COPENHAGEN--The tyrosine kinase inhibitor erlotinib (Tarceva®)showed encouraging activity with relatively tolerable side effects inelderly, previously untreated patients with advanced non-small celllung cancer (NSCLC), reports a team led by investigators fromDana-Farber Cancer Institute in Boston.
The uncontrolled, Phase II results are sufficiently promising tomerit a Phase III trial comparing erlotinib with single-agent navelbinein this population, the researchers say. The findings will be presentedat the 15th Annual Congress of the European Respiratory Society inCopenhagen, Denmark.
"While further research is needed, our findings suggest that itmay be beneficial to use erlotinib, a relatively non-toxic targetedagent, to initially treat patients with advanced lung cancer, ratherthan use conventional chemotherapy regimens," said Dana-Farber's BruceJohnson, MD, who headed the research.
Erlotinib is designed to specifically and potently block anoveractive growth-signaling molecule (EGFR) in cancer cells. Earlierstudies have shown that erlotinib produced promising activity in NSCLCpatients for whom chemotherapy has failed. The single-center Phase 2study being reported now is the first assessment of erlotinib inpatients 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 between2003 and 2005 at Dana-Farber. All had Stage IIIB or IV disease; halfwere male; median age was 75, and all but five were current or formersmokers.
All patients were evaluated for survival and toxicity; 69 wereevaluated for best response. Ten patients were discontinued from thestudy because of toxicity, and there was one treatment-related deathfrom pneumonitis. Rashes (74 percent of patients) and diarrhea (60percent) were the most common side effects.
There were no complete responses to the drug, but 60 percent ofthe patients experienced either a partial response or had stabledisease. Eight patients had partial responses, 33 had stable diseaseand 28 had progressive disease. The median survival was 46 weeks, andthe median duration of partial response and stable disease was 65 weeksand 24 weeks, respectively.
The researchers conclude that erlotinib "appears to berelatively well-tolerated and demonstrates encouraging activity andmedian survival" in previously untreated patients 70 years or olderwith NSCLC.
In addition to Jackman, Janne and Johnson, the study's otherauthors are Joan Lucca, RN, Michael Rabin, MD, and Arthur Skarin, MD,of Dana-Farber; and Thomas Lynch, MD, Patricia Ostler, RN, JenniferTemel, MD, and Panagiotis Fidias, MD, of the Massachusetts GeneralHospital.
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 isamong the leading cancer research and care centers in the UnitedStates. It is a founding member of the Dana-Farber/Harvard CancerCenter (DF/HCC), designated a comprehensive cancer center by theNational Cancer Institute.
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