Table 1. Triggers for mutational analysis: DASISION 3-year database.
On-treatment, clinically relevant events | Off-treatment, reason for discontinuation from study |
---|---|
No confirmed CCyR within 12 months | Disease progressiona |
No MMR within 12 months | Maximum clinical benefitb |
Fivefold increase in BCR-ABL1 transcript | Intolerance Treatment failure |
levels with loss of MMR | |
Loss of CCyRc | Adverse event unrelated to study drug |
Withdrew consent | |
Pregnancy | |
Loss to follow-up | |
Poor/noncompliance | |
Subject request to discontinue |
Abbreviations: CCyR, complete cytogenetic response; DASISION, Dasatinib versus Imatinib Study in Treatment-Naive CML-CP; MMR, major molecular response.
Increasing white blood cell count, loss of complete hematologic response (CHR), loss of major cytogenetic response, transformation to accelerated phase/blast phase and death.
Any subject who received study therapy and then discontinued treatment for intolerance (recurrent ≥grade 3 hematologic toxicity or ≥grade 2 nonhematologic toxicity despite dose reduction necessitating discontinuation of therapy) or treatment failure (lack of hematologic response at 3 months, lack of CHR or CyR at 6 months, lack of partial cytogenetic response at 12 months and lack of CCyR at 18 months).
As of last patient status; patients with interim loss of CCyR who subsequently regained a CCyR were not included.