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According to results announced by ImClone Systems, the addition of the targeted agent cetuximab (Erbitux®) to chemotherapy including a platinum agent improves survival compared with chemotherapy alone for the treatment of advanced non–small cell lung cancer.

Lung cancer remains the leading cause of cancer-related deaths in the United States. Non–small cell lung cancer (NSCLC) refers to the most common type of lung cancer, accounting for approximately 75–80% of all lung cancers in the U.S. Advanced NSCLC refers to cancer that has spread from the lung to distant sites in the body.

Chemotherapy is a main component of treatment for NSCLC. Researchers continue to evaluate more therapies that may improve survival and quality of life for these patients.

Cetuximab is an agent that is targeted against the epidermal growth factor receptor (EGFR). The epidermal growth factor receptor is involved in the growth and replication of cells. If EGFR is overexpressed or mutated, it may be responsible for uncontrolled replication and spread of cancer cells. Cetuximab binds to EGFR and reduces or prevents its effects on cancer growth.

Researchers recently conducted a Phase III clinical trial (phase prior to FDA review) to evaluate cetuximab as initial therapy for the treatment of advanced NSCLC. This trial, referred to as the First-Line Treatment for Patients with Epidermal Growth Factor Inhibitor (EGFR)-Expressing Advanced NSCLC, or FLEX trial, included patients with advanced NSCLC who were treated with either cetuximab plus platinum-based therapy or platinum-based therapy only.

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  • Patients treated with cetuximab plus chemotherapy achieved significantly improved survival compared with patients treated with chemotherapy only.
  • Data from this trial will be presented at an upcoming medical conference.

The researchers concluded that the addition of cetuximab to platinum-based chemotherapy significantly improves survival compared with platinum-based chemotherapy only as initial therapy in patients with advanced NSCLC. Patients with advanced NSCLC may wish to speak with their physician regarding their individual risks and benefits of participating in a clinical trial further evaluating cetuximab or other novel therapeutic approaches. Two sources of information regarding ongoing clinical trials include the National Cancer Institute ( and

Reference: ImClone Systems, Inc. Erbitux® Meets Primary Endpoint of Increasing Survival in Phase III Lung Cancer Study. Available at: =. Accessed September 2007.

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