Patient characteristics
. | Control; . | HDC/IL-2; . |
|---|---|---|
. | n = 160 . | n = 160 . |
| Sex | ||
| Men | 86 (54)* | 86 (54) |
| Women | 74 (46) | 74 (46) |
| Age, y, median (range) | ||
| Overall | 54 (18-84) | 55 (18-81) |
| Older than 60 y | 59 (37) | 66 (41) |
| CR status | ||
| CR1 | 132 (82) | 129 (81) |
| CR > 1 | 28 (18) | 31 (19) |
| FAB classification | ||
| M0/M1/M5/M6 | 56 (35) | 60 (38) |
| M2/M3/M4 | 93 (58) | 87 (54) |
| Performance status† | ||
| 0 | 114 (71) | 125 (78) |
| 1 | 46 (29) | 35 (22) |
| WBC count at diagnosis, × 109/L | ||
| Fewer than 20 | 111 (69) | 97 (61) |
| 20-100 | 36 (23) | 51 (32) |
| More than 100 | 13 (8) | 12 (7) |
| Karyotype‡ | ||
| Favorable | 13 (8) | 14 (9) |
| Intermediate | 95 (59) | 95 (59) |
| Adverse | 7 (4) | 10 (6) |
| Unknown | 45 (28) | 41 (26) |
| No more than 15% blasts after first induction | 144 (90) | 147 (92) |
| Antecedent hematologic disorder§ | 14 (9) | 15 (9) |
| Previous high dose AraC∥ | 108 (68) | 105 (66) |
| Previous auto-SCT | 17 (11) | 22 (14) |
| CR - Rx¶, d, median (range) | ||
| Overall | 135 (4-553) | 147 (6-727) |
| 6 mo or fewer | 125 (78) | 117 (73) |
| More than 6 mo | 35 (22) | 43 (27) |
| Consolidation - Rx#, d, median (range) | ||
| Overall | 64 (14-468) | 63 (20-545) |
| 3 mo or fewer | 122 (76) | 125 (78) |
| More than 3 mo | 35 (22) | 34 (21) |
. | Control; . | HDC/IL-2; . |
|---|---|---|
. | n = 160 . | n = 160 . |
| Sex | ||
| Men | 86 (54)* | 86 (54) |
| Women | 74 (46) | 74 (46) |
| Age, y, median (range) | ||
| Overall | 54 (18-84) | 55 (18-81) |
| Older than 60 y | 59 (37) | 66 (41) |
| CR status | ||
| CR1 | 132 (82) | 129 (81) |
| CR > 1 | 28 (18) | 31 (19) |
| FAB classification | ||
| M0/M1/M5/M6 | 56 (35) | 60 (38) |
| M2/M3/M4 | 93 (58) | 87 (54) |
| Performance status† | ||
| 0 | 114 (71) | 125 (78) |
| 1 | 46 (29) | 35 (22) |
| WBC count at diagnosis, × 109/L | ||
| Fewer than 20 | 111 (69) | 97 (61) |
| 20-100 | 36 (23) | 51 (32) |
| More than 100 | 13 (8) | 12 (7) |
| Karyotype‡ | ||
| Favorable | 13 (8) | 14 (9) |
| Intermediate | 95 (59) | 95 (59) |
| Adverse | 7 (4) | 10 (6) |
| Unknown | 45 (28) | 41 (26) |
| No more than 15% blasts after first induction | 144 (90) | 147 (92) |
| Antecedent hematologic disorder§ | 14 (9) | 15 (9) |
| Previous high dose AraC∥ | 108 (68) | 105 (66) |
| Previous auto-SCT | 17 (11) | 22 (14) |
| CR - Rx¶, d, median (range) | ||
| Overall | 135 (4-553) | 147 (6-727) |
| 6 mo or fewer | 125 (78) | 117 (73) |
| More than 6 mo | 35 (22) | 43 (27) |
| Consolidation - Rx#, d, median (range) | ||
| Overall | 64 (14-468) | 63 (20-545) |
| 3 mo or fewer | 122 (76) | 125 (78) |
| More than 3 mo | 35 (22) | 34 (21) |
FAB indicates French-American-British; WBC, white blood cell; auto-SCT, autologous stem cell transplantation; Rx, random assignment.
If not otherwise indicated, results are presented as absolute numbers with percentages shown in parenthesis.
Assessed at the time of random assignment.
Classified according to MRC criteria.27
Twelve (control) and 13 (HDC/IL-2) patients had myelodysplastic syndrome prior to AML. Two patients in each arm had other previous hematologic malignancies.
At least 2 g/m2 per day for 3 or more days during induction or consolidation.
Time (days) from current CR to date of random assignment.
Time (days) from the completion of consolidation to date of random assignment.