Table 2.
Response in all patients and pre-defined subgroups by treatment arm (N=711)
| CR, % (95% CI) | Combined CR (CR/CRp/CRi), % (95% CI) | |||||||
|---|---|---|---|---|---|---|---|---|
|
| ||||||||
| vos/cyt | pla/cyt | difference | p value | vos/cyt | pla/cyt | difference | p value | |
| Overall | 30·1 (25·3, 35·1) | 16·3 (12·6, 20·6) | 13.7 (7.6, 19.8) | <0·0001 | 37·1 (32·0, 42·3) | 18·6 (14·7, 23·0) | 18.5 (12.0, 24.9) | <0·0001 |
| By age, years | ||||||||
| <60 | 26·9 (19·5, 35·4) | 20·8 (14·2, 28·8) | 6.2 (−4.2, 16.5) | 0·24 | 34·6 (26·5, 43·5) | 23·1 (16·1, 31·3) | 11.5 (0.6, 22.5) | 0·0400 |
| ≥60 | 31·9 (25·8, 38·4) | 13·8 (9·6, 19·0) | 18.1 (10.5, 25.6) | <0·0001 | 38·5 (32·1, 45·2) | 16·0 (11·5, 21·5) | 22.5 (14.5, 30.4) | <0·0001 |
| By disease status | ||||||||
| Early relapse* | 27·6 (20·0, 36·2) | 12·4 (7·3, 19·4) | 15.2 (5.5, 24.8) | 0·0024 | 34·6 (26·4, 43·6) | 15·5 (9·7, 22·9) | 19.1 (8.8, 29.5) | 0·0004 |
| Late relapse† | 53·2 (41·5, 64·7) | 33·8 (23·4, 45·4) | 19.5 (4.1, 34.8) | 0·0148 | 59·7 (47·9, 70·8) | 36·4 (25·7, 48·1) | 23.4 (8.0, 38.7) | 0·0037 |
| Refractory | 20·4 (14·3, 27·7) | 10·7 (6·3, 16·9) | 9.7 (1.5, 17.8) | 0·0210 | 27·6 (20·7, 35·5) | 12·1 (7·3, 18·4) | 15.6 (6.7, 24.4) | 0·0007 |
| By region | ||||||||
| US | 28·0 (21·2, 35·6) | 14·5 (9·4, 20·9) | 13.5 (4.7, 22.3) | 0·0032 | 35·4 (28·0, 43·3) | 17·0 (11·5, 23·7) | 18.4 (9.0, 27.8) | 0·0002 |
| Outside US | 31·8 (25·3, 38·8) | 17·9 (12·8, 23·9) | 13.9 (5.5, 22.4) | 0·0014 | 38·5 (31·6, 45·7) | 19·9 (14·5, 26·2) | 18.6 (9.7, 27.4) | <0·0001 |
*
First complete remission duration of 90 days to 12 months.
†
First complete remission duration of 12 months to 24 months.
CR=complete remission; CRi=CR with incomplete recovery of platelets or neutrophils; CRp=CR with incomplete recovery of platelets; cyt=cytarabine; pla=placebo; vos=vosaroxin