The tyrosine kinase inhibitor erlotinib shows encouraging activity with relatively tolerable side effects in elderly patients with previously untreated advanced non-small cell lung cancer, according to a presentation at the 15th Annual Congress of the European Respiratory Society in Copenhagen, Denmark.

The uncontrolled, Phase II results are sufficiently promising to merit a Phase III trial comparing erlotinib with single-agent navelbine in this population, the researchers said.

"While further research is needed, our findings suggest that it may be beneficial to use erlotinib, a relatively non-toxic targeted agent, to initially treat patients with advanced lung cancer, rather than use conventional chemotherapy regimens," said Dana-Farber's Bruce Johnson, MD, who headed the research.

Erlotinib is designed to specifically and potently block endothelial growth factor receptors in cancer cells. Earlier studies have shown that erlotinib produced promising activity in patients with non-small cell lung cancer for whom chemotherapy had failed. The current, single-center Phase II study is the first assessment of erlotinib in patients who have not received chemotherapy.

The 80 patients in the study were treated with erlotinib between 2003 and 2005 at Dana-Farber. All had Stage IIIB or IV disease; half were male; median age was 75, and all but five were current or former smokers.

All 80 patients were evaluated for survival and toxicity; 69 were evaluated for best response. A total of 10 patients were discontinued from the study because of toxicity, and there was one treatment-related death from pneumonitis. Rashes (74 percent of patients) and diarrhea (60 percent) were the most common side effects.

There were no complete responses to the drug, but 60 percent of patients experienced either a partial response or had stable disease. Overall, 8 patients had partial responses, 33 had stable disease and 28 had progressive disease. The median survival was 46 weeks, and the median duration of partial response and stable disease was 65 weeks and 24 weeks, respectively.

The researchers concluded that erlotinib "appears to be relatively well-tolerated and demonstrates encouraging activity and median survival" in previously untreated patients 70 years or older with non-small cell lung cancer.