TY - JOUR
T1 - Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX)
T2 - an open-label randomised phase III trial
AU - Pirker, Robert
AU - Pereira, Jose R
AU - Szczesna, Aleksandra
AU - von Pawel, Joachim
AU - Krzakowski, Maciej
AU - Ramlau, Rodryg
AU - Vynnychenko, Ihor
AU - Park, Keunchil
AU - Yu, Chih-Teng
AU - Ganul, Valentyn
AU - Roh, Jae-Kyung
AU - Bajetta, Emilio
AU - O'Byrne, Kenneth
AU - de Marinis, Filippo
AU - Eberhardt, Wilfried
AU - Goddemeier, Thomas
AU - Emig, Michael
AU - Gatzemeier, Ulrich
AU - FLEX Study Team
AU - Berchem, Guy
PY - 2009/5/2
Y1 - 2009/5/2
N2 - 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.
AB - 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.
KW - Adolescent
KW - Adult
KW - Aged
KW - Aged, 80 and over
KW - Antibodies, Monoclonal/adverse effects
KW - Antibodies, Monoclonal, Humanized
KW - Antineoplastic Agents/therapeutic use
KW - Antineoplastic Combined Chemotherapy Protocols/adverse effects
KW - Carcinoma, Non-Small-Cell Lung/drug therapy
KW - Cetuximab
KW - Cisplatin/administration & dosage
KW - ErbB Receptors/analysis
KW - Female
KW - Humans
KW - Lung Neoplasms/drug therapy
KW - Male
KW - Middle Aged
KW - Neoplasm Staging
KW - Proportional Hazards Models
KW - Survival Analysis
KW - Survival Rate
KW - Treatment Outcome
KW - Vinblastine/administration & dosage
KW - Vinorelbine
KW - Young Adult
UR - https://www.ncbi.nlm.nih.gov/pubmed/19410716
U2 - 10.1016/S0140-6736(09)60569-9
DO - 10.1016/S0140-6736(09)60569-9
M3 - Article
C2 - 19410716
SN - 0140-6736
VL - 373
SP - 1525
EP - 1531
JO - The Lancet
JF - The Lancet
IS - 9674
ER -