Critical milestones in first-line CML therapy as defined by the European LeukemiaNet,9 the National Comprehensive Cancer Network,10 and the European Society of Medical Oncology11
| Month . | Optimal response . | Warning . | Failure . |
|---|---|---|---|
| 3 mo | |||
| ELN | BCR-ABL1 ≤ 10% ± Ph+ ≤ 35% | BCR-ABL1 > 10% ± Ph+ 36%-95% | No CHR or Ph+ > 95% |
| NCCN | BCR-ABL1 ≤ 10% | BCR-ABL1 > 10% | NA |
| ESMO | BCR-ABL1 < 10% ± Ph+ ≤ 35% | BCR-ABL1 > 10% ± Ph+ 36%-95% | No CHR or Ph+ > 95% |
| 6 mo | |||
| ELN | BCR-ABL1 < 1% ± Ph+ 0 | BCR-ABL1 1%-10% ± Ph+ 1%-35% | BCR-ABL1 > 10% ± Ph+ > 35% |
| NCCN | BCR-ABL1 ≤ 10% | NA | BCR-ABL1 > 10% |
| ESMO | BCR-ABL1 < 1% ± Ph+ 0% | BCR-ABL1 1%-10% ± Ph+ 1%-35% | BCR-ABL1 > 10% or Ph+ > 35% |
| 12 mo | |||
| ELN | BCR-ABL1 ≤ 0.1% | BCR-ABL1 > 0.1%-1% | BCR-ABL1 > 1% ± Ph+ > 0 |
| NCCN | BCR-ABL1 < 1% | BCR-ABL1 1%-10% | BCR-ABL1 > 10% |
| ESMO | BCR-ABL1 < 0.1% | BCR-ABL1 0.1%-1% | BCR-ABL1 > 1% ± Ph+ ≥ 1 |
| 18 mo | |||
| ESMO | BCR-ABL1 < 0.01% | BCR-ABL1 0.1%-1% | NA |
| At any time >12 mo | |||
| ELN | BCR-ABL1 ≤ 0.1% | CCA/Ph− (-7 or 7q-) | Loss of CHR |
| Loss of CCyR | |||
| Confirmed loss of MMR* | |||
| Mutations | |||
| CCA/Ph+ | |||
| NCCN | BCR-ABL1 < 0.1% | BCR-ABL1 0.1%-1% | BCR-ABL1 > 1% |
| Clinical considerations9,10 | Monitor response and side effects | Evaluate for patient compliance and drug interactions | Evaluate for patient compliance and drug interactions |
| No change to patient therapy | Consider mutation analysis | Consider mutation analysis | |
| Recommend TKI switch if no compliance issues or drug interactions identified |
| Month . | Optimal response . | Warning . | Failure . |
|---|---|---|---|
| 3 mo | |||
| ELN | BCR-ABL1 ≤ 10% ± Ph+ ≤ 35% | BCR-ABL1 > 10% ± Ph+ 36%-95% | No CHR or Ph+ > 95% |
| NCCN | BCR-ABL1 ≤ 10% | BCR-ABL1 > 10% | NA |
| ESMO | BCR-ABL1 < 10% ± Ph+ ≤ 35% | BCR-ABL1 > 10% ± Ph+ 36%-95% | No CHR or Ph+ > 95% |
| 6 mo | |||
| ELN | BCR-ABL1 < 1% ± Ph+ 0 | BCR-ABL1 1%-10% ± Ph+ 1%-35% | BCR-ABL1 > 10% ± Ph+ > 35% |
| NCCN | BCR-ABL1 ≤ 10% | NA | BCR-ABL1 > 10% |
| ESMO | BCR-ABL1 < 1% ± Ph+ 0% | BCR-ABL1 1%-10% ± Ph+ 1%-35% | BCR-ABL1 > 10% or Ph+ > 35% |
| 12 mo | |||
| ELN | BCR-ABL1 ≤ 0.1% | BCR-ABL1 > 0.1%-1% | BCR-ABL1 > 1% ± Ph+ > 0 |
| NCCN | BCR-ABL1 < 1% | BCR-ABL1 1%-10% | BCR-ABL1 > 10% |
| ESMO | BCR-ABL1 < 0.1% | BCR-ABL1 0.1%-1% | BCR-ABL1 > 1% ± Ph+ ≥ 1 |
| 18 mo | |||
| ESMO | BCR-ABL1 < 0.01% | BCR-ABL1 0.1%-1% | NA |
| At any time >12 mo | |||
| ELN | BCR-ABL1 ≤ 0.1% | CCA/Ph− (-7 or 7q-) | Loss of CHR |
| Loss of CCyR | |||
| Confirmed loss of MMR* | |||
| Mutations | |||
| CCA/Ph+ | |||
| NCCN | BCR-ABL1 < 0.1% | BCR-ABL1 0.1%-1% | BCR-ABL1 > 1% |
| Clinical considerations9,10 | Monitor response and side effects | Evaluate for patient compliance and drug interactions | Evaluate for patient compliance and drug interactions |
| No change to patient therapy | Consider mutation analysis | Consider mutation analysis | |
| Recommend TKI switch if no compliance issues or drug interactions identified |
All BCR-ABL1 values are expressed using IS. CCA/Ph−, clonal chromosome abnormalities in Ph− cells; CCA/Ph+, clonal chromosome abnormalities in Ph+ cells; CHR, complete hematological response; ELN, European LeukemiaNet; ESMO, European Society of Medical Oncology; NA, not applicable; NCCN, National Comprehensive Cancer Network; Ph+, Philadelphia-positive cells.
In 2 consecutive tests, one had BCR-ABL1 transcripts ≥1%.