Patient characteristics by randomized treatment group
. | No. of patients (%) . | . | . | . | |||
|---|---|---|---|---|---|---|---|
. | Group A, G-CSF-/- . | Group B, G-CSF+/- . | Group C, G-CSF-/+ . | Group D, G-CSF+/+ . | |||
| Total | 182 | 180 | 180 | 180 | |||
| Group | |||||||
| EORTC | 105 (57.7) | 111 (61.7) | 110 (61.1) | 114 (63.3) | |||
| GIMEMA | 77 (42.3) | 69 (38.3) | 70 (38.9) | 66 (36.7) | |||
| Age, y | |||||||
| 61 to 70 | 112 (61.5) | 116 (64.4) | 124 (68.9) | 127 (70.6) | |||
| 71 to 80 | 70 (38.5) | 64 (35.6) | 56 (31.1) | 53 (29.4) | |||
| Sex | |||||||
| Male | 97 (53.3) | 91 (50.6) | 86 (47.8) | 111 (61.7) | |||
| Female | 82 (45.1) | 86 (47.8) | 89 (49.4) | 67 (37.2) | |||
| Missing | 3 (1.6) | 3 (1.7) | 5 (2.8) | 2 (1.1) | |||
| Performance status* | |||||||
| PS 0 | 59 (32.4) | 52 (28.9) | 51 (28.3) | 54 (30.0) | |||
| PS 1 | 81 (44.5) | 91 (50.6) | 87 (48.3) | 83 (46.1) | |||
| PS 2 | 38 (20.9) | 34 (18.9) | 38 (21.1) | 37 (20.6) | |||
| PS 3 to 4 | 1 (0.5) | 0 (0.0) | 0 (0.0) | 3 (1.7) | |||
| Missing/unknown | 3 (1.6) | 3 (1.7) | 4 (2.3) | 3 (1.7) | |||
| Type of AML | |||||||
| De novo | 140 (76.9) | 139 (77.2) | 140 (77.8) | 145 (80.6) | |||
| Secondary | 42 (23.1) | 41 (22.8) | 40 (22.2) | 35 (19.4) | |||
| FAB subtype | |||||||
| M0 | 12 (6.6) | 18 (10.0) | 15 (8.3) | 8 (4.4) | |||
| M1 | 42 (23.1) | 35 (19.4) | 29 (16.1) | 34 (18.9) | |||
| M2 | 58 (31.9) | 47 (26.1) | 58 (32.2) | 56 (31.1) | |||
| M3 | 0 (0.0) | 1 (0.6)† | 0 (0.0) | 0 (0.0) | |||
| M4 | 29 (15.9) | 25 (13.9) | 29 (16.1) | 40 (22.2) | |||
| M5 | 22 (12.1) | 32 (17.8) | 29 (16.1) | 32 (17.8) | |||
| M6 | 6 (3.3) | 10 (5.6) | 4 (2.2) | 4 (2.2) | |||
| M7 | 1 (0.5) | 2 (1.1) | 2 (1.1) | 1 (0.6) | |||
| Missing/unknown | 12 (6.5) | 10 (5.6) | 14 (7.8) | 5 (2.8) | |||
| WBC, × 109/L | |||||||
| Less than 25 | 113 (62.1) | 123 (68.3) | 118 (65.6) | 124 (68.9) | |||
| 25 to 99.9 | 45 (24.7) | 35 (19.4) | 39 (21.7) | 38 (21.1) | |||
| ≤100 | 17 (9.3) | 16 (8.9) | 16 (8.9) | 16 (8.9) | |||
| Missing/unknown | 7 (3.8) | 6 (3.3) | 7 (3.9) | 2 (1.1) | |||
| Cytogenetics | |||||||
| Favorable | 2 (1.1) | 3 (1.7) | 1 (0.6) | 8 (4.4) | |||
| Intermediate‡ | 43 (23.6) | 37 (20.6) | 52 (28.9) | 58 (32.2) | |||
| Unfavorable§ | 16 (8.8) | 31 (17.2) | 21 (11.7) | 21 (11.7) | |||
| Other | 31 (17.0) | 26 (14.4) | 31 (17.2) | 24 (13.3) | |||
| Missing/unknown | 90 (49.5) | 83 (46.1) | 75 (41.7) | 69 (38.3) | |||
. | No. of patients (%) . | . | . | . | |||
|---|---|---|---|---|---|---|---|
. | Group A, G-CSF-/- . | Group B, G-CSF+/- . | Group C, G-CSF-/+ . | Group D, G-CSF+/+ . | |||
| Total | 182 | 180 | 180 | 180 | |||
| Group | |||||||
| EORTC | 105 (57.7) | 111 (61.7) | 110 (61.1) | 114 (63.3) | |||
| GIMEMA | 77 (42.3) | 69 (38.3) | 70 (38.9) | 66 (36.7) | |||
| Age, y | |||||||
| 61 to 70 | 112 (61.5) | 116 (64.4) | 124 (68.9) | 127 (70.6) | |||
| 71 to 80 | 70 (38.5) | 64 (35.6) | 56 (31.1) | 53 (29.4) | |||
| Sex | |||||||
| Male | 97 (53.3) | 91 (50.6) | 86 (47.8) | 111 (61.7) | |||
| Female | 82 (45.1) | 86 (47.8) | 89 (49.4) | 67 (37.2) | |||
| Missing | 3 (1.6) | 3 (1.7) | 5 (2.8) | 2 (1.1) | |||
| Performance status* | |||||||
| PS 0 | 59 (32.4) | 52 (28.9) | 51 (28.3) | 54 (30.0) | |||
| PS 1 | 81 (44.5) | 91 (50.6) | 87 (48.3) | 83 (46.1) | |||
| PS 2 | 38 (20.9) | 34 (18.9) | 38 (21.1) | 37 (20.6) | |||
| PS 3 to 4 | 1 (0.5) | 0 (0.0) | 0 (0.0) | 3 (1.7) | |||
| Missing/unknown | 3 (1.6) | 3 (1.7) | 4 (2.3) | 3 (1.7) | |||
| Type of AML | |||||||
| De novo | 140 (76.9) | 139 (77.2) | 140 (77.8) | 145 (80.6) | |||
| Secondary | 42 (23.1) | 41 (22.8) | 40 (22.2) | 35 (19.4) | |||
| FAB subtype | |||||||
| M0 | 12 (6.6) | 18 (10.0) | 15 (8.3) | 8 (4.4) | |||
| M1 | 42 (23.1) | 35 (19.4) | 29 (16.1) | 34 (18.9) | |||
| M2 | 58 (31.9) | 47 (26.1) | 58 (32.2) | 56 (31.1) | |||
| M3 | 0 (0.0) | 1 (0.6)† | 0 (0.0) | 0 (0.0) | |||
| M4 | 29 (15.9) | 25 (13.9) | 29 (16.1) | 40 (22.2) | |||
| M5 | 22 (12.1) | 32 (17.8) | 29 (16.1) | 32 (17.8) | |||
| M6 | 6 (3.3) | 10 (5.6) | 4 (2.2) | 4 (2.2) | |||
| M7 | 1 (0.5) | 2 (1.1) | 2 (1.1) | 1 (0.6) | |||
| Missing/unknown | 12 (6.5) | 10 (5.6) | 14 (7.8) | 5 (2.8) | |||
| WBC, × 109/L | |||||||
| Less than 25 | 113 (62.1) | 123 (68.3) | 118 (65.6) | 124 (68.9) | |||
| 25 to 99.9 | 45 (24.7) | 35 (19.4) | 39 (21.7) | 38 (21.1) | |||
| ≤100 | 17 (9.3) | 16 (8.9) | 16 (8.9) | 16 (8.9) | |||
| Missing/unknown | 7 (3.8) | 6 (3.3) | 7 (3.9) | 2 (1.1) | |||
| Cytogenetics | |||||||
| Favorable | 2 (1.1) | 3 (1.7) | 1 (0.6) | 8 (4.4) | |||
| Intermediate‡ | 43 (23.6) | 37 (20.6) | 52 (28.9) | 58 (32.2) | |||
| Unfavorable§ | 16 (8.8) | 31 (17.2) | 21 (11.7) | 21 (11.7) | |||
| Other | 31 (17.0) | 26 (14.4) | 31 (17.2) | 24 (13.3) | |||
| Missing/unknown | 90 (49.5) | 83 (46.1) | 75 (41.7) | 69 (38.3) | |||
Results are presented as absolute numbers, with percentages shown in parentheses.
-/- indicates not administered; +/-, administered on days 1 to 7; -/+, administered on days 8 to 28; and +/+, administered on days 1 to 28.
WHO scale.
This case was considered morphologically as FAB M3, but lacked both the t(15;17) translocation at conventional cytogenetics and the promyelocytic leukemiaretinoic acid receptor α (PML/RAR-α) rearrangement at a molecular level.
NN, -Y.
Presence of -5, -7, 5q-, 7q-, complex abnormalities.