Abstract: AIM: To evaluate the efficacy and safety in the patients with advanced non-small cell lung cancer (NSCLC), treated with thalidomide combined with paclitaxel plus cis-platinum (TP) chemotherapy.METHODS: 110 patients with stages ⅢB and Ⅳ NSCLC were divided randomly into two groups, the trial and the control groups. The trial group were treated with thalidomide and TP chemotherapy, in which thalidomide was given 100 mg per night for the first week and then added to 200 mg per night for 3 months if tolerable. The control group were treated with TP chemotherapy only. All patients were treated primarily and received treatments for at least two periods, 21 days for one period.RESULTS: Of 110 assessable patients, the overall response rate was 41.18% in the trial group and 37.74% in the control group (P＞0.05). The clinical benefit rate was 86.27% in the trial group and 69.81% in the control group (P＜0.05). Besides, the trial group indicated considerable improvement as compared with the control group in the increased appetite rate, weight gain rate and the KPS score improvement rate. The median PFS was 7.45 (5-26) months for the trial group, and 5.77 (4-20) months for the control group (P<0.05); The median OS was 12.88 (6-26) months for the trial group, and 11.32 (5-21) months for the control group (P<0.05).The Ⅲ -Ⅳ grade untoward effects were rare in both groups.Nausea,vomiting of Ⅲ-Ⅳ grade incidence in the treatment group was significantly lower than the control group (P=0.03). But there were no significant differences in the remaining toxicities between the two groups (P＞0.05). The most common untoward effects of thalidomide, somnolence and constipation, were rare (incidence rate 10%-30%).CONCLUSION: Though without considerable improvement in short term efficacy, TP regimen combined with thalidomide with high safety significantly improve clinical benefit rate, quality of life and free survival in patients with advanced NSCLC. Therefore the treatment of TP regimen combined with thalidomide deserves clinical popularization.

Key words: TP regimen, Thalidomide, Advanced non-small cell lung cancer, Chemotherapy