Table 3.
Randomized trials of gemtuzumab ozogamicin (GO) associated with intensive chemotherapy
| Study | Treatment phase (age range [y]) | Patients (N) | GO dose and schedule | Conclusions |
|---|---|---|---|---|
| SWOG S010619 | Induction (18-60) | 637 | GO, 6 mg/m2 | Similar response rate |
| d4 cycle 1* | Higher early death rate | |||
| Similar RFS | ||||
| Similar OS | ||||
| NCRI AML1520 | Induction (18-60) | 1113 | GO, 3 mg/m2 | Similar response rate |
| d1 cycle 1 | Similar RFS and OS | |||
| d1 cycle 3† | Longer OS in favorable AML | |||
| NCRI AML1621 | Induction (>60) | 1115 | GO, 3 mg/m2 | Similar response rate |
| d1 cycle 1 | Longer RFS, OS from CR, and OS | |||
| ALFA-070122 | Induction | 278 | GO, 3 mg/m2 | Similar response rate |
| Consolidation | d1/4/7 cycle 1 | Longer EFS, RFS, and OS | ||
| (50-70) | d1 conso 1 | |||
| d1 conso 2 | ||||
| GOELAMS 200623 | Induction (18-60) | 254 | GO, 6 mg/m2 | Similar response rate |
| d4 cycle 1 | Similar EFS and OS | |||
| d4 conso 1 | Longer EFS in non–allo-HSCT patients | |||
| NCRI AML1724 | Induction (0-81) | 788 | GO, 3 vs 6 mg/m2 | Similar responses rate |
| d1 cycle 1 | Lower early death rate with 3 mg/m2 | |||
| Similar RFS and OS | ||||
| EORTC-GIMEMA | Prior to induction (61-75) | 472 | GO, 6 mg/m2 | Similar response rate |
| AML-1725 | d1/15 before cycle 1 | Higher early death rate | ||
| Similar RFS | ||||
| Similar EFS and OS | ||||
| HOVON-SAKK-AMLSG26 | Maintenance (>60) | 232 | GO, 6 mg/m2 | Similar relapse incidence |
| 3 monthly cycles | Similar RFS and OS | |||
| SWOG S010619 | Maintenance (18-60) | 174 | GO, 5 mg/m2 | Similar RFS |
| 3 monthly cycles |
EFS, event-free survival; OS, overall survival; RFS, relapse-free survival.
*
Daunorubicin dose was reduced from 60 mg/m2 per day in the control arm to 45 mg/m2 per day in the GO arm.
†
Additional randomization for GO during cycle 3, irrespective of cycle 1 GO treatment.