Measurement of<i>BCR-ABL1</i>transcripts on the International Scale in the United States: current status and best practices

Arora, Ranjana; Press, Richard D.

doi:10.1080/10428194.2016.1190974

Cited by 20 publications

(16 citation statements)

References 44 publications

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“…There should be an accepted method for standardizing reporting of molecular responses. This is the one used by most locales today, but it still has not been adopted universally . Additionally, the laboratory must have adequate quality control mechanisms to ensure that the results provided are accurate and reproducible.…”

Section: Molecular Monitoringmentioning

confidence: 99%

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Treatment‐free remission with first‐ and second‐generation tyrosine kinase inhibitors

2018

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Chronic myeloid leukemia (CML) has become a chronic disease, for which the chronic phase is manageable with tyrosine kinase inhibitor (TKI) therapy. Patients with optimal responses to TKIs have achieved long‐term survival, and treatment‐free remission (TFR) has since become an additional treatment goal in CML. In this review, we discuss important factors to consider prior to stopping treatment. In addition, published and presented data with the first‐generation TKI imatinib, as well as current clinical trials evaluating TFR with the second‐generation TKIs dasatinib and nilotinib, are examined. Results obtained outside of clinical trials have been included as well. Because successful TKI discontinuation depends upon accurate BCR‐ABL1 monitoring, emerging technologies are also discussed. Clinical data obtained to date indicate that for many patients who achieve deep molecular response (DMR) on TKI therapy, TFR is a safe treatment goal, and, if the response is lost, patients can expect to regain their responses immediately upon reinitiation of TKI. It is also clear that there remains much room for improvement to make TFR a successful reality for most patients. Data from ongoing trials should help refine decisions as to which patients are the best candidates to attempt TKI discontinuation with safe monitoring in place.

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Section: Molecular Monitoringmentioning

confidence: 99%

“…RQ‐PCR has become an increasingly standard technique, yet still more sensitive techniques may be used in the future. Digital PCR is reported to be 100 times more sensitive than RQ‐PCR, which can detect a single BCR‐ABL1+ cell out of 10 7 cells .…”

Section: Molecular Monitoringmentioning

confidence: 99%

Treatment‐free remission with first‐ and second‐generation tyrosine kinase inhibitors

2018

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“…Thanks to the high sensitivity of molecular methods to detect BCR-ABL1 transcripts, deeper molecular responses can now be ascertained, including major molecular response (MMR), MR4 or MR4.5 (4 and 4.5- log reduction of BCR-ABL1 fusion transcripts, respectively), and molecularly undetectable leukemia (MUL). 2, 3 It seems intuitive that the deeper the treatment response, the better the survival of patients with CML-CP is. 4, 5 However, multiple studies have shown that deeper responses beyond CCyR confer no survival benefit.…”

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confidence: 99%

Differential depth of treatment response required for optimal outcome in patients with blast phase versus chronic phase of chronic myeloid leukemia

Chen

Medeiros

Kantajian

et al. 2017

Blood Cancer Journal

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“…Current recommendations for the definition of MRs may be changed after accumulation of further data. Although we performed all experimental procedures with great care, the introduction of some errors caused by human factors cannot be completely excluded, as noted in a recent commentary (32).…”

Section: Discussionmentioning

confidence: 99%

A new highly sensitive real-time quantitative-PCR method for detection of BCR-ABL1 to monitor minimal residual disease in chronic myeloid leukemia after discontinuation of imatinib

Tabe

Kitamura

Tsuchiya

et al. 2018

Preprint

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21Tyrosine kinase inhibitors (TKIs) targeting the BCR-ABL1 fusion protein, encoded by the 22 Philadelphia chromosome, have drastically improved the outcomes for patients with 23 chronic myeloid leukemia (CML). Although several real-time quantitative polymerase 24 chain reaction (RQ-PCR) kits for the detection of BCR-ABL1 transcripts are 25 commercially available, their accuracy and efficiency in laboratory practice require 26 reevaluation. We have developed a new in-house RQ-PCR method to detect minimal 27 residual disease (MRD) in CML cases. MRD was analyzed in 102 patients with CML 28 from the DOMEST study, a clinical trial to study the rationale for imatinib mesylate 29 discontinuation in Japan. The BCR-ABL1/ABL1 ratio was evaluated using the 30 international standard (IS) ratio, where IS < 0.01% was defined as a major molecular 31 response. At enrollment, BCR-ABL1 transcripts were undetectable in all samples using a 32 widely-applied RQ-PCR method performed in the commercial laboratory, BML (BML 33Inc., Tokyo, Japan); however, the in-house method detected the BCR-ABL1 transcripts in 34 five samples (5%) (mean IS ratio: 0.0062 ± 0.0010%). After discontinuation of imatinib, 35BCR-ABL1 transcripts were detected using the in-house RQ-PCR in 21 patients (21%) 36 that were not positive using the BML method. Nineteen samples were also tested using a 37 commercially available RQ-PCR assay kit with a detection limit of IS ratio, 0.0007% Page3 38 (ODK-1201, Otsuka Pharmaceutical Co., Tokyo, Japan). This method detected low levels 39 of BCR-ABL1 transcripts in 14 samples (74%), but scored negative for five samples (26%) 40 that were positive using the in-house method. These data suggest that our new in-house 41 RQ-PCR method is effective for monitoring MRD in CML. 42 43 44 48 (t(9;22)(q34;q11.2)), referred to as the Philadelphia chromosome, which generates BCR-49 ABL1 fusion transcripts. The BCR-ABL1 protein constitutively activates tyrosine kinase 50

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Measurement ofBCR-ABL1transcripts on the International Scale in the United States: current status and best practices

Cited by 20 publications

References 44 publications

Treatment‐free remission with first‐ and second‐generation tyrosine kinase inhibitors

Treatment‐free remission with first‐ and second‐generation tyrosine kinase inhibitors

Differential depth of treatment response required for optimal outcome in patients with blast phase versus chronic phase of chronic myeloid leukemia

A new highly sensitive real-time quantitative-PCR method for detection of BCR-ABL1 to monitor minimal residual disease in chronic myeloid leukemia after discontinuation of imatinib

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