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Rationale for the recommendations for harmonizing current methodology for detecting BCR-ABL transcripts in patients with chronic myeloid leukaemia

Leukemia volume 20, pages 1925–1930 (2006)Cite this article

Abstract

Molecular monitoring for patients with chronic myeloid leukaemia (CML) has become an important practice in the era of imatinib therapy. For successful widespread introduction into the mainstream patient monitoring schedule, many procedural aspects of the complex real-time quantitative polymerase chain reaction (RQ-PCR) technique for measuring BCR-ABL transcripts require optimization. Recommendations for harmonizing the differing methodologies have recently been proposed. These recommendations were designed to maximize reliability of analysis for clinical decision making and proposed the adoption of an International Scale of measurement. The purpose of this review is to present the evidence and supporting data for specific recommendations. These recommendations include use of the same source of cells, either blood or marrow, for analysis; for validation of equal PCR amplification efficiencies of cDNA and standards when using a plasmid to construct standard curves and for ensuring ongoing high-level performance by undertaking a quality assurance programme. Clinicians must know the measurement reliability of an RQ-PCR assay to be able to determine the significance of a change in BCR-ABL level. An assay with poor precision limits the clinical usefulness of results. International harmonization should establish RQ-PCR measurement of BCR-ABL as the best method for monitoring treatment response for patients with CML.

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Acknowledgements

This work was supported in part by grants from Novartis Pharmaceuticals and the European LeukemiaNet.

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Authors and Affiliations

  1. Division of Molecular Pathology, Institute of Medical and Veterinary Science, Adelaide, South Australia

    S Branford

  2. National Genetics Reference Laboratory, University of Southampton, Salisbury, UK

    N C P Cross

  3. Faculty of Clinical Medicine Mannheim, University of Heidelberg, Mannheim, Germany

    A Hochhaus

  4. Divisions of Clinical Research, Fred Hutchinson Cancer Research Center, Seattle, USA

    J Radich

  5. Division of Hematology and Internal Medicine, University of Turin, Orbassano, Italy

    G Saglio

  6. Department of Haematology, Imperial College at Hammersmith Hospital, London, UK

    J Kaeda

  7. Hematology Branch, National Heart, Lung & Blood Institute, NIH, Bethesda, MD, USA

    J Goldman

  8. Division of Haematology, Institute of Medical and Veterinary Science, Adelaide, South Australia

    T Hughes

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Correspondence to S Branford.

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Branford, S., Cross, N., Hochhaus, A. et al. Rationale for the recommendations for harmonizing current methodology for detecting BCR-ABL transcripts in patients with chronic myeloid leukaemia. Leukemia 20, 1925–1930 (2006). https://doi.org/10.1038/sj.leu.2404388

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