Cross, N.C.P., White, H., Müller, M.C., Saglio, G. and Hochhaus, A.
Standardized definitions of molecular response in chronic myeloid leukemia
Leukemia, 26, (10), . (doi:10.1038/leu.2012.104). (PMID:22504141).
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The International Randomized Study of Interferon and STI571 (IRIS) study demonstrated long-term cytogenetic responses in patients with chronic-phase chronic myeloid leukemia (CML-CP) treated with the tyrosine kinase inhibitor (TKI) imatinib. However, deep molecular responses (MRs), as measured by reductions in BCR-ABL transcript levels below the threshold of major molecular response (MMR), were achieved only by a small proportion of patients. With the advent of the second-generation TKIs nilotinib and dasatinib for the treatment of patients with newly diagnosed CML-CP, the proportion of patients who achieve the deepest levels of MR is likely to increase significantly. With these changes, the potential for patient eligibility in TKI cessations studies is becoming a more widely discussed topic and area for research. These recent and dramatic shifts in the CML treatment paradigm highlight the need for robust, standardized and workable definitions of deep molecular responses. Specifically, it is critical that the measurement of MR is standardized in a manner to withstand both intra- and inter-laboratory variability as well as new methodological developments. This review summarizes the relevant clinical background and proposes a framework within which standardization of MR can be taken forward
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