Clinical study on concurrent chemoradiotherapy combined with Kanglaite injection in the treatment of regionally advanced unresectable non-small cell lung cancer

Objective： To evaluate the clinical effects and toxicity of concurrent chemoradiotherapy combined with Kanglaite injection in the treatment of regionally advanced unresectable non-small cell lung cancer. Methods： 48 patients with regionally advanced unresectable non-small cell lung cancer were randomized to two groups, 25 patients in the combination group （concurrent chemoradiotherapy ＋ Kanglaite） and 23 patients in the control group （concurrent chemoradiotherapy）. The combination group received chemotherapy of vinorelbine （NVB） plus cisplatin （DDP） regimen, radiotherapy was given with conventional fraction in 2 Gy per fraction and five fractions per week concurrently. The total tumor doses were 56-60 Gy. Combined with Kanglaite injection 200 mud for twenty-one days for two courses in the combination group, the control group was chemoradiotherapy only. Effects and toxicities were evaluated according to the criteria of WHO. Results： The CR rates in the combination group and control group were 24.0% （6/25） and 13.0% （3/23）, respectively （P 〉 0.05）. Response （CR ＋ PR） rates of combination group were 76.0 % （19/25） and 69.6% （16/23） in control group, P 〉 0.05. The incidence rates of grades 3-4 leukocytopenia, grades 3-4 digestive system （nausea and vomiting） and grades 3-4 esophagitis in the combination group and control group were 40.0% （10/25）, 8.0% （2/25）, 16.0% （4/25） and 69.6% （16/23）, 34.8% （8/23）, 43.5% （10/23）, respectively （P 〈 0.05）. KPS and body weight score significantly increased in combination group after the combined treatment, P 〈 0.05. Conclusion： Concurrent chemoradiotherapy combined with Kanglaite injection can relieve side effects of chemoradiotherapy in the treatment of regionally advanced unresectable non-small cell lung cancer, and improve quality of life. Kanglaite injection may increase effective rate of regionally advanced unresectable non-small cell lung cancer combined with concurrent chemoradiotherapy.

Effect and safety of Kanglaite injection combined with chemotherapy in the treatment of advanced colorectal cancer:a systematic review and meta-analysis

Objective:To evaluate the clinical efficacy and safety of Kanglaite injection combined with chemotherapy and chemotherapy alone in the treatment of advanced colorectal cancer.Methods:PubMed,Cochrane library,CNKI,VIP,Wanfang database were systematically searched by inputting keywords to explore the efficacy of Kanglaite injection combined with chemotherapy in the treatment of advanced colorectal cancer.A random-effects model was selected to evaluate the treatment outcomes.The screening of literature,the extraction of data and the assessment of methodology were independently undertaken by two reviewers.Meta analysis was performed using Revman5.3 software and stata15.0 software.Results:A total of 12 RCTs were included,with 792 cases.Compared with chemotherapy alone,Metaanalysis suggested that Kanglaite injection combined with chemotherapy can improve clinical efficiency(RR=1.45,95%CI:1.21-1.74,P<0.0001)and improve patients'quality of life(RR=1.55,95%CI:1.32-1.82,P<0.00001),improve the patient's immune function(CD3+cells:SWD=1.42,95%CI:1.11-1.73;CD4+/CD8+cell ratio:SWD=0.95,95%CI:0.66-1.25;NK cell activity:SWD=3.24,95%CI:2.81-3.66,P<0.00001);Leukopenia rate(RR=0.63,95%CI:0.54-0.74,P<0.0001),incidence of gastrointestinal adverse reactions(RR=0.56,95%CI:0.48-0.66,P<0.00001),incidence of peripheral neurotoxicity(RR=0.79,95%CI:0.65-0.96,P=0.02)were lower than the chemotherapy alone group,the difference was statistically significant.In improving the hand-foot syndrome and oral mucositis after chemotherapy,there was some difference between the Kanglaite injection combined with chemotherapy group and the chemotherapy alone group,but the difference was not significant.Puber bias detection and sensitivity analysis were performed with clinically effective relative risk(RR)as indicators.The results suggested that the publication bias was not obvious.The results of this study are stable.Conclusion:Compared with chemotherapy alone group in the treatment of advanced colorectal cancer,Kanglaite injection combined with chemotherapy can improve the effective rate,quality of life,immune function of patients and reduce the incidence of leukopenia after chemotherapy,gastrointestinal adverse reactions and peripheral neurotoxicity.

Network pharmacology-based elucidation of molecular biological mechanisms of Kanglaite injection for treatment of non-small cell lung cancer

Objective: To investigate the effective compounds, potential targets and molecular mechanism of Kanglaite injection (KLTi) in the treatment of Non-Small Cell Lung Cancer (NSCLC) based on network pharmacology. Methods: The active compounds and targets of KLTi which extracted and isolated from Coix Seed were screened by Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform (TCMSP). The related genes of NSCLC were obtained by searching the Human Gene Database (GeneCards) and Online Mendelian Inheritance in Man (OMIM). The candidate targets of KLTi in the treatment of NSCLC were obtained after extracting the intersection network. The "drug-component-target-disease" network was constructed with the help of Cytoscape 3.7.2. The Protein- Protein Interaction networks were constructed on the STRING platform and core network modules were screened. The Gene Ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG) enrichment analysis of candidate genes were performed using Metascape platform, and a "pathway-target- compounds" network was constructed to further screen key genes and active compounds. Results: A total of 11 compounds, 22 candidate targets, 206 GO functions and 12 KEGG pathways were obtained. Conclusion: The active compounds of KLTi in the treatment of NSCLC are stigmasterol, stigmasterol α1 and ergosterol. The key targets are PGR, NCOA2, PTGS2, NR3C2, and PTGS1. The core GO functions included receptor activity and binding, neuronal signal transmission and hormone stimulation;KEGG mainly involves cancer pathways, neuroactive ligand-receptor interactions and calcium signaling pathways. This study reveals the molecular biological mechanism of KLTi in the treatment of NSCLC, which is speculated to be related to neuroendocrine, providing a new basis and therapeutic direction for subsequent clinical application and experimental research.

The efficacy of Kanglaite injection during treatment with tyrosine kinase inhibitor in elderly patients with non-small cell lung cancer

Objective Epidermal growth factor receptor–tyrosine kinase inhibitors(EGFR–TKIs) are widely used in the treatment of EGFR mutation-positive non-small cell lung cancer(NSCLC) patients. The Kanglaite injection(KLT) is a novel broad-spectrum anti-cancer injection produced from traditional Chinese medicinal herbs(coix seed). After its approval in 1995, KLT has become the most popular anti-cancer drug in China. As of this writing, no standard treatment guideline is available for elder patients with NSCLC, and the role of traditional Chinese medicinal herbs, including KLT, combined with TKI treatment remains unknown. This retrospective study evaluated the efficacy and safety of KLT in elderly NSCLC patients during TKI treatment.Methods Thirty elderly patients aged 71-79 years with histopathologically confirmed NSCLC attending the General Hospital of the Shenyang Military Region were enrolled in the study and received EGFR-TKI treatment. All participants received 200 m L KLT injections at the same time on days 1–21. Erlotinib(150 mg) or gefitinib(250 mg) was administered daily from days 1 to 21, and the cycle was repeated every 21 days. The endpoint of the primary study was the disease control rate.Results Thirty elderly patients were enrolled in this study. The objective response rate was 21.3% [95% confidence interval(CI): 8.6% to 35.2%], whereas the disease control rate was 80.4%(95% CI: 71.8% to 97.0%). The grade 3 or 4 adverse effects included leucopenia(13.7%), neutropenia(13.4%), anemia(2.9%), and nausea or vomiting(2.7%). Conclusion The administration of KLT combined with erlotinib or gefitinib showed high efficacy in elderly NSCLC patients. The adverse effects of the drug combination were well tolerated by the patients. KLT combined with TKI treatment might provide a satisfactory therapeutic strategy for elderly NSCLC patients.