Abstract
Background:Compound Kushen injection (CKI) is a commonly used anti-tumor Chinese patent medicine, which is extracted from Kushen (Radix Sophorae Flavescentis) and Baituling (Rhizoma Smilacis Glabrae) and has been widely prescribed as an add-on therapy to platinum-based chemotherapy (PBC) for advanced non-small cell lung cancer (NSCLC). However, the efficacy and safety of this combination therapy remain controversial.Methods and analysis:A systematic review and meta-analysis will be 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 will be retrieved and assessed for inclusion. Analyses will be performed using Review Manager 5.3, Comprehensive Meta-Analysis 3.0 and Trial Sequential Analysis software. The disease control rate (DCR) will be defined as the primary outcome, and the objective response rate (ORR), quality of life (QOL), survival rate, and toxicities will be the secondary outcomes.Results:This study will systematically evaluate the efficacy and safety of Compound Kushen injection combined with platinum-based chemotherapy in the treatment of stage III/IV NSCLC. The results of this study will be published in a peer-reviewed journal.Conclusions:This systematic review and meta-analysis of eligible randomized controlled trials will evaluate the effects of Compound Kushen injection as adjunctive therapy to platinum-based chemotherapy in patients with stage III/IV non-small cell lung cancer, thus providing evidence to the clinical use of this combination therapy for the specific subsets of patients.PROSPERO registration number:CRD42019134892
Highlights
This study will systematically evaluate the efficacy and safety of Compound Kushen injection combined with platinumbased chemotherapy in the treatment of stage III/IV non-small cell lung cancer (NSCLC)
This systematic review and meta-analysis of eligible randomized controlled trials will evaluate the effects of Compound Kushen injection as adjunctive therapy to platinum-based chemotherapy in patients with stage III/IV non-small cell lung cancer, providing evidence to the clinical use of this combination therapy for the specific subsets of patients
Changes will not be incorporated into the protocol
Summary
Platinum-based chemotherapy (PBC) is a commonly recommended treatment choice for the advanced NSCLC patients, especially for those not treated with targeted therapy and immunotherapy due to lack of an actionable biomarker or unavailability of precision therapies.[6,7,8,9,10] The prognosis of stage IIIB/IV NSCLC is extremely poor with a median survival of 7.9 months,[11] and compared with precision therapies, the treatment with PBC alone is usually associated with worse survival, poor quality of life (QOL), and increased risk of toxic effects.[7,9,12] it is necessary to find better therapy to improve the outcomes and reduce adverse events in the advanced NSCLC patients treated with PBC. The efficacy and safety of this combination therapy remain controversial
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