Journal
LEUKEMIA
Volume 29, Issue 5, Pages 1123-1132Publisher
NATURE PUBLISHING GROUP
DOI: 10.1038/leu.2015.36
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Funding
- Deutsche Krebshilfe, Germany [106642]
- Deutsches Kompetenznetz fur Akute und Chronische Leukamien (BMBF), Germany [01GI0270]
- Deutsche Jose-Carreras Leukamiestiftung (DJCLS), Germany [H09/01 f, H06/04v, H03/01, R05/23]
- European LeukemiaNet, Germany [LSHC-CT-2004-503216]
- Novartis, Nurnberg, Germany
- Roche, Grenzach-Wyhlen, Germany
- Essex Pharma, Munich, Germany
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Tyrosine kinase inhibitors (TKI) have changed the natural course of chronic myeloid leukemia (CML). With the advent of secondgeneration TKI safety and efficacy issues have gained interest. The randomized CML-Study IV was used for a long-term evaluation of imatinib (IM). 1503 patients have received IM, 1379 IM monotherapy. After a median observation of 7.1 years, 965 patients (64%) still received IM. At 10 years, progression-free survival was 82%, overall survival 84%, 59% achieved MR5, 72% MR4.5, 81% MR4, 89% major molecular remission and 92% MR2 (molecular equivalent to complete cytogenetic remission). All response levels were reached faster with IM800 mg except MR5. Eight-year probabilities of adverse drug reactions (ADR) were 76%, of grades 3-4 22%, of non-hematologic 73%, and of hematologic 28%. More ADR were observed with IM800 mg and IM400 mg plus interferon alpha (IFN). Most patients had their first ADR early with decreasing frequency later on. No new late toxicity was observed. ADR to IM are frequent, but mostly mild and manageable, also with IM 800 mg and IM 400 mg+IFN. The deep molecular response rates indicate that most patients are candidates for IM discontinuation. After 10 years, IM continues to be an excellent initial choice for most patients with CML.
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