Gemtuzumab ozogamicin for treatment of newly diagnosed acute myeloid leukaemia: a systematic review and meta‐analysis

Summary Evidence regarding the efficacy of gemtuzumab ozogamicin ( GO ) addition to standard induction chemotherapy in newly diagnosed acute myeloid leukaemia ( AML ) is conflicting. This systematic review aimed to identify and summarize all evidence regarding the benefits and harms of adding GO to conventional chemotherapy for induction treatment of AML . A comprehensive literature search of two databases ( PUBMED and C ochrane) from inception up to N ovember 22, 2012, and 4 years of proceedings from four major haematology/oncology conferences was undertaken. Endpoints included benefits (complete remission, relapse‐free, event‐free, and overall survival), and harms (early mortality and incidence of hepatic veno‐occlusive disease/sinusoidal obstructive syndrome). Seven trials (3942 patients) met all inclusion criteria. Addition of GO showed improved relapse‐free [ H azard R atio ( HR ) = 0·84 (95% confidence interval ( CI ) 0·71–0·99)] and event‐free survival [ HR  = 0·59 (95% CI 0·48–0·74)] but not overall survival [ HR  = 0·95 (95% CI 0·83–1·08)]. Addition of GO resulted in higher rate of early mortality [ R isk R atio = 1·60 (95% CI 1·07–2·39)]. Improved overall survival was observed in studies using a lower cumulative GO dose (<6 mg/m 2 ) [ HR  = 0·89 (95% CI 0·81–0·99)]. Addition of GO to conventional chemotherapy as induction therapy may improve relapse‐free and event‐free survival, but does not impact overall survival and significantly increases early mortality in AML .