Multi-Institutional Randomized Phase II Trial of Gefitinib for Previously Treated Patients With Advanced Non–Small-Cell Lung Cancer
作者： Masahiro Fukuoka , Seiji Yano , Giuseppe Giaccone , Tomohide Tamura , Kazuhiko Nakagawa
关键词: Chemotherapy 、 Survival rate 、 Randomized controlled trial 、 Tolerability 、 Randomization 、 Lung cancer 、 Clinical trial 、 Internal medicine 、 Medicine 、 Surgery 、 Gastroenterology 、 Gefitinib
摘要: Purpose: To evaluate the efficacy and tolerability of two doses gefitinib (Iressa [ZD1839]; AstraZeneca, Wilmington, DE), a novel epidermal growth factor receptor tyrosine kinase inhibitor, in patients with pretreated advanced non–small-cell lung cancer (NSCLC). Patients Methods: This was randomized, double-blind, parallel-group, multicenter phase II trial. Two hundred ten NSCLC who were previously treated one or chemotherapy regimens (at least containing platinum) randomized to receive either 250-mg 500-mg oral once daily. Results: Efficacy similar for 250- 500-mg/d groups. Objective tumor response rates 18.4% (95% confidence interval [CI], 11.5 27.3) 19.0% CI, 12.1 27.9); among evaluable patients, symptom improvement 40.3% 28.5 53.0) 37.0% 26.0 49.1); median progression-free survival times 2.7 2.8 months; overall 7.6 8....
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