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| |  Cetuximab Plus Platinum-Based Therapy Sets New Standard for First-Line Treatment of Advanced Non-Small-Cell Lung Cancer: Presented at ASCO By Bruce Sylvester CHICAGO -- June 2, 2008 -- The positive effect of adding cetuximab to platinum-based therapy sets a new standard for the first-line treatment of patients with advanced non-small-cell lung cancer (NSCLC), according to study findings presented here at the American Society of Clinical Oncology (ASCO) 44th Annual Meeting. "Cetuximab opens new treatment options in earlier stages of advanced non-small-cell lung cancer," said lead investigator Robert Pirker, MD, Medical University of Vienna, Vienna, Austria. Dr. Pirker presented the results of the First-Line Treatment of Advanced Non-Small-Cell Lung Cancer (FLEX) study in a plenary session on June 1. Dysregulation of the epidermal growth factor receptor (EGFR) is common in NSCLC and is associated with poor prognosis, according to the study authors. In their phase 3 study, Dr. Pirker and colleagues sought to evaluate the efficacy and safety of the EGFR-targeted monoclonal antibody cetuximab in combination with cisplatin/vinorelbine compared with cisplatin/vinorelbine alone, in the treatment of advanced NSCLC. The investigators randomised subjects with EGFR-detectable advanced NSCLC in a 1:1 fashion to receive cetuximab (400 mg/m2 initial dose, then 250 mg/m2/week) plus cisplatin (80 mg/m2 on day 1) and vinorelbine (25 mg/m2 days 1 and 8) every 3 weeks (arm A) or cisplatin/vinorelbine alone (arm B). The primary endpoint was overall survival. Secondary endpoints were progression-free survival, tumour response, disease control, and safety. The investigators randomised 557 patients to arm A and 568 patients to arm B. At randomisation, the median age was 59 years (range, 18-83); 70% of patients were male; 94% had stage IV NSCLC; 47% had adenocarcinoma; 34% had squamous cell carcinoma; and 83% had Eastern Cooperative Oncology Group performance status 0/1. Median treatment duration was 14 weeks for both groups. The investigators reported that overall survival was significantly improved among subjects receiving cetuximab (11.3 months for cisplatin/vinorelbine/cetuximab vs 10.1 months for cisplatin/vinorelbine alone, P = .044). Median response rate was 36% in the cisplatin/vinorelbine/cetuximab group compared with 29% in the cisplatin/vinorelbine alone group (P = .012). Median progression-free survival was 4.8 months in both cohorts. Median time to treatment failure was 4.2 months in the cisplatin/vinorelbine/cetuximab group and 3.7 months in the cisplatin/vinorelbine alone group (P = .015). There were no unexpected adverse events, but acne-like rash and infusion reactions were higher in the cetuximab group. The authors concluded, "Cetuximab added to first-line chemotherapy with cisplatin/vinorelbine demonstrated superior overall survival compared to chemotherapy alone in patients with advanced EGFR-expressing NSCLC. Cetuximab added to platinum-based chemotherapy sets a new standard for the first-line treatment of patients with advanced NSCLC." Cetuximab is marketed in the United States by Bristol-Myers Squibb Co. and in Europe by Merck KGaA, which conducted the FLEX study.
[Presentation title: FLEX: A Randomized, Multicenter, Phase III Study of Cetuximab in Combination With Cisplatin/Vinorelbine (CV) Versus CV Alone in the First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC). Abstract 3]
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