Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX) : an open-label randomised phase III trial

Pirker, Robert, Pereira, Jose R., Szczesna, Aleksandra, von Pawel, Joachim, Krzakowski, Maciej, Ramlau, Rodrig, Vynnychenko, Ihor, Park, Keunchil, Yu, Chih-Teng, Ganul, Valentyl, Roh, Jae-Kyung, Bajetta, Emilio, O'Byrne, Kenneth J., de Marinis, Filippo, Eberhardt, Wilfried, Goddemeier, Thomas, Emig, Michael, & Gatzemeier, Ulrich (2009) Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX) : an open-label randomised phase III trial. The Lancet, 373(9674), pp. 1525-1531.

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Abstract

Background: Use of cetuximab, a monoclonal antibody targeting the epidermal growth factor receptor (EGFR), has the potential to increase survival in patients with advanced non-small-cell lung cancer. We therefore compared chemotherapy plus cetuximab with chemotherapy alone in patients with advanced EGFR-positive non-small-cell lung cancer.

Methods: In a multinational, multicentre, open-label, phase III trial, chemotherapy-naive patients (≥18 years) with advanced EGFR-expressing histologically or cytologically proven stage wet IIIB or stage IV non-small-cell lung cancer were randomly assigned in a 1:1 ratio to chemotherapy plus cetuximab or just chemotherapy. Chemotherapy was cisplatin 80 mg/m 2 intravenous infusion on day 1, and vinorelbine 25 mg/m 2 intravenous infusion on days 1 and 8 of every 3-week cycle) for up to six cycles. Cetuximab-at a starting dose of 400 mg/m 2 intravenous infusion over 2 h on day 1, and from day 8 onwards at 250 mg/m 2 over 1 h per week-was continued after the end of chemotherapy until disease progression or unacceptable toxicity had occurred. The primary endpoint was overall survival. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00148798. Findings: Between October, 2004, and January, 2006, 1125 patients were randomly assigned to chemotherapy plus cetuximab (n=557) or chemotherapy alone (n=568). Patients given chemotherapy plus cetuximab survived longer than those in the chemotherapy-alone group (median 11·3 months vs 10·1 months; hazard ratio for death 0·871 [95% CI 0·762-0·996]; p=0·044). The main cetuximab-related adverse event was acne-like rash (57 [10%] of 548, grade 3).

Interpretation: Addition of cetuximab to platinum-based chemotherapy represents a new treatment option for patients with advanced non-small-cell lung cancer. Funding: Merck KGaA. © 2009 Elsevier Ltd. All rights reserved.

Impact and interest:

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ID Code: 65348
Item Type: Journal Article
Refereed: Yes
Additional URLs:
Keywords: cetuximab, cisplatin, epidermal growth factor receptor, navelbine, adult, advanced cancer, aged, anaphylaxis, anemia, article, brain hemorrhage, cancer combination chemotherapy, cancer growth, cancer mortality, cancer staging, cancer survival, clinical trial, congestive heart failure, controlled clinical trial, controlled study, diarrhea, drug dose reduction, drug hypersensitivity, dyspnea, fatigue, febrile neutropenia, female, fever, heart arrhythmia, heart infarction, heart muscle ischemia, hematemesis, hemoptysis, human, hypokalemia, leukopenia, lung embolism, lung hemorrhage, lung non small cell cancer, major clinical study, male, multicenter study, multiple cycle treatment, neutropenia, overall survival, phase 3 clinical trial, priority journal, randomized controlled trial, rash, respiratory failure, sepsis, sudden deafness, vomiting, Adolescent, Aged, 80 and over, Antibodies, Monoclonal, Antineoplastic Agents, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Non-Small-Cell Lung, Humans, Lung Neoplasms, Middle Aged, Neoplasm Staging, Proportional Hazards Models, Receptor, Epidermal Growth Factor, Survival Analysis, Survival Rate, Treatment Outcome, Vinblastine, Young Adult
DOI: 10.1016/S0140-6736(09)60569-9
ISSN: 0140-6736
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 2009 The Lancet Publishing Group
Deposited On: 12 Dec 2013 04:06
Last Modified: 13 Mar 2014 00:39

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