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.