Objective:To investigate clinical efficacy and safety of gefitinib as single-agent maintenance therapy after first-line chemotherapy in patients with advanced pulmonary adenocarcinoma. Methods:A total number of 60 adults advanced pulmonary adenocarcinoma patiensts were enrolled in this clinical trial,and randomized into gefitinib treatment group and observation control group after conventional cisplatin-base chemotherapy. Gefitinib was oral administered at the dose of 250 mg/d in treatment group as maintenance therapy,the primary end point was defined as death from any cause or disease progression. Median progression free survival(PFS)and overall survival(OS)were evaluated by Kaplan-Meier method. Results:Median PFS in gefitinib group was 8.2 months(95%CI:7.6~8.8)vs 5.2 months(95%CI:4.6~5.8)in observation group(P < 0.01),and median OS was 15.0 months(95%CI:12.2~17.8)vs 8.8 months(95%CI:8.5~9.1)respectively(P < 0.01). The major toxic effects of gefitinib were rash,acne,diarrhea and anorexia,all of which were manageable after supportive treatment,and no therapy-associated death occurred. Conclusion:Single-agent gefitinib as maintenance therapy can prolong PFS and OS of advanced pulmonary adenocarcinoma patients significantly,and side effects are manageable.