Abstract | BACKGROUND: METHODS: 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: FUNDING: Merck KGaA.
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Authors | Robert Pirker, Jose R Pereira, Aleksandra Szczesna, Joachim von Pawel, Maciej Krzakowski, Rodryg Ramlau, Ihor Vynnychenko, Keunchil Park, Chih-Teng Yu, Valentyn Ganul, Jae-Kyung Roh, Emilio Bajetta, Kenneth O'Byrne, Filippo de Marinis, Wilfried Eberhardt, Thomas Goddemeier, Michael Emig, Ulrich Gatzemeier, FLEX Study Team |
Journal | Lancet (London, England)
(Lancet)
Vol. 373
Issue 9674
Pg. 1525-31
(May 02 2009)
ISSN: 1474-547X [Electronic] England |
PMID | 19410716
(Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antibodies, Monoclonal
- Antibodies, Monoclonal, Humanized
- Antineoplastic Agents
- Vinblastine
- ErbB Receptors
- Cetuximab
- Cisplatin
- Vinorelbine
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Topics |
- Adolescent
- Adult
- Aged
- Aged, 80 and over
- Antibodies, Monoclonal
(adverse effects, therapeutic use)
- Antibodies, Monoclonal, Humanized
- Antineoplastic Agents
(therapeutic use)
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects, therapeutic use)
- Carcinoma, Non-Small-Cell Lung
(drug therapy, mortality, pathology)
- Cetuximab
- Cisplatin
(administration & dosage)
- ErbB Receptors
(analysis, antagonists & inhibitors, drug effects)
- Female
- Humans
- Lung Neoplasms
(drug therapy, mortality, pathology)
- Male
- Middle Aged
- Neoplasm Staging
- Proportional Hazards Models
- Survival Analysis
- Survival Rate
- Treatment Outcome
- Vinblastine
(administration & dosage, analogs & derivatives)
- Vinorelbine
- Young Adult
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