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03-06-2016 | Chronic myeloid leukemia | Article

European LeukemiaNet recommendations for the management and avoidance of adverse events of treatment in chronic myeloid leukaemia

Authors: J L Steegmann, M Baccarani, M Breccia, L F Casado, V García-Gutiérrez, A Hochhaus, D-W Kim, T D Kim, H J Khoury, P Le Coutre, J Mayer, D Milojkovic, K Porkka, D Rea, G Rosti, S Saussele, R Hehlmann, R E Clark

Abstract

Most reports on chronic myeloid leukaemia (CML) treatment with tyrosine kinase inhibitors (TKIs) focus on efficacy, particularly on molecular response and outcome. In contrast, adverse events (AEs) are often reported as infrequent, minor, tolerable and manageable, but they are increasingly important as therapy is potentially lifelong and multiple TKIs are available. For this reason, the European LeukemiaNet panel for CML management recommendations presents an exhaustive and critical summary of AEs emerging during CML treatment, to assist their understanding, management and prevention. There are five major conclusions. First, the main purpose of CML treatment is the antileukemic effect. Suboptimal management of AEs must not compromise this first objective. Second, most patients will have AEs, usually early, mostly mild to moderate, and which will resolve spontaneously or are easily controlled by simple means. Third, reduction or interruption of treatment must only be done if optimal management of the AE cannot be accomplished in other ways, and frequent monitoring is needed to detect resolution of the AE as early as possible. Fourth, attention must be given to comorbidities and drug interactions, and to new events unrelated to TKIs that are inevitable during such a prolonged treatment. Fifth, some TKI-related AEs have emerged which were not predicted or detected in earlier studies, maybe because of suboptimal attention to or absence from the preclinical data. Overall, imatinib has demonstrated a good long-term safety profile, though recent findings suggest underestimation of symptom severity by physicians. Second and third generation TKIs have shown higher response rates, but have been associated with unexpected problems, some of which could be irreversible. We hope these recommendations will help to minimise adverse events, and we believe that an optimal management of them will be rewarded by better TKI compliance and thus better CML outcomes, together with better quality of life.

Leukemia 2016; 30: 1648–1671. doi:10.1038/leu.2016.104

Although successful pharmacologic treatment of chronic myeloid leukaemia (CML) is nowadays likely to result in near-normal life expectancy, at least a quarter of patients will change TKI at least once during their life, because of either inadequate response or intolerance.^{1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11} The clinical imperative for continuous daily treatment over many years is burdened by the accompanying long-standing adverse effects (AEs) and a resultant decreased quality of life. The attention given by the scientific community to AEs has grown over recent years, but our understanding remains poor. We have no knowledge of why only some (and not all) patients develop particular AEs, and this might be related to many factors, including polymorphisms in genes that affect TKI movement and metabolism.¹² More generally, publications about prevention and management of TKI AEs are scarce. Although this problem has been addressed by the Council of Europe several years ago,¹³ the dissemination and implementation of these recommendations has been suboptimal.¹⁴

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Medicine Matters Oncology

Abstract