Table 2.
Outcome according to treatment arm for randomized patients
| All randomized patients (n=96) | De novo patients (n=78) | |||||
|---|---|---|---|---|---|---|
| Arm A | Arm B | p | Arm A | Arm B | p | |
| CR after window* | 0.026 | 0.068 | ||||
| Yes | 21 (43) | 30 (65) | 16 (43) | 27 (66) | ||
| No | 29 (57) | 16 (35) | 21 (57) | 14 (34) | ||
|
| ||||||
| MRD after window | 0.756 | 0.746 | ||||
| < 0.1% | 13 (54) | 8 (47) | 12 (57) | 8 (50) | ||
| ≥ 0.1% | 11 (46) | 9 (53) | 9 (43) | 8 (50) | ||
|
| ||||||
| Grade 3/4 toxicity | 0.019 | 0.032 | ||||
| Yes | 12 (24) | 22 (48) | 8 (22) | 19 (46) | ||
| No | 38 (76) | 24 (52) | 29 (78) | 22 (54) | ||
|
| ||||||
| CR after DAV #1 | 0.008 | 0.077 | ||||
| Yes | 38 (76) | 44 (96) | 30 (81) | 39 (95) | ||
| No | 12 (24) | 2 (4) | 7 (19) | 2 (5) | ||
|
| ||||||
| MRD after DAV #1 | 1.000 | 1.000 | ||||
| < 0.1% | 16 (67) | 11 (69) | 15 (71) | 11 (74) | ||
| ≥ 0.1% | 8 (33) | 5 (31) | 6 (29) | 4 (26) | ||
|
| ||||||
| Grade 3/4 toxicity | 1.000 | 1.000 | ||||
| Yes | 20 (40) | 16 (37) | 16 (43) | 17 (42) | ||
| No | 30 (60) | 27 (63) | 21 (57) | 24 (58) | ||
|
| ||||||
| 5-yr EFS±SE | 40.0% ± 6.8% 52.2% ± 7.4% 0.216 | 48.6% ± 8.0% 48.8% ± 7.8 0.933 | ||||
|
| ||||||
| 5-yr OS±SE | 40.0% ± 6.8% 60.9% ± 7.2% 0.069 | 48.6% ± 8.0% 58.8% ± 7.7 0.561 | ||||
*
The upfront window therapy consisted of daily cladribine with daily 2-hour infusions of cytarabine (arm A) or with a continuous infusion of cytarabine (arm B).
Numbers in parentheses represent percentages.