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ASH 2025 | Comparing PCR for BCR::ABL1 versus NGS-based MRD in Ph+ ALL: which method is superior?
Nicholas Short, MD, The University of Texas MD Anderson Cancer Center, Houston, TX, discusses the findings of a comprehensive analysis of PCR for BCR::ABL1 and next-generation sequencing (NGS)-based measurable residual disease (MRD) in patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), highlighting that NGS-based MRD is more sensitive and potentially more specific for the lymphoblast clone. However, Dr Short notes that both methods should be used when considering discontinuation of tyrosine kinase inhibitor (TKI) therapy. This interview took place at the 67th ASH Annual Meeting and Exposition, held in Orlando, FL.
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Transcript
So in Philadelphia chromosome positive ALL, historically we’ve used PCR for BCR-ABL as our MRD marker. There’s multiple studies that have shown that this is an important prognostic tool, and patients who have clearance by PCR for BCR-ABL do better than those who do not. But now that we have NGS MRD, specifically the Clonoseq assay, which we use in the US, I think that there’s been a lot of data challenging that PCR for BCR-ABL is really the optimal tool...
So in Philadelphia chromosome positive ALL, historically we’ve used PCR for BCR-ABL as our MRD marker. There’s multiple studies that have shown that this is an important prognostic tool, and patients who have clearance by PCR for BCR-ABL do better than those who do not. But now that we have NGS MRD, specifically the Clonoseq assay, which we use in the US, I think that there’s been a lot of data challenging that PCR for BCR-ABL is really the optimal tool. For example, NGS-based MRD is more sensitive and likely also more specific for the actual lymphoblast clone. So we previously published that about a quarter of patients who are Clonoseq negative might still have persistent PCR positivity. And this is something that we wanted to look at more in this abstract.
So we identified, again, about 25% of patients who will achieve Clonoseq negativity but still have persistent PCR for BCR-ABL. We looked into those patients. We found no difference in long-term outcomes between those patients who were PCR positive versus PCR negative, as long as they were Clonoseq negative. And it also didn’t matter the quantification of the PCR. So even if they had a PCR of 0.1% or even 1% or higher, they still had excellent outcomes that were no different than those patients who were PCR negative. So I think we’re really moving in the field to think about NGS-based MRD rather than PCR for BCR-ABL to do our risk stratification for these patients.
In this abstract, we also describe a couple patients who had this PCR positivity but were Clonoseq negative, and we discontinued the TKI. Well, actually, the patient self-discontinued the TKI, and we found that the PCR rapidly rose, suggesting that we should probably continue the TKI for these patients with persistent PCR positivity. So in my own practice now, we really rely on the Clonoseq or NGS MRD assay for all of our risk stratification decisions, but the PCR is helpful because we do not consider stopping the TKI for patients who are PCR positive versus after patients have been PCR and Clonoseq negative for at least five years. We often consider stopping the TKI for those patients since they are likely cured from their leukemia.
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