Baseline characteristics by treatment
| . | BAT (n = 52) . | Ruxolitinib (n = 58) . | Overall (N = 110) . |
|---|---|---|---|
| Age, y | |||
| Mean (SD) [range] | 65.6 (13.5) [37.2, 85.4] | 62.9 (12.3) [34.5, 90.5] | 64.2 (12.9) [34.5, 90.5] |
| Sex, n (%) | |||
| Female | 30 (57.7) | 36 (62.1) | 66 (60.0) |
| Male | 22 (42.3) | 22 (37.9) | 44 (40.0) |
| Mutation status, n (%) | |||
| JAK2V617F positive | 26 (50.0) | 28 (48.3) | 54 (49.1) |
| CALR mutation positive | 14 (26.9) | 20 (34.5) | 34 (30.9) |
| MPL mutation positive | 3 (5.8) | 3 (5.2) | 6 (5.5) |
| Triple negative | 7 (13.5) | 6 (10.3) | 13 (11.8) |
| Not run | 2 (3.8) | 1 (1.7) | 3 (2.7) |
| HC resistant or intolerant,*n (%) | |||
| Resistant | 25 (48.1) | 28 (48.3) | 53 (48.2) |
| Intolerant | 27 (51.9) | 30 (51.7) | 57 (51.8) |
| Time from diagnosis to randomization, y† | |||
| Mean (SD) [range] | 6.9 (5.8) [0.4, 23.6] | 10.4 (6.7) [0.7, 31.2] | 8.8 (6.5) [0.4, 31.2] |
| Hemoglobin, g/L† | |||
| Mean (SD) [range] | 126 (17) [90.0, 160.0] | 119 (17) [87.0, 152.0] | 122 (17) [87.0, 160.0] |
| Platelet count, ×109/L | |||
| Mean (SD) [range] | 573.0 (227.1) [166.0, 1406.0] | 545.4 (215.3) [89.0, 1139.0] | 558.4 (220.4) [89.0, 1406.0] |
| WBC count, ×109/L | |||
| Mean (SD) [range] | 6.8 (2.7) [2.8, 15.2] | 7.5 (4.8) [1.7, 29.8] | 7.2 (3.9) [1.7, 29.8] |
| Hematocrit | |||
| Mean (SD) [range] | 0.4 (0.1) [0.3, 0.5] | 0.4 (0.1) [0.3, 0.5] | 0.4 (0.1) [0.3, 0.5] |
| Spleen size | |||
| Enlarged | 9 | 14 | 23 |
| Normal | 38 | 37 | 75 |
| Splenectomy | 2 | 3 | 5 |
| Missing | 3 | 4 | 7 |
| Number of previous therapies, n (%) | |||
| 1 | 15 (28.8) | 14 (24.1) | 28 (26.4) |
| 2 | 20 (38.5) | 24 (41.4) | 44 (40.0) |
| 3 | 8 (15.4) | 12 (20.7) | 20 (18.2) |
| 4 | 5 (9.6) | 5 (8.6) | 10 (9.1) |
| 5 | 2 (3.8) | 2 (3.4) | 4 (3.6) |
| 6 | 2 (3.8) | 0 (0) | 2 (1.8) |
| 9 | 0 (0) | 1 (1.7) | 1 (0.9) |
| Total number of previous therapies by treatment, n (%)‡ | |||
| HC | 59 (52.2) | 70 (58.8) | 129 (55.6) |
| Anagrelide | 29 (25.7) | 31 (26.1) | 60 (25.9) |
| Interferon | 7 (6.2) | 11 (9.2) | 18 (7.8) |
| Pegylated interferon | 2 (1.8) | 2 (1.7) | 4 (1.7) |
| Busulfan | 8 (7.1) | 1 (0.8) | 9 (3.9) |
| 32P | 3 (2.7) | 1 (0.8) | 4 (1.7) |
| Pipobroman | 1 (0.9) | 1 (0.8) | 2 (.09) |
| Fedratinib | 1 (0.9) | 1 (0.8) | 2 (0.9) |
| Vorinostat | 2 (1.8) | 0 (0) | 2 (0.9) |
| Thalidomide | 0 (0) | 1 (0.8) | 1 (0.4) |
| Missing | 1 (0.9) | 0 (0) | 1 (0.4) |
| . | BAT (n = 52) . | Ruxolitinib (n = 58) . | Overall (N = 110) . |
|---|---|---|---|
| Age, y | |||
| Mean (SD) [range] | 65.6 (13.5) [37.2, 85.4] | 62.9 (12.3) [34.5, 90.5] | 64.2 (12.9) [34.5, 90.5] |
| Sex, n (%) | |||
| Female | 30 (57.7) | 36 (62.1) | 66 (60.0) |
| Male | 22 (42.3) | 22 (37.9) | 44 (40.0) |
| Mutation status, n (%) | |||
| JAK2V617F positive | 26 (50.0) | 28 (48.3) | 54 (49.1) |
| CALR mutation positive | 14 (26.9) | 20 (34.5) | 34 (30.9) |
| MPL mutation positive | 3 (5.8) | 3 (5.2) | 6 (5.5) |
| Triple negative | 7 (13.5) | 6 (10.3) | 13 (11.8) |
| Not run | 2 (3.8) | 1 (1.7) | 3 (2.7) |
| HC resistant or intolerant,*n (%) | |||
| Resistant | 25 (48.1) | 28 (48.3) | 53 (48.2) |
| Intolerant | 27 (51.9) | 30 (51.7) | 57 (51.8) |
| Time from diagnosis to randomization, y† | |||
| Mean (SD) [range] | 6.9 (5.8) [0.4, 23.6] | 10.4 (6.7) [0.7, 31.2] | 8.8 (6.5) [0.4, 31.2] |
| Hemoglobin, g/L† | |||
| Mean (SD) [range] | 126 (17) [90.0, 160.0] | 119 (17) [87.0, 152.0] | 122 (17) [87.0, 160.0] |
| Platelet count, ×109/L | |||
| Mean (SD) [range] | 573.0 (227.1) [166.0, 1406.0] | 545.4 (215.3) [89.0, 1139.0] | 558.4 (220.4) [89.0, 1406.0] |
| WBC count, ×109/L | |||
| Mean (SD) [range] | 6.8 (2.7) [2.8, 15.2] | 7.5 (4.8) [1.7, 29.8] | 7.2 (3.9) [1.7, 29.8] |
| Hematocrit | |||
| Mean (SD) [range] | 0.4 (0.1) [0.3, 0.5] | 0.4 (0.1) [0.3, 0.5] | 0.4 (0.1) [0.3, 0.5] |
| Spleen size | |||
| Enlarged | 9 | 14 | 23 |
| Normal | 38 | 37 | 75 |
| Splenectomy | 2 | 3 | 5 |
| Missing | 3 | 4 | 7 |
| Number of previous therapies, n (%) | |||
| 1 | 15 (28.8) | 14 (24.1) | 28 (26.4) |
| 2 | 20 (38.5) | 24 (41.4) | 44 (40.0) |
| 3 | 8 (15.4) | 12 (20.7) | 20 (18.2) |
| 4 | 5 (9.6) | 5 (8.6) | 10 (9.1) |
| 5 | 2 (3.8) | 2 (3.4) | 4 (3.6) |
| 6 | 2 (3.8) | 0 (0) | 2 (1.8) |
| 9 | 0 (0) | 1 (1.7) | 1 (0.9) |
| Total number of previous therapies by treatment, n (%)‡ | |||
| HC | 59 (52.2) | 70 (58.8) | 129 (55.6) |
| Anagrelide | 29 (25.7) | 31 (26.1) | 60 (25.9) |
| Interferon | 7 (6.2) | 11 (9.2) | 18 (7.8) |
| Pegylated interferon | 2 (1.8) | 2 (1.7) | 4 (1.7) |
| Busulfan | 8 (7.1) | 1 (0.8) | 9 (3.9) |
| 32P | 3 (2.7) | 1 (0.8) | 4 (1.7) |
| Pipobroman | 1 (0.9) | 1 (0.8) | 2 (.09) |
| Fedratinib | 1 (0.9) | 1 (0.8) | 2 (0.9) |
| Vorinostat | 2 (1.8) | 0 (0) | 2 (0.9) |
| Thalidomide | 0 (0) | 1 (0.8) | 1 (0.4) |
| Missing | 1 (0.9) | 0 (0) | 1 (0.4) |
WBC, white blood cell.
Twenty-five patients were both resistant and intolerant. These patients have been included as resistant.
Time from diagnosis to randomization and baseline hemoglobin were different between the 2 treatment arms.
Patients were allowed to receive multiple therapies; therefore, total number of therapies in each category might exceed number of patients.