Table 1.
Comparison of Frontline Therapy Outcomes in Chronic Phase CML
| Clinical Outcome (%) | TOPS22
|
ENESTnd34
|
DASISION41
|
||||
|---|---|---|---|---|---|---|---|
| IM 400 (n=157) | IM 800 (n=319) | NIL 600 (n=282) | NIL 800 (n=281) | IM 400 (n=283) | DAS 100 (n=259) | IM 400 (n=260) | |
|
|
|
|
|||||
| BCR-ABL <10% by 3 mo | NR | NR | 91 | 89 | 67 | 84 | 64 |
| BCR-ABL <10% by 6 mo | NR | NR | 97 | 93 | 84 | 89 | 83 |
| CCyR by 12 mo | 67 | 70 | 80 | 78 | 65 | 83 | 72 |
| MMR by 12 mo | 39 | 45 | 44 | 43 | 22 | 46 | 28 |
| Cumulative MR4.5 | NR | NR | 40 | 37 | 23 | 42 | 33 |
| Minimum f/u (months) | 42 | 42 | 48 | 48 | 48 | 60 | 60 |
| Still on study drug at last f/u | 73 | 68 | 66 | 69 | 57 | 61 | 63 |
| Progression-free survival | 92 | 94 | 93 | 96 | 92 | 85 | 86 |
| Overall Survival | 94 | 94 | 94 | 97 | 93 | 91 | 90 |
CML, chronic myeloid leukemia; IM 400 or 800, imatinib total daily dose of 400 or 800 mg; NIL 600 or 800, nilotinib total daily dose of 600 or 800 mg; DAS 100, dasatinib total daily dose of 100 mg; n, number of patients randomized to the particular arm; f/u, follow-up; BCR/ABL1 transcript level in international scale(IS); CCyR (complete cytogenetic response), absence of Ph chromosome-positive metaphase; MMR (major molecular response), BCR-ABL1/ABL1 transcript ratio ≤ 0.1% (IS); MR4.5, BCR-ABL1 transcript ≤ 0.0032%