Table 6

Definitions of the response to second-line therapy in case of failure of imatinib

OptimalWarningFailure
Baseline NA No CHR or loss of CHR on imatinib or
lack of CyR to first-line TKI
or
high risk 
NA 
3 mo BCR-ABL1 ≤10%
and/or
Ph+ < 65% 
BCR-ABL1 >10%
and/or
Ph+ 65-95% 
No CHR
or
Ph+ >95%
or
new mutations 
6 mo BCR-ABL1 ≤10%
and/or
Ph+ < 35% 
Ph+ 35-65% BCR-ABL1 >10%
and/or
Ph+ >65%
and/or
new mutations 
12 mo BCR-ABL1 <1%
and/or
Ph+ 0 
BCR-ABL1 1-10%
and/or
Ph+ 1-35% 
BCR-ABL1 >10%
and/or
Ph+ >35%
and/or
new mutations 
Then, and at any time BCR-ABL1 ≤0.1% CCA/Ph– (–7 or 7q–)
or
BCR-ABL1 >0.1% 
Loss of CHR
or
loss of CCyR or PCyR
New mutations
Confirmed loss of MMR*
CCA/Ph+ 
OptimalWarningFailure
Baseline NA No CHR or loss of CHR on imatinib or
lack of CyR to first-line TKI
or
high risk 
NA 
3 mo BCR-ABL1 ≤10%
and/or
Ph+ < 65% 
BCR-ABL1 >10%
and/or
Ph+ 65-95% 
No CHR
or
Ph+ >95%
or
new mutations 
6 mo BCR-ABL1 ≤10%
and/or
Ph+ < 35% 
Ph+ 35-65% BCR-ABL1 >10%
and/or
Ph+ >65%
and/or
new mutations 
12 mo BCR-ABL1 <1%
and/or
Ph+ 0 
BCR-ABL1 1-10%
and/or
Ph+ 1-35% 
BCR-ABL1 >10%
and/or
Ph+ >35%
and/or
new mutations 
Then, and at any time BCR-ABL1 ≤0.1% CCA/Ph– (–7 or 7q–)
or
BCR-ABL1 >0.1% 
Loss of CHR
or
loss of CCyR or PCyR
New mutations
Confirmed loss of MMR*
CCA/Ph+ 

These definitions are mainly based on data reported for nilotinib and dasatinib,5,42,,,-46,69,77,104,,,,-109 but can be used provisionally also for bosutinib and ponatinib, until more data are available. These definitions cannot apply to the evaluation of the response to third-line treatment.

NA, not applicable; MMR, BCR-ABL1 ≥0.1% = MR3.0 or better; CCA/Ph+, clonal chromosome abnormalities in Ph+ cells; CCA/Ph–, clonal chromosome abnormalities in Ph– cells.

*

In 2 consecutive tests, of which one with a BCR-ABL transcripts level ≥1%.

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