BACKGROUNDTo investigate the antitumor effects and toxicity of epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor ZD1839 (Iressa) in patients with advanced non-small cell lung cancer (NSCLC).

METHODSFrom December 2002 to August 2003, 39 patients with unresectable NSCLC were enrolled for 250 mg once-daily oral treatment with ZD1839. Clinical data was analysed using chi-square test, t test and Kaplan-Meier survival analysis. Quality of Life (QoL) was analyzed using Chinese Version of European Organization for Research and Treatment of Cancer (EORTC) core questionnaire QLQ-C30 and lung cancer related questionnaire QLQ-LC13.

RESULTSTumor response rate (complete response and partial response) was 28.2% . Disease control rate, which included both tumor responses and stable disease, was 59.0%. Objective tumor response was correlated with gender and pathological type. Time to progress was (6.6±1.6) months (95% CI, 3.4-9.7), and 1 year survival rate was 54.3%. Response rate of global, functional and lung cancer-related symptom scales were 34.8%, 65.2% and 73.9% respectively. The ZD1839 of 250 mg/d was well tolerated by patients. The majority of adverse events were grade I or grade II skin rash and diarrhea, which were manageable and reversible.

CONCLUSIONSZD1839 offers a new treatment option providing meaningful tumor control and symptom relief for many patients with advanced NSCLC.