Table 6.

Major randomized prospective trials.

Intent to Treat/Actually Treated + Regimen
Study Group, Years, Age rangeNo. of Patients Attained CR/ Total PatientsInductionPostremission Therapy Before Receiving the Assigned Therapy (IC/ASCT/Allo SCT)Randomized, %Time of RandomizationAllo SCTAssigned ICASCT
Abbreviations: CR, complete remission; IC, intensive chemotherapy; ASCT, autologous stem cell transplantation; allo SCT, allogeneic stem cell transplantation; EORTC/GIMEMA, European Organization for Research and Treatment of Cancer/Gruppo Italiano Malattie Ematologiche Maligne dell’Adulto; AML, acute myeloid leukemia; ABMT, autologous bone marrow transplantation; PBSCT, peripheral blood stem cell transplantation; BM, bone marrow; PB, peripheral blood; GOELAM, Groupe Ouest Est Leucemies Aigues Myeloblastiques; MRC, Medical Research Council; DAT, daunorubicin, cytarabine, thioguanine; ADE, cytarabine, daunorubicin, etoposide; MACE, amsacrine, cytarabine, etoposide; MIDAC, mitoxantrone, cytarabine; CTX, cyclophosphamide; TBI, total body irradiation; MAE, mitoxantrone, cytarabine, etoposide; S-DAT, daunorubicin, cytarabine 100/m2/d, thioguanine; H-DAT, daunorubicin, cytarabine 200/m2/d, thioguanine; Bu, busulfan. 
† Second course has been given to patients who failed to achieve CR with first induction. 
‡1966 patients entered the study, but some were taken out because of incorrect diagnosis; 83% of the patients with confirmed AML attained CR. 
EORTC/GIMEMA AML 8 1986–1991 10-59 y 623/941 (66%) Daunorubicin 45 mg/m2 + cytarabine 200 mg/m2 1-2 courses† Cytarabine 6 g/m2/course + amsacrine 63 After 2 (or 3) courses† 144/168 (86%) 104/126 (83%) cytarabine 16 g/m2/course + daunorubicin 95/128 (74%) 
EORTC/GIMEMA AML 10 11/1993–12/1999 16-60 y 1445/2038 (71%) Anthracycline + cytarabine + etoposide Anthracycline + cytarabine 67 ABMT vs PBSCT 198/292 (68%) No arm for only IC 87/146-BM 99/146-PB 
GOELAM 11/1993–12/1999 15-50 y 367/517 (71%) (87%)2 Cytarabine 200 mg/m2 + anthracycline (1-2 courses)† Cytarabine 500 mg/m2/course + amsacrine for pt assigned allo SCT cytarabine 24 g/m2/course + anthracycline for pt assigned ASCT/IC 61 or After 2 (or 3) 73/88 courses† 71/78 (91%) (83%) 75/86 amsacrine + etoposide 
MRC AML 10 1988–1966 < 55 y 1609/1966‡ (83%) (66%) DAT or ADE (1-2 courses)† All patients received 3 additional courses of DAT/ADE (1), MACE (1), MIDAC (1) if they had not received 2 courses already 34 After 3rd 257/419 course No additional (61%) 126/190 (4 courses previously) 
MRC AML12 1995–2002 < 60 y n = 3459 (85% CR) 2 courses of ADE vs MAE replaced by S-DAT vs H-DAT MACE (1)  After 3rd course Still un-published Randomization between 1 and 2 additional courses: ICE vs Still un-published ICE followed by MIDAC 
Intergroup study 1990–1995 16-55 y 518/740 (70%) Cytarabine 100 mg/m2 + idarubicin All patients who achieved CR received 1 course of cytarabine 500 mg/m2/course + idarubicin 60 After 2 (or 3) courses† 92/113 (81%) 106/117 (91%) cytarabine 36 g/m2/course 63/116 (54%) 
Intent to Treat/Actually Treated + Regimen
Study Group, Years, Age rangeNo. of Patients Attained CR/ Total PatientsInductionPostremission Therapy Before Receiving the Assigned Therapy (IC/ASCT/Allo SCT)Randomized, %Time of RandomizationAllo SCTAssigned ICASCT
Abbreviations: CR, complete remission; IC, intensive chemotherapy; ASCT, autologous stem cell transplantation; allo SCT, allogeneic stem cell transplantation; EORTC/GIMEMA, European Organization for Research and Treatment of Cancer/Gruppo Italiano Malattie Ematologiche Maligne dell’Adulto; AML, acute myeloid leukemia; ABMT, autologous bone marrow transplantation; PBSCT, peripheral blood stem cell transplantation; BM, bone marrow; PB, peripheral blood; GOELAM, Groupe Ouest Est Leucemies Aigues Myeloblastiques; MRC, Medical Research Council; DAT, daunorubicin, cytarabine, thioguanine; ADE, cytarabine, daunorubicin, etoposide; MACE, amsacrine, cytarabine, etoposide; MIDAC, mitoxantrone, cytarabine; CTX, cyclophosphamide; TBI, total body irradiation; MAE, mitoxantrone, cytarabine, etoposide; S-DAT, daunorubicin, cytarabine 100/m2/d, thioguanine; H-DAT, daunorubicin, cytarabine 200/m2/d, thioguanine; Bu, busulfan. 
† Second course has been given to patients who failed to achieve CR with first induction. 
‡1966 patients entered the study, but some were taken out because of incorrect diagnosis; 83% of the patients with confirmed AML attained CR. 
EORTC/GIMEMA AML 8 1986–1991 10-59 y 623/941 (66%) Daunorubicin 45 mg/m2 + cytarabine 200 mg/m2 1-2 courses† Cytarabine 6 g/m2/course + amsacrine 63 After 2 (or 3) courses† 144/168 (86%) 104/126 (83%) cytarabine 16 g/m2/course + daunorubicin 95/128 (74%) 
EORTC/GIMEMA AML 10 11/1993–12/1999 16-60 y 1445/2038 (71%) Anthracycline + cytarabine + etoposide Anthracycline + cytarabine 67 ABMT vs PBSCT 198/292 (68%) No arm for only IC 87/146-BM 99/146-PB 
GOELAM 11/1993–12/1999 15-50 y 367/517 (71%) (87%)2 Cytarabine 200 mg/m2 + anthracycline (1-2 courses)† Cytarabine 500 mg/m2/course + amsacrine for pt assigned allo SCT cytarabine 24 g/m2/course + anthracycline for pt assigned ASCT/IC 61 or After 2 (or 3) 73/88 courses† 71/78 (91%) (83%) 75/86 amsacrine + etoposide 
MRC AML 10 1988–1966 < 55 y 1609/1966‡ (83%) (66%) DAT or ADE (1-2 courses)† All patients received 3 additional courses of DAT/ADE (1), MACE (1), MIDAC (1) if they had not received 2 courses already 34 After 3rd 257/419 course No additional (61%) 126/190 (4 courses previously) 
MRC AML12 1995–2002 < 60 y n = 3459 (85% CR) 2 courses of ADE vs MAE replaced by S-DAT vs H-DAT MACE (1)  After 3rd course Still un-published Randomization between 1 and 2 additional courses: ICE vs Still un-published ICE followed by MIDAC 
Intergroup study 1990–1995 16-55 y 518/740 (70%) Cytarabine 100 mg/m2 + idarubicin All patients who achieved CR received 1 course of cytarabine 500 mg/m2/course + idarubicin 60 After 2 (or 3) courses† 92/113 (81%) 106/117 (91%) cytarabine 36 g/m2/course 63/116 (54%) 
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