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According to results of a Phase III clinical trial, initial treatment of advanced non–small cell lung cancer with the targeted therapy Erbitux® (cetuximab) plus chemotherapy improves overall survival by roughly five weeks compared with chemotherapy alone. These results were published in the Lancet and were previously presented at the 2008 annual meeting of the American Society of Clinical Oncology. 

Non–small cell lung cancer (NSCLC) accounts for roughly 85% of all lung cancer. In advanced NSCLC, cancer has spread outside the lung; standard therapy for this stage of disease includes chemotherapy. Because of suboptimal survival rates for advanced NSCLC, researchers continue to evaluate novel ways to improve outcomes for patients with this disease.

Erbitux is a targeted therapy that inhibits growth of the cancer by binding to a portion of the epidermal growth factor receptor (EGFR), a protein located on the surface of many cancer cells, including NSCLC. Erbitux is currently approved for the treatment of selected patients with advanced head and neck cancer or advanced colorectal cancer.

The FLEX trial evaluated the addition of Erbitux to chemotherapy in the initial treatment of advanced, EGFR-expressing NSCLC. The study enrolled 1,125 patients from 30 countries. Ninety-four percent of the patients had Stage IV cancer.

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Half the patients received chemotherapy alone (chemotherapy consisted of cisplatin and vinorelbine), and half the patients received chemotherapy plus Erbitux.

  • Median overall survival was 11.3 months among patients who received chemotherapy plus Erbitux versus 10.1 months among patients who received chemotherapy alone.
  • At one year 47% of patients treated with chemotherapy plus Erbitux were still alive compared with 42% of patients treated with chemotherapy alone.
  • The benefit of Erbitux was seen in all histological subtypes of NSCLC (adenocarcinoma, squamous cell carcinoma, etc.).
  • Moderate (grade 3) acne-like rashes occurred in 10% of patients treated with chemotherapy plus Erbitux and less than 1% of patients treated with chemotherapy alone.

These results suggest that Erbitux improves survival when added to platinum-based chemotherapy in the first-line treatment of advanced NSCLC. Based on these results, the authors note that Erbitux will also be evaluated in earlier stages of NSCLC.

Reference: Pirker R, Pereira JR, Szczesna A et al. Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX): an open-label randomized phase III trial. Lancet. 2009;373;1525-31.

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