Table 3.
Response Evaluation and Management of CML in the Frontline Setting (ELN 2013)69
| Milestones | Continue Current TKI | Closer Monitoring | Switch TKI |
|---|---|---|---|
| 3 months | BCR/ABL1 ≤ 10% and/or Ph+ ≤35% | BCR/ABL1 > 10% and/or Ph+36–95% | No CHR and/or Ph+ >95% |
| 6 months | BCR/ABL1 ≤ 1% and/or Ph+ 0% | BCR/ABL1 1–10% and/or Ph+ 1–35% | BCR/ABL1 > 10% and/or Ph >35% |
| 12 months | BCR/ABL1 ≤ 0.1% | BCR-ABL1 0.1–1% | BCR/ABL1 > 1% and/or Ph >0% |
CML, chronic myeloid leukemia; TKI, tyrosine kinase inhibitor; Ph +, % of Philadelphia chromosome positive metaphases on bone marrow examination; BCR/ABL1 transcript level in international scale; CHR, complete hematologic response
At any time loss of CHR, loss of complete cytogenetic response (Ph + 0%), loss of confirmed major molecular response (BCR/ABL1 ≤ 0.1%), and clonal evolution in Ph positive cells means failure