Objectives:

Imatinib changed the treatment paradigm of chronic myeloid leukemia (CML) after yielding better response rates and progression free survival than interferon-α, with an acceptable safety profile. The aim of this study was to evaluate the effectiveness, safety and adherence of imatinib in the treatment of CML in clinical practice.

Methods:

Retrospective study carried out in patients with CML in chronic phase treated with imatinib. Primary endpoints: complete hematological response (CHR), complete cytogenetic response (CCyR), major molecular response (MMR), treatment adherence (ADH) and adverse events (AE). Response rates were defined according to the criteria of The European LeukemiaNet and ADH was estimated as number of dosage units dispensed x 100/ number of dosage units prescribed. Patients were adherent if their ADH was ≥85%. Secondary endpoints: progression free survival (PFS) and overall survival (OS).

Results:

39 patients were included. Response rates: CHR 100% (39/39); CCyR 84.6% (33/39); and MMR 66.7% (26/39). The mean ADH was 94.9% (59.0%-100%), with a 92.3% of patients considered adherents. PFS and OS rates estimated at 8 years were: 94.4% (95% CI: 86.9-100.0) and 94.4% (95% CI: 87.3-100.0), respectively. Most frequent non-hematological AE: edema 53.8% (21/39), musculoskeletal pain 43.6% (17/39) and muscle cramps 38.5% (15/39). Grade 3-4 neutropenia and thrombocytopenia were found in 10.3% (4/39) and 5.1% (2/39) of patients, respectively.

Conclusions:

Imatinib induced sustainable responses in a remarkable proportion of real world patients, managing to keep the disease under control. This study confirms the benefits of imatinib in clinical practice. The safety profile was consistent with earlier reports.

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