Table 2.
Baseline demographics and disease characteristics
| Characteristic | Patients receiving RP2D n = 59 | All treated patients n = 84 |
|---|---|---|
| Median age, years (range) | 63 (34‐79) | 63.5 (34‐83) |
| Sex, n (%) | ||
| Female | 28 (47) | 41 (49) |
| Male | 31 (53) | 43 (51) |
| Median time since initial diagnosis, years (range) | 4.6 (0.5‐16.4) | 4.6 (0.5‐25.3) |
| ECOG performance status, n (%) | ||
| 0 | 21 (36) | 27 (32) |
| 1 | 32 (54) | 50 (60) |
| 2 | 6 (10) | 7 (8) |
| ISS stage at baseline, n (%) | ||
| I | 24 (41) | 39 (46) |
| II | 18 (31) | 23 (27) |
| III | 11 (19) | 16 (19) |
| Cytogenetic riska | ||
| High‐risk | 18 (31) | 22 (26) |
| Non–high‐risk | 33 (56) | 51 (61) |
| Unknown | 8 (14) | 11 (13) |
| Median hemoglobin, g/L (range) | 114 (69‐149) | 109 (69–149) |
| Median platelets, 109/L (range) | 164 (61‐443) | 167 (61‐443) |
| Median absolute neutrophil count, 109/L (range) | 2.3 (1.0‐9.3) | 2.3 (1.0–9.3) |
Abbreviations: ECOG, Eastern Cooperative Oncology Group; ISS, International Staging System; RP2D, recommended phase 2 dose.
a
Cytogenetic risk assessment was performed locally. High cytogenetic risk was defined as the presence of t(4;14) and/or del17p.