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Chronic Myeloid Leukemia |
1 Department of Pathology, Laboratory of Molecular Pathology, Haartman Institute and HUSLAB, Helsinki, Finland;
2 Hematology Research Unit, Biomedicum Helsinki, Helsinki, Finland;
3 Department of Clinical Genetics, University of Oulu and Oulu University Hospital, Oulu, Finland;
4 TYKSLAB, Turku University Hospital Laboratories, Turku, Finland;
5 III. Medizinische Klinik, Medizinische Fakultaet Mannheim der Universitaet Heidelberg, Mannheim, Germany
6 Department of Clinical Chemistry, HUSLAB, Laboratory of Hematology, Helsinki University Central Hospital, Helsinki, Finland;
7 Department of Medical Genetics, University of Turku, Turku, Finland and
8 Department of Medicine, Division of Hematology, Helsinki University Central Hospital, Helsinki, Finland
Correspondence: Sakari Knuutila, Laboratory of Molecular Pathology, HUSLAB, Haartmaninkatu 3, PO BOX 400, 00029 Helsinki, Finland. E-mail: sakari.knuutila{at}helsinki.fi
Background: Recently, an International Scale was proposed for standardizing BCR-ABL transcript measurements and reporting in the assessment of minimal residual disease by real-time quantitative polymerase chain reaction (RQ-PCR). Here we present the setting up of the International Scale conversion factors for a national laboratory by performing both a cross-analysis of a set of standard samples from a reference laboratory and an analysis of bone marrow and peripheral blood samples at diagnosis (from 32 and 27 patients, respectively).
Design and Methods: A total of 222 bone marrow and 173 peripheral blood mononuclear cell samples from 96 patients with chronic myeloid leukemia were analyzed with RQ-PCR according to Europe Against Cancer protocols. Additionally, 291 bone marrow samples were analyzed with high mitotic index metaphase fluorescence in situ hybridization (metaphase FISH).
Results: Major molecular response according to the International Scale in BCR-ABL/GUS transcript levels corresponded to a ratio of 0.035% in peripheral blood and 0.034% in bone marrow, yielding the same conversion factor of 2.86 for both types of sample. Based on metaphase FISH, values of 10%/–1.0 log, 1%/–2.0 log and 0.1%/–3.0 log on the International Scale, corresponded to 13%, 2%, and 0.3% of Philadelphia chromosome positive cells in bone marrow, respectively.
Conclusions: In conclusion, conversion factors can be determined either by cross-analyzing a number of samples with a laboratory that has already established the International Scale or utilizing sufficient numbers of reference samples from chronic myeloid leukemia patients at diagnosis, or using the upcoming international standards.
Key words: chronic myeloid leukemia, minimal residual disease, BCR-ABL, real time quantitative PCR, standardization.
Related Article
Haematologica 2008 93: 161-169.
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  M. Baccarani, F. Pane, and G. Saglio Monitoring treatment of chronic myeloid leukemia Haematologica, February 1, 2008; 93(2): 161 - 169. [Full Text] [PDF]
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