Vol 5, No 1 (2014)
Review paper
Published online: 2014-05-23

open access

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Comparing the efficacy of nilotinib and imatinib in the first line treatment of chronic myelogenous leukaemia during its chronic phase and their effects on long term outcomes…

Tomasz Sacha
Hematologia 2014;5(1):22-29.

Abstract

The ENESTnd trial compares the efficacy of nilotinib and imatinib as the first line treatment of patients in chronic phase of chronic myelogenous leukemia (CML). The primary endpoint of the ENESTnd trial is the comparison of major molecular response rate after 12 months for patients treated with nilotinib vs. imatinib. Five years of follow-up confirms the superior efficacy of nilotinib over imatinib. In patients with chronic phase of early molecular response is associated with improved outcome. After the first 3 months of treatment, deep molecular responses were more frequently noted in those patients achieving a reduction of up to ≤ 10% in BCR-ABL1 levels, whereevent-free and overall survival were also greatly improved. Significantly more patients on frontlinenilotinib achieved BCR-ABL1 ≤ 10% and ≤ 1% at 3 months irrespective of the Sokal risk score. The ENESTcmr study was focused on patients with complete cytogenetic response and detectable BCR-ABL1 transcripts, where the deep molecular response rate was compared between those being treated with imatinib for 2 following years to those who after 24 months had switched to nilotnib. For the latter group, the confirmed rates of undetectable BCR-ABL1 and MR4.5 observed after 24 months were significantly higher and responses achieved faster compared to imatinib, with a median time to MR4.5 shorter by over a year. None of the imatinib treated patients with detectable BCR-ABL1 at 2 years, showed complete absence of this transcript after another treatment year. After 3 years, the ENESTcmr findings thus support the strategy of switching to nilotinib in those patients where the therapeutic aim is to achieve deep molecular responses, thereby making it possible to qualify them for safe tyrosine kinase inhibitor-free remission trials.



Hematology in Clinical Practice