Table I.
Patient Characteristics, including the entire cohort, as well as the subset of controls (n=43) included in the day +68 landmark analysis.
| Sorafenib Patients (n=26) | All Control Patients (n=55) | P-value vs. Sorafenib | Day +68 Landmark Controls (n=43) | P-value vs. Sorafenib | |
|---|---|---|---|---|---|
|
| |||||
| Age, years; median (range) | 55 (20–74) | 56 (25–73) | 0.75 | 56 (25–73) | 0.78 |
|
| |||||
| Sex, male | 12 (46%) | 19 (35%) | 0.34 | 13 (30%) | 0.21 |
|
| |||||
| Race, white | 24 (92%) | 48 (87%) | 0.99 | 37 (86%) | 0.99 |
|
| |||||
| Antecedent Disease | 0.62 | 0.64 | |||
| De novo | 22 (85%) | 43 (78%) | 34 (79%) | ||
| tAML | 3 (12%) | 6 (11%) | 4 (9%) | ||
| Prior MDS or MPN | 1 (4%) | 6 (11%) | 5 (12%) | ||
|
| |||||
| Cytogenetic Risk | 0.99 | 0.84 | |||
| Favourable | 1 (4%) | 2 (4%) | 2 (5%) | ||
| Intermediate | 23 (88%) | 47 (87%) | 38 (90%) | ||
| Adverse | 2 (8%) | 4 (8%) | 2 (5%) | ||
|
| |||||
| NPM1 mutation | 14 (56%) | 21 (76%) | 0.17 | 21 (78%) | 0.14 |
|
| |||||
| Induction Treatment | 0.71 | 0.67 | |||
| 7+3 based induction | 23 (88%) | 50 (91%) | 40 (93%) | ||
| ADE | 0 | 3 | 1 | ||
| Cytarabine/Mitoxantrone | 3 | 0 | 0 | ||
| IA | 0 | 2 | 2 | ||
|
| |||||
| Consolidation Therapy | 0.0045 | 0.016 | |||
| None | 10 | 10 | 8 | ||
| High/Int Cytarabine – 1 cycle | 14 | 19 | 15 | ||
| High/Int Cytarabine – 2+ cycles | 1 | 13 | 6 | ||
| Cytarabine + Anthracycline | 0 | 10 | 9 | ||
| Sorafenib based | 1 | 3 | 2 | ||
|
| |||||
| TKI prior to HCT | 7 (27%) | 15 (27%) | 0.99 | 11 (26%) | 0.99 |
| Midostaurin vs. Placebo | 0 | 8 | 6 | ||
| Sorafenib | 7 | 7 | 5 | ||
|
| |||||
| ECOG PS at HCT | 0.76 | 0.79 | |||
| 0 | 6 (25%) | 17 (31%) | 12 (28%) | ||
| 1 | 14 (58%) | 27 (49%) | 21 (49%) | ||
| 2 | 4 (17%) | 11 (20%) | 10 (23%) | ||
|
| |||||
| Induction Intensity prior to HCT | 0.81 | 0.99 | |||
| Myeloablative | 14 (54%) | 27 (49%) | 22 (51%) | ||
| Reduced intensity | 12 (46%) | 28 (51%) | 21 (49%) | ||
|
| |||||
| Donor Type | 0.99 | 0.74 | |||
| Matched | 21 (81%) | 45 (82%) | 37 (86%) | ||
| Mismatched | 5 (19%) | 10 (18%) | 6 (14%) | ||
|
| |||||
| aGVHD prophylaxis | 0.23 | 0.46 | |||
| CNI and Methotrexate | 17 (65%) | 27 (49%) | 24 (56%) | ||
All values given as n (%) unless otherwise indicated
ADE: cytarabine, daunorubicin; aGVHD: acute graft-versus-host disease; CNI: calcineurin inhibitor; ECOG PS: Eastern Cooperative Oncology Group performance score; HCT: haematopoietic cell transplantation; IA: idarubicin, cytarabine; MDS: myelodysplastic syndrome; MPN: myeloproliferative neoplasm; tAML: therapy-related acute myeloid leukaemia; TKI: tyrosine kinase inhibitor.