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Annals of Oncology Advance Access published online on June 14, 2005
Annals of Oncology, doi:10.1093/annonc/mdi340
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© 2005 European Society for Medical Oncology
Received March 9, 2005
Revised May 1, 2005
Accepted May 3, 2005

Original article

The EGFR mutation and its correlation with response of gefitinib in previously treated Chinese patients with advanced non-small-cell lung cancer

X.-T. Zhang 1*, L.-Y. Li 1, X.-L. Mu 1, Q.-C. Cui 2, X.-Y. Chang 2, W. Song 3, S.-L. Wang 1, M.-Z. Wang 1, W. Zhong 1, and L. Zhang 1

1 Department of Pulmonary Medicine, Beijing 100730 China
2 Department of Pathology, Beijing 100730 China
3 Department of Radiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China

* To whom correspondence should be addressed.
X.-T. Zhang, E-mail: ajxt{at}public3.bta.met.cn


  Abstract

Background: The aim of the study was to evaluate the efficacy of gefitinib and the epidermal growth factor receptor (EGFR) mutation to gefitinib response in a series of Chinese patients with pretreated advanced non-small-cell lung cancer (NSCLC).

Methods: A total of 98 patients who had failed at least one platinum-based regimen received gefitinib 250 mg once daily. The mutation analysis of the EGFR kinase domain was performed for 30 patients using paraffin-embedded tumor tissue.

Results: The response rate was 31.6% and the disease control rate was 67.3%. Objective response was correlated with adenocarcinoma, female gender and non-smokers. Median progress free survival (PFS) was 7.0 months, median overall survival (OS) was 12.0 months and 1-year survival was 53.1%. The median PFS and OS were improved among patients with adenocarcinoma, gefitinib responders and non-smokers. Active gene mutation was detected in 12 patients. Mutation rates were higher among gefitinib responders, non-smokers, patients with adenocarcinoma and female patients. OS was longer for patients with gene mutation than for patients without mutation.

Conclusion: Gefitinib demonstrated significant antitumor activity with a favorable toxicity profile for pretreated Chinese patients with advanced NSCLC. The active mutation of the EGFR kinase domain was strongly associated with response to gefitinib and prolonged overall survival.

Keywords: EGFR mutation; gefitinib; non-small-cell lung cancer; p-EGFR; predictive marker; targeted therapy.
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