Standardization of molecular monitoring of CML: results and recommendations from the European treatment and outcome study
Autoři
WHITE, Helen E, Matthew SALMON, Francesco ALBANO, Christina Sos Auour ANDERSEN, Stefan BALABANOV, Gueorgui BALATZENKO, Gisela BARBANY, Jean-Michel CAYUELA, Nuno CERVEIRA, Pascale COCHAUX, Dolors COLOMER, Daniel CORIU, Joana DIAMOND, Christian DIETZ, Stephanie DULUCQ, Marie ENGVALL, Georg N FRANKE, Egle GINEIKIENE-VALENTINE, Michal GNIOT, Maria Teresa GOMEZ-CASARES, Enrico GOTTARDI, Chloe HAYDEN, Sandrine HAYETTE, Andreas HEDBLOM, Anca ILEA, Barbara IZZO, Antonio JIMENEZ-VELASCO, Tomáš JURČEK (203 Česká republika, domácí), Veli KAIRISTO, Stephen E LANGABEER, Thomas LION, Nora MEGGYESI, Semir MESANOVIC, Luboslav MIHOK, Gerlinde MITTERBAUER-HOHENDANNER, Sylvia MOECKEL, Nicole NAUMANN, Olivier NIBOUREL, Oppliger Leibundgut ELISABETH, Panayiotis PANAYIOTIDIS, Helena PODGORNIK, Christiane POTT, Inmaculada RAPADO, Susan J ROSE, Vivien SCHAEFER, Tasoula TOULOUMENIDOU, Christopher VEIGAARD, Bianca VENNIKER-PUNT, Claudia VENTURI, Paolo VIGNERI, Ingvild VORKINN, Elizabeth WILKINSON, Renata ZADRO, Magdalena ZAWADA, Hana ZIZKOVA, Martin C MUELLER, Susanne SAUSSELE, Thomas ERNST, Katerina MACHOVA POLAKOVA, Andreas HOCHHAUS a Nicholas C P CROSS (garant)
Standardized monitoring of BCR::ABL1 mRNA levels is essential for the management of chronic myeloid leukemia (CML) patients. From 2016 to 2021 the European Treatment and Outcome Study for CML (EUTOS) explored the use of secondary, lyophilized cell-based BCR::ABL1 reference panels traceable to the World Health Organization primary reference material to standardize and validate local laboratory tests. Panels were used to assign and validate conversion factors (CFs) to the International Scale and assess the ability of laboratories to assess deep molecular response (DMR). The study also explored aspects of internal quality control. The percentage of EUTOS reference laboratories (n = 50) with CFs validated as optimal or satisfactory increased from 67.5% to 97.6% and 36.4% to 91.7% for ABL1 and GUSB, respectively, during the study period and 98% of laboratories were able to detect MR4.5 in most samples. Laboratories with unvalidated CFs had a higher coefficient of variation for BCR::ABL1(IS) and some laboratories had a limit of blank greater than zero which could affect the accurate reporting of DMR. Our study indicates that secondary reference panels can be used effectively to obtain and validate CFs in a manner equivalent to sample exchange and can also be used to monitor additional aspects of quality assurance.
WHITE, Helen E, Matthew SALMON, Francesco ALBANO, Christina Sos Auour ANDERSEN, Stefan BALABANOV, Gueorgui BALATZENKO, Gisela BARBANY, Jean-Michel CAYUELA, Nuno CERVEIRA, Pascale COCHAUX, Dolors COLOMER, Daniel CORIU, Joana DIAMOND, Christian DIETZ, Stephanie DULUCQ, Marie ENGVALL, Georg N FRANKE, Egle GINEIKIENE-VALENTINE, Michal GNIOT, Maria Teresa GOMEZ-CASARES, Enrico GOTTARDI, Chloe HAYDEN, Sandrine HAYETTE, Andreas HEDBLOM, Anca ILEA, Barbara IZZO, Antonio JIMENEZ-VELASCO, Tomáš JURČEK, Veli KAIRISTO, Stephen E LANGABEER, Thomas LION, Nora MEGGYESI, Semir MESANOVIC, Luboslav MIHOK, Gerlinde MITTERBAUER-HOHENDANNER, Sylvia MOECKEL, Nicole NAUMANN, Olivier NIBOUREL, Oppliger Leibundgut ELISABETH, Panayiotis PANAYIOTIDIS, Helena PODGORNIK, Christiane POTT, Inmaculada RAPADO, Susan J ROSE, Vivien SCHAEFER, Tasoula TOULOUMENIDOU, Christopher VEIGAARD, Bianca VENNIKER-PUNT, Claudia VENTURI, Paolo VIGNERI, Ingvild VORKINN, Elizabeth WILKINSON, Renata ZADRO, Magdalena ZAWADA, Hana ZIZKOVA, Martin C MUELLER, Susanne SAUSSELE, Thomas ERNST, Katerina MACHOVA POLAKOVA, Andreas HOCHHAUS a Nicholas C P CROSS. Standardization of molecular monitoring of CML: results and recommendations from the European treatment and outcome study. Leukemia. London: Nature Publishing Group, 2022, roč. 36, č. 7, s. 1834-1842. ISSN 0887-6924. Dostupné z: https://dx.doi.org/10.1038/s41375-022-01607-z.
@article{2247605, author = {White, Helen E and Salmon, Matthew and Albano, Francesco and Andersen, Christina Sos Auour and Balabanov, Stefan and Balatzenko, Gueorgui and Barbany, Gisela and Cayuela, JeanandMichel and Cerveira, Nuno and Cochaux, Pascale and Colomer, Dolors and Coriu, Daniel and Diamond, Joana and Dietz, Christian and Dulucq, Stephanie and Engvall, Marie and Franke, Georg N and GineikieneandValentine, Egle and Gniot, Michal and GomezandCasares, Maria Teresa and Gottardi, Enrico and Hayden, Chloe and Hayette, Sandrine and Hedblom, Andreas and Ilea, Anca and Izzo, Barbara and JimenezandVelasco, Antonio and Jurček, Tomáš and Kairisto, Veli and Langabeer, Stephen E and Lion, Thomas and Meggyesi, Nora and Mesanovic, Semir and Mihok, Luboslav and MitterbauerandHohendanner, Gerlinde and Moeckel, Sylvia and Naumann, Nicole and Nibourel, Olivier and Elisabeth, Oppliger Leibundgut and Panayiotidis, Panayiotis and Podgornik, Helena and Pott, Christiane and Rapado, Inmaculada and Rose, Susan J and Schaefer, Vivien and Touloumenidou, Tasoula and Veigaard, Christopher and VennikerandPunt, Bianca and Venturi, Claudia and Vigneri, Paolo and Vorkinn, Ingvild and Wilkinson, Elizabeth and Zadro, Renata and Zawada, Magdalena and Zizkova, Hana and Mueller, Martin C and Saussele, Susanne and Ernst, Thomas and Machova Polakova, Katerina and Hochhaus, Andreas and Cross, Nicholas C P}, article_location = {London}, article_number = {7}, doi = {http://dx.doi.org/10.1038/s41375-022-01607-z}, keywords = {CML; molecular monitoring;standardization}, language = {eng}, issn = {0887-6924}, journal = {Leukemia}, title = {Standardization of molecular monitoring of CML: results and recommendations from the European treatment and outcome study}, url = {https://www.nature.com/articles/s41375-022-01607-z}, volume = {36}, year = {2022} }
TY - JOUR ID - 2247605 AU - White, Helen E - Salmon, Matthew - Albano, Francesco - Andersen, Christina Sos Auour - Balabanov, Stefan - Balatzenko, Gueorgui - Barbany, Gisela - Cayuela, Jean-Michel - Cerveira, Nuno - Cochaux, Pascale - Colomer, Dolors - Coriu, Daniel - Diamond, Joana - Dietz, Christian - Dulucq, Stephanie - Engvall, Marie - Franke, Georg N - Gineikiene-Valentine, Egle - Gniot, Michal - Gomez-Casares, Maria Teresa - Gottardi, Enrico - Hayden, Chloe - Hayette, Sandrine - Hedblom, Andreas - Ilea, Anca - Izzo, Barbara - Jimenez-Velasco, Antonio - Jurček, Tomáš - Kairisto, Veli - Langabeer, Stephen E - Lion, Thomas - Meggyesi, Nora - Mesanovic, Semir - Mihok, Luboslav - Mitterbauer-Hohendanner, Gerlinde - Moeckel, Sylvia - Naumann, Nicole - Nibourel, Olivier - Elisabeth, Oppliger Leibundgut - Panayiotidis, Panayiotis - Podgornik, Helena - Pott, Christiane - Rapado, Inmaculada - Rose, Susan J - Schaefer, Vivien - Touloumenidou, Tasoula - Veigaard, Christopher - Venniker-Punt, Bianca - Venturi, Claudia - Vigneri, Paolo - Vorkinn, Ingvild - Wilkinson, Elizabeth - Zadro, Renata - Zawada, Magdalena - Zizkova, Hana - Mueller, Martin C - Saussele, Susanne - Ernst, Thomas - Machova Polakova, Katerina - Hochhaus, Andreas - Cross, Nicholas C P PY - 2022 TI - Standardization of molecular monitoring of CML: results and recommendations from the European treatment and outcome study JF - Leukemia VL - 36 IS - 7 SP - 1834-1842 EP - 1834-1842 PB - Nature Publishing Group SN - 08876924 KW - CML KW - molecular monitoring;standardization UR - https://www.nature.com/articles/s41375-022-01607-z N2 - Standardized monitoring of BCR::ABL1 mRNA levels is essential for the management of chronic myeloid leukemia (CML) patients. From 2016 to 2021 the European Treatment and Outcome Study for CML (EUTOS) explored the use of secondary, lyophilized cell-based BCR::ABL1 reference panels traceable to the World Health Organization primary reference material to standardize and validate local laboratory tests. Panels were used to assign and validate conversion factors (CFs) to the International Scale and assess the ability of laboratories to assess deep molecular response (DMR). The study also explored aspects of internal quality control. The percentage of EUTOS reference laboratories (n = 50) with CFs validated as optimal or satisfactory increased from 67.5% to 97.6% and 36.4% to 91.7% for ABL1 and GUSB, respectively, during the study period and 98% of laboratories were able to detect MR4.5 in most samples. Laboratories with unvalidated CFs had a higher coefficient of variation for BCR::ABL1(IS) and some laboratories had a limit of blank greater than zero which could affect the accurate reporting of DMR. Our study indicates that secondary reference panels can be used effectively to obtain and validate CFs in a manner equivalent to sample exchange and can also be used to monitor additional aspects of quality assurance. ER -
WHITE, Helen E, Matthew SALMON, Francesco ALBANO, Christina Sos Auour ANDERSEN, Stefan BALABANOV, Gueorgui BALATZENKO, Gisela BARBANY, Jean-Michel CAYUELA, Nuno CERVEIRA, Pascale COCHAUX, Dolors COLOMER, Daniel CORIU, Joana DIAMOND, Christian DIETZ, Stephanie DULUCQ, Marie ENGVALL, Georg N FRANKE, Egle GINEIKIENE-VALENTINE, Michal GNIOT, Maria Teresa GOMEZ-CASARES, Enrico GOTTARDI, Chloe HAYDEN, Sandrine HAYETTE, Andreas HEDBLOM, Anca ILEA, Barbara IZZO, Antonio JIMENEZ-VELASCO, Tomáš JURČEK, Veli KAIRISTO, Stephen E LANGABEER, Thomas LION, Nora MEGGYESI, Semir MESANOVIC, Luboslav MIHOK, Gerlinde MITTERBAUER-HOHENDANNER, Sylvia MOECKEL, Nicole NAUMANN, Olivier NIBOUREL, Oppliger Leibundgut ELISABETH, Panayiotis PANAYIOTIDIS, Helena PODGORNIK, Christiane POTT, Inmaculada RAPADO, Susan J ROSE, Vivien SCHAEFER, Tasoula TOULOUMENIDOU, Christopher VEIGAARD, Bianca VENNIKER-PUNT, Claudia VENTURI, Paolo VIGNERI, Ingvild VORKINN, Elizabeth WILKINSON, Renata ZADRO, Magdalena ZAWADA, Hana ZIZKOVA, Martin C MUELLER, Susanne SAUSSELE, Thomas ERNST, Katerina MACHOVA POLAKOVA, Andreas HOCHHAUS a Nicholas C P CROSS. Standardization of molecular monitoring of CML: results and recommendations from the European treatment and outcome study. \textit{Leukemia}. London: Nature Publishing Group, 2022, roč.~36, č.~7, s.~1834-1842. ISSN~0887-6924. Dostupné z: https://dx.doi.org/10.1038/s41375-022-01607-z.