Hello Folks,
Last night I had a chance to look at my notes from ASH and I am happy to say I have lots and hope to finish posting them up by this weekend. There is still quite a bit from Sunday's sessions that I haven't posted but that will be following shortly.
Monday Simultaneous Sessions - Part I
Molecular Monitoring of Residual Disease and BCR-ABL Kinase Mutation
The Frequency of Detection of BCR-ABL Mutations in IM treated patients with CML who attain a CCR does not diminish with increasing duration of CCR but the associated loss of response is usually gradual.
This was from the Australian group and much of the data that was presented on Thursday night’s special Tim Hughes presentation was presented here. In fact Mark and I couldn’t help but notice that we did see many of Dr. Hughes slides over and over again.
- Majority of patients with CP CML on IM achieve a CCR which is associated with a high progression free survival (PFS).
- BCR-ABL mutations have been observed in patients in ongoing CCR
- It has been previously reported that most patients with mutations go on to develop resistance.
- determine the incidence of mutations of those in CCR
- assess whether the incidence varies with duration
- and evaluate the rate of loss of response in those who do develop mutations
Of the 211, 159 (75%) achieved CCR in a median of 3 mos.and were followed for at least a median of 12 mos.
- 12 patients lost CCR, 8 of those were associated to a development of a mutation
- Median time to loss of CCR was 3 mos.
- 3 patients went to transplant and 9 went to increased IM. Of those 9, 4 maintained a MCR, 3 re-established a CCR, 1 lost a CHR (pt. had 2 mutations), none went to BP, this includes 3 patients who had p-loop mutations which is usually associated with poor prognosis.
Of the 159 patients in CCR mutations were detected in 11 of 25 with a 2> fold increase rise in BCR-ABL.
Of the 131 patients with stable or decreasing BCR ABL, no mutations were detected.
The probability of developing a mutation by 24 months after achieving CCR was 12%
The risk of developing a mutation did not vary with time during CCR, 6.7% during the first 12 mos, and 6.0% during the 2nd 12 mos.
Patients who had a mutation detected in CCR still had a favorable PFS (defined as MCR/MHR and lack of progression to AP and BP, 15 mos after the mutation was detected. This may be due to rapid response in terms of dose intensification.
BCR-ABL may still be detected in patients with low burden of CML and the risk does not appear to diminish up to 24 mos. Of those who had a gradual loss of CCR and developed a mutation, none have progressed to BC.
It is recommended that patients in CCR be closely monitored with QPCR. Patients with an emerging resistance will be recognized early on and get appropriate therapeutic intervention before disease progression.
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