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

 
  1. CR complete remission, CRi incomplete remission
  2. 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)
  3. bP-values are from one-sided sequential truncated probability ratio test (Whitehead)
  4. cP-values are from Fisher’s exact test
  5. dP-values are from log-rank test
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