CCG-2961: demographic, clinical, and biologic characteristics of patients at study entry and at time of first randomization
| . | Study entry . | First randomization . | A vs B (P) . | ||||
|---|---|---|---|---|---|---|---|
| Regimen A: IdaDCTER DCTER . | Regimen B: FLU/AC/IDA . | ||||||
| N . | % . | N . | % . | N . | % . | ||
| N | 901 | — | 367 | — | 371 | — | — |
| Age, y | |||||||
| Range | 0.01-20.9 | — | 0.04-20.9 | — | 0.01-19.8 | — | — |
| Median | 9.5 | — | 9.1 | — | 9.6 | — | .350 |
| Male sex | 468 | 52 | 185 | 50 | 196 | 53 | .559 |
| Race | |||||||
| White | 583 | 66 | 240 | 67 | 249 | 68 | .754 |
| Black | 84 | 16 | 35 | 10 | 38 | 10 | .863 |
| Hispanic | 157 | 18 | 61 | 17 | 55 | 15 | .546 |
| Asian | 26 | 3 | 8 | 2 | 10 | 3 | .839 |
| Other | 34 | 4 | 15 | 4 | 13 | 4 | .812 |
| Unknown | 17 | — | 8 | — | 6 | — | — |
| Hepatomegaly | 288 | 32 | 116 | 32 | 108 | 29 | .526 |
| Splenomegaly | 279 | 31 | 114 | 31 | 102 | 28 | .324 |
| CNS positive | 52 | 6 | 16 | 4 | 22 | 6 | .430 |
| FAB | |||||||
| M0 | 55 | 6 | 25 | 6 | 21 | 5 | .634 |
| M1 | 150 | 17 | 64 | 18 | 58 | 16 | .596 |
| M2 | 249 | 28 | 112 | 31 | 105 | 29 | .592 |
| M4 | 206 | 23 | 71 | 20 | 92 | 25 | .082 |
| M5 | 158 | 18 | 64 | 18 | 60 | 16 | .742 |
| M6 | 20 | 2 | 6 | 2 | 9 | 2 | .609 |
| M7 | 47 | 5 | 19 | 5 | 18 | 5 | .986 |
| AML (NOS) | 16 | 2 | 6 | 1 | 8 | 2 | .795 |
| Cytogenetics | |||||||
| Normal | 125 | 22 | 48 | 21 | 60 | 25 | .393 |
| t(8;21) | 89 | 16 | 45 | 20 | 40 | 17 | .434 |
| Abnormal 16 | 49 | 9 | 18 | 8 | 23 | 10 | .650 |
| Abnormal 11 | 132 | 23 | 52 | 23 | 56 | 23 | .981 |
| t(6;9) | 10 | 2 | 3 | 1 | 4 | 2 | 1.000 |
| -7/7- | 22 | 4 | 10 | 4 | 3 | 1 | .072 |
| -5/5- | 7 | 1 | 3 | 1 | 2 | 1 | .677 |
| +8 | 33 | 6 | 10 | 4 | 13 | 5 | .779 |
| +21 | 9 | 2 | 2 | 1 | 6 | 2 | .287 |
| Other | 87 | 15 | 37 | 16 | 35 | 14 | .687 |
| Unknown | 338 | 38 | 139 | 38 | 129 | 35 | — |
| Complexity | |||||||
| 3 or less | 371 | 85 | 155 | 86 | 154 | 85 | .800 |
| More than 3 | 67 | 15 | 25 | 14 | 28 | 15 | — |
| Unfavorable* | 86 | 15 | 36 | 15 | 31 | 12 | .324 |
| Standard | 343 | 61 | 137 | 59 | 155 | 62 | .507 |
| Favorable† | 134 | 24 | 60 | 26 | 65 | 26 | .971 |
| . | Study entry . | First randomization . | A vs B (P) . | ||||
|---|---|---|---|---|---|---|---|
| Regimen A: IdaDCTER DCTER . | Regimen B: FLU/AC/IDA . | ||||||
| N . | % . | N . | % . | N . | % . | ||
| N | 901 | — | 367 | — | 371 | — | — |
| Age, y | |||||||
| Range | 0.01-20.9 | — | 0.04-20.9 | — | 0.01-19.8 | — | — |
| Median | 9.5 | — | 9.1 | — | 9.6 | — | .350 |
| Male sex | 468 | 52 | 185 | 50 | 196 | 53 | .559 |
| Race | |||||||
| White | 583 | 66 | 240 | 67 | 249 | 68 | .754 |
| Black | 84 | 16 | 35 | 10 | 38 | 10 | .863 |
| Hispanic | 157 | 18 | 61 | 17 | 55 | 15 | .546 |
| Asian | 26 | 3 | 8 | 2 | 10 | 3 | .839 |
| Other | 34 | 4 | 15 | 4 | 13 | 4 | .812 |
| Unknown | 17 | — | 8 | — | 6 | — | — |
| Hepatomegaly | 288 | 32 | 116 | 32 | 108 | 29 | .526 |
| Splenomegaly | 279 | 31 | 114 | 31 | 102 | 28 | .324 |
| CNS positive | 52 | 6 | 16 | 4 | 22 | 6 | .430 |
| FAB | |||||||
| M0 | 55 | 6 | 25 | 6 | 21 | 5 | .634 |
| M1 | 150 | 17 | 64 | 18 | 58 | 16 | .596 |
| M2 | 249 | 28 | 112 | 31 | 105 | 29 | .592 |
| M4 | 206 | 23 | 71 | 20 | 92 | 25 | .082 |
| M5 | 158 | 18 | 64 | 18 | 60 | 16 | .742 |
| M6 | 20 | 2 | 6 | 2 | 9 | 2 | .609 |
| M7 | 47 | 5 | 19 | 5 | 18 | 5 | .986 |
| AML (NOS) | 16 | 2 | 6 | 1 | 8 | 2 | .795 |
| Cytogenetics | |||||||
| Normal | 125 | 22 | 48 | 21 | 60 | 25 | .393 |
| t(8;21) | 89 | 16 | 45 | 20 | 40 | 17 | .434 |
| Abnormal 16 | 49 | 9 | 18 | 8 | 23 | 10 | .650 |
| Abnormal 11 | 132 | 23 | 52 | 23 | 56 | 23 | .981 |
| t(6;9) | 10 | 2 | 3 | 1 | 4 | 2 | 1.000 |
| -7/7- | 22 | 4 | 10 | 4 | 3 | 1 | .072 |
| -5/5- | 7 | 1 | 3 | 1 | 2 | 1 | .677 |
| +8 | 33 | 6 | 10 | 4 | 13 | 5 | .779 |
| +21 | 9 | 2 | 2 | 1 | 6 | 2 | .287 |
| Other | 87 | 15 | 37 | 16 | 35 | 14 | .687 |
| Unknown | 338 | 38 | 139 | 38 | 129 | 35 | — |
| Complexity | |||||||
| 3 or less | 371 | 85 | 155 | 86 | 154 | 85 | .800 |
| More than 3 | 67 | 15 | 25 | 14 | 28 | 15 | — |
| Unfavorable* | 86 | 15 | 36 | 15 | 31 | 12 | .324 |
| Standard | 343 | 61 | 137 | 59 | 155 | 62 | .507 |
| Favorable† | 134 | 24 | 60 | 26 | 65 | 26 | .971 |
— indicates not applicable.
*Unfavorable cytogenetics are del (7), 7q−, del (5), 5q−, and >3 nonrandom abnormalities. Some cells may have more than one unfavorable cytogenetic feature.
†Favorable cytogenetics are t(8;21), inv (16), or t(16;16); normal and all other abnormalities are standard.