ELN operational definition of failure and suboptimal response for previously untreated, early chronic phase CML patients treated with 400 mg IM daily2
Time . | Failure . | Suboptimal response . | Warnings . |
---|---|---|---|
Diagnosis | NA | NA | High risk |
del 9q+ | |||
Additional chromosome abnormalities (ACA) in Ph+ cells | |||
3 months | No hematologic response (HR) (stable disease or disease progression) | Less than complete hematologic response (CHR) | |
6 months | Less than CHR | Less than partial cytogenetic response | |
No cytogenetic response (Ph+ > 95%) | (Ph+ > 35%) | ||
12 months | Less than partial cytogenetic response (Ph+ > 35%) | Less than complete cytogenetic response | Less than major molecular response (MMR) |
18 months | Less than complete cytogenetic response | Less than MMR | |
At any time | Loss of CHR* | ACA in Ph+ cells§ | Any rise in transcript level |
Loss of complete cytogenetic response† | Loss of MMR§ | ACA in Ph− cells | |
Mutation‡ | Mutation‖ |
Time . | Failure . | Suboptimal response . | Warnings . |
---|---|---|---|
Diagnosis | NA | NA | High risk |
del 9q+ | |||
Additional chromosome abnormalities (ACA) in Ph+ cells | |||
3 months | No hematologic response (HR) (stable disease or disease progression) | Less than complete hematologic response (CHR) | |
6 months | Less than CHR | Less than partial cytogenetic response | |
No cytogenetic response (Ph+ > 95%) | (Ph+ > 35%) | ||
12 months | Less than partial cytogenetic response (Ph+ > 35%) | Less than complete cytogenetic response | Less than major molecular response (MMR) |
18 months | Less than complete cytogenetic response | Less than MMR | |
At any time | Loss of CHR* | ACA in Ph+ cells§ | Any rise in transcript level |
Loss of complete cytogenetic response† | Loss of MMR§ | ACA in Ph− cells | |
Mutation‡ | Mutation‖ |
Failure implies that the patient should be moved to other treatments whenever available. Suboptimal response implies that the patient may still derive substantial benefit from continuing IM treatment but that the long-term outcome is probably not optimal, so that the patient will become eligible for other treatment. Warnings imply that the patient should be monitored very carefully and may become eligible for other treatments.
NA indicates not applicable.
To be confirmed on two occasions unless associated with progression to AP/BC.
To be confirmed on two occasions, unless associated with CHR loss or progression to AP/BC.
High level of insensitivity to imatinib.
To be confirmed on two occasions, unless associated with loss of CHR or loss of complete cytogenetic response.
Low level of insensitivity to imatinib.