Table 6.
Additional details of randomized trials of maintenance treatment in AML
| Reference | Induction | Consolidation | Outcome and follow-up | |||||
|---|---|---|---|---|---|---|---|---|
| Randomized | Regimen | Randomized | Regimen | Primary | Secondary | QoL* | Median follow-up | |
| 22 | No | Cytarabine-daunorubicin (BART III) × 2 | No | Cyclophosphamide + 6-thioguanine | NA | NA | No | NA |
| 20 | No | Cytarabine-daunorubicin (7+3)-vincristine; cytarabine-daunorubicin (5+2)-vincristine | No | Cytarabine-daunorubicin (7+3)-vincristine | NA | NA | No | NA |
| 11 | No | 6-Thioguanine-cytarabine-daunorubicin | No | 6-Thioguanine-cytarabine-daunorubicin | NA | NA | No | NA |
| 13 | No | Cytarabine-daunorubicin (5+2) × 2 | No | C1: 5+2; C2: intermediate-dose cytarabine |
NA | NA | No | NA |
| 16 | No | 6-Thioguanine-cytarabine-daunorubicin | No | C1 and C4: 6-thioguanine-cytarabine-daunorubicin; C2 and C5: azacitidine- cyclophosphamide-etoposide-vincristine; C3 and C6: methotrexate |
NA | NA | No | 82 mo |
| 15 | Yes | Cytarabine with or without daunorubicin vs mitoxantrone | No | Same as induction | DFS | OS | No | NA |
| 18 | No | Cytarabine-mitoxantrone | No | Daunorubicin–intermediate-dose cytarabine; daunorubicin–high-dose cytarabine-Ams-Asp | NA | NA | No | NA |
| 10 | Yes | Cytarabine-daunorubicin-etoposide with or without PSC-833 | No | Same as induction | NA | NA | No | NA |
| 14 | Yes | Cytarabine + daunorubicin vs liposomal daunorubicin | No | Same as induction | DFS, CR (induction) | DFS (maintenance) | No | NA |
| 21 | Yes | Cytarabine-daunorubicin-etoposide vs high-dose cytarabine-daunorubicin-etoposide | No | Daunorubicin–intermediate-dose cytarabine | OS | DFS/EFS/ Toxicity | No | 3.6 y |
| 17 | Yes | Cytarabine + daunorubicin vs idarubicin3 vs idarubicin4 | No | Idarubicin-daunorubicin + intermediate-dose cytarabine | EFS | NA | No | 49 mo |
| 19 | No | Cytarabine-mitoxantrone | No | C1 and C3: high-dose cytarabine | Relapse/EFS | Toxicity | No | 5 y |
| 12 | Yes | Cytarabine + daunorubicin vs clofarabine with or without gemtuzumab ozogamicin × 2 | Yes | 5+2 vs none | OS | TTR, Toxicity | No | 50 mo |
Positive trials are shown in bold.
Ams, amsacrine; Asp, asparaginase; BART III, BCG + allogeneic cells vs no maintenance randomized trial; idarubicin3, 3 days of idarubicin; idarubicin4, 4 days of idarubicin; NA, not available; PSC-833, Valspodar; TTR, time to relapse.
*
QoL formally assessed.