Abstract
Molecular pathologists play a central role in monitoring disease response in patients with chronic myeloid leukemia (CML). Imatinib, nilotinib, and dasatinib regimens have been shown to be highly effective therapies in the management of this disease. Optimal benefit from these agents depends on regular molecular monitoring of disease burden, achieved through measurements of transcript levels of the BCR-ABL chimeric gene. Major molecular response is a key milestone that correlates with improved long-term outcomes and has recently been shown to predict increased survival. Because of the clinical importance of accurate BCR-ABL monitoring, laboratory reports of BCR-ABL levels must be accurate, relevant, and readily understood by physicians. We discuss herein the key areas for optimizing BCR-ABL reports and emerging technologies for standardization and automation of these processes. * CML : chronic myeloid leukemia ABL1 : c-abl oncogene 1 BCR : breakpoint cluster gene Ph : Philadelphia chromosome NCCN : National Comprehensive Cancer Network ELN : European LeukemiaNet qRT-PCR : quantitative real-time polymerase chain reaction MMR : major molecular response IRIS : International Randomized Study of Interferon and STI571 CMR : complete molecular response EAC : Europe Against Cancer ABL : Abelson B2M : beta-2-microglobulin GUSB : beta-glucuronidase IS : International Scale CAP : College of American Pathologists TKI : tyrosine kinase inhibitor LOD : limit of detection NCN : normalized copy number
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