Table 1:
Baseline characteristics
| Pacritinib (n=220) |
BAT (n=107) |
|
|---|---|---|
| Median age (years) | 67(60–73) | 65 (59–72) |
| ≥65 | 135 (61%) | 55 (51%) |
| Sex | ||
| Male | 125 (57%) | 60 (56%) |
| Female | 95 (43%) | 47 (44%) |
| ECOG performance status | ||
| 0–1 | 192 (87%) | 96 (90%) |
| 2–3 | 28 (13%) | 11 (10%) |
| Myelofibrosis diagnosis | ||
| Primary myelofibrosis | 144 (65%) | 59 (55%) |
| Post-polycythaemia vera myelofibrosis | 48 (22%) | 33 (31%) |
| Post-essential thrombocythaemia myelofibrosis | 27 (12%) | 15 (14%) |
| Missing | 1 (<1%) | 0 |
| DIPSS score | ||
| Intermediate-1 | 124 (56%) | 49 (46%) |
| Intermediate-2 | 63 (29%) | 43 (40%) |
| High | 32 (15%) | 15 (14%) |
| Missing | 1 (<1%) | 0 |
| Median spleen length by physical exam (cm)* | 12 (8–16) | 12 (8–17) |
| Median spleen volume by MRI/CT (cm3)† | 2005·6 (1396·6–2889·0) |
2152·7 (1545·2–3136·0) |
| JAK2 Val6l7Phe-positive | 154 (70%) | 92 (86%) |
| Bone marrow biopsy completed | 219 (>99%) | 107 (100%) |
| Reticulin and collagen fibrosis staging | ||
| MF 0–1 | 32/219 (15%) | 18 (17%) |
| MF 2–3 | 180/219 (82%) | 83 (78%) |
| Missing | 7/219 (3%) | 6 (6%) |
| Peripheral blasts | ||
| <1% | 78 (35%) | 44 (41%) |
| ≥1% | 94 (43%) | 38 (36%) |
| <5% | 159 (72%) | 74 (69%) |
| ≥5% | 13 (6%) | 8 (7%) |
| Missing | 48 (22%) | 25 (23%) |
| White blood cell count | ||
| Median×109/L | 9·9 (6·1–21·1) |
11·7 (6·3–24·5) |
| ≤25×109/L | 177 (80%) | 80 (75%) |
| >25×109/L | 43 (20%) | 26 (24%) |
| Haemoglobin | ||
| <10 g/dL | 84 (38%) | 47 (44%) |
| ≥10 g/dL | 136 (62%) | 59 (55%) |
| Red blood cell transfusion dependence‡ | ||
| Dependent | 36 (16%) | 16 (15%) |
| Independent | 156 (71%) | 75 (70%) |
| Indeterminate | 29 (13%) | 16 (15%) |
| Missing | 0 | 0 |
| Platelet count | ||
| <50 000/μL | 35 (16%) | 16 (15%) |
| 50 000–99 999/μL | 37 (17%) | 18 (17%) |
| ≥100 000/μL | 148 (67%) | 73 (68%) |
Data are n (%) or median (IQR). BAT=best available therapy. DIPSS=Dynamic International Prognostic Scoring System. ECOG=Eastern Cooperative Oncology Group.
*
n=219 for pacritinib, n=106 for BAT.
†
n=218 for pacritinib.
‡
≥6 units per 90 days as defined as per Gale criteria.24