OBJECTIVETo investigate the antitumor efficacy, time to tumor progression (TTP) and toxicity of gefitinib (Iressa, ZD1839)--a selective epidermal growth factor receptor tyrosine kinase inhibitor in the treatment of male patients with advanced non-small-cell lung cancer (NSCLC). Methods Fifty-nine male patients with stage IV NSCLC orally took Iressa 250 mg once daily until disease progression or intolerable toxicity ocurred. They were required to conduct tumor-evaluation before the treatment, one month after Iressa administration and then every other month.

RESULTSOf these 59 patients, no complete regression was observed, 23.7% had partial response (PR), and 16.9% stable disease (SD) with a disease control (PR + SD) rate of 40.7%, while 59.3% had progress of disease (PD). The median time to tumor progression (TTP) was 1.8 months, and the median survival was 8.5 months. Fifty-nine patients were followed up over one year, 35 over two year and 15 over three year, and the 1-, 2- and 3-year survival rates were 42.4%, 17.1% and 13.3%. The most common adverse effects were grade 1 or 2 skin reaction and diarrhea.

CONCLUSIONIressa is effective in antitumor for the male patients with advanced non-small-cell lung cancer, and can improve the survival for those responsing to gefitinib. The adverse effects are usually tolerable.