Clinical descriptors, hematologic variables, and endpoints of analysis for each set of patients
| . | Normal (N = 307) . | Trisomy 8 in karyotype (N = 108) . | Trisomy 8 sole aberration (N = 43) . | Other clonal aberrations (excludes + 8) (N = 434) . |
|---|---|---|---|---|
| Race, white/nonwhite | 274/33 | 94/13‡ | 35/7‡ | 375/59 |
| Sex, male/female | 146/161 | 63/452-153 | 23/20 | 259/175 |
| Age (y), median (range) | 60 (16-83) | 61 (20-83) | 61 (21-78) | 55 (15-88) |
| SWOG performance status (N = 836) | ||||
| 0 | 97 | 27 | 13 | 145 |
| 1 | 145 | 53 | 21 | 192 |
| 2 | 41 | 16 | 6 | 66 |
| 3 | 20 | 10 | 2 | 24 |
| Extramedullary skin involvement (N = 818) (%) | 20 (6.7) | 6 (5.8) | 3 (7.3) | 24 (5.8) |
| FAB classification | ||||
| M0 | 14 | 3 | 0 | 12 |
| M1 | 68 | 26 | 16 | 71 |
| M2 | 106 | 18 | 9 | 127 |
| M3 | 5 | 15 | 1 | 68 |
| M4 | 70 | 17 | 6 | 86 |
| M5 | 26 | 19 | 10 | 28 |
| M6 | 7 | 5 | 0 | 13 |
| M7 | 0 | 2 | 0 | 8 |
| Other AML | 7 | 0 | 0 | 6 |
| Miscellaneous other* | 4 | 3 | 1 | 15 |
| Baseline hematologic data median (range) | ||||
| Peripheral blasts (%) N = 800 | 36 (0-99) | 10 (0-99)# | 7 (0-95)# | 27 (0-99) |
| Hemoglobin (g/dL) N = 831 | 9.2 (1.7-25.0) | 9.2 (4.5-14.1) | 9.4 (5.7-12.6) | 9.1 (2.8-14.2) |
| Marrow blasts (%) N = 775 | 66 (1-99) | 60 (0-99) | 61 (0-99) | 60 (0-99) |
| Platelets × 103 N = 839 | 56 (3-1052) | 53 (7-358) | 67 (8-358) | 45 (3-1200) |
| WBC × 103 N = 841 | 20.9 (0.3-274.0) | 6.3 (0.8-271.2)# | 6.3 (1.1-80.3)# | 8.4 (0.5-262.0) |
| CR† Yes (%) | 164 (53%) | 54 (50%)‡ | 29 (67%)‡ | — |
| DFS median, mo (95% CI) | 15.8 (12.9-21.4) | 13.3 (10.1-14.7) | 13.3 (8.3-16.0) | — |
| OS median, mo (95% CI) | 15.4 (12.0-19.2) | 9.9 (6.5-12.5)# | 12.5 (9.4-15.0) | — |
| . | Normal (N = 307) . | Trisomy 8 in karyotype (N = 108) . | Trisomy 8 sole aberration (N = 43) . | Other clonal aberrations (excludes + 8) (N = 434) . |
|---|---|---|---|---|
| Race, white/nonwhite | 274/33 | 94/13‡ | 35/7‡ | 375/59 |
| Sex, male/female | 146/161 | 63/452-153 | 23/20 | 259/175 |
| Age (y), median (range) | 60 (16-83) | 61 (20-83) | 61 (21-78) | 55 (15-88) |
| SWOG performance status (N = 836) | ||||
| 0 | 97 | 27 | 13 | 145 |
| 1 | 145 | 53 | 21 | 192 |
| 2 | 41 | 16 | 6 | 66 |
| 3 | 20 | 10 | 2 | 24 |
| Extramedullary skin involvement (N = 818) (%) | 20 (6.7) | 6 (5.8) | 3 (7.3) | 24 (5.8) |
| FAB classification | ||||
| M0 | 14 | 3 | 0 | 12 |
| M1 | 68 | 26 | 16 | 71 |
| M2 | 106 | 18 | 9 | 127 |
| M3 | 5 | 15 | 1 | 68 |
| M4 | 70 | 17 | 6 | 86 |
| M5 | 26 | 19 | 10 | 28 |
| M6 | 7 | 5 | 0 | 13 |
| M7 | 0 | 2 | 0 | 8 |
| Other AML | 7 | 0 | 0 | 6 |
| Miscellaneous other* | 4 | 3 | 1 | 15 |
| Baseline hematologic data median (range) | ||||
| Peripheral blasts (%) N = 800 | 36 (0-99) | 10 (0-99)# | 7 (0-95)# | 27 (0-99) |
| Hemoglobin (g/dL) N = 831 | 9.2 (1.7-25.0) | 9.2 (4.5-14.1) | 9.4 (5.7-12.6) | 9.1 (2.8-14.2) |
| Marrow blasts (%) N = 775 | 66 (1-99) | 60 (0-99) | 61 (0-99) | 60 (0-99) |
| Platelets × 103 N = 839 | 56 (3-1052) | 53 (7-358) | 67 (8-358) | 45 (3-1200) |
| WBC × 103 N = 841 | 20.9 (0.3-274.0) | 6.3 (0.8-271.2)# | 6.3 (1.1-80.3)# | 8.4 (0.5-262.0) |
| CR† Yes (%) | 164 (53%) | 54 (50%)‡ | 29 (67%)‡ | — |
| DFS median, mo (95% CI) | 15.8 (12.9-21.4) | 13.3 (10.1-14.7) | 13.3 (8.3-16.0) | — |
| OS median, mo (95% CI) | 15.4 (12.0-19.2) | 9.9 (6.5-12.5)# | 12.5 (9.4-15.0) | — |
Information is missing for 4 patients. FAB classification is from the institution of diagnosis.
Includes diagnoses of MDS and unknown.
Includes confirmed and unconfirmed complete responses.
Information is missing for 1 patient.
Marginally significant (P = .05) compared with patients with normal cytogenetics.
#Statistically significant compared with patients with normal cytogenetics.