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Recent studies demonstrate that early molecular response to tyrosine-kinase inhibitors is strongly predictive of outcome in chronic myeloid leukemia patients and that early response landmarks may identify patients at higher risk for transformation who would benefit from an early switch to second-line therapy. In this study, we evaluated the ability of the control gene  GUS  to identify relevant thresholds for known therapeutic decision levels ( BCR-ABL1/ABL1 IS    = 10% and 0.1%). We then defined the most relevant cut-offs for early molecular response markers (transcript level at 3 months, halving time and log reduction between diagnosis and 3 months of treatment) using  GUS  or  ABL1 . We demonstrated that, although both control genes could be used (in an equivalent way) to accurately assess early molecular response, the  BCR-ABL1/GUS  level at diagnosis is impacted by the higher  GUS  copy number over-expressed in CML cells, thus negatively impacting its ability to completely replace  ABL1  at diagnosis. Furthermore, we pointed out, for the first time, that it would be helpful to monitor  BCR-ABL1  levels at an earlier time point than that currently performed, in order to assess response to first-line tyrosine-kinase inhibitors and consider a potential switch of therapy as early as possible. We evaluated this optimal time point as being 19 days after the start of treatment in our cohort.

plos one

Major Molecular Response Achievement in CML Patients Can Be Predicted by BCR-ABL1/ABL1 or BCR-ABL1/GUS Ratio at an Earlier Time Point of Follow-Up than Currently Recommended