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Adapted from the NCI Cancer Bulletin, vol. 5/no. 12, June 10, 2008 (see the current issue).

Patients with advanced non-small-cell lung cancer (NSCLC) who received cetuximab (Erbitux) plus chemotherapy lived on average 5 weeks longer than patients who received chemotherapy alone, according to results reported at the ASCO annual meeting.

In the phase III FLEX trial, 1,125 patients with all types of NSCLC were randomly assigned to receive standard platinum-based chemotherapy alone or chemotherapy plus cetuximab. Nearly all of the patients had stage IV disease. Overall survival was higher for those who received cetuximab plus chemotherapy (11.3 months) compared with those who received chemotherapy alone (10.1 months).

The benefit of the combination therapy was seen in patients with all histological subtypes of NSCLC, including adenocarcinoma and squamous cell carcinoma, the two most common subtypes. The main side effect was an acne-like skin rash that could be managed.

"Patients with advanced NSCLC have limited treatment options and life expectancy is short, so the survival increase shown in this study is an important step for these patients," noted Dr. Robert Pirker, an associate professor of medicine at the Medical University of Vienna in Austria and the study's lead author.

The only other final-stage randomized trial to show a survival benefit in lung cancer was a 2005 study of bevacizumab (Avastin) plus chemotherapy. Unlike the current study, that trial did not include patients with squamous cell carcinoma.

Dr. Thomas Lynch of Massachusetts General Hospital, who commented on the findings at ASCO, said the study was well done and produced "a clinically meaningful benefit for a large population."

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