Annals of Oncology Advance Access published online on October 17, 2007
Annals of Oncology, doi:10.1093/annonc/mdm474
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© 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
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.
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