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. 2012 Dec 14;27(4):803–812. doi: 10.1038/leu.2012.313

Table 3. Efficacy data from CML-Study IV and SPIRIT.

  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)

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