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Multicenter Study
. 2018 Feb;180(3):356-364.
doi: 10.1111/bjh.15042. Epub 2017 Dec 19.

Nilotinib After Imatinib First-Line: A Real-Life Longitudinal Cohort of Patients With Chronic Myeloid Leukaemia in Chronic Phase

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Multicenter Study

Nilotinib After Imatinib First-Line: A Real-Life Longitudinal Cohort of Patients With Chronic Myeloid Leukaemia in Chronic Phase

Pascale Cony-Makhoul et al. Br J Haematol. .

Abstract

This prospective, observational study enrolled 150 adult patients with chronic myeloid leukaemia (CML) in chronic phase (CP) treated with nilotinib as second-line after imatinib, in a real life setting in France. Two-thirds of patients switched to nilotinib treatment due to lack of imatinib efficacy. Of 146 evaluable patients, 16 (11·0%) (95% confidence interval: 6·4-17·2%) achieved uMR4 , defined as undetectable molecular disease in cDNA with MR4 sensitivity (≥10 000 ABL1 transcripts) at 18 months and confirmed at 24 months (primary endpoint). Among patients without major molecular response (MMR) or deep molecular response (DMR) at study entry, 66·3% achieved MMR and 44·2% DMR within a median of 5·7 and 6·24 months, respectively. Fifty-three patients (36·3%) have prematurely terminated the study before 24 months of follow-up, primarily due to nilotinib treatment discontinuation (n = 43; 29·5%), mainly motivated by treatment intolerance (n = 27; 18·5%) and inefficacy (n = 10; 6·8%). The most frequent extra-haematological adverse events (AEs) reported as related to treatment with nilotinib were pruritus (16·4%), asthenia (13·7%) and dry skin (13·0%). Ischaemic cardiovascular AEs were reported in 18 patients (12·3%). This French nationwide large cohort adds valuable information to the body of evidence on the efficiency and safety of nilotinib in the treatment of patients with CP-CML.

Keywords: BCR-ABL1; chronic myeloid leukaemia; nilotinib; real-life practice; second line treatment.

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