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
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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. / Proetel, Ulrike; Pletsch, Nadine; Lauseker, Michael; Müller, Martin C; Hanfstein, Benjamin; Krause, Stefan W; Kalmanti, Lida; Schreiber, Annette; Heim, Dominik; Baerlocher, Gabriela M; Hofmann, Wolf-Karsten; Lange, Elisabeth; Einsele, Hermann; Wernli, Martin; Kremers, Stephan; Schlag, Rudolf; Müller, Lothar; Hänel, Mathias; Link, Hartmut; Hertenstein, Bernd; Pfirrman, Markus; Hochhaus, Andreas; Hasford, Joerg; Hehlmann, Rüdiger; Saußele, Susanne; German Chronic Myeloid Leukemia Study Group.
in: ANN HEMATOL, Jahrgang 93, Nr. 7, 01.07.2014, S. 1167-76.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - 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
AU - Proetel, Ulrike
AU - Pletsch, Nadine
AU - Lauseker, Michael
AU - Müller, Martin C
AU - Hanfstein, Benjamin
AU - Krause, Stefan W
AU - Kalmanti, Lida
AU - Schreiber, Annette
AU - Heim, Dominik
AU - Baerlocher, Gabriela M
AU - Hofmann, Wolf-Karsten
AU - Lange, Elisabeth
AU - Einsele, Hermann
AU - Wernli, Martin
AU - Kremers, Stephan
AU - Schlag, Rudolf
AU - Müller, Lothar
AU - Hänel, Mathias
AU - Link, Hartmut
AU - Hertenstein, Bernd
AU - Pfirrman, Markus
AU - Hochhaus, Andreas
AU - Hasford, Joerg
AU - Hehlmann, Rüdiger
AU - Saußele, Susanne
AU - German Chronic Myeloid Leukemia Study Group
AU - Bokemeyer, Carsten
PY - 2014/7/1
Y1 - 2014/7/1
N2 - 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, 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: NCT00055874
AB - 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, 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: NCT00055874
KW - Adolescent
KW - Adult
KW - Age Factors
KW - Aged
KW - Aged, 80 and over
KW - Benzamides
KW - Dose-Response Relationship, Drug
KW - Female
KW - Humans
KW - Leukemia, Myelogenous, Chronic, BCR-ABL Positive
KW - Male
KW - Middle Aged
KW - Piperazines
KW - Protein Kinase Inhibitors
KW - Pyrimidines
KW - Treatment Outcome
KW - Young Adult
U2 - 10.1007/s00277-014-2041-0
DO - 10.1007/s00277-014-2041-0
M3 - SCORING: Journal article
C2 - 24658964
VL - 93
SP - 1167
EP - 1176
JO - ANN HEMATOL
JF - ANN HEMATOL
SN - 0939-5555
IS - 7
ER -
