Comparative efficacy and safety of nivolumab vs. docetaxel as second-line treatment in advanced non-small cell lung cancer: A systematic review and meta-analysis.

Abstract

e20008 Background: In patients with stage IIIB-IV non-small cell lung cancer (NSCLC), response to first-line therapy is typically short-lived. Docetaxel is an established second-line therapy for advanced NSCLC after progression on platinum-based chemotherapy. The introduction of immunotherapies and targeted therapies has expanded second-line treatment options. Nivolumab, an antibody that blocks the immune checkpoint inhibitor programmed cell death protein 1 (PD-1), has shown promising results in clinical trials across all NSCLC subtypes. This study compares the efficacy of Nivolumab to the well-established second-line therapy, docetaxel. Methods: We searched five major databases (PubMed, Embase, Cochrane, Scopus and Web of Science) to identify RCTs evaluating the safety and efficacy of Nivolumab compared to Docetaxel as a second-line therapy in NSCLC. The quality of included studies was assessed using the Cochrane risk of bias tool (RoB2). Data analysis was conducted in RevMan 5.4 employing fixed effect model. Results were quantified as either odds ratio (OR) or hazard ratio (HR) across outcomes. Results: A total of 3 studies comprising a population of 1358 were included in quantitative analysis. The mean age of the participants was 59.3±36.1. In comparison to Docetaxel, Nivolumab demonstrated significant improvement in OS (HR: 0.69 [0.63, 0.76], p<0.00001) and PFS (HR: 0.77 [0.70, 0.85], p<0.00001). Further analysis of subgroups indicated comparable benefits in both patients with PD-L1>1% and PD-L1>1% with no statistically significant difference in OS (p=0.23) and PFS (p=0.28). The group receiving Nivolumab exhibited a significantly higher objective response rate (ORR) (OR: 0.33 [0.26, 0.42], p<0.00001) compared to the control group. Mortality rates were significantly reduced with nivolumab treatment (OR: 0.50 [0.37, 0.67], p<0.00001). Regarding safety profile, adverse events of all grades including anemia, neutropenia, fatigue and alopecia favored the intervention group. Conclusions: This meta-analysis demonstrates that Nivolumab offers superior efficacy and a more favorable safety profile compared to docetaxel as a second-line therapy for advanced NSCLC, improving OS, PFS, ORR, and mortality rates. The benefits across PD-L1 subgroups underscore its broad applicability. However, larger studies with extended follow-up are essential to confirm long-term outcomes and address potential resistance mechanisms, ensuring evidence for clinical implementation.