Table 1.
Univariate Cox regression analyses of baseline characteristics and overall survival (OS) in SIMPLIFY-1 and SIMPLIFY-2 study populations.
| Subgroup | Number of Events/ Number of Evaluable Patients (%) | Median OS (years) | 2-year OS (%) | Hazard Ratio (95% CI) | p-value |
|---|---|---|---|---|---|
| SIMPLIFY-1 | |||||
| TI | 74/297 (24.9) | NR | 86.0 | 0.373 (0.267, 0.523) | <0.0001 |
| non-TI | 65/133 (48.9) | 3.20 | 69.9 | ref | |
| TSS ≥ 18 | 62/196 (31.6) | NR | 78.9 | 1.059 (0.756, 1.482) | 0.7408 |
| TSS < 18 | 75/229 (32.8) | NR | 82.6 | ref | |
| Hgb ≥ 10 g/dL | 68/249 (27.3) | NR | 83.3 | 0.351 (0.222, 0.557) | <0.0001 |
| Hgb8-<10 g/dL | 45/131 (34.4) | 5.01 | 86.1 | 0.493 (0.302, 0.805) | |
| Hgb < 8 g/dL | 25/49 (51.0) | 3.76 | 55.6 | ref | |
| Spleen volume > 2000 cm3 | 74/208 (35.6) | NR | 74.2 | 1.448 (1.037, 2.022) | 0.0288 |
| Spleen volume ≤2000 cm3 | 65/221 (29.4) | NR | 87.5 | ref | |
| Platelets > 200 × 109/L | 73/260 (28.1) | NR | 84.5 | 0.466 (0.281, 0.773) | 0.0035 |
| Platelets 100-200 × 109/L | 47/129 (36.4) | NR | 78.0 | 0.713 (0.418, 1.215) | |
| Platelets <100 × 109/L | 19/41 (46.3) | 4.28 | 68.0 | ref | |
| Disease type: PET | 35/90 (38.9) | 5.02 | 80.4 | 1.125 (0.755, 1.674) | 0.2909 |
| Disease type: PPV | 25/96 (26.0) | NR | 82.7 | 0.752 (0.480, 1.179) | |
| Disease type: PMF | 79/244 (32.4) | NR | 80.7 | ref | |
| IPSS risk: High | 88/200 (44.0) | 3.76 | 72.2 | 5.494 (2.920, 10.340) | <0.0001 |
| IPSS risk: INT-2 | 40/143 (28.0) | NR | 85.7 | 2.792 (1.430, 5.451) | |
| IPSS risk: INT-1 | 11/87 (12.6) | NR | 93.9 | ref | |
| WBC ≥ 10 × 109/L | 79/219 (36.1) | 5.31 | 76.4 | 1.466 (1.045, 2.056) | 0.0258 |
| WBC < 10 × 109/L | 59/210 (28.1) | NR | 86.0 | ref | |
| SIMPLIFY-2 | |||||
| TI | 12/51 (23.5) | NR | 80.7 | 0.319 (0.171, 0.595) | 0.0002 |
| non-TI | 58/105 (55.2) | 2.28 | 56.1 | ref | |
| TSS ≥ 18 | 30/67 (44.8) | 2.86 | 57.2 | 1.272 (0.792, 2.044) | 0.3174 |
| TSS < 18 | 40/89 (44.9) | 5.31 | 69.3 | ref | |
| Hgb ≥ 10 g/dL | 18/51 (35.3) | NR | 67.9 | 0.335 (0.179, 0.624) | 0.0003 |
| Hgb 8-<10 g/dL | 29/72 (40.3) | 5.31 | 71.7 | 0.493 (0.302, 0.805) | |
| Hgb <8 g/dL | 23/33 (69.7) | 1.60 | 42.4 | ref | |
| Spleen volume > 2000 cm3 | 46/84 (54.8) | 2.19 | 53.2 | 2.329 (1.418, 3.824) | 0.0006 |
| Spleen volume ≤2000 cm3 | 24/72 (33.3) | NR | 76.1 | ref | |
| Platelets >200 × 109/L | 19/36 (52.8) | 2.02 | 52.3 | 1.926 (1.063, 3.489) | 0.0857 |
| Platelets 100-200 × 109/L | 23/49 (46.9) | 2.58 | 58.8 | 1.440 (0.821, 2.526) | |
| Platelets <100 × 109/L | 26/69 (37.7) | NR | 76.1 | ref | |
| Disease type: PET | 12/32 (37.5) | NR | 82.9 | 0.614 (0.326, 1.156) | 0.0606 |
| Disease type: PPV | 9/30 (30.0) | NR | 68.7 | 0.482 (0.237, 0.982) | |
| Disease type: PMF | 49/94 (52.1) | 2.76 | 56.4 | ref | |
| DIPSS risk: High | 19/27 (70.4) | 1.18 | 24.0 | 5.043 (2.374, 10.710) | <0.0001 |
| DIPSS risk: INT-2 | 40/90 (44.4) | 5.31 | 70.9 | 1.651 (0.847, 3.221) | |
| DIPSS risk: INT-1 | 11/39 (28.2) | NR | 73.9 | ref | |
| WBC ≥ 10 × 109/L | 37/59 (62.7) | 1.33 | 38.4 | 3.335 (2.072, 5.365) | <0.0001 |
| WBC < 10 × 109/L | 33/97 (34.0) | NR | 78.6 | ref | |
TI Transfusion independence, TSS Total symptom score, Hgb Hemoglobin, PET Post-essential thrombocythemia, PPV Post-polycythemia vera, PMF Primary myelofibrosis; IPSS, International Prognostic Scoring System, DIPSS Dynamic International Prognostic Scoring System, INT Intermediate, NR Not reached, Ref Reference group, WBC White blood cells. Bold font highlights statistically significant associations.