Table 1 Randomized studies of GO in... | American Society of Hematology

Table 1

Randomized studies of GO in newly diagnosed patients with AML

Study	n	Age, years	Characteristics	Dose of each administration of GO	Improved CR with GO	Improved RFS, EFS, DFS or OS with GO	Increased induction mortality	Increased hepatic toxicity
SWOG 0106⁴	637	18-60	DA+GO vs DA in induction and in maintenance	6 mg	No	No	Yes	No
MRC AML15⁷	1113	<60	Induction, consolidation, and maintenance, all with or without GO	3 mg	No	Yes: 1. Favorable cytogenetics 2. 70% of intermediate cytogenetics	No	No
ALFA 0701^9,10	280	50-70	DA+GO vs DA in induction and in consolidation	3 mg	No	Yes: In favorable/intermediate group	No	No
Groupe Ouest Est d'Etude des Leucémies Aiguës et Autres Maladies du Sang AML 2006 IR¹⁰	254	18-60	Induction with or without GO	6 mg	No	Yes: Improved EFS	No	Yes
National Cancer Research Institute AML16⁸	1115	51-84	Daunorubicin/clofarabine induction, with or without GO	3 mg	No	Yes: In favorable/intermediate group	No	No
Leukemia Research Fund AML14 and National Cancer Research Institute AML 16¹¹	495	Older adults, for conventional chemotherapy	Low-dose cytarabine, with or without GO	3 mg	Yes	No	No	No

Study	n	Age, years	Characteristics	Dose of each administration of GO	Improved CR with GO	Improved RFS, EFS, DFS or OS with GO	Increased induction mortality	Increased hepatic toxicity
SWOG 0106⁴	637	18-60	DA+GO vs DA in induction and in maintenance	6 mg	No	No	Yes	No
MRC AML15⁷	1113	<60	Induction, consolidation, and maintenance, all with or without GO	3 mg	No	Yes: 1. Favorable cytogenetics 2. 70% of intermediate cytogenetics	No	No
ALFA 0701^9,10	280	50-70	DA+GO vs DA in induction and in consolidation	3 mg	No	Yes: In favorable/intermediate group	No	No
Groupe Ouest Est d'Etude des Leucémies Aiguës et Autres Maladies du Sang AML 2006 IR¹⁰	254	18-60	Induction with or without GO	6 mg	No	Yes: Improved EFS	No	Yes
National Cancer Research Institute AML16⁸	1115	51-84	Daunorubicin/clofarabine induction, with or without GO	3 mg	No	Yes: In favorable/intermediate group	No	No
Leukemia Research Fund AML14 and National Cancer Research Institute AML 16¹¹	495	Older adults, for conventional chemotherapy	Low-dose cytarabine, with or without GO	3 mg	Yes	No	No	No

CR, complete remission; DA, daunorubicin/cytarabine; DFS, disease-free survival; EFS, event-free survival; FS, relapse-free survival.