Table 3. Clinically relevant on-treatment events, reasons for discontinuation and current status in patients with mutations in DASISION.
Dasatinib 100 mg once daily, n=17 | Imatinib 400 mg once daily, n=18 | |
---|---|---|
Clinically relevant on-treatment events, na | 14 | 16 |
No MMR within 12 months | 12 | 16 |
No cCCyR within 12 months | 8 | 12 |
Loss of CCyR | 6 | 4 |
Fivefold BCR-ABL1 increase with loss of MMR | 2 | 1 |
Discontinued treatment, n | 14 | 14 |
Protocol-defined disease progression | 11 | 8 |
Lost MCyR | 4 | 4 |
Transformed to AP/BP | 4 | 3 |
Lost CHR | 1 | 1 |
Increased WBC count | 1 | — |
Death | 1 | — |
Treatment failure | 1 | 4 |
No PCyR, 12 months | — | 2 |
No CCyR, 18 months | 1 | 2 |
Other | 2b | 2c |
Patient status (4-year minimum follow-up), n | ||
Off treatment | 14 | 14 |
Alive | 8 | 10 |
Dead | 6 | 4 |
On treatment | 3 | 4 |
% Mutation detected at trigger plus molecular response at last analysis | 90% G250Ed; 0.02% BCR-ABL1IS | 80% F359Id; 1.03% BCR-ABL1IS |
40% T315Id; 0.039% BCR-ABL1IS | 100% G250Ed; 11.3% BCR-ABL1IS | |
80% T315Id; 0.013% BCR-ABL1IS | 90% G250Ed; 7.7% BCR-ABL1IS | |
20% F359Vd; 20.5% BCR- ABL1IS |
Abbreviations: AP/BP, accelerated phase/blast phase; cCCyR, confirmed complete cytogenetic response; CCyR, complete cytogenetic response; CHR, complete hematologic response; DASISION, Dasatinib versus Imatinib Study in Treatment-Naive CML-CP; IS, international scale; MMR, major molecular response; MCyR, major cytogenetic response; PCyR, partial cytogenetic response; WBC, white blood cell.
Patients may have had multiple events.
One no CyR, one lost CCyR.
One poor/noncompliance, one patient request.
Estimated percentage of the mutation quantified in the sample.