OBJECTIVES: The aims of the study were to compare the efficacy and safety between PEG-ASP and L-ASP and estimate the cost of PEG-ASP and L-ASP.

METHODS: We conducted a systematic review of efficacy and safety of PEG-ASP and L-ASP. CNKI, WanFang Data, PubMed, EMbase, The Cochrane Library and ClinicalTrails.gov databases were electronically searched to collect randomized controlled trials (RCTs) and non-RCTs of asparaginase for children patients with ALL from inception to Mar 26th 2018. Two reviewers independently screened literature, extracted data, and assessed the risk of bias of included studies. Then meta-analysis was performed using Stata 14.0 software. Decision tree was conducted to perform cost- minimization analysis.

RESULTS: A total of 14 RCTs and 7 non-RCTs were included. The results of meta-analysis showed that, PEG-ASP had similar complete remission(CR), indicator of efficacy, with L-ASP (RCTs: MD=0.97, 95%CI 0.92 to 1.03, non-RCTs: MD=1.03, 95%CI 0.93 to 1.15). The incidence of hepatic insufficiency, hypocytosis, dysfunction of blood coagulation, gastrointestinal adverse reaction and hyperglycemia of PEG-ASP had no difference with L-ASP. The incidence of anaphylactic reaction of PEG-ASP was lower than that of L-ASP (PEG-ASP: MD=0.39, 95%CI 0.30 to 0.47, L-ASP: MD=0.49, 95%CI 0.41 to 0.57). PEG-ASP had higher drug cost than L-ASP in China (CNY 7588 vs CNY 928) and PEG-ASP had higher medical costs than L-ASP(CNY 37,677 vs 31,216) per year.

CONCLUSIONS: Compared with L-ASP, PEG-ASP has lower chance to trigger a anaphylactic reaction. There are no differences between L-ASP and PEG-ASP in efficacy. Patients who take PEG-ASP will cost more than those who take L-ASP in China.