The efficacy and safety of neoadjuvant buparlisib for breast cancer: A meta-analysis of randomized controlled studies

INTRODUCTION: The efficacy of neoadjuvant buparlisib for breast cancer remains controversial. We conduct a systematic review and meta-analysis to explore the influence of neoadjuvant buparlisib versus placebo for breast cancer. METHODS: We search PubMed, EMbase, Web of science, EBSCO, and Cochrane library databases through May 2019 for randomized controlled trials (RCTs) assessing the efficacy and safety of neoadjuvant buparlisib versus placebo for breast cancer. This meta-analysis is performed using the random-effect model. RESULTS: Four RCTs are included in the meta-analysis. Overall, compared with control group for breast cancer, neoadjuvant buparlisib can substantially reduce progressive disease (risk ratios [RR] = 0.66; 95% confidence interval [CI] = 0.52–0.82; P = .0003) and improve stable disease (RR = 1.29; 95% CI = 1.02–1.64; P = .04), but has no notable influence on overall response rate (RR = 1.32; 95% CI = 0.84–2.06; P = .22), clinical benefit rate (RR = 1.06; 95% CI = 0.79–1.43; P = .69). Neoadjuvant buparlisib results in the increase in adverse grade 3/4 adverse events including increased alanine aminotransferase (ALT) (RR = 11.87; 95% CI = 5.65–24.90; P < .00001), increased aspartate aminotransferase (AST) (RR = 6.50; 95% CI = 4.14–10.21; P < .00001) and hyperglycaemia (RR = 36.65; 95% CI = 10.44–128.68; P < .00001), as well as serious adverse events (RR = 1.47; 95% CI = 1.23–1.76; P < .0001) compared to placebo. Deaths is found to be similar between two groups (RR = 0.88; 95% CI = 0.75–1.04; P = .13). CONCLUSIONS: Neoadjuvant buparlisib may provide some efficacy for breast cancer, but leads to the increase in serious adverse events.