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 say. The findings will be presented at the 15th Annual Congress of the European Respiratory Society in Copenhagen, Denmark.
"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 an overactive growth-signaling molecule (EGFR) in cancer cells. Earlier studies have shown that erlotinib produced promising activity in NSCLC patients for whom chemotherapy has failed. The single-center Phase 2 study being reported now is the first assessment of erlotinib in patients who have not received chemotherapy.
David M. Jackman, MD, is the first author of the abstract, and Pasi A. Janne, MD, PhD, is the senior author.
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 patients were evaluated for survival and toxicity; 69 were evaluated for best response. Ten 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 the patients experienced either a partial response or had stable disease. Eight 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 conclude that erlotinib "appears to be relatively well-tolerated and demonstrates encouraging activity and median survival" in previously untreated patients 70 years or older with NSCLC.
In addition to Jackman, Janne and Johnson, the study's other authors are Joan Lucca, RN, Michael Rabin, MD, and Arthur Skarin, MD, of Dana-Farber; and Thomas Lynch, MD, Patricia Ostler, RN, Jennifer Temel, MD, and Panagiotis Fidias, MD, of the Massachusetts General Hospital.
The research was funded in part by Genentech.
Dana-Farber Cancer Institute (www.dana-farber.org) is a principal teaching affiliate of the Harvard Medical School and is among the leading cancer research and care centers in the United States. It is a founding member of the Dana-Farber/Harvard Cancer Center (DF/HCC), designated a comprehensive cancer center by the National Cancer Institute.