Digital droplet PCR at the time of TKI discontinuation in chronic‐phase chronic myeloid leukemia patients is predictive of treatment‐free remission outcome

Colafigli, Gioia; Scalzulli, Emilia; Porrazzo, Marika; Diverio, Daniela; Loglisci, Maria Giovanna; Latagliata, Roberto; Guarini, Anna; Foà, Robin; Breccia, Massimo

doi:10.1002/hon.2650

Cited by 19 publications

(20 citation statements)

References 12 publications

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“…Moreover, the ddPCR was found to be more reproducible than RT-qPCR in all the disease levels, meeting the efforts made by the CML community to standardize the results [5,7,15]. The improved reproducibility and repeatability of ddPCR compared to RT-qPCR which we observed, may partly explain the reason for the superiority of ddPCR in predicting relapses in TFR patients [14,[21][22][23][24][25]. In the context of the imatinib suspension and validation (ISAV) study (NCT01578213), ddPCR was able to detect one BCR-ABL1 positive cell out of 10 7 cells, predicting relapse in CML patients after imatinib discontinuation [13].…”

Section: Discussionsupporting

confidence: 65%

Droplet Digital PCR for BCR–ABL1 Monitoring in Diagnostic Routine: Ready to Start?

Bochicchio

Petiti

Berchialla

et al. 2021

Cancers

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BCR–ABL1 mRNA levels represent the key molecular marker for the evaluation of minimal residual disease (MRD) in chronic myeloid leukemia (CML) patients and real-time quantitative PCR (RT-qPCR) is currently the standard method to monitor it. In the era of tyrosine kinase inhibitors (TKIs) discontinuation, droplet digital PCR (ddPCR) has emerged to provide a more precise detection of MRD. To hypothesize the use of ddPCR in clinical practice, we designed a multicentric study to evaluate the potential value of ddPCR in the diagnostic routine. Thirty-seven RNA samples from CML patients and five from healthy donors were analyzed using both ddPCR QXDxTMBCR-ABL %IS Kit and LabNet-approved RT-qPCR methodologies in three different Italian laboratories. Our results show that ddPCR has a good agreement with RT-qPCR, but it is more precise to quantify BCR–ABL1 transcript levels. Furthermore, we did not find differences between duplicate or quadruplicate analysis in terms of BCR–ABL1% IS values. Droplet digital PCR could be confidently introduced into the diagnostic routine as a complement to the RT-qPCR.

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Section: Discussionsupporting

confidence: 65%

Droplet Digital PCR for BCR–ABL1 Monitoring in Diagnostic Routine: Ready to Start?

Bochicchio

Petiti

Berchialla

et al. 2021

Cancers

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“…In recent years, digital PCR (dPCR) has emerged as one of the most promising tools. Some recent findings indicated that dPCR is more efficient than RQ-PCR for monitoring MRD in CML and contributes to selecting patients more compatible with TFR (37,(86)(87)(88). In the study by Nicolini et al, low levels of BCR-ABL1 were assessed by dPCR in 175 patients at the time of discontinuation of imatinib.…”

Section: The New Technology Of Molecular Monitoringmentioning

confidence: 99%

Treatment-Free Remission in Chronic Myeloid Leukemia and New Approaches by Targeting Leukemia Stem Cells

et al. 2021

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The therapeutic landscape for chronic myeloid leukemia (CML) has improved significantly with the approval of tyrosine kinase inhibitors (TKIs) for therapeutic use. Most patients with optimal responses to TKIs can have a normal life expectancy. Treatment-free remission (TFR) after discontinuing TKI has increasingly become a new goal for CML treatment. However, TKI only “control“ CML, and relapse after discontinuation has become a key factor hindering patient access to attempt TFR. In this study, we reviewed studies on TKI discontinuation, including both first and second-generation TKI. We also reviewed predictors of relapse, new monitoring methods, and strategies targeting leukemic stem cells.

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“…Enhanced detection methods also include digital droplet PCR, which was found to be predictive of TFR outcomes when tested at the time of TKI discontinuation in CP-CML patients (93). Notably, residual leukemic cell load determined by digital droplet PCR was one of two key factors for predicting a successful TFR in CP-CML patients (94).…”

Section: Enhanced Detection Methodsmentioning

confidence: 99%

Current Strategies and Future Directions to Achieve Deep Molecular Response and Treatment-Free Remission in Chronic Myeloid Leukemia

et al. 2020

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The treatment of chronic myeloid leukemia (CML) has been radically changed by the approval of tyrosine kinase inhibitors (TKIs), which target BCR-ABL1 kinase activity. CML is now managed as a chronic disease requiring long-term treatment and close molecular monitoring. It has been shown that in a substantial number of patients who have achieved a stable deep molecular response (DMR), TKI treatment can be safely discontinued without loss of response. Therefore, treatment-free remission (TFR), through the achievement of a DMR, is increasingly regarded as a feasible treatment goal in many CML patients. However, only nilotinib has approval in this setting and a number of controversial aspects remain regarding treatment choices and timings, predictive factors, patient communication, and optimal strategies to achieve successful TFR. This narrative review aims to provide a comprehensive overview on how to optimize the path to DMR and TFR in patients with CML, and discusses recent data and future directions.

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Digital droplet PCR at the time of TKI discontinuation in chronic‐phase chronic myeloid leukemia patients is predictive of treatment‐free remission outcome

Cited by 19 publications

References 12 publications

Droplet Digital PCR for BCR–ABL1 Monitoring in Diagnostic Routine: Ready to Start?

Droplet Digital PCR for BCR–ABL1 Monitoring in Diagnostic Routine: Ready to Start?

Treatment-Free Remission in Chronic Myeloid Leukemia and New Approaches by Targeting Leukemia Stem Cells

Current Strategies and Future Directions to Achieve Deep Molecular Response and Treatment-Free Remission in Chronic Myeloid Leukemia

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