Incidence of moderate and severe DS according to baseline characteristics of patients (univariate analysis)
| Characteristic . | No. of patients . | Moderate DS . | Severe DS . | ||
|---|---|---|---|---|---|
| No. (%) . | P . | No. (%) . | P . | ||
| Overall | 739 | 90 (12.2) | 93 (12.6) | ||
| Protocol | |||||
| LPA 96 | 175 | 24 (13.7) | .48 | 29 (16.6) | .07 |
| LPA 99 | 564 | 66 (11.7) | 64 (11.3) | ||
| Age, y | |||||
| Younger than 19 | 84 | 9 (10.7) | .18* | 8 (9.5) | .29† |
| 19-50 | 429 | 54 (12.6) | 49 (11.4) | ||
| 51-60 | 95 | 6 (6.3) | 18 (18.9) | ||
| 61-70 | 87 | 12 (13.8) | 12 (13.8) | ||
| Older than 70 | 44 | 9 (20.5) | 6 (13.6) | ||
| Sex | |||||
| Male | 374 | 44 (11.8) | .74 | 56 (15.0) | .05 |
| Female | 365 | 46 (12.6) | 37 (10.1) | ||
| ECOG performance status | |||||
| 0-1 | 512 | 62 (12.1) | .74 | 61 (11.9) | .31 |
| 2 | 123 | 16 (13.0) | 21 (17.1) | ||
| 3 | 46 | 4 (8.7) | 6 (13.0) | ||
| Fever | |||||
| No | 447 | 56 (12.4) | .81 | 53 (11.8) | .47 |
| Yes | 285 | 34 (11.9) | 39 (13.7) | ||
| WBC count, ×109/L | |||||
| Less than 2 | 350 | 37 (10.6) | .15‡ | 32 (9.1) | .08§ |
| 2-5 | 140 | 16 (11.4) | 19 (13.6) | ||
| 5-10 | 62 | 6 (9.7) | 10 (16.1) | ||
| 10-50 | 133 | 25 (18.8) | 23 (17.4) | ||
| More than 50 | 53 | 6 (11.3) | 9 (17.0) | ||
| Platelets, ×109/L | |||||
| Less than 10 | 134 | 14 (10.4) | .64 | 18 (13.4) | .36‖ |
| 10-40 | 434 | 57 (13.1) | 59 (13.6) | ||
| More than 40 | 170 | 19 (11.2) | 16 (9.4) | ||
| Coagulopathy | |||||
| No | 171 | 14 (8.2) | .08 | 17 (9.9) | .24 |
| Yes | 563 | 76 (13.5) | 75 (13.3) | ||
| Creatinine, mg/dL | |||||
| Less than or equal to 1.4 | 702 | 86 (12.3) | .87 | 84 (12.0) | .002 |
| More than 1.4 | 14 | 1 (7.1) | 6 (42.9) | ||
| Albumin, mg/dL | |||||
| Less than or equal to 3.5 | 127 | 14 (11.0) | .68 | 20 (15.7) | .32 |
| More than 3.5 | 470 | 58 (12.3) | 56 (11.9) | ||
| LDH × ULN | |||||
| Less than or equal to 1 | 347 | 29 (8.4) | .004 | 38 (11.0) | .21 |
| More than 1 | 347 | 59 (15.9) | 49 (14.1) | ||
| FAB subtype | |||||
| Hypergranular | 598 | 74 (12.4) | .99 | 69 (11.5) | .05 |
| Microgranular | 131 | 16 (12.3) | 24 (18.3) | ||
| PML-RARΑ isoform | |||||
| BCR1/BCR2 | 382 | 51 (13.4) | .45 | 39 (10.2) | .05 |
| BCR3 | 273 | 31 (11.4) | 42 (15.4) | ||
| Blasts, % of PB | |||||
| Less than or equal to 70 | 494 | 52 (10.5) | .02 | 61 (12.3) | .33 |
| More than 70 | 184 | 31 (16.8) | 28 (15.2) | ||
| FLT3-ITD | |||||
| Negative | 224 | 29 (12.9) | .86 | 26 (12.6) | .05 |
| Positive | 66 | 8 (12.1) | 14 (24.6) | ||
| CD2 | |||||
| Negative | 107 | 44 (13.1) | .29 | 43 (12.8) | .61 |
| Positive | 337 | 19 (17.8) | 11 (10.3) | ||
| CD11b | |||||
| Negative | 296 | 33 (11.1) | .69 | 34 (11.5) | .74 |
| Positive | 41 | 6 (14.6) | 6 (14.6) | ||
| CD13 | |||||
| Negative | 38 | 5 (13.2) | .99 | 3 (7.9) | .49 |
| Positive | 478 | 62 (13.0) | 63 (13.2) | ||
| CD15 | |||||
| Negative | 322 | 46 (14.3) | .50 | 37 (11.5) | .59 |
| Positive | 140 | 16 (11.4) | 13 (9.3) | ||
| CD56 | |||||
| Negative | 352 | 49 (13.9) | .99 | 39 (11.1) | .45 |
| Positive | 43 | 6 (14.0) | 7 (16.3) | ||
| CD34 | |||||
| Negative | 439 | 56 (12.8) | .18 | 52 (11.8) | .64 |
| Positive | 91 | 17 (18.7) | 13 (14.3) | ||
| Characteristic . | No. of patients . | Moderate DS . | Severe DS . | ||
|---|---|---|---|---|---|
| No. (%) . | P . | No. (%) . | P . | ||
| Overall | 739 | 90 (12.2) | 93 (12.6) | ||
| Protocol | |||||
| LPA 96 | 175 | 24 (13.7) | .48 | 29 (16.6) | .07 |
| LPA 99 | 564 | 66 (11.7) | 64 (11.3) | ||
| Age, y | |||||
| Younger than 19 | 84 | 9 (10.7) | .18* | 8 (9.5) | .29† |
| 19-50 | 429 | 54 (12.6) | 49 (11.4) | ||
| 51-60 | 95 | 6 (6.3) | 18 (18.9) | ||
| 61-70 | 87 | 12 (13.8) | 12 (13.8) | ||
| Older than 70 | 44 | 9 (20.5) | 6 (13.6) | ||
| Sex | |||||
| Male | 374 | 44 (11.8) | .74 | 56 (15.0) | .05 |
| Female | 365 | 46 (12.6) | 37 (10.1) | ||
| ECOG performance status | |||||
| 0-1 | 512 | 62 (12.1) | .74 | 61 (11.9) | .31 |
| 2 | 123 | 16 (13.0) | 21 (17.1) | ||
| 3 | 46 | 4 (8.7) | 6 (13.0) | ||
| Fever | |||||
| No | 447 | 56 (12.4) | .81 | 53 (11.8) | .47 |
| Yes | 285 | 34 (11.9) | 39 (13.7) | ||
| WBC count, ×109/L | |||||
| Less than 2 | 350 | 37 (10.6) | .15‡ | 32 (9.1) | .08§ |
| 2-5 | 140 | 16 (11.4) | 19 (13.6) | ||
| 5-10 | 62 | 6 (9.7) | 10 (16.1) | ||
| 10-50 | 133 | 25 (18.8) | 23 (17.4) | ||
| More than 50 | 53 | 6 (11.3) | 9 (17.0) | ||
| Platelets, ×109/L | |||||
| Less than 10 | 134 | 14 (10.4) | .64 | 18 (13.4) | .36‖ |
| 10-40 | 434 | 57 (13.1) | 59 (13.6) | ||
| More than 40 | 170 | 19 (11.2) | 16 (9.4) | ||
| Coagulopathy | |||||
| No | 171 | 14 (8.2) | .08 | 17 (9.9) | .24 |
| Yes | 563 | 76 (13.5) | 75 (13.3) | ||
| Creatinine, mg/dL | |||||
| Less than or equal to 1.4 | 702 | 86 (12.3) | .87 | 84 (12.0) | .002 |
| More than 1.4 | 14 | 1 (7.1) | 6 (42.9) | ||
| Albumin, mg/dL | |||||
| Less than or equal to 3.5 | 127 | 14 (11.0) | .68 | 20 (15.7) | .32 |
| More than 3.5 | 470 | 58 (12.3) | 56 (11.9) | ||
| LDH × ULN | |||||
| Less than or equal to 1 | 347 | 29 (8.4) | .004 | 38 (11.0) | .21 |
| More than 1 | 347 | 59 (15.9) | 49 (14.1) | ||
| FAB subtype | |||||
| Hypergranular | 598 | 74 (12.4) | .99 | 69 (11.5) | .05 |
| Microgranular | 131 | 16 (12.3) | 24 (18.3) | ||
| PML-RARΑ isoform | |||||
| BCR1/BCR2 | 382 | 51 (13.4) | .45 | 39 (10.2) | .05 |
| BCR3 | 273 | 31 (11.4) | 42 (15.4) | ||
| Blasts, % of PB | |||||
| Less than or equal to 70 | 494 | 52 (10.5) | .02 | 61 (12.3) | .33 |
| More than 70 | 184 | 31 (16.8) | 28 (15.2) | ||
| FLT3-ITD | |||||
| Negative | 224 | 29 (12.9) | .86 | 26 (12.6) | .05 |
| Positive | 66 | 8 (12.1) | 14 (24.6) | ||
| CD2 | |||||
| Negative | 107 | 44 (13.1) | .29 | 43 (12.8) | .61 |
| Positive | 337 | 19 (17.8) | 11 (10.3) | ||
| CD11b | |||||
| Negative | 296 | 33 (11.1) | .69 | 34 (11.5) | .74 |
| Positive | 41 | 6 (14.6) | 6 (14.6) | ||
| CD13 | |||||
| Negative | 38 | 5 (13.2) | .99 | 3 (7.9) | .49 |
| Positive | 478 | 62 (13.0) | 63 (13.2) | ||
| CD15 | |||||
| Negative | 322 | 46 (14.3) | .50 | 37 (11.5) | .59 |
| Positive | 140 | 16 (11.4) | 13 (9.3) | ||
| CD56 | |||||
| Negative | 352 | 49 (13.9) | .99 | 39 (11.1) | .45 |
| Positive | 43 | 6 (14.0) | 7 (16.3) | ||
| CD34 | |||||
| Negative | 439 | 56 (12.8) | .18 | 52 (11.8) | .64 |
| Positive | 91 | 17 (18.7) | 13 (14.3) | ||
ULN indicates upper laboratory normal (values).
Age > 70 years versus age ≤ 70 years (20.0% versus 11.7%, P = .09).
Age > 50 years versus age ≤ 50 years (15.9% versus 11.1%, P = .07).
WBC > 10 × 109/L versus WBC ≤ 10 × 109/L (16.7% versus 10.7%, P = .03).
WBC > 5 × 109/L versus WBC ≤ 5 × 109/L (16.9% versus 10.4%, P = .01).
Platelets > 40 × 109/L versus platelets ≤ 40 × 109/L (13.6% versus 9.4%, P = .15).