Therapeutic efficacy and safety of Kang-ai injection combined with platinum-based doublet chemotherapy in advanced NSCLC: A meta-analysis.

AIMS: Kang-ai injection (KA) is a famous Chinese patent medicine authorized by China Food and Drug Administration, which is widely used to treat advanced non-small cell lung cancer (NSCLC) in China. This meta-analysis is aimed to evaluate the therapeutic efficacy and safety of KA on advanced NSCLC.

METHODS: Seven databases were examined for related studies until January 15, 2018. Odds ratio (OR) was used to evaluate tumor response, Karnofsky Performance Scale (KPS) improvement and adverse reactions, and mean difference (MD) was used to estimate immune functions.

KEY FINDINGS: Thirty randomized controlled trials involving 1956 patients with advanced NSCLC were included. The results showed that compared with the platinum-based doublet chemotherapy (PBDC) alone, KA combined with PBDC could significantly enhance tumor response (OR = 1.69, 95% CI [1.40, 2.04], P < 0.00001), KPS improvement (OR = 3.01, 95% CI [2.36, 3.84], P < 0.00001) and immune functions including the percentages of CD3 + (MD = 8.90, 95% CI [3.06, 14.73], P = 0.003), CD4 + (MD = 9.43, 95% CI [6.32, 12.53], P < 0.00001) and NK (MD = 4.81, 95% CI [1.95, 7.68], P = 0.001) and the ratio of CD4+ /CD8+ (MD = 0.29, 95% CI [0.04, 0.53], P = 0.02). Moreover, KA combined with PBDC markedly decreased the incidences of adverse reactions including gastrointestinal reaction (OR = 0.38, 95% CI [0.30, 0.47], P < 0.00001), myelosuppression (OR = 0.32, 95% CI [0.23, 0.45], P < 0.00001) and hair loss (OR = 0.53, 95% CI [0.36, 0.76], P < 0.00001). However, there was no significant difference between the combination treatment group and the control group in the percentage of CD8 + (MD = -2.93, 95% CI [-6.68, 0.82], P = 0.13).

SIGNIFICANCE: Despite the small sample size and study limitations, the results of this meta-analysis indicated that the combination therapy of KA and PBDC (especially NP regimen) might be a beneficial therapeutic method for advanced NSCLC patients.