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

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          Abstract

          Purpose: To 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 Methods: This 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.

          Results: Efficacy was similar for the 250- and 500-mg/d groups. Objective tumor response rates were 18.4% (95% confidence interval [CI], 11.5 to 27.3) and 19.0% (95% CI, 12.1 to 27.9); among evaluable patients, symptom improvement rates were 40.3% (95% CI, 28.5 to 53.0) and 37.0% (95% CI, 26.0 to 49.1); median progression-free survival times were 2.7 and 2.8 months; and median overall survival times were 7.6 and 8.0 months, respectively. Symptom improvements were recorded for 69.2% (250 mg/d) and 85.7% (500 mg/d) of patients with a tumor response. Adverse events (AEs) at both dose levels were generally mild (grade 1 or 2) and consisted mainly of skin reactions and diarrhea. Drug-related toxicities were more frequent in the higher-dose group. Withdrawal due to drug-related AEs was 1.9% and 9.4% for patients receiving gefitinib 250 and 500 mg/d, respectively.

          Conclusion: Gefitinib showed clinically meaningful antitumor activity and provided symptom relief as second- and third-line treatment in these patients. At 250 mg/d, gefitinib had a favorable AE profile. Gefitinib 250 mg/d is an important, novel treatment option for patients with pretreated advanced NSCLC.

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          Author and article information

          Journal
          Journal of Clinical Oncology
          JCO
          American Society of Clinical Oncology (ASCO)
          0732-183X
          1527-7755
          June 15 2003
          June 15 2003
          : 21
          : 12
          : 2237-2246
          Affiliations
          [1 ]From the Kinki University School of Medicine, Osaka City University School of Medicine, and AstraZeneca, Osaka, Tokushima University School of Medicine, Tokushima, National Cancer Center, Central Hospital, and Japanese Foundation for Cancer Research, Tokyo, National Cancer Center, East Hospital, Chiba, Kanagawa Cancer Center, Yokohama, and National Shikoku Cancer Center, Matsuyama, Japan; C.R.L.C.C. Rene Gauducheau, Saint-Herblain, France; University Hospital Gasthuisberg, Leuven, Belgium; Centre for...
          Article
          10.1200/JCO.2003.10.038
          12748244
          5f8be803-c85a-456e-8758-4f3b9a0071c8
          © 2003
          History

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