Comparing the Adverse Event Profiles of Nivolumab and Docetaxel in Previously-treated or Refractory Advanced Non-small Cell Lung Cancer: A Meta-analysis of Two Phase 3 Trials

Abstract

Nivolumab has recently been approved as a second-line treatment for squamous and non-squamous advanced non-small cell lung cancers (NSCLC). However, no studies have statistically evaluated the adverse event profiles for nivolumab and conventional second-line agents, such as docetaxel. Thus, there is unmet medical need for statistical analysis comparing the adverse effects of nivolumab and docdetaxel in patients with advanced NSCLC. This meta-analysis evaluated the non-inferiority and superiority of the adverse event profiles for nivolumab and docetaxel in patients with previously-treated or refractory advanced NSCLC. The meta-analysis examined two phase 3 trials and compared the incidences of drug-induced adverse events for the nivolumab-treated and docetaxel-treated patient groups. The primary outcomes were the odds ratios (ORs) and 95% confidence intervals (CIs) for any adverse event, fatigue, nausea, decreased appetite, diarrhea, myalgia, anemia, alopecia, neutropenia, febrile neutropenia, and leukopenia. Compared to docetaxel, the adverse event profile for nivolumab was non-inferior and superior for any adverse event (OR, 0.27; 95% CI, 0.19-0.39), fatigue (OR, 0.44; 95% CI, 0.31-0.62), nausea (OR, 0.37; 95% CI, 0.25-0.54), decreased appetite (OR, 0.58; 95% CI, 0.39-0.87), diarrhea (OR, 0.29; 95% CI, 0.19-0.45), myalgia (OR, 0.18; 95% CI, 0.09-0.38), anemia (OR, 0.08; 95% CI, 0.04-0.16), alopecia (OR, 0.01; 95% CI, 0.00-0.06), neutropenia (OR, 0.01; 95% CI, 0.00-0.04), febrile neutropenia (OR, 0.02; 95% CI, 0.00-0.16), and leukopenia (OR, 0.04; 95% CI, 0.01-0.19). These results suggest that, compared to docetaxel, nivolumab may be better tolerated for managing advanced NSCLC.