Prospective Study of Gefitinib in Epidermal Growth Factor Receptor Fluorescence In Situ Hybridization–Positive/Phospho-Akt–Positive or Never Smoker Patients With Advanced Non–Small-Cell Lung Cancer: The ONCOBELL Trial
作者： Federico Cappuzzo , Claudia Ligorio , Pasi A. Jänne , Luca Toschi , Elisa Rossi
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摘要: Purpose In non–small-cell lung cancer (NSCLC), clinical and biologic predictors for epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor sensitivity have been identified in retrospective studies, there is urgent need to validate these results prospective trials. The ONCOBELL trial a phase II study evaluating gefitinib NSCLC patients who never smoked or increased EGFR gene copy number activation of the antiapoptotic protein Akt. Patients Methods was evaluated using fluorescence situ hybridization (FISH), presence phospho-Akt immunohistochemistry. Additional tests included immunohistochemistry analysis EGFR, FISH HER2, mutation K-ras. Results From November 2004 February 2006, 183 were screened, 42 enrolled onto trial. We observed one complete 19 partial responses, an overall response rate (RR) 47.6% (95% ...
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