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Gemtuzumab ozogamicin for treatment of newly diagnosed acute myeloid leukaemia: a systematic review and meta‐analysis
Author(s) -
KharfanDabaja Mohamed A.,
Hamadani Mehdi,
Reljic Tea,
Pyngolil Rachel,
Komrokji Rami S.,
Lancet Jeffrey E.,
Fernandez Hugo F.,
Djulbegovic Benjamin,
Kumar Ambuj
Publication year - 2013
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1111/bjh.12528
Subject(s) - gemtuzumab ozogamicin , medicine , induction chemotherapy , confidence interval , meta analysis , hematology , oncology , myeloid leukaemia , chemotherapy , cumulative incidence , cohort , cd33 , stem cell , genetics , biology , cd34
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 .