European (ELN) and US (NCCN) guidelines for assessing responses and directing treatment changes
| Time, months . | ELN . | NCCN . | ||||
|---|---|---|---|---|---|---|
| Optimal . | Warning . | Failure . | Green* . | Yellow† . | Red‡ . | |
| 3 | BCR-ABL1 ≤10% and/or Ph+ ≤35% | BCR-ABL1 >10% and/or Ph+ 36%-95% | Non-CHR and/or Ph+ >95% | BCR-ABL1 ≤10% | BCR-ABL1 >10% | Not defined |
| 6 | BCR-ABL1 <1% and/or Ph+ 0% | BCR-ABL1 1%-10% and/or Ph+ 1%-35% | BCR-ABL1 >10% and/or Ph+ >35% | BCR-ABL1 ≤10% | Not defined | BCR-ABL1 >10% |
| 12 | BCR-ABL1 ≤0.1% | BCR-ABL1 >0.1%-1% | BCR-ABL1 >1% and/or Ph+ >0% | BCR-ABL1 ≤1% | BCR-ABL1 >1%-10% | BCR-ABL1 >10% |
| >12 | BCR-ABL1 ≤0.1% | CCA/Ph− (−7 or 7q−) | Loss of CHR, loss of CCyR, confirmed loss of MMR§ mutations, CCA/Ph+ | BCR-ABL1 ≤0.1% | BCR-ABL1 >0.1%-1% | BCR-ABL1 >1% |
| Time, months . | ELN . | NCCN . | ||||
|---|---|---|---|---|---|---|
| Optimal . | Warning . | Failure . | Green* . | Yellow† . | Red‡ . | |
| 3 | BCR-ABL1 ≤10% and/or Ph+ ≤35% | BCR-ABL1 >10% and/or Ph+ 36%-95% | Non-CHR and/or Ph+ >95% | BCR-ABL1 ≤10% | BCR-ABL1 >10% | Not defined |
| 6 | BCR-ABL1 <1% and/or Ph+ 0% | BCR-ABL1 1%-10% and/or Ph+ 1%-35% | BCR-ABL1 >10% and/or Ph+ >35% | BCR-ABL1 ≤10% | Not defined | BCR-ABL1 >10% |
| 12 | BCR-ABL1 ≤0.1% | BCR-ABL1 >0.1%-1% | BCR-ABL1 >1% and/or Ph+ >0% | BCR-ABL1 ≤1% | BCR-ABL1 >1%-10% | BCR-ABL1 >10% |
| >12 | BCR-ABL1 ≤0.1% | CCA/Ph− (−7 or 7q−) | Loss of CHR, loss of CCyR, confirmed loss of MMR§ mutations, CCA/Ph+ | BCR-ABL1 ≤0.1% | BCR-ABL1 >0.1%-1% | BCR-ABL1 >1% |
Adapted from European LeukemiaNet (ELN) guidelines (version 2013)10 and National Comprehensive Cancer Network (NCCN) guidelines (version 2.2018)11 with permission.
CCA, clonal chromosome abnormality; CCyR, complete cytogenetic remission; CHR, complete hematological response; MMR, major molecular remission; Ph, Philadelphia chromosome.
Equivalent to good response, where no treatment change is recommended.
Equivalent to suboptimal response, where switch to alternative TKI, Imatinib dose escalation or hematopoietic stem cell transplant may be considered, according to the clinical scenario.
Equivalent to treatment failure, which imposes switching to alternative TKI and evaluation of hematopoietic stem-cell transplantation.
In 2 consecutive tests, 1 of which with a BCR-ABL1 transcript level ≥1%.