Table 1.
Patient baseline characteristics in the AML and solid tumour dose-escalation studies
| AML dose-escalation study n = 32 | Solid tumour dose-escalation study n = 35 | |
|---|---|---|
| Age, years | ||
| Median | 65 | 65 |
| Range | 18–89 | 28–81 |
| Sex | ||
| Male | 21 (65.6) | 17 (48.6) |
| Female | 11 (34.4) | 18 (51.5) |
| Race | ||
| White | 26 (81.3) | 19 (54.3) |
| Asian | 3 (9.4) | 16 (45.7) |
| Other | 3 (9.4) | 0 |
| Extent of disease at baseline | ||
| Locally advanced | NA | 13 (37.1) |
| Metastatic | NA | 31 (88.6) |
| Disease under study | ||
| Refractory AML (primary only) | 21 (65.6) | NA |
| First relapse | 3 (9.4) | NA |
| Second relapse | 4 (12.5) | NA |
| Third or further relapse | 4 (12.5) | NA |
| ECOG PS | ||
| 0 | 6 (18.8) | 16 (47.1) |
| 1 | 21 (65.6) | 18 (52.9) |
| 2 | 5 (15.6) | 0 |
| Prior therapy | ||
| Surgery | NA | 27 (77.1) |
| Radiotherapy | 2 (6.3) | 35 (100) |
| Chemotherapy, n (%), median | 32 (100), 4.0 | 34 (97.1), NA |
| Immuno-/hormonal therapy | NA | 6 (17.1) |
| Other systemic anticancer therapya | 2 (6.3) | 0 |
| Stem cell transplant | 5 (15.6) | NA |
| Molecular mutation status | ||
| FLT3 | ||
| Detected | 3 (9.4) | NA |
| Not detected | 12 (37.5) | NA |
| Unknown | 17 (53.1) | NA |
| NPM1 | ||
| Detected | 0 | NA |
| Not detected | 12 (37.5) | NA |
| Unknown | 20 (62.5) | NA |
| Cytogenetics | ||
| Normal | 14 (43.8) | NA |
| t (8:21) | 1 (3.1) | NA |
| Inv 16 or t (16:16) | 1 (3.1) | NA |
| Abnormalities of 5 and/or 7 | 7 (21.9) | NA |
| Complex (>3 abnormalities) | 8 (25.0) | NA |
| Other | 14 (43.8) | NA |
Data are n (%) unless otherwise stated.
AML acute myeloid leukaemia, ECOG PS Eastern Oncology Cooperative Group Performance Status, FLT3 FMS-like tyrosine kinase 3, NA not applicable, NPM1 nucleophosmin.
aDetails of ‘other systemic anticancer prior therapy’ are not known