Abstract

Recent advances have shown that immune checkpoint inhibitors are emerging as promising therapeutic targets to improve the quality of life in cancer patients. This meta-analysis was conducted to evaluate the influence of Kanglaite injection (KLTi) combined with chemotherapy versus chemotherapy alone on clinical efficacy, immune function, and safety for the treatment of advanced non-small-cell lung cancer (NSCLC). Several electronic databases, including PubMed, Web of Science, Wan-Fang, VMIS, EMBASE, Cochrane Library, CNKI, CBM, and MEDLINE, as well as grey literatures, were comprehensively searched from January 2000 to November 2019. Randomized controlled trials (RCTs) reporting outcomes of clinical efficacy and immune function were collected according to their inclusion and exclusion criteria. Cochrane Reviewers' Handbook 5.2 was applied to assess the risk of bias of included trials. STATA 13.0 and Review Manager 5.3 software were used for meta-analysis. Twenty-five RCTs comprising 2151 patients meeting the inclusion criteria were identified. Meta-analysis showed that compared with chemotherapy alone, KLTi plus the same chemotherapy significantly improved clinical efficacy, including complete response, partial response, stable disease, and progressive disease, as well as immune function, including CD3+, CD4+, CD8+, and CD4+/CD8+. There was a significant reduction in nausea and vomiting, thrombocytopenia, and leukopenia in combination treatments. However, the outcomes were limited because of the low quality and small sample size of the included studies. In conclusion, this work might provide beneficial evidence of KLTi combined with chemotherapy for improving clinical efficacy and immune function, as well as reducing the incidence of adverse events in advanced NSCLC patients. KLTi might be a beneficial therapeutic method for the treatment of advanced NSCLC. Due to the quality of the data, more rigorous and well-designed RCTs are needed to confirm these findings.

Highlights

  • Lung cancer remains one of the most common leading causes of cancer-related death, with high incidence rates all over the world [1,2,3]

  • Several published systematic reviews and meta-analyses demonstrated that Kanglaite injection (KLTi) combined with chemotherapy improves clinical efficacy, performance status, and Karnofsky (KPS) score and reduces radiotherapy and chemotherapy side effects compared with chemotherapy alone in patients with advanced non-small-cell lung cancer (NSCLC) [15, 16]

  • Our results indicated that KLTi combined with chemotherapy exhibited a superior shortterm clinical effective rate (CR + partial response (PR)) (RR 1.28, 95% confidence interval (95% CI) 1.16–1.41) (Figure 5(a)) and disease control rate (RR 1.11, 95% CI 1.06–1.17) (Figure 5(b)) than chemotherapy alone

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Summary

Introduction

Lung cancer remains one of the most common leading causes of cancer-related death, with high incidence rates all over the world [1,2,3]. Drugs that exhibit clinical efficacy and promote immune function, improve QOL, and alleviate side effects and adverse reactions may be preferable for advanced NSCLC patients. Traditional Chinese medicine (TCM) combined with chemotherapy to increase effectiveness, reduce side-effects, and improve QOL has shown its advantages as an adjunct therapy for lung cancer treatment [10]. Several published systematic reviews and meta-analyses demonstrated that KLTi combined with chemotherapy improves clinical efficacy, performance status, and Karnofsky (KPS) score and reduces radiotherapy and chemotherapy side effects compared with chemotherapy alone in patients with advanced NSCLC [15, 16]. E study objectives were to assess the clinical efficacy, immune function (including CD3+, CD4+, CD8+, CD4+/CD8+, natural killer (NK) cell count, IgA, IgG, and IgM), adverse events such as nausea and vomiting, thrombocytopenia, and leukopenia of combination therapy in patients with advanced NSCLC (Figure 1). The overall number of KLTi clinical studies on cancer needs to be improved, so that the clinical efficacy and safety of KLTi can be approved by the international community and possibly enter the international market

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