Summary of therapy administered
| Treatment details . | Treatment protocol (reference no.) . | |||||
|---|---|---|---|---|---|---|
| 8221 (Mayer et al26) . | 8525 (Mayer et al27) . | 8923 (Stone et al28) . | 9022 (Moore et al29) . | 9222 (Moore et al30) . | ||
| Accrual period for 8461 | 8/84–10/85 | 11/85–9/90 | 2/90–11/93 | 10/90–3/92 | 7/92–12/95 | |
| Induction 1 | ||||||
| Daunorubicin 45 mg/m2 ivp × 3 d | Yes | Yes | Yes* | Yes | Yes | |
| Cytarabine 200 mg/m2 by ci × 7 d | Yes | Yes | Yes | Yes | Yes | |
| Induction 2, if needed | ||||||
| Daunorubicin 45 mg/m2 ivp × 2 d | Yes | Yes | Yes | Yes | Yes | |
| Cytarabine 200 mg/m2 by ci × 5 d | Yes | Yes | Yes | Yes | Yes | |
| Intensification therapy randomized | No | Yes; arms A, B, C | Yes; arms A, B | No | Yes; arms A, B | |
| Intensification therapy 1 | HDAC or IDAC | A: SDAC | A: SDAC | HDAC | A: HDAC | |
| B: IDAC | B: M + IDAC | B: HDAC | ||||
| C: HDAC | ||||||
| Intensification therapy 2 | HDAC or IDAC | A: SDAC | A: SDAC | E + C | A: HDAC | |
| B: IDAC | B: M + IDAC | B: E + C | ||||
| C: HDAC | ||||||
| Intensification therapy 3 | HDAC or IDAC | A: SDAC | A: SDAC | M + D | A: HDAC | |
| B: IDAC | B: NA | B: M + D | ||||
| C: HDAC | ||||||
| Intensification therapy 4 | HDAC or IDAC | A: SDAC | A: SDAC | NA | NA | |
| B: IDAC | B: NA | |||||
| C: HDAC | ||||||
| Maintenance therapy | Yes | Yes | No | No | No | |
| Treatment details . | Treatment protocol (reference no.) . | |||||
|---|---|---|---|---|---|---|
| 8221 (Mayer et al26) . | 8525 (Mayer et al27) . | 8923 (Stone et al28) . | 9022 (Moore et al29) . | 9222 (Moore et al30) . | ||
| Accrual period for 8461 | 8/84–10/85 | 11/85–9/90 | 2/90–11/93 | 10/90–3/92 | 7/92–12/95 | |
| Induction 1 | ||||||
| Daunorubicin 45 mg/m2 ivp × 3 d | Yes | Yes | Yes* | Yes | Yes | |
| Cytarabine 200 mg/m2 by ci × 7 d | Yes | Yes | Yes | Yes | Yes | |
| Induction 2, if needed | ||||||
| Daunorubicin 45 mg/m2 ivp × 2 d | Yes | Yes | Yes | Yes | Yes | |
| Cytarabine 200 mg/m2 by ci × 5 d | Yes | Yes | Yes | Yes | Yes | |
| Intensification therapy randomized | No | Yes; arms A, B, C | Yes; arms A, B | No | Yes; arms A, B | |
| Intensification therapy 1 | HDAC or IDAC | A: SDAC | A: SDAC | HDAC | A: HDAC | |
| B: IDAC | B: M + IDAC | B: HDAC | ||||
| C: HDAC | ||||||
| Intensification therapy 2 | HDAC or IDAC | A: SDAC | A: SDAC | E + C | A: HDAC | |
| B: IDAC | B: M + IDAC | B: E + C | ||||
| C: HDAC | ||||||
| Intensification therapy 3 | HDAC or IDAC | A: SDAC | A: SDAC | M + D | A: HDAC | |
| B: IDAC | B: NA | B: M + D | ||||
| C: HDAC | ||||||
| Intensification therapy 4 | HDAC or IDAC | A: SDAC | A: SDAC | NA | NA | |
| B: IDAC | B: NA | |||||
| C: HDAC | ||||||
| Maintenance therapy | Yes | Yes | No | No | No | |
Maintenance therapy indicates daunorubicin 45 mg/m2by intravenous bolus (ivb) on day 1 plus cytarabine 100 mg/m2 subcutaneously (sq) twice daily on days 1 to 5 repeated monthly × 4; ivp indicates intravenous push; HDAC, cytarabine 3 g/m2 by ivb over 3 hours twice daily on days 1, 3, and 5; IDAC, cytarabine 400 mg/m2 by continuous infusion (ci) every day × 5 days; SDAC, cytarabine 100 mg/m2 by ci every day × 5 days; M + IDAC, mitoxantrone plus alternative IDAC; E + C, etoposide 1800 mg/m2 by ci on day 1 plus cyclophosphamide 50 mg/kg ivb on days 2 and 3; NA, not applicable; M + D, mitoxantrone 12 mg/m2 ivb plus diaziquone 24 mg/m2 by ci on days 1, 2, and 3 plus filgrastim 5 μg/kg sq on days 4 to 28.
Fifty percent of enrolled patients received GM-CSF during induction.