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Previous Volume 353:133-144 July 14, 2005 Number 2 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Supplementary Material Editorial by Doroshow, J. H. Letters Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear Related Article PubMed Citation

ABSTRACT

Background A clinical trial that compared erlotinib with a placebo for non–small-cell lung cancer demonstrated a survival benefit for erlotinib. We used tumor-biopsy samples from participants in this trial to investigate whether responsiveness to erlotinib and its impact on survival were associated with expression by the tumor of epidermal growth factor receptor (EGFR) and EGFR gene amplification and mutations.

Methods EGFR expression was evaluated immunohistochemically in non–small-cell lung cancer specimens from 325 of 731 patients in the trial; 197 samples were analyzed for EGFR mutations; and 221 samples were analyzed for the number of EGFR genes.

Results In univariate analyses, survival was longer in the erlotinib group than in the placebo group when EGFR was expressed (hazard ratio for death, 0.68; P=0.02) or there was a high number of copies of EGFR (hazard ratio, 0.44; P=0.008). In multivariate analyses, adenocarcinoma (P=0.01), never having smoked (P<0.001), and expression of EGFR (P=0.03) were associated with an objective response. In multivariate analysis, survival after treatment with erlotinib was not influenced by the status of EGFR expression, the number of EGFR copies, or EGFR mutation.

Conclusions Among patients with non–small-cell lung cancer who receive erlotinib, the presence of an EGFR mutation may increase responsiveness to the agent, but it is not indicative of a survival benefit.

Source Information

From the University Health Network, Princess Margaret Hospital Site, and the Ontario Cancer Institute, University of Toronto, Toronto (M.-S.T., A.S., J.-C.C., C.-Q.Z., S.K.-R., J.S., T.Z., N.L., P.M., G.C.S., F.A.S.); the Ottawa Health Research Institute, University of Ottawa, Ottawa (I.L., M.D., A.L.); OSI Pharmaceuticals, Boulder, Colo. (F.R.); and the National Cancer Institute of Canada Clinical Trials Group and Queen's University, Kingston, Ont., Canada (L.S., M.W., K.D., J.P.).

Drs. Sakurada, Cutz, and Zhu contributed equally to this article.

Full Text of this Article

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Extract | Full Text | PDF  
N Engl J Med 2005; 353:1739-1741, Oct 20, 2005. Correspondence

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Marchetti A., Felicioni L., Buttitta F., Tsao M.-S., Kamel-Reid S., Shepherd F. A.
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