Dataset Information

Kangai Injection Combined with Platinum-based Chemotherapy for the Treatment of Stage III/IV Non-Small Cell Lung Cancer: A Meta-analysis and Systematic Review of 35 Randomized Controlled Trials.

ABSTRACT: Objective: In an effort to inform evidence-based guidelines for clinical practice, we performed a meta-analysis to systematically evaluate the safety and efficacy of Kangai injection (KAI) plus platinum-based chemotherapy for stage III/IV non-small cell lung cancer (NSCLC). Methods: Randomized controlled trials (RCTs) comparing KAI plus platinum-based chemotherapy (experimental group) to chemotherapy alone (control group) were electronically retrieved from the Cochrane Library, PubMed, EMbase, Web of Science, Chinese National Knowledge Infrastructure (CNKI), Chinese Biological Medicine (CBM) Database, Wanfang Database, and the VIP Database for Chinese Technical Periodicals. RCTs published from the date of inception to July 5, 2018, were included. All trials were assessed for methodological quality in accordance with the Cochrane Reviewer's Handbook for Systematic Reviews of Intervention. Meta-analysis was performed using RevMan5.3 Software and Comprehensive Meta-Analysis (CMA) 2.0. Results: The final analysis included 35 RCTs involving 2,618 patients. Our meta-analysis revealed that KAI combined with platinum-based chemotherapy was associated with significantly greater objective response rate (ORR) (RR=1.36, 95% CI: 1.25-1.49, P<0.00001) and disease control rate (DCR) (RR=1.14, 95% CI: 1.09-1.18, P<0.00001), improvements in quality of life (QOL) (RR=1.75, 95% CI: 1.59-1.93, P<0.00001), and decreases in the incidence of gastrointestinal reactions (RR=0.64, 95% CI: 0.54-0.77, P<0.00001), leukocytopenia (RR=0.54, 95% CI: 0.46-0.63, P<0.00001) and thrombocytopenia (RR=0.52, 95% CI: 0.36-0.76, P=0.0007) when compared with chemotherapy alone. In addition, combined treatment was associated with greater regulation of tumor immune function, as indicated by increases in the proportion of NK, CD₃ ⁺ , and CD₄ ⁺ cells (MD=2.27, 95% CI: 1.18-3.36, P<0.0001; MD=12.86, 95% CI: 11.64-14.08, P<0.00001; and MD=5.48, 95% CI: 2.68-8.28, P=0.0001) and decreases in the percentage of CD₈ ⁺ cells (MD= -2.37, 95% CI from -4.51 to -0.23, P=0.03). Conclusions: From the available evidence, our results indicate that KAI plus platinum-based chemotherapy could be more effective in improving clinical efficacy, decreasing the incidence of adverse reactions and regulating the tumor immune function than chemotherapy alone in the treatment of stage III/IV NSCLC. Nevertheless, considering the limitations of the included studies, rigorous designed, high-quality, multicenter clinical trials are still need to further confirm the results.

SUBMITTER: Li H

PROVIDER: S-EPMC6775612 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Kangai Injection Combined with Platinum-based Chemotherapy for the Treatment of Stage III/IV Non-Small Cell Lung Cancer: A Meta-analysis and Systematic Review of 35 Randomized Controlled Trials.

Li Hongxiao H Ji Yuejin Y Zhang Shiping S Gao Zishan Z Hu Cheng C Jiang Rilei R Chen Meijuan M Li Guochun G Zhang Xu X

Journal of Cancer 20190828 21

<b>Objective</b>: In an effort to inform evidence-based guidelines for clinical practice, we performed a meta-analysis to systematically evaluate the safety and efficacy of Kangai injection (KAI) plus platinum-based chemotherapy for stage III/IV non-small cell lung cancer (NSCLC). <b>Methods</b>: Randomized controlled trials (RCTs) comparing KAI plus platinum-based chemotherapy (experimental group) to chemotherapy alone (control group) were electronically retrieved from the Cochrane Library, Pub ...[more]

PMID: 31602279

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Project description: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.

Project description:BACKGROUND:Brentuximab vedotin is an anti-CD30 antibody-drug conjugate that has been approved for relapsed and refractory Hodgkin's lymphoma. METHODS:We conducted an open-label, multicenter, randomized phase 3 trial involving patients with previously untreated stage III or IV classic Hodgkin's lymphoma, in which 664 were assigned to receive brentuximab vedotin, doxorubicin, vinblastine, and dacarbazine (A+AVD) and 670 were assigned to receive doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD). The primary end point was modified progression-free survival (the time to progression, death, or noncomplete response and use of subsequent anticancer therapy) as adjudicated by an independent review committee. The key secondary end point was overall survival. RESULTS:At a median follow-up of 24.6 months, 2-year modified progression-free survival rates in the A+AVD and ABVD groups were 82.1% (95% confidence interval [CI], 78.8 to 85.0) and 77.2% (95% CI, 73.7 to 80.4), respectively, a difference of 4.9 percentage points (hazard ratio for an event of progression, death, or modified progression, 0.77; 95% CI, 0.60 to 0.98; P=0.04). There were 28 deaths with A+AVD and 39 with ABVD (hazard ratio for interim overall survival, 0.73 [95% CI, 0.45 to 1.18]; P=0.20) [corrected]. All secondary efficacy end points trended in favor of A+AVD. Neutropenia occurred in 58% of the patients receiving A+AVD and in 45% of those receiving ABVD; in the A+AVD group, the rate of febrile neutropenia was lower among the 83 patients who received primary prophylaxis with granulocyte colony-stimulating factor than among those who did not (11% vs. 21%). Peripheral neuropathy occurred in 67% of patients in the A+AVD group and in 43% of patients in the ABVD group; 67% of patients in the A+AVD group who had peripheral neuropathy had resolution or improvement at the last follow-up visit. Pulmonary toxicity of grade 3 or higher was reported in less than 1% of patients receiving A+AVD and in 3% of those receiving ABVD. Among the deaths that occurred during treatment, 7 of 9 in the A+AVD group were associated with neutropenia and 11 of 13 in the ABVD group were associated with pulmonary-related toxicity. CONCLUSIONS:A+AVD had superior efficacy to ABVD in the treatment of patients with advanced-stage Hodgkin's lymphoma, with a 4.9 percentage-point lower combined risk of progression, death, or noncomplete response and use of subsequent anticancer therapy at 2 years. (Funded by Millennium Pharmaceuticals and Seattle Genetics; ECHELON-1 ClinicalTrials.gov number, NCT01712490 ; EudraCT number, 2011-005450-60 .).

Project description: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.

Dataset Information

Kangai Injection Combined with Platinum-based Chemotherapy for the Treatment of Stage III/IV Non-Small Cell Lung Cancer: A Meta-analysis and Systematic Review of 35 Randomized Controlled Trials.

Publications

Kangai Injection Combined with Platinum-based Chemotherapy for the Treatment of Stage III/IV Non-Small Cell Lung Cancer: A Meta-analysis and Systematic Review of 35 Randomized Controlled Trials.

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