1. Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX): an open-label randomised phase III trial
- Author
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Pirker, Robert, Pereira, Jose R, Szczesna, Aleksandra, Von Pawel, Joachim, Krzakowski, Maciej, Ramlau, Rodryg, Vynnychenko, Ihor, Park, Keunchil, Yu, Chih-Teng, Ganul, Valentyn, Roh, Jae-Kyung, Bajetta, Emilio, O'Byrne, Kenneth, De Marinis, Filippo, Eberhardt, Wilfried, Goddemeier, Thomas, Emig, Michael, Gatzemeier, Ulrich, Renseigné, Non, Chouaid, Christos, Department of Medicine I and Clinical Pathology, Universität Wien, Institut de Recherche Pierre Fabre, Centre de Recherche Pierre Fabre (Centre de R&D Pierre Fabre), PIERRE FABRE-PIERRE FABRE, Epidémiologie des maladies infectieuses et modélisation (ESIM), Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), R Pirker, JR Pereira, Roh JK, E Bajetta, K O'Byrne, de Marinis F, W Eberhardt, Goddemeier T, M Emig, Gatzemeier U, équipe de l'étude FLEX ., Szczesna A, von Pawel J, M Krzakowski, R Ramlau, Vynnychenko I, K Park, CT Yu, and V Ganul
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Male ,Lung Neoplasms ,medicine.medical_treatment ,Cetuximab ,Gastroenterology ,MESH: Antibodies, Monoclonal ,MESH: Proportional Hazards Models ,MESH: Aged, 80 and over ,0302 clinical medicine ,Carcinoma, Non-Small-Cell Lung ,Antineoplastic Combined Chemotherapy Protocols ,Medicine ,MESH: Treatment Outcome ,Aged, 80 and over ,MESH: Aged ,0303 health sciences ,MESH: Middle Aged ,Antibodies, Monoclonal ,Vinorelbine ,MESH: Neoplasm Staging ,General Medicine ,Middle Aged ,3. Good health ,ErbB Receptors ,Survival Rate ,MESH: Antineoplastic Combined Chemotherapy Protocols ,Treatment Outcome ,MESH: Young Adult ,MESH: Survival Analysis ,030220 oncology & carcinogenesis ,Female ,medicine.drug ,Adult ,medicine.medical_specialty ,Adolescent ,MESH: Survival Rate ,MESH: Vinblastine ,Antineoplastic Agents ,MESH: Receptor, Epidermal Growth Factor ,Antibodies, Monoclonal, Humanized ,Vinblastine ,Young Adult ,03 medical and health sciences ,Internal medicine ,Humans ,Lung cancer ,Survival rate ,Aged ,Neoplasm Staging ,Proportional Hazards Models ,030304 developmental biology ,Cancer staging ,MESH: Adolescent ,Chemotherapy ,MESH: Humans ,business.industry ,Cancer ,MESH: Adult ,medicine.disease ,Survival Analysis ,MESH: Male ,MESH: Lung Neoplasms ,Surgery ,MESH: Cisplatin ,MESH: Antineoplastic Agents ,[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie ,Cisplatin ,business ,MESH: Female ,MESH: Carcinoma, Non-Small-Cell Lung ,Necitumumab - Abstract
International audience; 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 (>or=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.
- Published
- 2009
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