Skip Navigation



Annals of Oncology Advance Access published online on October 17, 2007
Annals of Oncology, doi:10.1093/annonc/mdm474
This Article
Right arrow Full Text Freely available
Right arrow FREE Full Text (PDF) Freely available
Right arrow All Versions of this Article:
19/2/362    most recent
mdm474v1
Right arrow E-letters: Submit a response
Right arrow Alert me when this article is cited
Right arrow Alert me when E-letters are posted
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
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 Add to My Personal Archive
Right arrow Download to citation manager
Right arrowRequest Permissions
Right arrow Disclaimer
Google Scholar
Right arrow Articles by Rosell, R.
Right arrow Articles by Reck, M.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Rosell, R.
Right arrow Articles by Reck, M.
Social Bookmarking
Add to CiteULike   Add to Connotea   Add to Del.icio.us  
What's this?

© 2007 European Society for Medical Oncology

Randomized phase II study of cetuximab plus cisplatin/vinorelbine compared with cisplatin/vinorelbine alone as first-line therapy in EGFR-expressing advanced non-small-cell lung cancer

R. Rosell1,*, G. Robinet2, A. Szczesna3, R. Ramlau4, M. Constenla5, B. C. Mennecier6, W. Pfeifer7, K. J. O`Byrne8, T. Welte9, R. Kolb10, R. Pirker11, A. Chemaissani12, M. Perol13, M. R. Ranson14, P. A. Ellis15, K. Pilz16 and M. Reck17

1 Catalan Institute of Oncology, Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain
2 Institut de Cancérologie, CHU Morvan, Brest, France
3 Mazowieckie Centrum Chorob Pluc i Gruzlicy, III Oddzial Chorob Pluc, Otwock
4 Wielkopolskie Centrum Chorob Pluc i Gruzlicy, Oddzial Onkologii, Poznan, Poland
5 Unidad de Oncología, Hospital de Pontevedra, Spain
6 Service de Pneumologie, Pavillon Laennec, Hôpitaux Universitaires, Strasbourg, France
7 Abt. f. Atem-u. Lungenkrankheiten, A.ö. Krankenhaus d. Stadt Linz, Linz, Austria
8 Department of Oncology, St James’ Hospital, Dublin, Ireland
9 Abt. Pneumologie, Medizinische Hochschule Hannover, Hannover, Germany
10 Abteilung f. Lungenkrankheiten, Klinikum Kreuzschwestern Wels, Wels
11 Klinische Abteilung für Onkologie, Univ.-Klinik f. Innere Medizin I, Wien, Austria
12 Lungenklinik Köln-Merheim, Köln, Germany
13 Service de Pneumologie, Hôpital de la Croix Rousse, Lyon, France
14 Department of Medical Oncology, Christie Hospital, University of Manchester, Manchester
15 Department of Medical Oncology, Guy's Hospital, London, UK
16 Medical Sciences Oncology, Clinical Research & Development, Merck Serono, Darmstadt
17 Onkologischer Schwerpunkt, Zentrum für Pneumologie und Thoraxchirurgie, Krankenhaus Großhansdorf, Wohrendamm, Grosshansdorf, Germany

* Correspondence to: Dr R. Rosell, Medical Oncology Service, Scientific Director of Oncology Research, Catalan Institute of Oncology, Hospital Germans Trias i Pujol, Ctra Canyet, s/n, 08916 Badalona, Barcelona, Spain. Tel: +34-93-497-89-25; Fax: +34-93-497-89-50; E-mail: rrosell{at}ico.scs.es

Background: The Lung Cancer Cetuximab Study is an open-label, randomized phase II pilot study of cisplatin and vinorelbine combined with the epidermal growth factor receptor (EGFR)-targeted monoclonal antibody cetuximab versus cisplatin and vinorelbine alone, in patients with advanced EGFR-expressing, non-small-cell lung cancer (NSCLC). End points of the study are activity, safety and pharmacokinetics.

Patients and methods: Following randomization, for a maximum of eight cycles, patients received three-weekly cycles of cisplatin (80 mg/m2, day 1) and vinorelbine (25 mg/m2 on days 1 and 8) alone or following cetuximab treatment (initial dose 400 mg/m2, followed by 250 mg/m2 weekly thereafter).

Results: Eighty-six patients were randomly allocated to the study (43 per arm). Confirmed response rates were 28% in the cisplatin/vinorelbine arm (A) and 35% in the cetuximab plus cisplatin/vinorelbine arm (B). Median progression-free survival (PFS) was 4.6 months in arm A and 5.0 months in arm B, with PFS rates at 12 months of 0% and 15%, respectively. Median survival was 7.3 months in arm A and 8.3 months in arm B. The 24-month survival rates were 0% and 16%, respectively. The cetuximab combination was well tolerated.

Conclusion: In the first-line treatment of advanced NSCLC, the combination of cetuximab plus cisplatin/vinorelbine demonstrated an acceptable safety profile and the potential to improve activity over cisplatin/vinorelbine alone.

cetuximab, cisplatin, epidermal growth factor receptor, first-line, NSCLC, vinorelbine

Received for publication June 1, 2007. Revision received August 22, 2007. Accepted for publication September 10, 2007.


Add to CiteULike CiteULike   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us    What's this?


This article has been cited by other articles:


Home page
 Clin. Cancer Res.Home page
L. Horn and A. Sandler
Epidermal Growth Factor Receptor Inhibitors and Antiangiogenic Agents for the Treatment of Non-Small Cell Lung Cancer
Clin. Cancer Res., August 15, 2009; 15(16): 5040 - 5048.
[Abstract] [Full Text] [PDF]

Home page
 Ann OncolHome page
M. A. Socinski, M. N. Saleh, D. F. Trent, T. W. Dobbs, L. M. Zehngebot, M. A. Levine, R. Bordoni, and P. J. Stella
A randomized, phase II trial of two dose schedules of carboplatin/paclitaxel/cetuximab in stage IIIB/IV non-small-cell lung cancer (NSCLC)
Ann. Onc., June 1, 2009; 20(6): 1068 - 1073.
[Abstract] [Full Text] [PDF]

Home page
 The OncologistHome page
C. Gridelli, P. Maione, M. L. Ferrara, and A. Rossi
Cetuximab and Other Anti-Epidermal Growth Factor Receptor Monoclonal Antibodies in the Treatment of Non-Small Cell Lung Cancer
Oncologist, June 1, 2009; 14(6): 601 - 611.
[Abstract] [Full Text] [PDF]

Home page
 Proc Am Thorac SocHome page
T. E. Stinchcombe and M. A. Socinski
Current Treatments for Advanced Stage Non-Small Cell Lung Cancer
Proceedings of the ATS, April 15, 2009; 6(2): 233 - 241.
[Abstract] [Full Text] [PDF]

Home page
 The OncologistHome page
N. A. Pennell and T. J. Lynch Jr.
Combined Inhibition of the VEGFR and EGFR Signaling Pathways in the Treatment of NSCLC
Oncologist, April 1, 2009; 14(4): 399 - 411.
[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
 Am Soc Clin Oncol Ed BookHome page
M. A. Socinski
What Guides Decisions about the Use of Epidermal Growth Factor Receptor Antibody or Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors in Advanced Non-small Cell Lung Cancer?
ASCO Educational Book, January 1, 2009; 2009(1): 436 - 443.
[Abstract] [Full Text] [PDF]

Home page
 JNCI J Natl Cancer InstHome page
A. U. Ahmed, R. L. Schmidt, C. H. Park, N. R. Reed, S. E. Hesse, C. F. Thomas, J. R. Molina, C. Deschamps, P. Yang, M. C. Aubry, et al.
Effect of Disrupting Seven-in-Absentia Homolog 2 Function on Lung Cancer Cell Growth
J Natl Cancer Inst, November 19, 2008; 100(22): 1606 - 1629.
[Abstract] [Full Text] [PDF]

Home page
 ChestHome page
P. S. Hodkinson, A. MacKinnon, and T. Sethi
Targeting Growth Factors in Lung Cancer
Chest, May 1, 2008; 133(5): 1209 - 1216.
[Abstract] [Full Text] [PDF]


Disclaimer: Please note that abstracts for content published before 1996 were created through digital scanning and may therefore not exactly replicate the text of the original print issues. All efforts have been made to ensure accuracy, but the Publisher will not be held responsible for any remaining inaccuracies. If you require any further clarification, please contact our Customer Services Department.