What question did this study set out to answer?

To compare the sensitivity and diagnostic performance of TaqMan and LightCycler qRT-PCR monitoring systems for BCR-ABL1 detection and assess their impact on patient eligibility for treatment-free remission trials.

March 21, 2019PLoS ONEOpen Access

Diagnostic performance of the molecular BCR-ABL1 monitoring system may impact on inclusion of CML patients in stopping trials

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To compare the sensitivity and diagnostic performance of TaqMan and LightCycler qRT-PCR monitoring systems for BCR-ABL1 detection and assess their impact on patient eligibility for treatment-free remission trials.
Comparative analysis of peripheral blood mononuclear cell RNA from 92 patients with chronic myeloid leukemia achieving major molecular remission or better.
Evaluation of 128 patients undergoing treatment cessation within the EURO-SKI stopping trial using LightCycler/ABL1 versus TaqMan/GUSB qRT-PCR systems.
Assays demonstrated 99% concordance for determining major molecular remission, but TaqMan/GUSB reclassified 34 of 92 routine patients to an inferior molecular response log level and detected BCR-ABL1 in 13 samples previously negative on LightCycler/ABL1.
Among 128 EURO-SKI trial participants, 114 showed concordant molecular findings, whereas 14 were reclassified to an inferior log level by TaqMan/GUSB; eight of these 14 relapsed after stopping therapy, including two reclassified from MR4 to MMR who would have failed inclusion criteria.

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Comparative molecular study reveals enhanced TaqMan qRT-PCR sensitivity reclassifies molecular response levels in chronic myeloid leukemia, indicating diagnostic assays influence treatment...

Cite This Study

Spieß et al. (2019) studied this question.

synapsesocial.com/papers/6a7473de1078cf7de2b1c150 https://doi.org/10.1371/journal.pone.0214305

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Implication

Comparative molecular study reveals enhanced TaqMan qRT-PCR sensitivity reclassifies molecular response levels in chronic myeloid leukemia, indicating diagnostic assays influence treatment...

Diagnostic performance of the molecular BCR-ABL1 monitoring system may impact on inclusion of CML patients in stopping trials

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Discussion

Implication

Cite This Study

Diagnostic performance of the molecular BCR-ABL1 monitoring system may impact on inclusion of CML patients in stopping trials

Key Points

Discussion

Implication

Cite This Study

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