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Older patients with chronic myeloid leukemia (≥65 years) profit more from higher imatinib doses than younger patients: a subanalysis of the randomized CML-Study IV

Please always quote using this URN: urn:nbn:de:bvb:20-opus-121574
  • The impact of imatinib dose on response rates and survival in older patients with chronic myeloid leukemia in chronic phase has not been studied well. We analyzed data from the German CML-Study IV, a randomized five-arm treatment optimization study in newly diagnosed BCR-ABL-positive chronic myeloid leukemia in chronic phase. Patients randomized to imatinib 400 mg/day (IM400) or imatinib 800 mg/day (IM800) and stratified according to age (≥65 years vs. <65 years) were compared regarding dose, response, adverse events, rates of progression, andThe impact of imatinib dose on response rates and survival in older patients with chronic myeloid leukemia in chronic phase has not been studied well. We analyzed data from the German CML-Study IV, a randomized five-arm treatment optimization study in newly diagnosed BCR-ABL-positive chronic myeloid leukemia in chronic phase. Patients randomized to imatinib 400 mg/day (IM400) or imatinib 800 mg/day (IM800) and stratified according to age (≥65 years vs. <65 years) were compared regarding dose, response, adverse events, rates of progression, and survival. The full 800 mg dose was given after a 6-week run-in period with imatinib 400 mg/day. The dose could then be reduced according to tolerability. A total of 828 patients were randomized to IM400 or IM800. Seven hundred eighty-four patients were evaluable (IM400, 382; IM800, 402). One hundred ten patients (29 %) on IM400 and 83 (21 %) on IM800 were ≥65 years. The median dose per day was lower for patients ≥65 years on IM800, with the highest median dose in the first year (466 mg/day for patients ≥65 years vs. 630 mg/day for patients <65 years). Older patients on IM800 achieved major molecular remission and deep molecular remission as fast as younger patients, in contrast to standard dose imatinib with which older patients achieved remissions much later than younger patients. Grades 3 and 4 adverse events were similar in both age groups. Five-year relative survival for older patients was comparable to that of younger patients. We suggest that the optimal dose for older patients is higher than 400 mg/day. ClinicalTrials.gov identifier: NCT00055874show moreshow less

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Metadaten
Author: Ulrike Proetel, Nadine Pletsch, Michael Lauseker, Martin C. Müller, Benjamin Hanfstein, Stefan W. Krause, Lida Kalmanti, Annette Schreiber, Dominik Heim, Gabriela M. Baerlocher, Wolf-Karsten Hofmann, Elisabeth Lange, Hermann Einsele, Martin Wernli, Stephan Kremers, Rudolf Schlag, Lothar Müller, Mathias Hänel, Hartmut Link, Bernd Hertenstein, Markus Pfirrmann, Andreas Hochhaus, Joerg Hasford, Rüdiger Hehlmann, Susanne Saußele
URN:urn:nbn:de:bvb:20-opus-121574
Document Type:Journal article
Faculties:Medizinische Fakultät / Medizinische Klinik und Poliklinik II
Language:English
Parent Title (English):Annals of Hematology
ISSN:0939-5555
Year of Completion:2014
Volume:93
Issue:7
Pagenumber:1167-76
Source:Annals of Hematology (2014) 93:1167–1176 DOI 10.1007/s00277-014-2041-0
DOI:https://doi.org/10.1007/s00277-014-2041-0
Pubmed Id:http://www.ncbi.nlm.nih.gov/pubmed?term=24658964
Dewey Decimal Classification:6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit
Tag:chronic myeloid leukemia; different imatinib dose regimens; early applied higher imatinib dosages; older patients
Release Date:2016/02/19
Contributing Corporation:for the German Chronic Myeloid Leukemia Study Group, and the Schweizerische Arbeitsgemeinschaft für Klinische Krebsforschung (SAKK)
Licence (German):License LogoCC BY: Creative-Commons-Lizenz: Namensnennung