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Journal of Clinical Oncology, Vol 24, No 31 (November 1), 2006: pp. 5034-5042
© 2006 American Society of Clinical Oncology.
DOI: 10.1200/JCO.2006.06.3958
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Molecular Predictors of Outcome With Gefitinib in a Phase III Placebo-Controlled Study in Advanced Non–Small-Cell Lung Cancer

Fred R. Hirsch, Marileila Varella-Garcia, Paul A. Bunn, Jr, Wilbur A. Franklin, Rafal Dziadziuszko, Nick Thatcher, Alex Chang, Purvish Parikh, José Rodrigues Pereira, Tudor Ciuleanu, Joachim von Pawel, Claire Watkins, Angela Flannery, Gillian Ellison, Emma Donald, Lucy Knight, Dinah Parums, Nicholas Botwood, Brian Holloway

From the University of Colorado Cancer Center, Aurora, CO; Medical University of Gdansk, Gdansk, Poland; Christie Hospital, Manchester; AstraZeneca, Macclesfield, United Kingdom; Johns Hopkins Singapore International Medical Center, Singapore; Tata Memorial Hospital, Mumbai, India; Arnaldo Vieira de Carvalho Cancer Institute, São Paulo, Brazil; Oncology Institute Ion Chiricuta, Cluj-Napoca, Romania; and Asklepios Fachkliniken, Gauting, Germany

Address reprint requests to Fred R. Hirsch, MD, PhD, University of Colorado Cancer Center, PO Box 6511, Mail Stop 8111, Aurora, CO 80045; e-mail: Fred.Hirsch{at}UCHSC.edu

Purpose The phase III Iressa Survival Evaluation in Lung Cancer (ISEL) trial compared gefitinib with placebo in 1,692 patients with refractory advanced non–small-cell lung cancer. We analyzed ISEL tumor biopsy samples to examine relationships between biomarkers and clinical outcome after gefitinib treatment in a placebo-controlled setting.

Methods Biomarkers included epidermal growth factor receptor (EGFR) gene copy number by fluorescence in situ hybridization (n = 370); EGFR (n = 379) and phosphorylated Akt (p-Akt) protein expression (n = 382) by immunohistochemistry; and mutations in EGFR (n = 215), KRAS (n = 152), and BRAF (n = 118).

Results High EGFR gene copy number was a predictor of a gefitinib-related effect on survival (hazard ratio [HR], 0.61 for high copy number and HR, 1.16 for low copy number; comparison of high v low copy number HR, P = .045). EGFR protein expression was also related to clinical outcome (HR for positive, 0.77; HR for negative, 1.57; comparison of high v low protein expression HR, P = .049). Patients with EGFR mutations had higher response rates than patients without EGFR mutations (37.5% v 2.6%); there were insufficient data for survival analysis. No relationship was observed between p-Akt protein expression and survival outcome, and the limited amount of data collected for KRAS and BRAF mutations prevented any meaningful evaluation of clinical outcomes in relation to these mutations.

Conclusion EGFR gene copy number was a predictor of clinical benefit from gefitinib in ISEL. Additional studies are warranted to assess these biomarkers fully for the identification of patients most likely to benefit from gefitinib treatment.

Supported in part by AstraZeneca; a National Cancer Institute-International Union Aganist Cancer Traslational Cancer Research Fellowship, funded by the National Cancer Institute (R.D.); and by Bristol-Myers Squibb and Pfizer (A.C.).

Presented in part at the Annual Meeting of the American Association for Cancer Research-National Cancer Institute-European Organisation for Research and Treatment of Cancer, Philadelphia, PA, November 14-18, 2005.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.


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