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Defining therapy goals for major molecular remission in chronic myeloid leukemia: results of the randomized CML Study IV

Please always quote using this URN: urn:nbn:de:bvb:20-opus-227528
  • Major molecular remission (MMR) is an important therapy goal in chronic myeloid leukemia (CML). So far, MMR is not a failure criterion according to ELN management recommendation leading to uncertainties when to change therapy in CML patients not reaching MMR after 12 months. At monthly landmarks, for different molecular remission status Hazard ratios (HR) were estimated for patients registered to CML study IV who were divided in a learning and a validation sample. The minimum HR for MMR was found at 2.5 years with 0.28 (compared to patientsMajor molecular remission (MMR) is an important therapy goal in chronic myeloid leukemia (CML). So far, MMR is not a failure criterion according to ELN management recommendation leading to uncertainties when to change therapy in CML patients not reaching MMR after 12 months. At monthly landmarks, for different molecular remission status Hazard ratios (HR) were estimated for patients registered to CML study IV who were divided in a learning and a validation sample. The minimum HR for MMR was found at 2.5 years with 0.28 (compared to patients without remission). In the validation sample, a significant advantage for progression-free survival (PFS) for patients in MMR could be detected (p-value 0.007). The optimal time to predict PFS in patients with MMR could be validated in an independent sample at 2.5 years. With our model we provide a suggestion when to define lack of MMR as therapy failure and thus treatment change should be considered. The optimal response time for 1% BCR-ABL at about 12-15 months was confirmed and for deep molecular remission no specific time point was detected. Nevertheless, it was demonstrated that the earlier the MMR is achieved the higher is the chance to attain deep molecular response later.show moreshow less

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Metadaten
Author: Susanne Saussele, Ruediger Hehlmann, Alice Fabarius, Sabine Jeromin, Ulrike Proetel, Sebastien Rinaldetti, Katharina Kohlbrenner, Hermann Einsele, Christine Falge, Lothar Kanz, Andreas Neubauer, Michael Kneba, Frank Stegelmann, Michael Pfreundschuh, Cornelius F. Waller, Elisabeth Oppliger Leibundgut, Dominik Heim, Stefan W. Krause, Wolf-Karsten Hofmann, Joerg Hasford, Markus Pfirrmann, Martin C. Müller, Andreas Hochhaus, Michael Lauseker
URN:urn:nbn:de:bvb:20-opus-227528
Document Type:Journal article
Faculties:Medizinische Fakultät / Medizinische Klinik und Poliklinik II
Language:English
Parent Title (English):Leukemia
Year of Completion:2018
Volume:32
Issue:5
Pagenumber:1222-1228
Source:Leukemia (2018) 32:1222–1228
DOI:https://doi.org/10.1038/s41375-018-0055-7
Dewey Decimal Classification:6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit
Tag:Chronic myeloid leukaemia; Molecularly targeted therapy; Risk factors; Risk factors; Translational research
Release Date:2021/11/23
Licence (German):License LogoCC BY-NC-SA: Creative-Commons-Lizenz: Namensnennung, Nicht kommerziell, Weitergabe unter gleichen Bedingungen 4.0 International