Objective   To investigate the efficacy and adverse reactions of thalidomide-chemotherapy combination regimen in advanced Chinese non-small cell lung cancer patients by meta-analysis.

  Methods  Data of randomized controlled trials were collected from different databases by two independent researchers according to inclusion and exclusion criteria. Meta-analysis of the response rate, clinical benefit response, and different adverse reactions between the thalidomide-chemotherapy combination group and chemotherapy-only group was performed using RevMan 5.1 software.

  Results  A total of 691 patients in 12 randomized clinical trials were included. The meta- analysis results showed that the thalidomide-chemotherapy group had higher response rate OR=1.62, 95%CI (1.18-2.22) and clinical benefit response OR = 2.05, 95% CI (1.40-3.02) (P=0.003, P<0.001, respectively). In the thalidomide-chemotherapy group, the incidence of nausea and vomiting were statistically lower (P=0.002), but the incidence of constipation, somnolence, erythra, and peripheral neurotoxicity were statistically higher (P=0.002, 0.000 2, 0.001, and 0.05, respectively). The differences among the marrow suppression incidences were not statistically significant.

  Conclusion   Thalidomide addition to chemotherapy can improve the response rate and clinical benefit response of Chinese patients, but their overall survival remains to be explored. No serious adverse reaction was observed in the combination therapy group.