Clinical observation of maintenance therapy with gefitinib after the first-line chemotherapy for patients with advanced non-small-cell lung cancer

Objective To evaluate RR,DCR,PFS,OS and toxicities in a population affected by NSCLC using gefitinib as maintenance therapy after the first line chemotherapy.Methods From January,2006 to January,2008,seventy-one patients were enrolled with stable disease or partial response after firstline chemotherapy.They were divided into the observing group and the control group.Gefitinib was administered at the dose of 250 mg in observing group;placebo was also administered everyday in control group.Results Of 71 assessable patients ,overall response rate was 36.1% (13/36) in observing group and 14.3 % (5/35) in control group respectively (x 2 = 4.633,P = 0.036),and one patient (2.8 %) was observed complete response (CR) in observing group.The disease control rate was 83.3 % (30/36) in observing group and 42.9 % (15/35) in control group,respectively,(x2 = 14.782,P ＜ 0.001).The median PFS (progression free survival time) was 13 weeks in observing group and 11 weeks in control group respectively (x2 = 10.401,P =0.001).The median overall survival time (OS) was 13.2 months in observing group and 10.4 months in control group respectively (x2 = 7.696,P= 0.006).The median OS was 18.5 months in women and 11.2 months in men(x2 =22.864,P=0.011) .The median OS was 15.3 months in non-smokers and 10.3 months in smokers (x2 =10.389,P =0.007).The median OS was 16.0 months in adenocarcinoma and alveolar cell carcinoma patients and 10.2 months in squamous cell carcinoma patients (x 2 = 4.638,P = 0.001).The most common toxicity was rash ,diarrhea,fatigue and dry skin itching,and most of them were 1 or 2 grade.Conclusion Maintenance therapy with gefitinib after first-line chemotherapy may improve overall survival time and progression free survival time in patients with NSCLC,and it is effective and safe. Key words: Carcinoma,non-small-cell lung; Gefitinib; Maintenance therapy