Can Aidi injection improve overall survival in patients with non-small cell lung cancer? A systematic review and meta-analysis of 25 randomized controlled trials.

OBJECTIVES: Aidi injection can significantly improve clinical response and reduce radiochemotherapy related toxicity. Can Aidi injection improve the survival in non-small-cell lung cancer (NSCLC)? Therefore, to further reveal it, we systematically evaluated all related studies.

METHODS: We collected all studies about Aidi injection for NSCLC in Medline, Embase, Web of Science(ISI), China National Knowledge Infrastructure Database(CNKI), Chinese Scientific Journals Full-Text Database(VIP), Wanfang, China Biological Medicine Database (CBM), Cochrane Central Register of Controlled Trials (CENTRAL), Chinese clinical trial registry (Chi-CTR) and WHO International Clinical Trials Registry Platform (WHO-ICTRP), and US-clinical trials (established to June 2016). We evaluated their quality according to the Cochrane evaluation handbook of randomized controlled trials (RCTs) (5.1.0), extracted data following the PICO principles, and synthesized the data by meta-analysis.

RESULTS: We included 25 RCTs involving 2662 patients with NSCLC which most studies had unclear risk of bias. The merged risk ratios (RR) values and their 95% CI of meta-analysis for objective response rate (ORR) and disease control rate (DCR) were as following: 1.19(1.09-1.29) and 1.07(1.03-1.11). The merged RR values and their 95% CI of meta-analysis for the 1-, 2- and 3-year overall survival (OS) rate were as following: 1.23(1.14-1.33), 1.46(1.22-1.74) and 1.67(1.04-2.69). All differences were statistically significant. Subgroup analysis showed that Aidi injection plus different therapies had different effects on 1-, 2- and 3-year OS rate. Sensitivity analysis showed that the RR of ORR, DCR, 1- and 2- year OS rate had good stability, and 3-year OS rate had poor stability.

CONCLUSIONS: Available evidences indicate that Aidi injection can significantly improve the clinical response and OS rates in patients with NSCLC and especially, the 1- and 2-year OS rate. But, Aidi injection plus different therapies had different effects on overall survival. It is still unclear whether Aidi injection can improve the PFS and HR.