Friday, May 1, 2009
FRIDAY, May 1 (HealthDay News) -- Patients with advanced non-small-cell lung cancer treated with chemotherapy and cetuximab (Erbitux) survived significantly longer than patients treated with chemotherapy alone, according to a multinational study reported in the May 2 issue of The Lancet.
Robert Pirker, M.D., of the Medical University of Vienna in Austria, and colleagues conducted the FLEX (First-Line ErbituX in lung cancer) phase III clinical trial in which 1,125 patients with advanced epidermal growth factor receptor (EGFR)-expressing stage wet IIIB or stage IV non-small-cell lung cancer were randomized to receive chemotherapy (cisplatin and vinorelbine), plus cetuximab (n = 557) or chemotherapy alone (n = 568). The cetuximab was initially infused at a dose of 400 mg/m2 and, after day eight, at a dose of 250 mg/m2. The cetuximab was continued beyond the end of chemotherapy until the occurrence of disease progression or intolerable toxicity. Overall survival was the primary study endpoint.
The researchers found that the patients on the chemotherapy plus cetuximab regimen had a median survival of 11.3 months versus 10.1 months for the chemotherapy-only group. The main side effect of cetuximab was an acne-like rash reported in 57 patients.
"In conclusion, cetuximab added to platinum-based chemotherapy can be regarded as a new standard first-line treatment option for patients with EGFR-expressing advanced non-small-cell lung cancer," the authors write.
Merck KGaA, which distributes cetuximab outside the United States, funded the study. Several of the investigators reported financial relationships with Merck KGaA and other pharmaceutical companies.
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