Researchers from several European medical centers have reported the results of a meta-analysis that demonstrates improvement in overall survival (OS), progression-free survival (PFS), and overall response rate (ORR) when Erbitux® (cetuximab) is added to platinum-based chemotherapy for patients with advanced non–small cell lung cancer (NSCLC). The details of this study were reported at the Joint ECCO 15-34th ESMO Multidisciplinary Congress in Berlin, September 20-24.[1]
Therapy of patients with advanced NSCLC continues to be unsatisfactory. The advent of targeted agents, however, has shown some promise in improving outcomes of these patients when these agents are combined with chemotherapy. Currently, Iressa® (gefitinib) and Avastin® (bevacizumab) are approved by the U.S. Food and Drug Administration for the treatment of NSCLC. Erbitux is a drug 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 approved by the FDA for treatment of head and neck cancers and colorectal cancer. Previous Phase II studies have suggested that the addition of Erbitux to chemotherapy is tolerable and may improve outcomes. These studies also suggested that females and patients with EGFR-positive cancers had a better response to the addition of Erbitux. However, in January of 2009, ImClone Systems and Bristol-Meyers Squibb Company withdrew their supplemental biologics application from the U.S. Food and Drug Administration for Erbitux for treatment of NSCLC. One randomized study reported that the addition of Erbitux to platinum-based chemotherapy improves median survival by one month in patients with advanced NSCLC.
The current study reported that the addition of Erbitux improved OS (HR=0.878, P=0.01), PFS (HR=0.899, P=0.036), and ORR (HR=1.463, P=<0.001) compared with chemotherapy alone.
Comments: Erbitux appears to have a therapeutic effect in patients with NSCLC, but future use for this purpose remains to be determined. Possible use may be in combination with other targeted agents.
Reference:
[1] Pujol J, Lyncy TJ, Rosell R, et al. A meta-analysis of four randomized phase II/III trials adding cetuximab to platinum-based chemotherapy as 1st-line treatment in patients with non-small cell lung cancer (NSCLC). European Journal of Cancer Supplements, Vol 7 No 2, September 2009, page 508, abstract O-9009.
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