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 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 type of 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 NSCLC. The study enrolled 1,125 patients from 30 countries. Ninety-four of the patients had Stage IV cancer.
Half the patients received chemotherapy alone (chemotherapy consisted of cisplatin and vinorelbine), and half the patients received chemotherapy plus Erbitux.
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- Median overall survival was 11.3 months among patients who received chemotherapy plus Erbitux versus 10.1 months among patients who received chemotherapy alone.
- The benefit of Erbitux was seen in all histological subtypes of NSCLC (adenocarcinoma, squamous cell carcinoma, etc.).
- Moderate rashes occurred in 10.4% of patients treated with chemotherapy plus Erbitux and 0.2% 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 be evaluated in earlier stages of NSCLC.
Reference: Pirker R, Szczesna A, von Pawel J et al. 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). Proceedings from the 44th annual meeting of the American Society of Clinical Oncology. Chicago, IL. 2008. Abstract #3.
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