The tyrosine kinase inhibitor erlotinib (Tarceva) showed encouraging activity with relatively tolerable side effects in elderly, previously untreated patients with advanced non-small cell lung cancer (NSCLC), reports a team led by investigators from Dana-Farber Cancer Institute in Boston.
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.
"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.