer

J Baselga, D Tripathy, J Mendelsohn, S Baughman, CC Benz, L Dantis, NT Sklarin, AD Seidman, CA Hudis, J Moore, PP Rosen, T Twaddell, IC Henderson and L Norton
Department of Medicine, Services of Breast and Gynecological Cancer Medicine and Clinical Immunology, Department of Pathology, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.

PURPOSE: Breast cancer frequently overexpresses the product of the HER2 proto-oncogene, a 185-kd growth factor receptor (p185HER2). The recombinant humanized monoclonal antibody (rhuMAb) HER2 has high affinity for p185HER2 and inhibits the growth of breast cancer cells that overexpress HER2. We evaluated the efficacy and toxicity of weekly intravenous administration of rhuMAb HER2 in patients with HER2- overexpressing metastatic breast cancer. PATIENTS AND METHODS: We treated 46 patients with metastatic breast carcinomas that overexpressed HER2. Patients received a loading dose of 250 mg of intravenous rhuMAb HER2, then 10 weekly doses of 100 mg each. Patients with no disease progression at the completion of this treatment period were offered a maintenance phase of 100 mg/wk. RESULTS: Study patients had extensive metastatic disease, and most had received extensive prior anticancer therapy. Adequate pharmacokinetic levels of rhuMAb HER2 were obtained in 90% of the patients. Toxicity was minimal and no antibodies against rhuMAb HER2 were detected in any patients. Objective responses were seen in five of 43 assessable patients, and included one complete remission and four partial remissions (overall response rate, 11.6%; 95% confidence interval, 4.36 to 25.9). Responses were observed in liver, mediastinum, lymph nodes, and chest wall lesions. Minor responses, seen in two patients, and stable disease, which occurred in 14 patients, lasted for a median of 5.1 months. CONCLUSION: rhuMAb HER2 is well tolerated and clinically active in patients with HER2- overexpressing metastatic breast cancers that had received extensive prior therapy. This is evidence that targeting growth factor receptors can cause regression of human cancer and justifies further evaluation of this agent.
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J. W. Park, R. S. Kerbel, G. J. Kelloff, J. C. Barrett, B. A. Chabner, D. R. Parkinson, J. Peck, R. W. Ruddon, C. C. Sigman, and D. J. Slamon
Rationale for Biomarkers and Surrogate End Points in Mechanism-Driven Oncology Drug Development
Clin. Cancer Res., June 1, 2004; 10(11): 3885 - 3896.
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 Clin. Cancer Res.Home page
G. J. S. Rustin, R. C. Bast Jr., G. J. Kelloff, J. C. Barrett, S. K. Carter, P. D. Nisen, C. C. Sigman, D. R. Parkinson, and R. W. Ruddon
Use of CA-125 in Clinical Trial Evaluation of New Therapeutic Drugs for Ovarian Cancer
Clin. Cancer Res., June 1, 2004; 10(11): 3919 - 3926.
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 Clin. Cancer Res.Home page
G. J. Kelloff, D. S. Coffey, B. A. Chabner, A. P. Dicker, K. Z. Guyton, P. D. Nisen, H. R. Soule, and A. V. D'Amico
Prostate-Specific Antigen Doubling Time as a Surrogate Marker for Evaluation of Oncologic Drugs to Treat Prostate Cancer
Clin. Cancer Res., June 1, 2004; 10(11): 3927 - 3933.
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 Clin. Cancer Res.Home page
C. I. Spiridon, S. Guinn, and E. S. Vitetta
A Comparison of the in Vitro and in Vivo Activities of IgG and F(ab')2 Fragments of a Mixture of Three Monoclonal Anti-Her-2 Antibodies
Clin. Cancer Res., May 15, 2004; 10(10): 3542 - 3551.
[Abstract] [Full Text] [PDF]

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 JCOHome page
H. Burris III, D. Yardley, S. Jones, G. Houston, C. Broome, D. Thompson, F. A. Greco, M. White, and J. Hainsworth
Phase II Trial of Trastuzumab Followed by Weekly Paclitaxel/Carboplatin As First-Line Treatment for Patients With Metastatic Breast Cancer
J. Clin. Oncol., May 1, 2004; 22(9): 1621 - 1629.
[Abstract] [Full Text] [PDF]

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 Protein Eng Des SelHome page
T. Olafsen, G. J. Tan, C.-w. Cheung, P. J. Yazaki, J. M. Park, J. E. Shively, L. E. Williams, A. A. Raubitschek, M. F. Press, and A. M. Wu
Characterization of engineered anti-p185HER-2 (scFv-CH3)2 antibody fragments (minibodies) for tumor targeting
Protein Eng. Des. Sel., April 1, 2004; 17(4): 315 - 323.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
K. Kono, E. Sato, H. Naganuma, A. Takahashi, K. Mimura, H. Nukui, and H. Fujii
Trastuzumab (Herceptin) Enhances Class I-Restricted Antigen Presentation Recognized by HER-2/neu-Specific T Cytotoxic Lymphocytes
Clin. Cancer Res., April 1, 2004; 10(7): 2538 - 2544.
[Abstract] [Full Text] [PDF]

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 JCOHome page
K.L. Tedesco, A.D. Thor, D.H. Johnson, Y. Shyr, K.A. Blum, L.J. Goldstein, W.J. Gradishar, B.P. Nicholson, D.E. Merkel, D. Murrey, et al.
Docetaxel Combined With Trastuzumab Is an Active Regimen in HER-2 3+ Overexpressing and Fluorescent In Situ Hybridization-Positive Metastatic Breast Cancer: A Multi-Institutional Phase II Trial
J. Clin. Oncol., March 15, 2004; 22(6): 1071 - 1077.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
W. J. Kostler, B. Schwab, C. F. Singer, R. Neumann, E. Rucklinger, T. Brodowicz, S. Tomek, M. Niedermayr, M. Hejna, G. G. Steger, et al.
Monitoring of Serum Her-2/neu Predicts Response and Progression-Free Survival to Trastuzumab-Based Treatment in Patients with Metastatic Breast Cancer
Clin. Cancer Res., March 1, 2004; 10(5): 1618 - 1624.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
A. Argiris, C.-X. Wang, S. G. Whalen, and M. P. DiGiovanna
Synergistic Interactions between Tamoxifen and Trastuzumab (Herceptin)
Clin. Cancer Res., February 15, 2004; 10(4): 1409 - 1420.
[Abstract] [Full Text] [PDF]

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G. Bianchi, J. Albanell, W. Eiermann, G. Vitali, D. Borquez, L. Vigano, R. Molina, G. Raab, A. Locatelli, B. Vanhauwere, et al.
Pilot Trial of Trastuzumab Starting with or after the Doxorubicin Component of a Doxorubicin plus Paclitaxel Regimen for Women with HER2-Positive Advanced Breast Cancer
Clin. Cancer Res., December 1, 2003; 9(16): 5944 - 5951.
[Abstract] [Full Text] [PDF]

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M. Cobleigh and D. Frame
Is Trastuzumab Every Three Weeks Ready for Prime Time?
J. Clin. Oncol., November 1, 2003; 21(21): 3900 - 3901.
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B. Leyland-Jones, K. Gelmon, J.-P. Ayoub, A. Arnold, S. Verma, R. Dias, and P. Ghahramani
Pharmacokinetics, Safety, and Efficacy of Trastuzumab Administered Every Three Weeks in Combination With Paclitaxel
J. Clin. Oncol., November 1, 2003; 21(21): 3965 - 3971.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
R. Nahta and F. J. Esteva
HER-2-Targeted Therapy: Lessons Learned and Future Directions
Clin. Cancer Res., November 1, 2003; 9(14): 5078 - 5084.
[Abstract] [Full Text] [PDF]

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P. Heinmoller, C. Gross, K. Beyser, C. Schmidtgen, G. Maass, M. Pedrocchi, and J. Ruschoff
HER2 Status in Non-Small Cell Lung Cancer: Results from Patient Screening for Enrollment to a Phase II Study of Herceptin
Clin. Cancer Res., November 1, 2003; 9(14): 5238 - 5243.
[Abstract] [Full Text] [PDF]

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 Molecular Cancer TherapeuticsHome page
K. Liang, Y. Lu, W. Jin, K. K. Ang, L. Milas, and Z. Fan
Sensitization of breast cancer cells to radiation by trastuzumab
Mol. Cancer Ther., November 1, 2003; 2(11): 1113 - 1120.
[Abstract] [Full Text] [PDF]

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 Cancer Res.Home page
H. H. van Ojik, L. Bevaart, C. E. Dahle, A. Bakker, M. J. H. Jansen, M. J. van Vugt, J. G. J. van de Winkel, and G. J. Weiner
CpG-A and B Oligodeoxynucleotides Enhance the Efficacy of Antibody Therapy by Activating Different Effector Cell Populations
Cancer Res., September 1, 2003; 63(17): 5595 - 5600.
[Abstract] [Full Text] [PDF]

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Y. She, F. Lee, J. Chen, A. Haimovitz-Friedman, V. A. Miller, V. R. Rusch, M. G. Kris, and F. M. Sirotnak
The Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor ZD1839 Selectively Potentiates Radiation Response of Human Tumors in Nude Mice, with a Marked Improvement in Therapeutic Index
Clin. Cancer Res., September 1, 2003; 9(10): 3773 - 3778.
[Abstract] [Full Text] [PDF]

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B. K. Ko, K. Kawano, J. L. Murray, M. L. Disis, C. L. Efferson, H. M. Kuerer, G. E. Peoples, and C. G. Ioannides
Clinical Studies of Vaccines Targeting Breast Cancer
Clin. Cancer Res., August 1, 2003; 9(9): 3222 - 3234.
[Abstract] [Full Text] [PDF]

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T. Repka, E. G. Chiorean, J. Gay, K. E. Herwig, V. K. Kohl, D. Yee, and J. S. Miller
Trastuzumab and Interleukin-2 in HER2-positive Metastatic Breast Cancer: A Pilot Study
Clin. Cancer Res., July 1, 2003; 9(7): 2440 - 2446.
[Abstract] [Full Text] [PDF]

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G. Tonini, B. Vincenzi, D. Santini, G. Avvisati, A. La Cesa, and A. Baldi
Unusual Problems in Breast Cancer and a Rare Lung Cancer Case: Case 1. Clinical Complete Response of Breast Cancer Metastases After Trastuzumab-Based Immunotherapy
J. Clin. Oncol., June 1, 2003; 21(11): 2215 - 2216.
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 Clin. Cancer Res.Home page
C. L. Arteaga and J. Baselga
Clinical Trial Design and End Points for Epidermal Growth Factor Receptor-targeted Therapies: Implications for Drug Development and Practice
Clin. Cancer Res., May 1, 2003; 9(5): 1579 - 1589.
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A. M. Scott, G. Wiseman, S. Welt, A. Adjei, F.-T. Lee, W. Hopkins, C. R. Divgi, L. H. Hanson, P. Mitchell, D. N. Gansen, et al.
A Phase I Dose-Escalation Study of Sibrotuzumab in Patients with Advanced or Metastatic Fibroblast Activation Protein-positive Cancer
Clin. Cancer Res., May 1, 2003; 9(5): 1639 - 1647.
[Abstract] [Full Text] [PDF]

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 J. Immunol.Home page
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]

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 The OncologistHome page
R. Nahta, G. N. Hortobagyi, and F. J. Esteva
Growth Factor Receptors in Breast Cancer: Potential for Therapeutic Intervention
Oncologist, February 1, 2003; 8(1): 5 - 17.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
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]

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M. A. Bookman, K. M. Darcy, D. Clarke-Pearson, R. A. Boothby, and I. R. Horowitz
Evaluation of Monoclonal Humanized Anti-HER2 Antibody, Trastuzumab, in Patients With Recurrent or Refractory Ovarian or Primary Peritoneal Carcinoma With Overexpression of HER2: A Phase II Trial of the Gynecologic Oncology Group
J. Clin. Oncol., January 15, 2003; 21(2): 283 - 290.
[Abstract] [Full Text] [PDF]

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 Cancer Res.Home page
C. Kumar-Sinha, K. W. Ignatoski, M. E. Lippman, S. P. Ethier, and A. M. Chinnaiyan
Transcriptome Analysis of HER2 Reveals a Molecular Connection to Fatty Acid Synthesis
Cancer Res., January 1, 2003; 63(1): 132 - 139.
[Abstract] [Full Text] [PDF]

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G. F. Fleming, N. J. Meropol, G. L. Rosner, D. R. Hollis, W. E. Carson III, M. Caligiuri, J. Mortimer, K. Tkaczuk, R. Parihar, R. L. Schilsky, et al.
A Phase I Trial of Escalating Doses of Trastuzumab Combined with Daily Subcutaneous Interleukin 2: Report of Cancer and Leukemia Group B 9661
Clin. Cancer Res., December 1, 2002; 8(12): 3718 - 3727.
[Abstract] [Full Text] [PDF]

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 Cancer Res.Home page
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]

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 Cancer Res.Home page
K. Kono, A. Takahashi, F. Ichihara, H. Sugai, H. Fujii, and Y. Matsumoto
Impaired Antibody-dependent Cellular Cytotoxicity Mediated by Herceptin in Patients with Gastric Cancer
Cancer Res., October 15, 2002; 62(20): 5813 - 5817.
[Abstract] [Full Text] [PDF]

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 Proc. Natl. Acad. Sci. USAHome page
W. Xu, M. Marcu, X. Yuan, E. Mimnaugh, C. Patterson, and L. Neckers
Chaperone-dependent E3 ubiquitin ligase CHIP mediates a degradative pathway for c-ErbB2/Neu
PNAS, October 1, 2002; 99(20): 12847 - 12852.
[Abstract] [Full Text] [PDF]

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 Hum ReprodHome page
S. Kathuria, R. Sriraman, R. Nath, M. Sack, R. Pal, O. Artsaenko, G.P. Talwar, R. Fischer, and R. Finnern
Efficacy of plant-produced recombinant antibodies against HCG
Hum. Reprod., August 1, 2002; 17(8): 2054 - 2061.
[Abstract] [Full Text] [PDF]

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 Cancer Res.Home page
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]

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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.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
C. I. Spiridon, M.-A. Ghetie, J. Uhr, R. Marches, J.-L. Li, G.-L. Shen, and E. S. Vitetta
Targeting Multiple Her-2 Epitopes with Monoclonal Antibodies Results in Improved Antigrowth Activity of a Human Breast Cancer Cell Line in Vitro and in Vivo
Clin. Cancer Res., June 1, 2002; 8(6): 1720 - 1730.
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