Table 3 Efficacy data from CML-Study IV and SPIRIT

From: Re-emergence of interferon-α in the treatment of chronic myeloid leukemia

 

SPIRIT

CML-Study IV

 

Imatinib 400 mg per day (n=159)

Imatinib 600 mg per day (n=160)

Imatinib 400 mg per day+cytarabine (n=158)

Imatinib 400 mg per day+PegIFNα-2a (n=159)

Imatinib 400 mg per day (n=306)

Imatinib 800 mg per day (n=328)

Imatinib 400 mg per day+IFNα (n=336)

Molecular response

 6-Month major response

  

NA

 

9 (5–11)

18 (14–23)

8 (5–11)

 12-Month major response

38 (30–46)

49 (41–57)

46 (38–54)

57 (49–65)

31 (27–36)

55 (49–60)

35 (29–39)

 

Unadjusted P<0.001; adjusted P=0.005

   

 12-Month superior response

14 (9–21)

17 (11–24)

15 (10–22)

30 (23–37)

NA

 

Unadjusted P=0.001; adjusted P=0.001

   

 18-Month major response

42 (34–50)

50 (42–58)

53 (45–61)

62 (54–69)

50 (44–56)

68 (62–73)

54 (48–59)

 

Unadjusted P=0.004; adjusted P=0.003

   

 18-Month superior response

18 (13–25)

22 (16–29)

19 (13–26)

35 (27–43)

NA

 

Unadjusted P=0.002; adjusted P=0.001

   

 24-Month major response

43 (35–50)

53 (45–60)

54 (46–62)

64 (56–71)

63 (57–68)

76 (71–81)

63 (57–68)

 

Unadjusted P=0.006; adjusted P=0.003

   

 24-Month superior response

21 (15–28)

26 (20–34)

26 (19–34)

38 (30–46)

NA

 

Unadjusted P=0.001; adjusted P=0.007

   

 24-Month undetectable residual disease

9 (5–14)

8 (4–13)

8 (4–13)

16 (12–24)

NA

 

Unadjusted P=0.01; adjusted P=0.01

   

 36-Month major response

NA

79 (74–84)

82 (76–86)

71 (65–75)

Complete cytogenetic response

 6 Months

50 (42–58)

69 (61–76)

59 (51–67)

57 (49–65)

21 (16–26)

32 (26–37)

20 (15–24)

 

Unadjusted P=0.007; adjusted P=0.005

   

 12 Months

58 (50–66)

65 (57–72)

70 (62–77)

66 (58–73)

49 (43–54)

63 (56–68)

50 (44–55)

 

Unadjusted P>0.05

   

 18 Months

NA

66 (59–71)

69 (63–74)

75 (69–79)

 24 Months

NA

74 (68–79)

82 (77–87)

77 (70–81)

  1. Abbreviations: CML, chronic myeloid leukemia; NA, not available; PegIFNα, pegylated IFNα; SPIRIT, STI571 Prospective Randomized Trial.