Baseline characteristics of 419 elderly patients with AML by treatment arm
Characteristic . | DNR/Ara-C . | DNR/Ara-C + PSC-833 . |
|---|---|---|
| Total no. of patients | 211 | 208 |
| Median age, y (range) | 67 (58-85) | 67 (60-83) |
| 58-65, no. (%) | 77 (36) | 77 (37) |
| 66-70, no. (%) | 71 (34) | 69 (33) |
| 71-85, no. (%) | 63 (30) | 62 (30) |
| Secondary AML | ||
| No, no. (%) | 155 (73) | 160 (77) |
| Yes, no. (%) | 56 (27) | 48 (23) |
| Sex | ||
| Male, no. (%) | 117 (55) | 132 (63) |
| Female, no. (%) | 94 (45) | 76 (37) |
| FAB classification | ||
| MO, no. (%) | 14 (7) | 17 (8) |
| M1, no. (%) | 55 (26) | 34 (16) |
| M2, no. (%) | 70 (33) | 74 (36) |
| M4, no. (%) | 35 (17) | 40 (19) |
| M5, no. (%) | 14 (7) | 19 (9) |
| M6, no. (%) | 14 (7) | 12 (6) |
| M7, no. (%) | 4 (2) | 1 (0) |
| Unclassified, no. (%) | 5 (2) | 11 (5) |
| WHO performance | ||
| 0, no. (%) | 41 (20) | 45 (22) |
| 1, no. (%) | 110 (53) | 103 (51) |
| 2, no. (%) | 54 (26) | 49 (24) |
| 3, no. (%) | 1 (0) | 4 (2) |
| No data, no.* | 5 | 7 |
| Median WBC count, × 109/L (range) | 7.0 (0.1-389) | 11.3 (0.5-300) |
| P-gp assessment: IPS | ||
| Negative, no. (%) | 37 (24) | 45 (29) |
| Low-positive, no. (%) | 50 (32) | 40 (26) |
| Positive, no. (%) | 43 (28) | 42 (27) |
| High-positive, no. (%) | 24 (16) | 28 (18) |
| No data, no.* | 57 | 53 |
| Cytogenetic study at diagnosis | ||
| Not done, no. (%) | 21 (12) | 25 (14) |
| Done successfully,† no. (%) | 146 (80) | 147 (82) |
| Failure, no. (%) | 15 (8) | 8 (4) |
| No data, no.* | 29 | 28 |
| Cytogenetic risk classification† | ||
| Favorable, no. (%) | 3 (2) | 2 (1) |
| Intermediate, no. (%) | 108 (74) | 114 (78) |
| Unfavorable, no. (%) | 35 (24) | 31 (21) |
Characteristic . | DNR/Ara-C . | DNR/Ara-C + PSC-833 . |
|---|---|---|
| Total no. of patients | 211 | 208 |
| Median age, y (range) | 67 (58-85) | 67 (60-83) |
| 58-65, no. (%) | 77 (36) | 77 (37) |
| 66-70, no. (%) | 71 (34) | 69 (33) |
| 71-85, no. (%) | 63 (30) | 62 (30) |
| Secondary AML | ||
| No, no. (%) | 155 (73) | 160 (77) |
| Yes, no. (%) | 56 (27) | 48 (23) |
| Sex | ||
| Male, no. (%) | 117 (55) | 132 (63) |
| Female, no. (%) | 94 (45) | 76 (37) |
| FAB classification | ||
| MO, no. (%) | 14 (7) | 17 (8) |
| M1, no. (%) | 55 (26) | 34 (16) |
| M2, no. (%) | 70 (33) | 74 (36) |
| M4, no. (%) | 35 (17) | 40 (19) |
| M5, no. (%) | 14 (7) | 19 (9) |
| M6, no. (%) | 14 (7) | 12 (6) |
| M7, no. (%) | 4 (2) | 1 (0) |
| Unclassified, no. (%) | 5 (2) | 11 (5) |
| WHO performance | ||
| 0, no. (%) | 41 (20) | 45 (22) |
| 1, no. (%) | 110 (53) | 103 (51) |
| 2, no. (%) | 54 (26) | 49 (24) |
| 3, no. (%) | 1 (0) | 4 (2) |
| No data, no.* | 5 | 7 |
| Median WBC count, × 109/L (range) | 7.0 (0.1-389) | 11.3 (0.5-300) |
| P-gp assessment: IPS | ||
| Negative, no. (%) | 37 (24) | 45 (29) |
| Low-positive, no. (%) | 50 (32) | 40 (26) |
| Positive, no. (%) | 43 (28) | 42 (27) |
| High-positive, no. (%) | 24 (16) | 28 (18) |
| No data, no.* | 57 | 53 |
| Cytogenetic study at diagnosis | ||
| Not done, no. (%) | 21 (12) | 25 (14) |
| Done successfully,† no. (%) | 146 (80) | 147 (82) |
| Failure, no. (%) | 15 (8) | 8 (4) |
| No data, no.* | 29 | 28 |
| Cytogenetic risk classification† | ||
| Favorable, no. (%) | 3 (2) | 2 (1) |
| Intermediate, no. (%) | 108 (74) | 114 (78) |
| Unfavorable, no. (%) | 35 (24) | 31 (21) |
WBC indicates white blood cell.
Data not included when calculating percentages.
Classification of cytogenetic abnormalities for 293 patients with successful cytogenetics. Favorable risk was defined as the presence of t(8;21), inv(16), or t(16;16). Unfavorable risk was defined by the presence of monosomies or deletions of chromosomes 5 or 7, abnormalities of the long arm of chromosome 3(q21;q26), t(6;9), abnormalities involving the long arm of chromosome 11 (11q23), or complex cytogenetic abnormalities (defined as at least 3 unrelated cytogenetic clones). Patients who did not meet the criteria for favorable or unfavorable risk were classified as being intermediate risk.