Dataset Information

Compound Kushen injection combined with platinum-based chemotherapy for stage III/IV non-small cell lung cancer: A meta-analysis of 37 RCTs following the PRISMA guidelines.

ABSTRACT: Objective: Compound Kushen injection (CKI), one of the commonly used antitumor Chinese patent medicines, has been widely prescribed as adjunctive treatment to platinum-based chemotherapy (PBC) in patients with advanced non-small cell lung cancer (NSCLC). However, the efficacy and safety of this combination therapy for advanced NSCLC remain controversial. The objective of this study is to evaluate the effects of CKI combined with PBC on patients with stage III/IV non-small cell lung cancer. Methods: A systematic review and meta-analysis were performed following the PRISMA (Preferred Reported Items for Systematic Review and Meta-analysis) guidelines. All randomized controlled trials (RCTs) comparing CKI in combination with PBC versus PBC alone were retrieved and assessed for inclusion. Analyses were performed using Review Manager 5.3 (Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2014), Comprehensive Meta-Analysis 3.0 (Biostat, Englewood, NJ, United States; 2016) and Trial Sequential Analysis software (TSA) (Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen, Denmark; 2011). The disease control rate (DCR) was regarded as the primary outcome, and the objective response rate (ORR), quality of life (QOL), survival rate, and toxicities were the secondary outcomes. Results: Thirty-seven trials, recruiting 3,272 patients with stage III/IV NSCLC, were included. The results showed that, CKI combined with PBC resulted in significant improvements in DCR (RR = 1.11, 95% CI 1.07 to 1.15, P < 0.00001), ORR (RR = 1.30, 95% CI 1.20 to 1.40, P < 0.00001), QOL (RR = 1.73, 95% CI 1.55 to 1.92, P < 0.00001), 1-year survival rate (RR = 1.51, 95% CI 1.18 to 1.94, P = 0.001), and a 58% decline in the incidence of severe toxicities (RR = 0.42, 95% CI 0.37 to 0.49, P < 0.00001). Conclusions: From the available evidence, our data indicate that CKI plus platinum-based chemotherapy is more effective in improving clinical efficacy and alleviating the toxicity of chemotherapy than platinum-based chemotherapy alone in the treatment of stage III/IV NSCLC. However, considering the intrinsic limitations of the included trials, high-quality RCTs with survival outcomes are still needed to further confirm our findings.

SUBMITTER: Chen H

PROVIDER: S-EPMC7052862 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Compound Kushen injection combined with platinum-based chemotherapy for stage III/IV non-small cell lung cancer: A meta-analysis of 37 RCTs following the PRISMA guidelines.

Chen Hongwei H Yao Xiaojun X Li Ting T Lam Christopher Wai-Kei CW Zhang Ruonan R Zhang Huixia H Wang Jue J Zhang Wei W Leung Elaine Lai-Han EL Wu Qibiao Q

Journal of Cancer 20200120 7

<b>Objective:</b> Compound Kushen injection (CKI), one of the commonly used antitumor Chinese patent medicines, has been widely prescribed as adjunctive treatment to platinum-based chemotherapy (PBC) in patients with advanced non-small cell lung cancer (NSCLC). However, the efficacy and safety of this combination therapy for advanced NSCLC remain controversial. The objective of this study is to evaluate the effects of CKI combined with PBC on patients with stage III/IV non-small cell lung cancer ...[more]

PMID: 32194799

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Project description:Traditional Chinese Medicine (TCM) preparations are often extracts of single or multiple herbs containing hundreds of compounds, and hence it has been difficult to study their mechanisms of action. Compound Kushen Injection (CKI) is a complex mixture of compounds extracted from two medicinal plants and has been used in Chinese hospitals to treat cancer for over twenty years. To demonstrate that a systematic analysis of molecular changes resulting from complex mixtures of bioactives from TCM can identify a core set of differentially expressed (DE) genes and a reproducible set of candidate pathways. We used in vitro cancer models to measure the effect of CKI on cell cycle phases and apoptosis, and correlated those phenotypes with CKI induced changes in gene expression. We treated two cancer cell lines with or without CKI and assessed the resulting phenotypes by employing cell viability and proliferation assays. Based on these results, we carried out high-throughput transcriptome data analysis to identify genes and candidate pathways perturbed by CKI. We integrated these differential gene expression results with previously reported results and carried out validation of selected differentially expressed genes. CKI induced cell-cycle arrest and apoptosis in the cancer cell lines tested. In these cells CKI also altered the expression of 363 core candidate genes associated with cell cycle, apoptosis, DNA replication/repair, and various cancer pathways. Of these, 7 are clinically relevant to cancer diagnosis or therapy, 14 are cell cycle regulators, and most of these 21 candidates are downregulated by CKI. Comparison of our core candidate genes to a database of plant medicinal compounds and their effects on gene expression identified one-to-one, one-to-many and many-to-many regulatory relationships between compounds in CKI and DE genes. By identifying genes and promising candidate pathways associated with CKI treatment based on our transcriptome-based analysis, we have shown that this approach is useful for the systematic analysis of molecular changes resulting from complex mixtures of bioactives.

Project description:Objectives: Compound Kushen injection (CKI) combined with intraperitoneal chemotherapy (IPC) is widely used in the treatment of malignant ascites (MA). However, evidence about its efficacy and safety remains limited. This review aimed to evaluate the efficacy and safety of CKI combined with IPC for the treatment of MA. Methods: Protocol of this review was registered in PROSPERO (CRD42022304259). Randomized controlled trials (RCTs) on the efficacy and safety of IPC with CKI for the treatment of patients with MA were searched through 12 electronic databases and 2 clinical trials registration platforms from inception until 20 January 2023. The Cochrane risk-of-bias tool was used to assess the quality of the included trials through the risk of bias assessment. We included RCTs that compared IPC single used or CKI combined with IPC for patients with MA schedule to start IPC. The primary outcome was identified as an objective response rate (ORR), while the secondary outcomes were identified as the quality of life (QoL), survival time, immune functions, and adverse drug reactions (ADRs). The Revman5.4 and Stata17 software were used to calculate the risk ratio (RR) at 95% confidence intervals (CI) for binary outcomes and the mean difference (MD) at 95% CI for continuous outcomes. The certainty of the evidence was assessed according to the GRADE criteria. Results: A total of 17 RCTs were assessed, which included 1200 patients. The risk of bias assessment of the Cochrane risk-of-bias tool revealed that one study was rated high risk and the remaining as unclear or low risk. Meta-analysis revealed that CKI combined with IPC had an advantage in increasing ORR (RR = 1.31, 95% CI 1.20 to 1.43, p < 0.00001) and QoL (RR = 1.50, 95% CI 1.23 to 1.83, p < 0.0001) when compared with IPC alone. Moreover, the combined treatment group showed a lower incidence of myelosuppression (RR = 0.51, 95%CI 0.40-0.64, p < 0.00001), liver dysfunction (RR = 0.33, 95%CI 0.16 to 0.70, p = 0.004), renal dysfunction (RR = 0.39, 95%CI 0.17 to 0.89, p = 0.02), and fever (RR = 0.51, 95%CI 0.35 to 0.75, p = 0.0007) compared to those of the control group. The quality of evidence assessment through GRADE criteria showed that ORR, myelosuppression, and fever were rated moderate, renal dysfunction and liver dysfunction were rated low, and QoL and abdominal pain were rated very low. Conclusion: The efficacy and safety of CKI combined with IPC were superior to that with IPC alone for the treatment of MA, which indicates the potentiality of the treatment. However, more high-quality RCTs are required to validate this conclusion. Systematic Review Registration: [https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022304259], identifier [PROSPERO 2022 CRD42022304259].

Dataset Information

Compound Kushen injection combined with platinum-based chemotherapy for stage III/IV non-small cell lung cancer: A meta-analysis of 37 RCTs following the PRISMA guidelines.

Publications

Compound Kushen injection combined with platinum-based chemotherapy for stage III/IV non-small cell lung cancer: A meta-analysis of 37 RCTs following the PRISMA guidelines.

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