Journal article

Multi-Institutional Randomized Phase II Trial of Gefitinib for Previously Treated Patients With Advanced Non-Small-Cell Lung Cancer

M Fukuoka, S Yano, G Giaccone, T Tamura, K Nakagawa, JY Douillard, Y Nishiwaki, J Vansteenkiste, S Kudoh, D Rischin, R Eek, T Horai, K Noda, I Takata, E Smit, S Averbuch, A MacLeod, A Feyereislova, RP Dong, J Baselga

Journal of Clinical Oncology | LIPPINCOTT WILLIAMS & WILKINS | Published : 2023

Abstract

PURPOSETo evaluate the efficacy and tolerability of two doses of 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 AND METHODSThis was a randomized, double-blind, parallel-group, multicenter phase II trial. Two hundred ten patients with advanced NSCLC who were previously treated with one or two chemotherapy regimens (at least one containing platinum) were randomized to receive either 250-mg or 500-mg oral doses of gefitinib once daily.RESULTSEfficacy was similar for the 250- and 500-mg/d groups. Objective tumor response rates were 18.4% ..

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University of Melbourne Researchers