Omitting cytogenetic assessment from routine treatment response monitoring in chronic myeloid leukemia is safe

Geelen, Inge G.P.; Thielen, Noortje; Janssen, Jeroen; Hoogendoorn, Mels; Roosma, Tanja J.A.; Valk, Peter J.M.; Visser, Otto; Cornelissen, Jan J.; Westerweel, Peter E.

doi:10.1111/ejh.13023

Cited by 6 publications

(5 citation statements)

References 13 publications

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“…The role of molecular techniques to quantify the BCR-ABL1 transcript has become increasingly important, while the use of cytogenetic analyses diminished, as these are less sensitive and insufficiently informative. 1 Current European Leukemia Net (ELN) recommendations regarding response monitoring after first or second line TKI treatment rely primarily on the molecular response (MR), setting milestones at 3, 6 and 12 months based on welldefined BCR-ABL1 values with or without additional cytogenetics. 2 As TKI therapy does not fully eradicate the leukemic clone, it was initially thought that treatment would need to be continued indefinitely.…”

Section: Introductionmentioning

confidence: 99%

“…Since the advent of targeted therapy with tyrosine kinase inhibitors (TKI), the landscape of chronic myeloid leukemia (CML) changed drastically with markedly improved prognosis and many patients achieving deep molecular remissions. The role of molecular techniques to quantify the BCR‐ABL1 transcript has become increasingly important, while the use of cytogenetic analyses diminished, as these are less sensitive and insufficiently informative 1 . Current European Leukemia Net (ELN) recommendations regarding response monitoring after first or second line TKI treatment rely primarily on the molecular response (MR), setting milestones at 3, 6 and 12 months based on well‐defined BCR‐ABL1 values with or without additional cytogenetics 2 .…”

Section: Introductionmentioning

confidence: 99%

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Digital PCR for BCR‐ABL1 Quantification in CML: Current Applications in Clinical Practice

et al. 2020

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Molecular monitoring of the BCR-ABL1 transcript for patients with chronic phase chronic myeloid leukemia (CML) has become increasingly demanding. Real-time quantitative PCR (qPCR) is the routinely used method, but has limitations in quantification accuracy due to its inherent technical variation. Treatment recommendations rely on specific BCR-ABL1 values set at timed response milestones, making precise measurement of BCR-ABL1 a requisite. Furthermore, the sensitivity of qPCR may be insufficient to reliably quantify low levels of residual BCR-ABL1 in patients in deep molecular response (DMR) who could qualify for an attempt to discontinue Tyrosine Kinase Inhibitor (TKI) therapy. We reviewed the current use of digital PCR (dPCR) as a promising alternative for response monitoring in CML. dPCR offers an absolute BCR-ABL1 quantification at various disease levels with remarkable precision and a clinical sensitivity reaching down to at least MR5.0. Moreover, dPCR has been validated in multiple studies as prognostic marker for successful TKI treatment discontinuation, while this could not be achieved using classical qPCR. dPCR may thus prospectively be the preferred method to reliably identify patients achieving treatment milestones after initiation of TKI therapy as well as for the selection and timing for TKI discontinuation.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Digital PCR for BCR‐ABL1 Quantification in CML: Current Applications in Clinical Practice

et al. 2020

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“…The achievement of a complete cytogenetic response and/or a BCR-ABL1-value <1%IS or a two log reduction (CCyR/MR2.0) were pooled in the timeto-response analysis since they represent an equivalent disease burden. 6 However, in the main CICR analysis, patients without standardized (IS) molecular results were excluded. A Fine & Gray competing risks (CR) regression model was used for multivariable analysis including sex, age, EUTOS long term survival score (ELTS), leukocyte count at diagnosis and first-line TKI generation as covariates.…”

Section: The Use Of Hydroxyurea Pretreatment In Chronic Myeloid Leuke...mentioning

confidence: 99%

The use of hydroxyurea pretreatment in chronic myeloid leukemia in the current tyrosine kinase inhibitor era

et al. 2022

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“…Historically, bone marrow examination has formed a key component of evaluating response in CP CML, and has been performed until achievement of a CCyR. However, given that a 2-log reduction in BCR-ABL1 transcript levels roughly equates to a CCyR, many centres have moved towards only performing bone marrow cytogenetics after initial diagnosis in the setting of suspected treatment failure [30,63,64].…”

Section: Response Monitoring and Milestonesmentioning

confidence: 99%

Tyrosine Kinase Inhibitors in the Treatment of Chronic-Phase CML: Strategies for Frontline Decision-making

Kennedy

Hobbs

2018

Curr Hematol Malig Rep

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Extended follow-up of the seminal CML trials has demonstrated the long-term efficacy of TKIs, while also highlighting significant differences in their respective toxicity profiles and potency. Dasatinib and nilotinib generate deeper molecular responses than imatinib, particularly among patients with higher risk disease, but this has not translated into a significant survival advantage. Similar results have been obtained at 1 year with bosutinib; its efficacy and toxicity were well balanced at a dose of 400 mg daily, prompting its recent approval for this indication. Lastly, multiple studies have demonstrated that TKIs can be safely discontinued in select individuals who have maintained deep responses for extended periods, establishing treatment-free remission as a novel goal in CP CML. The careful consideration of parameters such as disease risk, the potency, and toxicity profile of each TKI, as well as each patient's unique comorbidities and preferences, enables truly individualized therapeutic decision-making in CP CML, with the goal of ensuring that a high quality of life accompanies the survival advantage conferred by these agents.

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Omitting cytogenetic assessment from routine treatment response monitoring in chronic myeloid leukemia is safe

Cited by 6 publications

References 13 publications

Digital PCR for BCR‐ABL1 Quantification in CML: Current Applications in Clinical Practice

Digital PCR for BCR‐ABL1 Quantification in CML: Current Applications in Clinical Practice

The use of hydroxyurea pretreatment in chronic myeloid leukemia in the current tyrosine kinase inhibitor era

Tyrosine Kinase Inhibitors in the Treatment of Chronic-Phase CML: Strategies for Frontline Decision-making

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