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




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 - Download this document for free, or read online. Document in PDF available to download.

Annals of Hematology

, Volume 93, Issue 7, pp 1167–1176

First Online: 22 March 2014Received: 14 February 2014Accepted: 17 February 2014DOI: 10.1007-s00277-014-2041-0

Cite this article as: Proetel, U., Pletsch, N., Lauseker, M. et al. Ann Hematol 2014 93: 1167. doi:10.1007-s00277-014-2041-0

Abstract

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

KeywordsChronic myeloid leukemia Older patients Different imatinib dose regimens Early applied higher imatinib dosages Data presented in part at the Congress of the European Hematology Association, Berlin, Germany, June 4–7, 2009; at the Annual Meeting of the American Society of Hematology, Orlando FL, USA, December 4–7, 2010; at the Annual Meeting of the German, Swiss, and Austrian Societies of Hematology and Oncology Basel, Switzerland, September 30–October 4, 2011; and at the Annual Meeting of the American Society of Hematology, New Orleans LA, USA, December 7–10, 2013.

Trial registration: ClinicalTrials.gov identifier: NCT00055874

UP and NP contributed equally to this manuscript.

Electronic supplementary materialThe online version of this article doi:10.1007-s00277-014-2041-0 contains supplementary material, which is available to authorized users.

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Author: Ulrike Proetel - Nadine Pletsch - Michael Lauseker - Martin C. Müller - Benjamin Hanfstein - Stefan W. Krause - Lida Kal

Source: https://link.springer.com/







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