Patient characteristics
| . | LDAC vs vosaroxin . | LDAC vs LDAC + vosaroxin . | ||
|---|---|---|---|---|
| Characteristic . | LDAC (n = 51) . | Vosaroxin (n = 53) . | LDAC (n = 51) . | LDAC+ vosaroxin (n = 53) . |
| Age (y) | ||||
| <60 | 0 | 0 | 0 | 0 |
| 60-64 | 1 | 2 | 0 | 1 |
| 65-69 | 11 | 8 | 7 | 6 |
| 70-74 | 13 | 13 | 17 | 17 |
| 75-79 | 19 | 20 | 20 | 14 |
| 80+ | 7 | 10 | 7 | 15 |
| Median (range) | 75 (60-89) | 75 (64-84) | 75 (65-87) | 75 (60-91) |
| Sex | ||||
| Female | 21 | 16 | 24 | 11 |
| Male | 30 | 37 | 27 | 42 |
| Diagnosis | ||||
| De novo | 31 | 34 | 32 | 33 |
| Secondary | 15 | 16 | 14 | 13 |
| High-risk MDS | 5 | 3 | 5 | 7 |
| WBC (×109/L) | ||||
| <10 | 28 | 30 | 31 | 33 |
| 10-49.9 | 14 | 16 | 14 | 18 |
| 50-99.9 | 5 | 4 | 5 | 2 |
| 100+ | 4 | 3 | 1 | 0 |
| Median (range) | 8.6 (0.5-168.4) | 5.9 (0.9-233.2) | 5.4 (0.7-145.1) | 4.7 (0.7-91.3) |
| Performance status | ||||
| WHO PS 0 | 10 | 13 | 7 | 11 |
| WHO PS 1 | 34 | 31 | 35 | 32 |
| WHO PS 2 | 5 | 8 | 8 | 10 |
| WHO PS 3,4 | 2 | 1 | 1 | 0 |
| Cytogenetics | ||||
| Favorable | 1 | 0 | 1 | 2 |
| Intermediate | 25 | 28 | 26 | 30 |
| Adverse | 8 | 9 | 8 | 7 |
| Unknown | 17 | 16 | 16 | 14 |
| Wheatley group | ||||
| Good | 2 | 1 | 1 | 0 |
| Standard | 15 | 22 | 17 | 24 |
| Poor | 34 | 30 | 33 | 29 |
| FLT3-ITD mutation | ||||
| WT | 40 | 37 | 41 | 39 |
| Mutant | 5 | 7 | 4 | 6 |
| Not known | 6 | 9 | 6 | 8 |
| NPM1c mutation | ||||
| WT | 37 | 40 | 36 | 39 |
| Mutant | 7 | 4 | 9 | 6 |
| Not known | 7 | 9 | 6 | 8 |
| Comorbidity | ||||
| Arrhythmia | 5/43 | 8/46 | 7/40 | 6/41 |
| Cardiac | 11/44 | 7/45 | 9/40 | 10/44 |
| Cerebrovascular | 2/44 | 4/46 | 3/40 | 1/44 |
| Diabetes | 8/44 | 6/46 | 7/40 | 6/43 |
| Mild hepatic | 2/44 | 0/46 | 0/40 | 1/44 |
| Severe hepatic | 0/44 | 0/46 | 0/40 | 1/44 |
| Heart valve disease | 1/44 | 2/46 | 2/40 | 2/44 |
| Inflammatory bowel | 1/44 | 3.46 | 1/40 | 2/43 |
| Infection | 7/44 | 1/44 | 3/40 | 4/43 |
| Obesity | 3/44 | 3/46 | 3/40 | 2/43 |
| Peptic ulcer | 3/44 | 0/46 | 2/40 | 3/44 |
| Prior tumor | 3/44 | 5/46 | 5/40 | 3/44 |
| Psychiatric | 2/44 | 0/46 | 2/40 | 0/44 |
| Moderate pulmonary | 3/43 | 10/45 | 1/37 | 6/42 |
| Severe pulmonary | 3/44 | 2/44 | 3/39 | 1/42 |
| Renal | 2/44 | 1/45 | 1/40 | 0/44 |
| Rheumatological | 2/44 | 5/46 | 3/40 | 4/44 |
| Reason for NI | ||||
| Age | 35/44 | 33/46 | 35/40 | 40/44 |
| Fitness | 15/44 | 21/46 | 19/40 | 22/44 |
| Age and fitness | 9/44 | 10/46 | 16/40 | 18/44 |
| Other | 4/44 | 2/46 | 4/40 | 1/44 |
| Patient choice | 4 | 1 | 2 | 0 |
| Previous methotrexate | 0 | 0 | 0 | 1 |
| Previous anthracycline | 0 | 0 | 1 | 0 |
| Miscellaneous comorbidities | 0 | 1 | 0 | 0 |
| Not stated | 0 | 0 | 1 | 0 |
| . | LDAC vs vosaroxin . | LDAC vs LDAC + vosaroxin . | ||
|---|---|---|---|---|
| Characteristic . | LDAC (n = 51) . | Vosaroxin (n = 53) . | LDAC (n = 51) . | LDAC+ vosaroxin (n = 53) . |
| Age (y) | ||||
| <60 | 0 | 0 | 0 | 0 |
| 60-64 | 1 | 2 | 0 | 1 |
| 65-69 | 11 | 8 | 7 | 6 |
| 70-74 | 13 | 13 | 17 | 17 |
| 75-79 | 19 | 20 | 20 | 14 |
| 80+ | 7 | 10 | 7 | 15 |
| Median (range) | 75 (60-89) | 75 (64-84) | 75 (65-87) | 75 (60-91) |
| Sex | ||||
| Female | 21 | 16 | 24 | 11 |
| Male | 30 | 37 | 27 | 42 |
| Diagnosis | ||||
| De novo | 31 | 34 | 32 | 33 |
| Secondary | 15 | 16 | 14 | 13 |
| High-risk MDS | 5 | 3 | 5 | 7 |
| WBC (×109/L) | ||||
| <10 | 28 | 30 | 31 | 33 |
| 10-49.9 | 14 | 16 | 14 | 18 |
| 50-99.9 | 5 | 4 | 5 | 2 |
| 100+ | 4 | 3 | 1 | 0 |
| Median (range) | 8.6 (0.5-168.4) | 5.9 (0.9-233.2) | 5.4 (0.7-145.1) | 4.7 (0.7-91.3) |
| Performance status | ||||
| WHO PS 0 | 10 | 13 | 7 | 11 |
| WHO PS 1 | 34 | 31 | 35 | 32 |
| WHO PS 2 | 5 | 8 | 8 | 10 |
| WHO PS 3,4 | 2 | 1 | 1 | 0 |
| Cytogenetics | ||||
| Favorable | 1 | 0 | 1 | 2 |
| Intermediate | 25 | 28 | 26 | 30 |
| Adverse | 8 | 9 | 8 | 7 |
| Unknown | 17 | 16 | 16 | 14 |
| Wheatley group | ||||
| Good | 2 | 1 | 1 | 0 |
| Standard | 15 | 22 | 17 | 24 |
| Poor | 34 | 30 | 33 | 29 |
| FLT3-ITD mutation | ||||
| WT | 40 | 37 | 41 | 39 |
| Mutant | 5 | 7 | 4 | 6 |
| Not known | 6 | 9 | 6 | 8 |
| NPM1c mutation | ||||
| WT | 37 | 40 | 36 | 39 |
| Mutant | 7 | 4 | 9 | 6 |
| Not known | 7 | 9 | 6 | 8 |
| Comorbidity | ||||
| Arrhythmia | 5/43 | 8/46 | 7/40 | 6/41 |
| Cardiac | 11/44 | 7/45 | 9/40 | 10/44 |
| Cerebrovascular | 2/44 | 4/46 | 3/40 | 1/44 |
| Diabetes | 8/44 | 6/46 | 7/40 | 6/43 |
| Mild hepatic | 2/44 | 0/46 | 0/40 | 1/44 |
| Severe hepatic | 0/44 | 0/46 | 0/40 | 1/44 |
| Heart valve disease | 1/44 | 2/46 | 2/40 | 2/44 |
| Inflammatory bowel | 1/44 | 3.46 | 1/40 | 2/43 |
| Infection | 7/44 | 1/44 | 3/40 | 4/43 |
| Obesity | 3/44 | 3/46 | 3/40 | 2/43 |
| Peptic ulcer | 3/44 | 0/46 | 2/40 | 3/44 |
| Prior tumor | 3/44 | 5/46 | 5/40 | 3/44 |
| Psychiatric | 2/44 | 0/46 | 2/40 | 0/44 |
| Moderate pulmonary | 3/43 | 10/45 | 1/37 | 6/42 |
| Severe pulmonary | 3/44 | 2/44 | 3/39 | 1/42 |
| Renal | 2/44 | 1/45 | 1/40 | 0/44 |
| Rheumatological | 2/44 | 5/46 | 3/40 | 4/44 |
| Reason for NI | ||||
| Age | 35/44 | 33/46 | 35/40 | 40/44 |
| Fitness | 15/44 | 21/46 | 19/40 | 22/44 |
| Age and fitness | 9/44 | 10/46 | 16/40 | 18/44 |
| Other | 4/44 | 2/46 | 4/40 | 1/44 |
| Patient choice | 4 | 1 | 2 | 0 |
| Previous methotrexate | 0 | 0 | 0 | 1 |
| Previous anthracycline | 0 | 0 | 1 | 0 |
| Miscellaneous comorbidities | 0 | 1 | 0 | 0 |
| Not stated | 0 | 0 | 1 | 0 |
MDS, myelodysplastic syndrome; NI, nonintensive therapy; PS, performance score; WBC, white blood cell; WHO, World Health Organization.