RESUMO
OBJECTIVE: The objective of the study was to evaluate the clinical efficacy of kanglaite (KLT) injection combined with gefitinib versus gefitinib alone in the treatment of nonsmall cell lung cancer (NSCLC). METHODS: The randomized controlled trials involving NSCLC treatment with KLT injection combined with gefitinib versus gefitinib alone were searched on seven medical databases up to October 2016. Two reviewers independently assessed the methodological quality of the included studies. The RevMan 5.3 software was employed for data analysis. RESULTS: Seven randomized trials involving 554 patients met our criteria. Compared with gefitinib alone, KLT injection combined with gefitinib showed significant effects in increasing objective response rate (relative risk [RR] =1.38; 95% confidence interval [CI], 1.09-1.75), improving the performance status (RR = 1.80; 95% CI: 1.34-2.42), raising the percentages of CD4+ cells (weighted mean difference [WMD] = 4.45; 95% CI: 2.61-6.28), natural killer cells (WMD = 4.43; 95% CI: 3.85-5.01), and ratio of CD4+/CD8+ (WMD = 0.08; 95% CI: 0.02-0.14), whereas the difference was not significant in gefitinib toxicity including rash (RR 0.90; 95% CI: 0.58-1.40, P = 0.65), diarrhea (RR 1.04; 95% CI: 0.66-1.64, P = 0.88), and liver injury (RR 1.00; 95% CI: 0.58-1.73, P = 1.00), CD3+ cells (WMD = 1.16; 95% CI: -2.64-4.97) and CD8+ cells (WMD = 6.78; 95% CI: -1.68-15.23). CONCLUSION: Co-use of KLT injection and gefitinib may benefit the patients with NSCLC through enhancing the therapeutic effectiveness compared with gefitinib alone. To confirm these results, further rigorously designed trials are warranted.