Table 2 Treatment outcome by randomization

From: Sequential high-dose cytarabine and mitoxantrone (S-HAM) versus standard double induction in acute myeloid leukemia—a phase 3 study

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