Measurement of BCR-ABL1 transcripts on the International Scale in the United States: current status and best practices

References

• Faderl S, Talpaz M, Estrov Z, et al. The biology of chronic myeloid leukemia. N Engl J Med. 1999;341:164–172.
   PubMed Web of Science ®Google Scholar
• National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology – chronic myelogenous leukemia. NCCN Evidence Blocks; 2015. Version 1.2016 [Internet]. Available from: www.nccn.org.
   Google Scholar
• O’Brien SG, Guilhot F, Larson RA, et al. Imatinib compared with interferon and low-dose cytarabine for newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med. 2003;348:994–1004.
   PubMed Web of Science ®Google Scholar
• Kantarjian H, O’Brien S, Jabbour E, et al. Improved survival in chronic myeloid leukemia since the introduction of imatinib therapy: a single-institution historical experience. Blood. 2012;119:1981–1987.
   PubMed Web of Science ®Google Scholar
• Baccarani M, Deininger MW, Rosti G, et al. European LeukemiaNet recommendations for the management of chronic myeloid leukemia: 2013. Blood. 2013;122:872–884.
   PubMed Web of Science ®Google Scholar
• Deininger M, O’Brien SG, Guilhot F, et al. International randomized study of interferon vs STI571 (IRIS) 8-year follow up: sustained survival and low risk for progression or events in patients with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP) treated with imatinib. Blood. 2009;114:Abstract 1126.
   Web of Science ®Google Scholar
• Druker BJ, Guilhot F, O’Brien SG, et al. Five-year follow-up of patients receiving imatinib for chronic myeloid leukemia. N Engl J Med. 2006;355:2408–2417.
   PubMed Web of Science ®Google Scholar
• Hughes TP, Saglio G, Kantarjian HM, et al. Early molecular response predicts outcomes in patients with chronic myeloid leukemia in chronic phase treated with frontline nilotinib or imatinib. Blood. 2014;123:1353–1360.
   PubMed Web of Science ®Google Scholar
• Jabbour E, Kantarjian HM, Saglio G, et al. Early response with dasatinib or imatinib in chronic myeloid leukemia: 3-year follow-up from a randomized phase 3 trial (DASISION). Blood. 2014;123:494–500.
   PubMed Web of Science ®Google Scholar
• Hehlmann R, Müller MC, Lauseker M, et al. Deep molecular response is reached by the majority of patients treated with imatinib, predicts survival, and is achieved more quickly by optimized high-dose imatinib: results from the randomized CML-Study IV. J Clin Oncol. 2014;32:415–423.
   PubMed Web of Science ®Google Scholar
• Etienne G, Dulucq S, Nicolini FE, et al. Achieving deeper molecular response is associated with a better clinical outcome in chronic myeloid leukemia patients on imatinib frontline therapy. Haematologica. 2014;99:458–464.
   PubMed Web of Science ®Google Scholar
• Mahon FX, Etienne G. Deep molecular response in chronic myeloid leukemia: the new goal of therapy? Clin Cancer Res. 2014;20:310–322.
   PubMed Web of Science ®Google Scholar
• Press RD, Kamel-Reid S, Ang D. BCR-ABL1 RT-qPCR for monitoring the molecular response to tyrosine kinase inhibitors in chronic myeloid leukemia. J Mol Diagn. 2013;15:565–576.
   PubMed Web of Science ®Google Scholar
• Hughes T, Deininger M, Hochhaus A, et al. Monitoring CML patients responding to treatment with tyrosine kinase inhibitors: review and recommendations for harmonizing current methodology for detecting BCR-ABL transcripts and kinase domain mutations and for expressing results. Blood. 2006;108:28–37.
   PubMed Web of Science ®Google Scholar
• Branford S, Fletcher L, Cross NC, et al. Desirable performance characteristics for BCR-ABL measurement on an international reporting scale to allow consistent interpretation of individual patient response and comparison of response rates between clinical trials. Blood. 2008;112:3330–3338.
   PubMed Web of Science ®Google Scholar
• Cross NC, White HE, Müller MC, et al. Standardized definitions of molecular response in chronic myeloid leukemia. Leukemia. 2012;26:2172–2175.
   PubMed Web of Science ®Google Scholar
• Radich JP. How I monitor residual disease in chronic myeloid leukemia. Blood. 2009;114:3376–3381.
   PubMed Web of Science ®Google Scholar
• Luu MH, Press RD. BCR-ABL PCR testing in chronic myelogenous leukemia: molecular diagnosis for targeted cancer therapy and monitoring. Expert Rev Mol Diagn. 2013;13:749–762.
   PubMed Web of Science ®Google Scholar
• Akard LP, Wang YL. Translating trial-based molecular monitoring into clinical practice: importance of international standards and practical considerations for community practitioners. Clin. Lymphoma Myeloma Leuk. 2011;11:385–395.
   PubMed Web of Science ®Google Scholar
• Beillard E, Pallisgaard N, van der Velden VH, et al. Evaluation of candidate control genes for diagnosis and residual disease detection in leukemic patients using ‘real-time’ quantitative reverse-transcriptase polymerase chain reaction (RQ-PCR) – a Europe against cancer program. Leukemia. 2003;17:2474–2486.
   PubMed Web of Science ®Google Scholar
• Wang YL, Lee JW, Cesarman E, et al. Molecular monitoring of chronic myelogenous leukemia: identification of the most suitable internal control gene for real-time quantification of BCR-ABL transcripts. J Mol Diagn. 2006;8:231–239.
   PubMed Web of Science ®Google Scholar
• Lee JW, Chen Q, Knowles DM, et al. beta-Glucuronidase is an optimal normalization control gene for molecular monitoring of chronic myelogenous leukemia. J Mol Diagn. 2006;8:385–389.
   PubMed Web of Science ®Google Scholar
• Cross NC. Standardisation of molecular monitoring for chronic myeloid leukaemia. Best Pract Res Clin Haematol. 2009;22:355–365.
   PubMed Web of Science ®Google Scholar
• Branford S, Cross NC, Hochhaus A, et al. Rationale for the recommendations for harmonizing current methodology for detecting BCR-ABL transcripts in patients with chronic myeloid leukaemia. Leukemia. 2006;20:1925–1930.
   PubMed Web of Science ®Google Scholar
• Hughes TP, Kaeda J, Branford S, et al. Frequency of major molecular responses to imatinib or interferon alfa plus cytarabine in newly diagnosed chronic myeloid leukemia. N Engl J Med. 2003;349:1423–1432.
   PubMed Web of Science ®Google Scholar
• White HE, Matejtschuk P, Rigsby P, et al. Establishment of the first World Health Organization International Genetic Reference Panel for quantitation of BCR-ABL mRNA. Blood. 2010;116:e111–e117.
   PubMed Web of Science ®Google Scholar
• White HE, Hedges J, Bendit I, et al. Establishment and validation of analytical reference panels for the standardization of quantitative BCR-ABL1 measurements on the international scale. Clin Chem. 2013;59:938–948.
   PubMed Web of Science ®Google Scholar
• Saleh MN, Haislip S, Sharpe J, et al. Assessment of treatment and monitoring patterns and subsequent outcomes among patients with chronic myeloid leukemia treated with imatinib in a community setting. Curr Med Res Opin. 2014;30:529–536.
   PubMed Web of Science ®Google Scholar
• Goldberg SL, Chen L, Guerin A, et al. Association between molecular monitoring and long-term outcomes in chronic myelogenous leukemia patients treated with first line imatinib. Curr Med Res Opin. 2013;29:1075–1082.
   PubMed Web of Science ®Google Scholar
• Guérin A, Chen L, Dea K, et al. Association between regular molecular monitoring and tyrosine kinase inhibitor therapy adherence in chronic myelogenous leukemia in the chronic phase. Curr Med Res Opin. 2014;30:1345–1352.
   PubMed Web of Science ®Google Scholar
• Guérin A, Chen L, Dea K, et al. Economic benefits of adequate molecular monitoring in patients with chronic myelogenous leukemia. J Med Econ. 2014;17:89–98.
   PubMedGoogle Scholar
• Hughes TP, Hochhaus A, Branford S, et al. Long-term prognostic significance of early molecular response to imatinib in newly diagnosed chronic myeloid leukemia: an analysis from the International Randomized Study of Interferon and STI571 (IRIS). Blood. 2010;116:3758–3765.
   PubMed Web of Science ®Google Scholar
• Quintas-Cardama A, Kantarjian H, Jones D, et al. Delayed achievement of cytogenetic and molecular response is associated with increased risk of progression among patients with chronic myeloid leukemia in early chronic phase receiving high-dose or standard-dose imatinib therapy. Blood. 2009;113:6315–6321.
   PubMed Web of Science ®Google Scholar
• Marin D, Ibrahim AR, Lucas C, et al. Assessment of BCR-ABL1 transcript levels at 3 months is the only requirement for predicting outcome for patients with chronic myeloid leukemia treated with tyrosine kinase inhibitors. J Clin Oncol. 2012;30:232–238.
   PubMed Web of Science ®Google Scholar
• Hanfstein B, Müller MC, Hehlmann R, et al. Early molecular and cytogenetic response is predictive for long-term progression-free and overall survival in chronic myeloid leukemia (CML). Leukemia. 2012;26:2096–2102.
   PubMed Web of Science ®Google Scholar
• Brümmendorf TH, Cortes JE, de Souza CA, et al. Bosutinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukaemia: results from the 24-month follow-up of the BELA trial. Br J Haematol. 2015;168:69–81.
   PubMed Web of Science ®Google Scholar
• Cross NCP, White HE, Colomer D, et al. Laboratory recommendations for scoring deep molecular response following treatment for chronic myeloid leukemia. Leukemia. 2015;29:999–1003.
   PubMed Web of Science ®Google Scholar
• Falchi L, Kantarjian HM, Wang X, et al. Significance of deeper molecular responses in patients with chronic myeloid leukemia in early chronic phase treated with tyrosine kinase inhibitors. Am J Hematol. 2013;88:1024–1029.
   PubMed Web of Science ®Google Scholar
• Kantarjian HM, Cortes J, Guilhot F, et al. Diagnosis and management of chronic myeloid leukemia: a survey of American and European practice patterns. Cancer. 2007;109:1365–1375.
   PubMed Web of Science ®Google Scholar
• Hermann R, Miller CB, Catchatorian R, et al. Understanding United States (US) treatment practices for the management of chronic myeloid leukemia (CML) in clinical practice: a US subgroup analysis of the WORLD CML Registry. Blood. 2012;120:Abstract 2781.
   Web of Science ®Google Scholar
• Di Bella NJ, Bhowmik D, Bhor M, et al. The effectiveness of tyrosine kinase inhibitors and molecular monitoring patterns in newly diagnosed patients with chronic myeloid leukemia in the community setting. Clin Lymphoma Myeloma Leuk. 2015;15:599–605.
   PubMed Web of Science ®Google Scholar
• Giles FJ. Molecular monitoring of BCR-ABL transcripts—standardization needed to properly use, and further investigate the value of, a critical surrogate marker for success in therapy of chronic myeloid leukemia. US Oncol Hematol. 2011;7:138–142.
   Google Scholar
• Zhang T, Grenier S, Nwachukwu B, et al. Inter-laboratory comparison of chronic myeloid leukemia minimal residual disease monitoring: summary and recommendations. J Mol Diagn. 2007;9:421–430.
   PubMed Web of Science ®Google Scholar
• Zhen C, Wang YL. Molecular monitoring of chronic myeloid leukemia: international standardization of BCR-ABL1 quantitation. J Mol Diagn. 2013;15:556–564.
   PubMed Web of Science ®Google Scholar
• Jennings LJ, Smith FA, Halling KC, et al. Design and analytic validation of BCR-ABL1 quantitative reverse transcription polymerase chain reaction assay for monitoring minimal residual disease. Arch Pathol Lab Med. 2012;136:33–40.
   PubMed Web of Science ®Google Scholar
• Müller MC, Cross NC, Erben P, et al. Harmonization of molecular monitoring of CML therapy in Europe. Leukemia. 2009;23:1957–1963.
   PubMed Web of Science ®Google Scholar