Table 2.
Treatment outcome by randomization
| Treatment arm | All randomized and evaluable patients in the study | ||||||
|---|---|---|---|---|---|---|---|
| Total patients | Standarda | S-HAM | |||||
| N (%) | 95% CI | N (%) | 95% CI | N (%) | 95% CI | P | |
| Patients randomized | |||||||
| Total | 387 | 184 | 203 | ||||
| Younger | 251 | 119 | 132 | ||||
| Older | 136 | 65 | 71 | ||||
| Overall response (CR + CRi) | |||||||
| Total | 289 (75) | 70–79 | 133 (72) | 65–79 | 156 (77) | 70–83 | 0.202b |
| Younger | 197 (79) | 73–83 | 91 (76) | 68–83 | 106 (80) | 73–86 | 0.539c |
| Older | 92 (68) | 59–75 | 42 (65) | 53–75 | 50 (70) | 59–80 | 0.582c |
| Induction result | |||||||
| Total | 0.309c | ||||||
| CR | 200 (52) | 46–57 | 86 (47) | 39–54 | 114 (56) | 49–63 | |
| CRi | 89 (23) | 19–28 | 47 (25) | 19–32 | 42 (21) | 15–27 | |
| Persistent leukemia | 48 (12) | 9–16 | 24 (13) | 8–19 | 24 (12) | 7–17 | |
| Early death | 50 (13) | 9–17 | 27 (15) | 9–21 | 23 (11) | 7–17 | |
| Younger | 0.717c | ||||||
| CR | 136 (54) | 47–60 | 60 (50) | 41–60 | 76 (57) | 48–66 | |
| CRi | 61 (24) | 19–30 | 31 (26) | 18–35 | 30 (23) | 16–31 | |
| Persistent leukemia | 24 (10) | 6–14 | 12 (10) | 6–17 | 12 (9) | 5–15 | |
| Early death | 30 (12) | 8–17 | 16 (14) | 8–21 | 14 (11) | 6–17 | |
| Older | 0.438c | ||||||
| CR | 64 (47) | 38–56 | 26 (40) | 28–53 | 38 (53) | 41–65 | |
| CRi | 28 (20) | 14–28 | 16 (25) | 15–37 | 12 (17) | 9–28 | |
| Persistent leukemia | 24 (18) | 12–25 | 12 (18) | 10–30 | 12 (17) | 9–27 | |
| Early death | 20 (15) | 9–22 | 11 (17) | 8–28 | 9 (13) | 6–23 | |
| Early death until day 90 | |||||||
| Total | 60 (16) | 12–20 | 29 (16) | 11–22 | 31 (15) | 11–21 | 1.000c |
| Younger | 36 (14) | 11–19 | 16 (13) | 8–21 | 20 (15) | 10–22 | 0.722c |
| Older | 24 (18) | 12–25 | 13 (20) | 12–31 | 11 (16) | 9–26 | 0.509c |
| Overall survival | |||||||
| Total | 0.323d | ||||||
| Median, months | 29 | 20–38 | 25 | 15–34 | 35 | 21–49 | |
| Younger | 0.742d | ||||||
| Median, months | 48 | 25–71 | 45 | 16–74 | 48 | 25–71 | |
| Older | 0.219d | ||||||
| Median, months | 19 | 12–25 | 19 | 10–27 | 19 | 11–28 | |
| Event-free survival | |||||||
| Total | 0.753d | ||||||
| Median, months | 11 | 8–13 | 10 | 6–15 | 11 | 8–14 | |
| Younger | 0.980d | ||||||
| Median, months | 14 | 7–22 | 18 | 7–29 | 14 | 6–21 | |
| Older | 0.441d | ||||||
| Median, months | 7 | 4–10 | 6 | 3–9 | 9 | 4–14 | |
CR complete remission, CRi incomplete remission
aStandard treatment in “younger” patients was TAD-HAM (double induction mandatory), in “older” patients it was HAM(-HAM) (double induction only conditional if no adequate blast clearance ( 5%) had been achieved after one cycle of HAM)
bP-values are from one-sided sequential truncated probability ratio test (Whitehead)
cP-values are from Fisher’s exact test
dP-values are from log-rank test