Background: Many clinical trials have been conducted to evaluate sorafenib for the treatment of advancedNSCLC, but the results for efficacy have been inconsistent. The aim of this study was to evaluate the efficacyand safety of sorafenib in patients with advanced NSCLC in more detail by meta-analysis.
Methods: Thismeta-analysis of randomized controlled trials (RCTs) was performed after searching PubMed, EMBASE,ASCO Abstracts, ESMO Abstracts, and the proceedings of major conferences for relevant clinical trials. Tworeviewers independently assessed the quality of the trials. Outcomes analysis were disease control rate (DCR),progression- free survival (PFS), overall survival (OS) with 95% confidence intervals (CI) and major toxicity.Subgroup analysis was conducted according to sorafenib monotherapy, in combination with chemotherapy orEGFR-TKI to investigate the preferred therapy strategy.
Results: Results reported from 6 RCTs involving 2, 748patients were included in the analysis. Compared to sorafenib-free group, SBT was not associated with higherDCR (RR 1.31 (0.96- 1.79), p=0.09), PFS (HR 0.82 (0.66-1.02), p=0.07) and OS (HR 1.01 (0.92-1.12), p=0.77). Interms of subgroup results, sorafenib monotherapy was associated with significant superior DCR and longer PFS,but failed to show advantage with regard to OS. Grade 3 or greater sorafenib-related adverse events includedfatigue, hypertension, diarrhea, oral mucositis, rash and HFSR.
Conclusions: SBT was revealed to yield noimprovement in DCR, PFS and OS. However, sorafenib as monotherapy showed some activity in NSCLC. Furtherevaluation may be considered in subsets of patients who may benefit from this treatment. Sorafenib combinedinhibition therapy should be limited unless the choice of platinum-doublet regimen, administration sequenceor identification of predictive biomarkers are considered to receive better anti-tumor activity and prevention ofresistance mechanisms.