By Shreeya Nanda, Senior medwireNews Reporter
The first-line treatment and monitoring of patients with chronic phase-chronic myeloid leukaemia (CML) is in accordance with the European LeukaemiaNet (ELN) recommendations, finds a real-world clinical practice study.
Of 697 patients attending consultations in clinical practice or a clinical trial over a 30-day period in 2013, 62.8% were receiving first-line treatment at the time of inclusion. The median duration since CML diagnosis was 4 years.
The majority (72.4%) of patients had been treated with the first-generation tyrosine kinase inhibitor (TKI) imatinib while 23.3% received the second-generation TKIs dasatinib or nilotinib.
Among 307 patients on first-line therapy in clinical practice, data on molecular response at 3, 6, 12 or 18 months was available for 87%, the research team reports in the British Journal of Haematology.
Cytogenetic response was assessed most often at 6 months, at 60.1% compared with 49.0% at 12 months and 34.1% at 18 months. By contrast, a higher proportion of patients underwent molecular monitoring at 12 months than at other timepoints, at 80.1% versus 74.0% at 6 months and 75.5% at 18 months.
The researchers highlight the effect of ELN recommendations on practice - for instance, cytogenetic response at 3 months was evaluated in 18.4% before 2009, rising to 43.7% subsequently, coinciding with the recommendation appearing in the 2009 update to the ELN guidelines. The evaluation of molecular response also increased after 2009, with, for instance, 27.6% of patients assessed at the 3-month timepoint before 2009 versus 81.6% after 2009.
Moreover, 35.8% of patients in clinical practice had not achieved major molecular response (BCR-ABL1 transcript level ≤0.1%) at 12 months; according to the 2013 update, these patients would fall into the warning category, say the study authors. Just 5.1% had BCR-ABL1 levels above 1% at this timepoint, corresponding to the definition of treatment failure. If treated today, this subset of patients would be recommended for a treatment switch, if alternatives were available, they add.
Gabriel Etienne, from Institut Bergonié in Bordeaux, France, and co-investigators summarise: "[T]his study, performed in an unselected everyday practice population of [chronic phase-CML] patients, suggests that monitoring of cytogenetic and molecular responses usually required in clinical trials and in line with ELN recommendations, seems to have been transferred to patients treated in real-life practice.
"The majority of patients still receiving first-line treatment are in optimal response, with few being classified as being in the warning area or [failing treatment]."
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Br J Haematol 2016; Advance online publication