Table 3.
Response category | Months after treatment initiation | Any time | Actions | |||
---|---|---|---|---|---|---|
3 | 6 | 12 | ||||
NCCN | Green (TKI sensitive) |
≤10% | ≤10% | <1% b | N/A | • Monitor response and AEs • Continue on the same TKI b |
Yellow (possible TKI resistance) |
>10% | N/A | >1% to 10% | |||
• Evaluate compliance and drug interactions • Consider mutational and bone marrow cytogenetic analyses to assess for MCyR at 3 months or CCyR at 12 months • Switch TKI, continue the same TKI (other than imatinib) • Consider evaluation for HCT | ||||||
• Evaluate compliance and drug interactions • Consider mutational analyses • Switch TKI and evaluate for HCT | ||||||
Red (TKI resistance) |
N/A | >10% | >10% | |||
ELN | Optimal | ≤10% | <1% | ≤0.1% | ≤0.1% | • Continue treatment |
Warning | >10% | >1% to 10% | >0.1% to 1% | >0.1% to 1%, loss of ≤0.1% (MMR) |
• Carefully consideration for continuation or change, depending on patient characteristics, comorbidities, and tolerance c |
|
Failure | >10%, if confirmed within 1-3 months | >10% | >1% | >1%, resistance mutations, high-risk additional chromosomal abnormalities | • Change treatment |
AE, adverse event; CCyR, complete cytogenetic response; ELN, European LeukemiaNet; HCT, hematopoietic cell transplant; IS, International Scale; MCyR, major cytogenetic response; MMR, major molecular response; N/A, not available; NCCN, National Comprehensive Cancer Network; TKI, tyrosine kinase inhibitor.
Definitions are the same across lines of therapy.
If treatment goal is long-term survival, ≤1% at 12 months is optimal. If treatment goal is treatment-free remission, ≤0.1% at 12 months is optimal. If response is optimal, continue the same TKI. A nonoptimal response per goals requires shared decision-making with the patient.
Additional quantitative polymerase chain reaction testing may be indicated if the kinetics of the response are not clear or if toxicity or intolerance cause dose interruptions or reductions.