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

Rosell, R., Robinet, G., Szczesna, A., Ramlau, Rodryg, Constenla, M., Mennecier, B. C., Pfeifer, W., O'Byrne, Kenneth J., Welte, T., Kolb, R., Pirker, R., Chemaissani, A., Perol, M., Ranson, M. R., Ellis, P. A., Pilz, K., & Reck, M. (2008) 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. Annals of Oncology, 19(2), pp. 362-369.

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Abstract

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/m, 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. © 2007 European Society for Medical Oncology.

Impact and interest:

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ID Code: 65380
Item Type: Journal Article
Refereed: Yes
Additional Information: Articles free to read on journal website after 12 months
Additional URLs:
Keywords: Cetuximab, Cisplatin, Epidermal growth factor receptor, First-line, NSCLC, Vinorelbine, antihistaminic agent, navelbine, acne, adult, advanced cancer, aged, antineoplastic activity, area under the curve, article, asthenia, cancer combination chemotherapy, cancer survival, clinical trial, continuous infusion, controlled clinical trial, controlled study, dose response, drug clearance, drug efficacy, drug exposure, drug half life, drug safety, drug withdrawal, female, fever, human, infection, leukocyte, lung non small cell cancer, major clinical study, male, maximum plasma concentration, multiple cycle treatment, nausea, neutrophil, open study, overall survival, phase 2 clinical trial, priority journal, randomized controlled trial, rash, respiratory tract disease, side effect, skin toxicity, survival rate, syncope, thrombocyte, treatment duration, treatment response, vomiting, Antibodies, Monoclonal, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Non-Small-Cell Lung, Confidence Intervals, Dose-Response Relationship, Drug, Drug Administration Schedule, Follow-Up Studies, Humans, Lung Neoplasms, Maximum Tolerated Dose, Middle Aged, Neoplasm Invasiveness, Neoplasm Staging, Probability, Reference Values, Risk Assessment, Survival Analysis, Treatment Outcome, Vinblastine
DOI: 10.1093/annonc/mdm474
ISSN: 0923-7534
Divisions: Current > Schools > School of Biomedical Sciences
Current > QUT Faculties and Divisions > Faculty of Health
Current > Institutes > Institute of Health and Biomedical Innovation
Copyright Owner: Copyright 2008 Oxford University Press
Deposited On: 13 Dec 2013 00:45
Last Modified: 27 Jan 2015 04:46

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