Advertisement
Journal of Clinical Oncology  
Search for:
Limit by:
  Browse by Subject or Issue
Home Search or Browse JCO My JCO Subscriptions Customer Service Site Map

Originally published as JCO Early Release 10.1200/JCO.2005.07.120 on July 11 2005

Journal of Clinical Oncology, Vol 23, No 24 (August 20), 2005: pp. 5578-5587
© 2005 American Society of Clinical Oncology.
This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow Purchase Article
Right arrow View Shopping Cart
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a colleague
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Save to my personal folders
Right arrow Download to citation manager
Right arrowRights & Permissions
Citing Articles
Right arrow Citing Articles via HighWire
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Herbst, R. S.
Right arrow Articles by Kies, M. S.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Herbst, R. S.
Right arrow Articles by Kies, M. S.
Related Articles
Right arrowRelated Editorial
Social Bookmarking
Add to CiteULike   Add to Complore   Add to Connotea   Add to Del.icio.us   Add to Digg   Add to Facebook   Add to Reddit   Add to Technorati   Add to Twitter  
What's this?

Phase II Multicenter Study of the Epidermal Growth Factor Receptor Antibody Cetuximab and Cisplatin for Recurrent and Refractory Squamous Cell Carcinoma of the Head and Neck

Roy S. Herbst, Matthew Arquette{dagger}, Dong M. Shin, Karel Dicke, Everett E. Vokes, Nozar Azarnia, Waun Ki Hong, Merrill S. Kies

From the Department of Thoracic/Head and Neck Medical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston; Arlington Cancer Center, Dallas, TX; Department of Oncology, Washington University, St Louis, MO; Winship Cancer Institute, Emory University, Atlanta, GA; Department of Medicine, Section of Hematology and Oncology, Head and Neck Oncology Program, University of Chicago, Chicago, IL; and Department of Clinical Affairs, ImClone Systems, Branchburg, NJ

Address reprint requests to Merrill S. Kies, MD, The University of Texas M.D. Anderson Cancer Center, Department of Thoracic/Head and Neck Medical Oncology, Unit 432, PO Box 301402, Houston, TX 77230-1402; e-mail: mkies{at}mdanderson.org

PURPOSE: This multicenter phase II study was undertaken to define the efficacy and safety of cetuximab, an antiepidermal growth factor receptor chimeric human and murine monoclonal antibody, administered with cisplatin to patients with refractory metastatic or recurrent squamous cell carcinoma of the head and neck (SCCHN).

PATIENTS AND METHODS: One hundred thirty-two patients were to receive two 3-week cycles with cisplatin/paclitaxel or cisplatin/fluorouracil. Patients (n = 30) with a complete or partial response continued standard therapy. Seventy-six patients with stable disease (SD; n = 51) or progressive disease (PD/1; n = 25) received combination therapy with cetuximab (400 mg/m2 intravenously on day 1, then 250 mg/m2/wk) and cisplatin (75 or 100 mg/m2 intravenously on day 1 every 3 weeks). The protocol was subsequently amended to enroll patients who had developed PD within 90 days after platinum-based therapy (PD/2; n = 54).

RESULTS: Five patients (20%) in PD/1, three patients (6%) in PD/2, and nine patients (18%) with SD achieved an objective response. Median duration of response was 4.2, 4.1, and 7.4 months for the PD/1, PD/2, and SD groups, respectively, with median overall survival times of 6.1, 4.3, and 11.7 months. The most common toxicities were anemia, acne-like skin rash, leukopenia, fatigue and malaise, and nausea and vomiting. Seven patients (5%) developed a grade 3 or 4 hypersensitivity reaction to cetuximab.

CONCLUSION: Cetuximab and cisplatin is an active regimen in refractory SCCHN. The relative contribution of cetuximab is better defined in a single-agent trial. Cetuximab did not exacerbate cisplatin toxicity but was associated with skin rash in a majority of patients and occasional serious allergic reactions. Further study of this compound is warranted.

{dagger} Deceased.

Authors' disclosures of potential conflicts of interest are found at the end of this article.


Add to CiteULike CiteULike   Add to Complore Complore   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us   Add to Digg Digg   Add to Facebook Facebook   Add to Reddit Reddit   Add to Technorati Technorati   Add to Twitter Twitter    What's this?

Related Editorial

  • Cetuximab and Cisplatin for Chemotherapy-Refractory Squamous Cell Cancer of the Head and Neck
    Barbara Burtness
    JCO 2005 23: 5440-5442 [Full Text]


This article has been cited by other articles:


Home page
 Ann OncolHome page
S. Lorenzen, T. Schuster, R. Porschen, S.-E. Al-Batran, R. Hofheinz, P. Thuss-Patience, M. Moehler, P. Grabowski, D. Arnold, T. Greten, et al.
Cetuximab plus cisplatin-5-fluorouracil versus cisplatin-5-fluorouracil alone in first-line metastatic squamous cell carcinoma of the esophagus: a randomized phase II study of the Arbeitsgemeinschaft Internistische Onkologie
Ann. Onc., October 1, 2009; 20(10): 1667 - 1673.
[Abstract] [Full Text] [PDF]

Home page
 JNMHome page
H. Schoder, M. Fury, N. Lee, and D. Kraus
PET Monitoring of Therapy Response in Head and Neck Squamous Cell Carcinoma
J. Nucl. Med., May 1, 2009; 50(Suppl_1): 74S - 88S.
[Abstract] [Full Text] [PDF]

Home page
 The OncologistHome page
M. J. Guarino, C. J. Schneider, M. A. Hosford, J. R. Brahmer, C. M. Rudin, F. G. Finckenstein, R. E. Philip-Norton, H. Lu, M. R. Weber, and D. S. Ettinger
Dual Inhibition of the Epidermal Growth Factor Receptor Pathway with Cetuximab and Erlotinib: A Phase I Study in Patients with Advanced Solid Malignancies
Oncologist, February 1, 2009; 14(2): 119 - 124.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
H. Wilke, R. Glynne-Jones, J. Thaler, A. Adenis, P. Preusser, E. A. Aguilar, M. S. Aapro, R. Esser, A. H. Loos, and S. Siena
Cetuximab Plus Irinotecan in Heavily Pretreated Metastatic Colorectal Cancer Progressing on Irinotecan: MABEL Study
J. Clin. Oncol., November 20, 2008; 26(33): 5335 - 5343.
[Abstract] [Full Text] [PDF]

Home page
 NEJMHome page
J. B. Vermorken, R. Mesia, F. Rivera, E. Remenar, A. Kawecki, S. Rottey, J. Erfan, D. Zabolotnyy, H.-R. Kienzer, D. Cupissol, et al.
Platinum-Based Chemotherapy plus Cetuximab in Head and Neck Cancer
N. Engl. J. Med., September 11, 2008; 359(11): 1116 - 1127.
[Abstract] [Full Text] [PDF]

Home page
 Cancer Epidemiol. Biomarkers Prev.Home page
A. Psyrri, B. Egleston, E. Pectasides, P. Weinberger, Z. Yu, D. Kowalski, C. Sasaki, B. Haffty, D. Rimm, and B. Burtness
Correlates and Determinants of Nuclear Epidermal Growth Factor Receptor Content in an Oropharyngeal Cancer Tissue Microarray
Cancer Epidemiol. Biomarkers Prev., June 1, 2008; 17(6): 1486 - 1492.
[Abstract] [Full Text] [PDF]

Home page
 Ann OncolHome page
B. A. Burtness, J. Manola, R. Axelrod, A. Argiris, and A. A. Forastiere
A randomized phase II study of ixabepilone (BMS-247550) given daily x 5 days every 3 weeks or weekly in patients with metastatic or recurrent squamous cell cancer of the head and neck: an Eastern Cooperative Oncology Group study
Ann. Onc., May 1, 2008; 19(5): 977 - 983.
[Abstract] [Full Text] [PDF]

Home page
 Mayo Clin Proc.Home page
S. Marur and A. A. Forastiere
Head and Neck Cancer: Changing Epidemiology, Diagnosis, and Treatment
Mayo Clin. Proc., April 1, 2008; 83(4): 489 - 501.
[Abstract] [Full Text] [PDF]

Home page
 NEJMHome page
F. Ciardiello and G. Tortora
EGFR Antagonists in Cancer Treatment
N. Engl. J. Med., March 13, 2008; 358(11): 1160 - 1174.
[Full Text] [PDF]

Home page
 JCOHome page
P. A. Janne, J. von Pawel, R. B. Cohen, L. Crino, C. A. Butts, S. S. Olson, I. A. Eiseman, A. A. Chiappori, B. Y. Yeap, P. F. Lenehan, et al.
Multicenter, Randomized, Phase II Trial of CI-1033, an Irreversible Pan-ERBB Inhibitor, for Previously Treated Advanced Non Small-Cell Lung Cancer
J. Clin. Oncol., September 1, 2007; 25(25): 3936 - 3944.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
C. Elser, L. L. Siu, E. Winquist, M. Agulnik, G. R. Pond, S. F. Chin, P. Francis, R. Cheiken, J. Elting, A. McNabola, et al.
Phase II Trial of Sorafenib in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck or Nasopharyngeal Carcinoma
J. Clin. Oncol., August 20, 2007; 25(24): 3766 - 3773.
[Abstract] [Full Text] [PDF]

Home page
 JAMAHome page
M. V. Karamouzis, J. R. Grandis, and A. Argiris
Therapies Directed Against Epidermal Growth Factor Receptor in Aerodigestive Carcinomas
JAMA, July 4, 2007; 298(1): 70 - 82.
[Abstract] [Full Text] [PDF]

Home page
 Jpn J Clin OncolHome page
S. Zenda, Y. Onozawa, N. Boku, Y. Iida, M. Ebihara, and T. Onitsuka
Single-agent Docetaxel in Patients with Platinum-refractory Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Jpn. J. Clin. Oncol., July 1, 2007; 37(7): 477 - 481.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
A. A. Forastiere and B. A. Burtness
Epidermal Growth Factor Receptor Inhibition in Head and Neck Cancer--More Insights, but More Questions
J. Clin. Oncol., June 1, 2007; 25(16): 2152 - 2155.
[Full Text] [PDF]

Home page
 JCOHome page
J. B. Vermorken, J. Trigo, R. Hitt, P. Koralewski, E. Diaz-Rubio, F. Rolland, R. Knecht, N. Amellal, A. Schueler, and J. Baselga
Open-Label, Uncontrolled, Multicenter Phase II Study to Evaluate the Efficacy and Toxicity of Cetuximab As a Single Agent in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck Who Failed to Respond to Platinum-Based Therapy
J. Clin. Oncol., June 1, 2007; 25(16): 2171 - 2177.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
L. L. Siu, D. Soulieres, E. X. Chen, G. R. Pond, S. F. Chin, P. Francis, L. Harvey, M. Klein, W. Zhang, J. Dancey, et al.
Phase I/II Trial of Erlotinib and Cisplatin in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck: A Princess Margaret Hospital Phase II Consortium and National Cancer Institute of Canada Clinical Trials Group Study
J. Clin. Oncol., June 1, 2007; 25(16): 2178 - 2183.
[Abstract] [Full Text] [PDF]

Home page
 Ann OncolHome page
J. Cruz, A Ocana, E Del Barco, and A Pandiella
Targeting receptor tyrosine kinases and their signal transduction routes in head and neck cancer
Ann. Onc., March 1, 2007; 18(3): 421 - 430.
[Abstract] [Full Text] [PDF]

Home page
 Clin. Cancer Res.Home page
P. M. Fracasso, H. Burris III, M. A. Arquette, R. Govindan, F. Gao, L. P. Wright, S. A. Goodner, F. A. Greco, S. F. Jones, N. Willcut, et al.
A Phase 1 Escalating Single-Dose and Weekly Fixed-Dose Study of Cetuximab: Pharmacokinetic and Pharmacodynamic Rationale for Dosing
Clin. Cancer Res., February 1, 2007; 13(3): 986 - 993.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
N. Hanna, R. Lilenbaum, R. Ansari, T. Lynch, R. Govindan, P. A. Janne, and P. Bonomi
Phase II Trial of Cetuximab in Patients With Previously Treated Non Small-Cell Lung Cancer
J. Clin. Oncol., November 20, 2006; 24(33): 5253 - 5258.
[Abstract] [Full Text] [PDF]

Home page
 Molecular Cancer TherapeuticsHome page
M. N. Younes, Y. W. Park, Y. D. Yazici, M. Gu, A. A. Santillan, X. Nong, S. Kim, S. A. Jasser, A. K. El-Naggar, and J. N. Myers
Concomitant inhibition of epidermal growth factor and vascular endothelial growth factor receptor tyrosine kinases reduces growth and metastasis of human salivary adenoid cystic carcinoma in an orthotopic nude mouse model.
Mol. Cancer Ther., November 1, 2006; 5(11): 2696 - 2705.
[Abstract] [Full Text] [PDF]

Home page
 Clin. Cancer Res.Home page
A. R. Tan, D. F. Moore, M. Hidalgo, J. H. Doroshow, E. A. Poplin, S. Goodin, D. Mauro, and E. H. Rubin
Pharmacokinetics of Cetuximab After Administration of Escalating Single Dosing and Weekly Fixed Dosing in Patients with Solid Tumors
Clin. Cancer Res., November 1, 2006; 12(21): 6517 - 6522.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
C. H. Chung, K. Ely, L. McGavran, M. Varella-Garcia, J. Parker, N. Parker, C. Jarrett, J. Carter, B. A. Murphy, J. Netterville, et al.
Increased Epidermal Growth Factor Receptor Gene Copy Number Is Associated With Poor Prognosis in Head and Neck Squamous Cell Carcinomas
J. Clin. Oncol., September 1, 2006; 24(25): 4170 - 4176.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
J. Bourhis, F. Rivera, R. Mesia, A. Awada, L. Geoffrois, C. Borel, Y. Humblet, A. Lopez-Pousa, R. Hitt, M. E. Vega Villegas, et al.
Phase I/II Study of Cetuximab in Combination With Cisplatin or Carboplatin and Fluorouracil in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
J. Clin. Oncol., June 20, 2006; 24(18): 2866 - 2872.
[Abstract] [Full Text] [PDF]

Home page
 Clin. Cancer Res.Home page
W. Yang, R. F. Barth, G. Wu, S. Kawabata, T. J. Sferra, A. K. Bandyopadhyaya, W. Tjarks, A. K. Ferketich, M. L. Moeschberger, P. J. Binns, et al.
Molecular Targeting and Treatment of EGFRvIII-Positive Gliomas Using Boronated Monoclonal Antibody L8A4.
Clin. Cancer Res., June 15, 2006; 12(12): 3792 - 3802.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
D. M. Brizel and R. Esclamado
Concurrent Chemoradiotherapy for Locally Advanced, Nonmetastatic, Squamous Carcinoma of the Head and Neck: Consensus, Controversy, and Conundrum
J. Clin. Oncol., June 10, 2006; 24(17): 2612 - 2617.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
A. D. Colevas
Chemotherapy Options for Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck
J. Clin. Oncol., June 10, 2006; 24(17): 2644 - 2652.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
E. E.W. Cohen
Role of Epidermal Growth Factor Receptor Pathway-Targeted Therapy in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck
J. Clin. Oncol., June 10, 2006; 24(17): 2659 - 2665.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
B. A. Conley
Treatment of Advanced Head and Neck Cancer: What Lessons Have We Learned?
J. Clin. Oncol., March 1, 2006; 24(7): 1023 - 1025.
[Full Text] [PDF]

Home page
 Cancer Res.Home page
A. Kong, P. Leboucher, R. Leek, V. Calleja, S. Winter, A. Harris, P. J. Parker, and B. Larijani
Prognostic value of an activation state marker for epidermal growth factor receptor in tissue microarrays of head and neck cancer.
Cancer Res., March 1, 2006; 66(5): 2834 - 2843.
[Abstract] [Full Text] [PDF]

Home page
 NEJMHome page
J. A. Bonner, P. M. Harari, J. Giralt, N. Azarnia, D. M. Shin, R. B. Cohen, C. U. Jones, R. Sur, D. Raben, J. Jassem, et al.
Radiotherapy plus Cetuximab for Squamous-Cell Carcinoma of the Head and Neck
N. Engl. J. Med., February 9, 2006; 354(6): 567 - 578.
[Abstract] [Full Text] [PDF]

Home page
 The Annals of PharmacotherapyHome page
D. A Frieze and J. S McCune
Current Status of Cetuximab for the Treatment of Patients with Solid Tumors
Ann. Pharmacother., February 1, 2006; 40(2): 241 - 250.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
B. Burtness, M. A. Goldwasser, W. Flood, B. Mattar, and A. A. Forastiere
Phase III Randomized Trial of Cisplatin Plus Placebo Compared With Cisplatin Plus Cetuximab in Metastatic/Recurrent Head and Neck Cancer: An Eastern Cooperative Oncology Group Study
J. Clin. Oncol., December 1, 2005; 23(34): 8646 - 8654.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
B. Burtness
Cetuximab and Cisplatin for Chemotherapy-Refractory Squamous Cell Cancer of the Head and Neck
J. Clin. Oncol., August 20, 2005; 23(24): 5440 - 5442.
[Full Text] [PDF]


About
JCO		 Editorial
Roster		 Advertising
Information		 Librarians &
Institutions		 Rights &
Permissions		 PDA Services

Copyright © 2005 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
Terms and Conditions of Use
  HighWire Press HighWire Press™ assists in the publication of JCO Online