Operational definition of failure and suboptimal response for previously untreated patients in ECP CML who are treated with 400 mg IM daily
Time . | Failure . | Suboptimal response . | Warnings . |
|---|---|---|---|
| Diagnosis | NA | NA | High risk, del9q+, ACAs in Ph+ cells |
| 3 mo after diagnosis | No HR (stable disease or disease progression) | Less than CHR | NA |
| 6 mo after diagnosis | Less than CHR, no CgR (Ph+ > 95%) | Less than PCgR (Ph+ > 35%) | NA |
| 12 mo after diagnosis | Less than PCgR (Ph+ > 35%) | Less than CCgR | Less than MMolR |
| 18 mo after diagnosis | Less than CCgR | Less than MMolR | NA |
| Anytime | Loss of CHR*, loss of CCgR†, mutation‡ | ACA in Ph+ cells§, loss of MMolR§, mutation∥ | Any rise in transcript level; other chromosome abnormalities in Ph- cells |
Time . | Failure . | Suboptimal response . | Warnings . |
|---|---|---|---|
| Diagnosis | NA | NA | High risk, del9q+, ACAs in Ph+ cells |
| 3 mo after diagnosis | No HR (stable disease or disease progression) | Less than CHR | NA |
| 6 mo after diagnosis | Less than CHR, no CgR (Ph+ > 95%) | Less than PCgR (Ph+ > 35%) | NA |
| 12 mo after diagnosis | Less than PCgR (Ph+ > 35%) | Less than CCgR | Less than MMolR |
| 18 mo after diagnosis | Less than CCgR | Less than MMolR | NA |
| Anytime | Loss of CHR*, loss of CCgR†, mutation‡ | ACA in Ph+ cells§, loss of MMolR§, mutation∥ | Any rise in transcript level; other chromosome abnormalities in Ph- cells |
Failure implies that the patient should be moved to other treatments whenever available. Suboptimal response implies that the patient may still have a substantial benefit from continuing IM treatment but that the long-term outcome is not likely to be optimal, so the patient becomes eligible for other treatments. Warnings imply that the patient should be monitored very carefully and may become eligible for other treatments. The same definitions can be used to define the response after IM dose escalation. For risk definitions refer to Table 2. For mutations refer to Table 5. For the definition of HR, CgR, and MolR, refer to Table 8.
PCgR indicates partial CgR; and NA, not applicable.
To be confirmed on 2 occasions unless associated with progression to AP/BC.
To be confirmed on 2 occasions, unless associated with CHR loss or progression to AP/BC.
High level of insensitivity to IM.
To be confirmed on 2 occasions, unless associated with CHR or CCgR loss.
Low level of insensitivity to IM.