Efficacy of Chinese herbal injections combined with fluoropyrimidine and oxaliplatin-based chemotherapy for advanced colorectal cancer: A protocol for systematic review and meta-analysis of randomized controlled trials

Abstract

Background: Fluoropyrimidine combined with oxaliplatin-based chemotherapy have become the first-line treatment for advanced colorectal cancer (CRC). Chinese herbal injections (CHIs), as an important part of TCM, have been widely applied as adjunctive treatments to chemotherapy in patients with advanced CRC. However, the efficacy of this combination therapy has not been evaluated comprehensively. Methods: We will conduct this systematic review and meta-analysis in accordance with the Preferred Reported Items for Systematic Review and Meta-analysis (PRISMA) guidelines. 7 databases will be searched for related randomized controlled trials (RCTs) from their inception to August 31, 2020: PubMed, Cochrane Library, EMBASE, China National Knowledge Infrastructure (CNKI), VIP Database for Chinese Technical Periodicals (VIP), SinoMED and Wanfang Database. Two researchers will perform study selection, data extraction, and assessment of risk of bias independently. The primary outcomes are the disease control rate (DCR) and the objective response rate (ORR), the secondary outcomes are progression-free survival (PFS), survival rate, quality of life (QoL) and adverse effects. Cochrane Review Manager (RevMan 5.3) software will be used to analyze the outcomes. Results and Conclusion: This systematic review will evaluate the efficacy of CHIs and fluoropyrimidine and oxaliplatin-based chemotherapy for advanced CRC so as to provide valuable evidence to the application of CHIs in advanced CRC. Systematic review registration: INPLASY registration number: INPLASY2020100050. Abbreviations: 5-FU = 5-fluorouracil, CHIs = Chinese herbal injections, CNKI = China National Knowledge Infrastructure, CR = complete response rates, CRC = colorectal cancer, DCR = disease control rate, EORTCQLQ-C30 = European Organization for the Research and Treatment of Cancer QLQ-C30, FACT-C = Functional Assessment of Cancer Therapy-Colorectal, FUs = Fluoropyrimidines, KPS = Karnofsky performance scale, NCI-CTCAE = National Cancer Institute Common Terminology Criteria for Adverse Events, NIH = National Cancer Institute, ORR = objective response rate, PD = progressive disease, PFS = progression-free survival, PR = partial response, QoL = quality of life, RCT = randomized controlled trial, RECIST = Response Evaluation Criteria in Solid Tumors, SD = stable disease, TCM = Traditional Chinese Medicine, WHO = World Health Organization.