Table 1.
Baseline characteristics of patients treated with vosaroxin plus cytarabine or placebo plus cytarabine (N=711)
| Vosaroxin + cytarabine (n=356) | Placebo + cytarabine (n=355) | |
|---|---|---|
|
| ||
| Sex, n (%) | ||
| Male | 202 (56·7) | 192 (54·1) |
| Female | 154 (43·3) | 163 (45·9) |
| Age, yr | ||
| Mean | 61·0 | 60·2 |
| Median (range) | 64 (20–80) | 63 (18–82) |
| Age subgroup*, n (%) | ||
| <60 | 130 (36·5) | 130 (36·6) |
| ≥60 | 226 (63·5) | 225 (63·4) |
| Disease status*, n (%) | ||
| Early relapse† | 127 (35·7) | 129 (36·3) |
| Late relapse‡ | 77 (21·6) | 77 (21·7) |
| Refractory | 152 (42·7) | 149 (42·0) |
| Region*, n (%) | ||
| US | 161 (45·2) | 159 (44·8) |
| Outside US | 195 (54·8) | 196 (55·2) |
| Race, n (%)§ | ||
| White | 253 (71·1) | 242 (68·2) |
| Black | 21 (5·9) | 11 (3·1) |
| Asian | 20 (5·6) | 18 (5·1) |
| Other | 4 (1·1) | 7 (2·0) |
| Multiple | 0 | 3 (0·8) |
| Type of AML, n (%)¶ | ||
| AML not otherwise specified | 188 (52·8) | 180 (50·7) |
| AML with myelodysplasia-related changes | 103 (28·9) | 93 (26·2) |
| AML with recurrent genetic abnormalities | 54 (15·2) | 71 (20·0) |
| Myeloid sarcoma | 2 (0·6) | 1 (0·3) |
| Therapy-related myeloid neoplasm | 9 (2·5) | 10 (2·8) |
| ECOG PS, n (%)# | ||
| 0 | 156 (44·1) | 143 (40·5) |
| 1 | 158 (44·6) | 162 (45·9) |
| 2 | 40 (11·3) | 48 (13·6) |
| Cytogenetic risk, n (%)^ | ||
| Favorable | 7 (2·9) | 9 (3·8) |
| Intermediate | 175 (72·9) | 155 (64·9) |
| Unfavorable | 58 (24·2) | 75 (31·4) |
| Number of prior induction cycles, n (%) | ||
| 1 | 274 (77·0) | 259 (73·0) |
| 2 | 82 (23·0) | 95 (26·8) |
| >2 | 0 | 1 (0·3) |
*
Pre-planned randomisation strata.
†
First complete remission duration of 90 days to 12 months.
‡
First complete remission duration of 12 months to 24 months.
§
Race not reported in 132 patients
¶
Per World Health Organization 2008 criteria.18
#
ECOG PS missing in 4 patients.
^
Per National Comprehensive Cancer Network Treatment Guidelines, AML, 2014; cytogenetic risk not available in 232 patients.
AML=acute myeloid leukaemia; ECOG PS=Eastern Cooperative Oncology Group performance status.