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Cetuximab plus chemotherapy in patients with advanced non-small cell lung cancer (FLEX): an open-label randomised phase III trial
The Lancet, 05/07/09

Pirker R et al. - In a trial to compare chemotherapy plus cetuximab with chemotherapy alone in pts with advanced epidermal growth factor receptor (EGFR)-positive non-small cell lung cancer (NSCLC), it was concluded that the addition of cetuximab to platinum-based chemotherapy represents a new treatment option for pts with advanced NSCLC.

Methods

Chemotherapy-naive pts (≥18 yrs) with advanced EGFR-expressing histologically or cytologically proven stage wet IIIB or stage IV NSCLC were randomly assigned in a 1:1 ratio to chemotherapy plus cetuximab or just chemotherapy.
Chemotherapy was cisplatin 80 mg/m2 intravenous infusion on day 1, and vinorelbine 25 mg/m2 intravenous infusion on days 1 and 8 of every 3-wk cycle for up to 6 cycles.
Cetuximab—at a starting dose of 400 mg/m2 intravenous infusion over 2 h on day 1, and from day 8 onwards at 250 mg/m2 over 1 h per week—was continued after the end of chemotherapy until disease progression or unacceptable toxicity had occurred.
Primary endpoint was overall survival; analysis was by intention to treat.

Results

1125 pts were randomly assigned to chemotherapy plus cetuximab (n=557) or chemotherapy alone (n=568).
Pts given chemotherapy plus cetuximab survived longer than those in the chemotherapy-alone group.
Main cetuximab-related adverse event was acne-like rash (57 [10%] of 548, grade 3).

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