Table 1.
Patient Characteristics by Randomized Treatment Group
| Characteristic | Treatment Arm |
|||||
|---|---|---|---|---|---|---|
| DNR |
MXR |
IDA |
||||
| No. | % | No. | % | No. | % | |
| Total | 721 | 719 | 717 | |||
| Cooperative group | 309 | 42.9 | 295 | 41.0 | 311 | 43.4 |
| EORTC | 309 | 42.9 | 295 | 41.0 | 311 | 43.4 |
| GIMEMA | 412 | 57.1 | 424 | 59.0 | 406 | 56.6 |
| Age at diagnosis, years | ||||||
| 15-25 | 96 | 13.3 | 104 | 14.5 | 83 | 11.6 |
| 26-45 | 308 | 42.7 | 294 | 40.9 | 314 | 43.8 |
| 46-60 | 317 | 44.0 | 321 | 44.6 | 320 | 44.6 |
| Male sex | 354 | 49.1 | 358 | 49.8 | 373 | 52.0 |
| Performance status* at random assignment | ||||||
| 0 | 305 | 42.3 | 308 | 42.8 | 312 | 43.5 |
| 1 | 307 | 42.3 | 310 | 43.1 | 301 | 42.0 |
| 2 | 97 | 13.5 | 89 | 12.4 | 92 | 12.8 |
| 3-4 | 12 | 1.6 | 12 | 1.7 | 12 | 1.7 |
| Missing | 16 | 2.2 | 19 | 2.6 | 13 | 1.8 |
| Type of AML | ||||||
| De novo | 693 | 96.1 | 688 | 95.7 | 683 | 95.3 |
| Therapy-related | 15 | 2.1 | 15 | 2.1 | 17 | 2.4 |
| Secondary | 13 | 1.8 | 16 | 2.2 | 17 | 2.4 |
| FAB subtype† | ||||||
| M0 | 30 | 4.2 | 31 | 4.3 | 31 | 4.3 |
| M1 | 115 | 16.0 | 141 | 19.6 | 131 | 18.3 |
| M2 | 233 | 32.3 | 231 | 32.1 | 226 | 31.5 |
| M3 | 2 | 0.3 | 4 | 0.6 | 3 | 0.4 |
| M4 | 163 | 22.6 | 139 | 19.3 | 147 | 20.5 |
| M5 | 136 | 18.9 | 133 | 18.5 | 133 | 18.5 |
| M6 | 22 | 3.1 | 24 | 3.3 | 23 | 3.2 |
| M7 | 8 | 1.1 | 5 | 0.7 | 6 | 0.8 |
| Missing/unknown | 12 | 1.7 | 11 | 1.5 | 17 | 2.3 |
| WBC count at random assignment, ×109/L | ||||||
| < 50 | 525 | 72.8 | 520 | 72.3 | 522 | 72.8 |
| 50-249.9 | 184 | 25.5 | 185 | 25.7 | 182 | 25.4 |
| ≥ 250 | 12 | 1.7 | 14 | 1.9 | 13 | 1.8 |
| Cytogenetics‡ | ||||||
| Favorable | 82 | 11.3 | 61 | 8.5 | 79 | 11.0 |
| Intermediate | 158 | 21.9 | 146 | 20.3 | 151 | 21.1 |
| Unfavorable | 50 | 6.9 | 63 | 8.8 | 66 | 9.2 |
| Other | 108 | 15.0 | 99 | 13.8 | 101 | 14.1 |
| Missing/unknown | 323 | 44.8 | 350 | 48.7 | 320 | 44.6 |
Abbreviations: DNR, daunorubicin; MXR, mitoxantrone; IDA, idarubicin; EORTC, European Organisation for Research and Treatment of Cancer; GIMEMA, Gruppo Italiano Malattie Ematologiche Maligne dell'Adulto; AML, acute myeloid leukemia; FAB, French-American-British.
WHO scale.
Based on the opinion of local cytologist or of the review, if available. Six patients were scored as M3 by the local cytologist: one was confirmed by the reviewer, one was not confirmed, and three were not reviewed. Five additional patients, initially considered as non-M3, were considered thereafter as M3 by the reviewer.
Abnormalities 16q22, and t(8;21) were considered favorable risk abnormalities, whether other abnormalities were present or not; eight patients with t(15;17), ineligible for this trial, have been randomly assigned and considered in this favorable group as well. NN karyotypes (ie no abnormalities seen in a minimum of 20 mitoses) or those with –Y only were classified as intermediate risk. Deletions of the long arm of chromosomes 5 (5q−) and/or 7 (7q−), or of the entire chromosomes (−5,−7) and complex abnormalities (> three abnormalities) were considered of unfavorable prognosis. Patients with other abnormalities were pooled into a separate cytogenetic risk group (“other”). Patients with unknown, not done, or unsuccessful cytogenetics were grouped together as unknown risk.