Efficacy and safety of ipilimumab for treatment of advanced melanoma: a Meta-analysis

CAO Yu-wei; SHAN Kui

Abstract：Objective:To conduct a Meta-analysis to evaluate the clinical efficacy and safety of ipilimumab for treatment of advanced melanoma.Methods:We searched the PubMed,Cochrane Library,Embase,CNKI,Wanfang and VIP database.Two reviewers independently evaluated the quality of the included studies and extracted the data.Meta-analysis was performed by RevMan 5.3 software.Results:Four randomized controlled trials involving 2 622 patients were included.The results of Meta-analyses showed that there were significant differences of the progression-free survival rate at 1 year (RR =0.94,95％ CI:0.91 ～ 0.98,P =0.001),overall survival rate at 1 year (RR =0.79,95％ CI:0.72～ 0.87,P ＜ 0.000 01) between the two groups.However,there were no significant difference of the progression-free survival (PFS) rate at 2 years (RR =0.99,95％ CI:0.97 ～ 1.01,P =0.45)and overall survival rate at3 years (RR=0.93,95％CI:0.84～ 1.03,P =0.17) between the two groups.The incidences of cutaneous,gastrointestinal and hepatic adverse events showed significant differences between the two groups,including,rash (RR =2.43,95％ CI:1.64 ～ 3.61,P ＜0.000 01),pruritu (RR =2.35,95％ CI:1.67 ～3.29,P＜0.00001),diarrhea (RR=1.82,95％CI:1.47～2.25,P＜0.00001),colitis (RR=11.21,95％CI:6.20 ～ 20.30,P ＜ 0.000 01),increase in alanine aminotransferase (RR =3.57,95％ CI:1.92 ～ 6.62,P ＜ 0.000 1),and increase in aspartate aminotransferase (RR =3.81,95％ CI:2.85 ～ 5.09,P ＜ 0.000 01).Conclusion:Ipilimumab can increase progression-free survival rate at 1 year and overall survival rate at 1 year for advanced melanoma.However,ipilimumab showed no remarkable advantage in progression-free survival rate at 2 years and Chinese Journal of New Drugs 2017,26(8) overall survival rate at 3 years.Ipilimumab increased risks of pruritu,rash,diarrhea,colitis,and increase of alanine aminotransferase and aspartate aminotransferase.