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@article{1593317, author = {Mobius, Susanne and Schenk, Thomas and Himsel, Danny and Maier, Jacqueline and Franke, GeorgandNikolaus and Saussele, Susanne and Pott, Christiane and Andrikovics, Hajnalka and Meggyesi, Nora and MachovaandPolakova, Katerina and Zizkova, Hana and Jurček, Tomáš and Mesanovic, Semir and Zadro, Renata and Gottardi, Enrico and Haenig, Jens and Schuld, Peter and Cross, Nicholas C. P. and Hochhaus, Andreas and Ernst, Thomas}, article_number = {6}, doi = {http://dx.doi.org/10.1007/s00432-019-02910-6}, keywords = {Chronic myeloid leukemia; CML; BCR-ABL; Molecular monitoring; Deep molecular remission; Treatment-free remission; TFR; Standardization; Eureka}, language = {eng}, issn = {0171-5216}, journal = {Journal of cancer research and clinical oncology}, title = {Results of the European survey on the assessment of deep molecular response in chronic phase CML patients during tyrosine kinase inhibitor therapy (EUREKA registry)}, url = {http://dx.doi.org/10.1007/s00432-019-02910-6}, volume = {145}, year = {2019} }
TY - JOUR ID - 1593317 AU - Mobius, Susanne - Schenk, Thomas - Himsel, Danny - Maier, Jacqueline - Franke, Georg-Nikolaus - Saussele, Susanne - Pott, Christiane - Andrikovics, Hajnalka - Meggyesi, Nora - Machova-Polakova, Katerina - Zizkova, Hana - Jurček, Tomáš - Mesanovic, Semir - Zadro, Renata - Gottardi, Enrico - Haenig, Jens - Schuld, Peter - Cross, Nicholas C. P. - Hochhaus, Andreas - Ernst, Thomas PY - 2019 TI - Results of the European survey on the assessment of deep molecular response in chronic phase CML patients during tyrosine kinase inhibitor therapy (EUREKA registry) JF - Journal of cancer research and clinical oncology VL - 145 IS - 6 SP - 1645-1650 EP - 1645-1650 PB - Springer-Verlag SN - 01715216 KW - Chronic myeloid leukemia KW - CML KW - BCR-ABL KW - Molecular monitoring KW - Deep molecular remission KW - Treatment-free remission KW - TFR KW - Standardization KW - Eureka UR - http://dx.doi.org/10.1007/s00432-019-02910-6 L2 - http://dx.doi.org/10.1007/s00432-019-02910-6 N2 - PurposeThe advent of tyrosine kinase inhibitor (TKI) therapies has revolutionized the treatment of chronic myeloid leukemia (CML). The European LeukemiaNet (ELN) recommends quantification of BCR-ABL1 transcripts by real-time quantitative PCR every 3months during TKI treatment. Since a proportion of patients in deep molecular response (DMR: MR4, MR4.5, MR5) maintain remission after treatment stop, assessment of DMR is crucial. However, systematically collected molecular data, monitored with sensitive standardized assays, are not available outside clinical trials.MethodsData were collected on the standardized assessment of molecular response in the context of real-life practice. BCR-ABL1 transcript levels after>2years of TKI therapy were evaluated for DMRby local laboratories as well as standardized EUTOS laboratories. Since standardized molecular monitoring is a prerequisite for treatment discontinuation, central surveillance of the performance of the participating laboratories was carried out.ResultsBetween 2014 and 2017, 3377 peripheral blood samples from 1117 CML patients were shipped to 11 standardized reference laboratories in six European countries. BCR-ABL1 transcript types were b3a2 (41.63%), b2a2 (29.99%), b2a2/b3a2 (3.58%) and atypical (0.54%). For 23.72% of the patients, the initial transcript type had not been reported. Response levels (EUTOS laboratory) were: no MMR, n=197 (6.51%); MMR, n=496 (16.40%); MR4, n=685 (22.64%); MR4.5, n=937 (30.98%); MR5, n=710 (23.47%). With a Cohen's kappa coefficient of 0.708, a substantial agreement between EUTOS-certified and local laboratories was shown.ConclusionsMulticenter DMR assessment is feasible in the context of real-life clinical practice in Europe. Information on the BCR-ABL1 transcript type at diagnosis is crucial to accurately monitor patients' molecular response during or after TKI therapy. ER -
MOBIUS, Susanne, Thomas SCHENK, Danny HIMSEL, Jacqueline MAIER, Georg-Nikolaus FRANKE, Susanne SAUSSELE, Christiane POTT, Hajnalka ANDRIKOVICS, Nora MEGGYESI, Katerina MACHOVA-POLAKOVA, Hana ZIZKOVA, Tomáš JURČEK, Semir MESANOVIC, Renata ZADRO, Enrico GOTTARDI, Jens HAENIG, Peter SCHULD, Nicholas C. P. CROSS, Andreas HOCHHAUS and Thomas ERNST. Results of the European survey on the assessment of deep molecular response in chronic phase CML patients during tyrosine kinase inhibitor therapy (EUREKA registry). \textit{Journal of cancer research and clinical oncology}. Springer-Verlag, 2019, vol.~145, No~6, p.~1645-1650. ISSN~0171-5216. Available from: https://dx.doi.org/10.1007/s00432-019-02910-6.
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