Abstract

Objective: Kanglaite(KLT), a type of Chinese medicine preparation, is considered as an adjuvant therapeutic option for malignant cancer treatment. This study aimed to systematically investigate the efficacy and safety of the combination of KLT and epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) for the treatment of stage III/IV non-small cell lung cancer.Methods: Randomized controlled trials (RCTs) that compared KLT plus EGFR-TKI with EGFR-TKI alone for the treatment of stage III/IV non-small cell lung cancer were reviewed. Literature searches (up to July 10, 2021) were performed on PubMed, Web of Science, Cochrane Library, Embase, ClinicalTrials.gov, China National Knowledge Infrastructure (CNKI), Wanfang Database, and the Chinese Scientific Journal Database. Two researchers independently assessed the risk of bias with the tool of Cochrane Collaboration. RevMan 5.3.0 was used in the analysis of the included trial data.Results: 12 RCTs recruiting 1,046 patients with stage III/IV NSCLC were included. Results showed that compared with EGFR-TKI alone, KLT plus EGFR-TKI significantly increased the disease control rate (DCR) (odds ratio [OR]=3.26; 95% confidence interval [CI]:2.22–4.77; p < 0.00001), the objective response rate (ORR) (OR=2.59; 95% CI:1.87–3.58; p < 0.00001) and Karnofsky performance status (KPS) (OR = 2.76; 95% CI:1.73–4.39; p < 0.00001). Furthermore, patient immunity was enhanced with KLT plus EGFR-TKI. The combined treatment increased the percentage of CD4 + T cells (weighted mean difference [WMD]=5.36; 95% CI:3.60–7.13; p < 0.00001),the CD4+/CD8 + ratio (WMD = 0.18; 95% CI: 0.08–0.27; p = 0.004), and percentage of NK cells (WMD=4.84; 95% CI: 3.66–6.02; p < 0.00001).With regard to drug toxicity, the occurrence rate of nausea and vomiting was significantly reduced by KLT plus EGFR-TKI (OR=0.37; 95% CI: 0.16–0.86; p = 0.02).Conclusion: KLT plus EGFR-TKI was effective in treating stage III/IV non-small cell lung cancer. Thus, its application in these patients is worth promoting. Additional double-blind, well-designed and multicenter RCTs are required to confirm the efficacy and safety of this treatment.

Highlights

  • Lung cancer remains the leading cause of cancer-related death worldwide (Sung et al, 2021)

  • The results showed that the percentage of CD3+ cells was similar between the KLT plus EGFR-TKI group and control group (WMD 6.61; 95% confidence intervals (CI): 0.46 to 13.68; p 0.07) (Figure 7)

  • The results showed that the KLT plus EGFR-TKI group had an advantage of increased NK cells (WMD 4.84; 95% CI: 3.66–6.02; p < 0.00001; I2 42%) (Figure 7)

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Summary

Introduction

Lung cancer remains the leading cause of cancer-related death worldwide (Sung et al, 2021). 57% of patients with lung cancer are diagnosed at an advanced or metastatic stage, during which the 5-years relative survival rate is only 5% (Richards et al, 2017). Epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) have improved clinical benefits for patients with metastatic non-small cell lung cancer (NSCLC) patients (Rosell et al, 2012). The National Comprehensive Cancer Network NSCLC Panel recommends identification of EGFR mutations for all patients with adenocarcinoma. EGFR-TKI combined with chemotherapy improved progression free survival (PFS) in untreated advanced NSCLC patients with EGFR mutation (Hosomi et al, 2020). Of patients with EGFR-mutated NSCLC, 20–40% experience primary resistance to first or second-generation EGFR-TKIs, which is attributed to genetic alterations (Wang et al, 2016). A EGFR-TKI-based combination treatment regimen may be more beneficial

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