Efficacy and safety of Kanglaite plus EGFR-TKI in the treatment of advanced non-small cell lung cancer: A meta-analysis of 13 RCTs.

Background: Kanglaite (KLT) is a Chinese medicine antitumor drug independently developed in China, which has been widely used in the treatment of advanced non-small cell lung cancer (NSCLC). The purpose of this study was to systematically evaluate the efficacy and safety of KLT plus epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) in the treatment of advanced NSCLC.

Methods: Up to September 1, 2022, the databases of PubMed, EMBASE, Cochrane Library, ClinicalTrials.gov, China National Knowledge Infrastructure, Chinese Biomedical Literature, China Science and Technology Journal, and Wanfang were searched, and the randomized controlled clinical trials (RCTs) of KLT plus EGFR-TKI in the treatment of advanced NSCLC were included. Two researchers independently screened the literature, extracted data, and evaluated the quality of the included literature. Revman5.4 software was used for meta-analysis.

Results: A total of 1057 patients were included in 13 RCTs. The results of meta-analysis showed that KLT plus EGFR-TKI could improve the objective response rate (ORR) (risk ratio (RR) confidence interval (CI) [RR = 1.54, 95% CI: 1.27-1.86, P < .00001]), the disease control rate (DCR) (RR = 1.23, 95% CI: 1.14-1.32, P < .00001), and quality of life (QOL) (RR = 1.79, 95% CI: 1.36-2.36, P < .0001) in patients with advanced NSCLC. The percentages of CD3+T cells (standardized mean difference [SMD = 2.37, 95% CI: 0.80-3.93, P = .003]), CD4+T cells (SMD = 1.39, 95% CI: 0.85-1.93, P < .00001), NK cells (SMD = 1.59, 95% CI: 0.88-2.30, P < .0001), and CD4+/CD8+ratio (SMD = 0.37, 95% CI: 0.19-0.55, P < .0001) were also increased. However, the results of subgroup analysis showed that in patients with EGFR mutation NSCLC, compared with EGFR-TKI alone, KLT plus EGFR-TKI did not significantly increase ORR and DCR (RR = 1.43, 95% CI: 0.88-2.32, P = .15; RR = 1.07, 95% CI: 0.96-1.20, P = .21). In terms of adverse events of drugs, the incidence of diarrhea, rash, anorexia, nausea and vomiting, liver and renal function damage of KLT plus EGFR-TKI was similar to that of EGFR-TKI alone (P > .05).

Conclusion: KLT plus EGFR-TKI has some clinical benefits and good safety compared with EGFR-TKI alone in the treatment of advanced NSCLC. However, it seems that patients with EGFR mutations do not get significant clinical benefits, and more high-quality RCTs are needed to prove the efficacy of the combined regimen.