Characteristics of 211 Elderly Study Patients With Previously Untreated Non-M3 AML
| Characteristic . | Placebo (N = 105) . | G-CSF (N = 106) . | Total (N = 211) . |
|---|---|---|---|
| Median age (yr) | 67 | 68 | 68 |
| Age 56-64 | 41 (39%) | 37 (35%) | 78 (37%) |
| Age 65+ | 64 (61%) | 69 (65%) | 133 (63%) |
| Range | 56-84 | 56-88 | 56-88 |
| Sex | |||
| Male | 66 (63%) | 56 (53%) | 122 (58%) |
| Female | 39 (37%) | 50 (47%) | 89 (42%) |
| Disease status | |||
| Secondary | 24 (23%) | 26 (25%) | 50 (24%) |
| De novo | 81 (77%) | 80 (75%) | 161 (76%) |
| Performance status | |||
| 0-1 | 76 (72%) | 73 (69%) | 149 (71%) |
| 2-3 | 29 (28%) | 33 (31%) | 62 (29%) |
| WBC count (×103/mL), median (range) | 13.4 (1.0-274) | 14.3 (0.6-298) | 13.5 (0.6-298) |
| Peripheral blasts (×103/mL), median (range) | 4.1 (0-209) | 1.8 (0-292) | 3.1 (0-292) |
| Platelet count (×103/mL), median (range) | 59 (11-317) | 59 (3-537) | 59 (3-537) |
| Cytogenetic status* | |||
| Favorable | 5 (5%) | 4 (4%) | 9 (4%) |
| Intermediate | 53 (50%) | 50 (47%) | 103 (49%) |
| Unfavorable | 26 (25%) | 26 (25%) | 52 (25%) |
| Unknown | 21 (20%) | 26 (25%) | 47 (22%) |
| MDR1 expression-151 | |||
| Bright | 37 (39%) | 32 (34%) | 69 (37%) |
| Moderate | 18 (19%) | 15 (16%) | 33 (17%) |
| Dim | 16 (17%) | 17 (18%) | 33 (17%) |
| Negative | 25 (26%) | 29 (31%) | 54 (29%) |
| Unknown | 9 | 13 | |
| FAB classification | |||
| M0 | 12 (11%) | 12 (11%) | 24 (11%) |
| M1 | 31 (30%) | 27 (25%) | 58 (27%) |
| M2 | 31 (30%) | 39 (37%) | 70 (33%) |
| M4 | 10 (10%) | 11 (10%) | 21 (10%) |
| M5 | 9 (9%) | 10 (9%) | 19 (9%) |
| M6 | 7 (7%) | 1 (1%) | 8 (4%) |
| M7 | 1 (1%) | 0 (0%) | 2 (1%) |
| Myeloid, NOS | 4 (4%) | 6 (6%) | 9 (4%) |
| Characteristic . | Placebo (N = 105) . | G-CSF (N = 106) . | Total (N = 211) . |
|---|---|---|---|
| Median age (yr) | 67 | 68 | 68 |
| Age 56-64 | 41 (39%) | 37 (35%) | 78 (37%) |
| Age 65+ | 64 (61%) | 69 (65%) | 133 (63%) |
| Range | 56-84 | 56-88 | 56-88 |
| Sex | |||
| Male | 66 (63%) | 56 (53%) | 122 (58%) |
| Female | 39 (37%) | 50 (47%) | 89 (42%) |
| Disease status | |||
| Secondary | 24 (23%) | 26 (25%) | 50 (24%) |
| De novo | 81 (77%) | 80 (75%) | 161 (76%) |
| Performance status | |||
| 0-1 | 76 (72%) | 73 (69%) | 149 (71%) |
| 2-3 | 29 (28%) | 33 (31%) | 62 (29%) |
| WBC count (×103/mL), median (range) | 13.4 (1.0-274) | 14.3 (0.6-298) | 13.5 (0.6-298) |
| Peripheral blasts (×103/mL), median (range) | 4.1 (0-209) | 1.8 (0-292) | 3.1 (0-292) |
| Platelet count (×103/mL), median (range) | 59 (11-317) | 59 (3-537) | 59 (3-537) |
| Cytogenetic status* | |||
| Favorable | 5 (5%) | 4 (4%) | 9 (4%) |
| Intermediate | 53 (50%) | 50 (47%) | 103 (49%) |
| Unfavorable | 26 (25%) | 26 (25%) | 52 (25%) |
| Unknown | 21 (20%) | 26 (25%) | 47 (22%) |
| MDR1 expression-151 | |||
| Bright | 37 (39%) | 32 (34%) | 69 (37%) |
| Moderate | 18 (19%) | 15 (16%) | 33 (17%) |
| Dim | 16 (17%) | 17 (18%) | 33 (17%) |
| Negative | 25 (26%) | 29 (31%) | 54 (29%) |
| Unknown | 9 | 13 | |
| FAB classification | |||
| M0 | 12 (11%) | 12 (11%) | 24 (11%) |
| M1 | 31 (30%) | 27 (25%) | 58 (27%) |
| M2 | 31 (30%) | 39 (37%) | 70 (33%) |
| M4 | 10 (10%) | 11 (10%) | 21 (10%) |
| M5 | 9 (9%) | 10 (9%) | 19 (9%) |
| M6 | 7 (7%) | 1 (1%) | 8 (4%) |
| M7 | 1 (1%) | 0 (0%) | 2 (1%) |
| Myeloid, NOS | 4 (4%) | 6 (6%) | 9 (4%) |
*Favorable: t(8;21), inv(16), t(16;16),+14. Unfavorable: complex, >3 abnl, inv(3q), −5/5q-, −7/7q-, 11q or 17p, del(20q),dmins/hsrs, +13, t(9;22).
MDR1 expression was evaluated by the MDR1 specific antibody MRK16 and quantified by the KS statistic.