Kanglaite injection plus fluorouracil-based chemotherapy on the reduction of adverse effects and improvement of clinical effectiveness in patients with advanced malignant tumors of the digestive tract: A meta-analysis of 20 RCTs following the PRISMA guidelines

BACKGROUND: The digestive tract malignancies are a series of malignant tumor with high morbidity and mortality. Traditional Chinese medicine (TCM) combined with chemotherapy drugs interventions have been applied for the treatment of malignant tumors in Asian countries for dacades. This study aimed to assess the effectiveness and safety on the combination of Kanglaite injection and fluorouracil-based chemotherapy for treating digestive tract malignancies. PURPOSE: To assess the effectiveness and safety on the combination of Kanglaite injection and fluorouracil-based chemotherapy for digestive tract malignancies. METHODS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed when conducting the meta-analysis. Randomized controlled trials (RCTs) of Kanglaite injection combined with fluorouracil-based chemotherapy in the treatment of digestive tract malignant tumors were selected and assessed for inclusion. RevMan 5.3 software (Cochrane Collaboration, Oxford, UK) was used for meta-analysis. The objective response rate (ORR) was defined as the primary endpoint, and the disease control rate (DCR), quality of life (QoL), and toxicities were the secondary outcomes. RESULTS: 20 RCTs enrolling 1339 patients with advanced digestive tract malignancies were included. The methodological quality of most included trials was low to moderate. Compared with fluorouracil-based chemotherapy alone, Kanglaite injection plus fluorouracil-based chemotherapy can improve DCR (risk ratio (RR) = 1.18, 95% confidence interval (CI) 1.11–1.25, P < .00001), ORR (RR = 1.35, 95% CI 1.18–1.54, P < .00001), QoL (RR = 1.58, 95% CI 1.35–1.85, P < .00001), and can reduce adverse drug reactions (ADRs) such as myelosuppression (RR = 0.33, 95% CI 0.25–0.43, P < .00001), leukopenia (RR = 0.31, 95% CI 0.22–0.43, P < .00001), thrombocytopenia (RR = 0.6, 95% CI 0.38–0.49, P = .03), neutropenia (RR = 0.26, 95% CI 0.12–0.55, P = .0005), anemia (RR = 0.41, 95% CI 0.23–0.75, P = .004), gastrointestinal reaction (RR = 0.35, 95% CI 0.27–0.46, P < .00001), nausea/vomiting (RR = 0.41, 95% CI 0.28–0.61, P < .00001), diarrhea (RR = 0.34, 95% CI 0.18–0.62, P = .0004), hepatotoxicity (RR = 0.28, 95% CI 0.17–0.47, P < .00001), neurotoxicity (RR = 0.58, 95% CI 0.41–0.82, P = .002), mucositis (RR = 0.59, 95% CI 0.29–1.21, P = .15). CONCLUSION: Kanglaite injection combined with fluorouracil-based chemotherapy could remarkably improve the clinical effectiveness and reduce the adverse effects in patients with advanced malignant tumors of the digestive tract which may provide evidence to judge whether TCM is an effective and safe intervention for the digestive tract malignancies.