Abstract
Objective: Imatinib mesylate, a tyrosine kinase inhibitor, is presently the drug of choice for chronic myeloid leukemia (CML). During therapy, a few patients may develop hematological and non-hematological adverse effects. Materials and Methods: The aim of this study was to evaluate the safety of imatinib therapy in patients with CML. Between December 2007 and October 2009 two hundred patients with CML in chronic phase were included in the study. Written informed consent was obtained from all patients prior to the start of the study. Imatinib was started at 400 mg orally daily. Patients were monitored carefully for any adverse effects. Complete blood count, liver, and renal function tests were done once in 2 weeks during the first month and on a monthly basis during follow-up. Toxicities that encountered were graded as per the National Cancer Institute common toxicity criteria version 2. Both hematologic and non-hematologic toxicities were managed with short interruptions of treatment and supportive measures, but the daily dose of imatinib was not reduced below 300 mg/day.Results: Two hundred CML patients in chronic phase were included in this study; the male:female ratio was 0.7:1 with mean age 39.06±13.21 years (ranged from 15-81 years). The study showed that the commonest hematological side effects were grade 2 anemia (12.5%) followed by leukopenia (8%) and thrombocytopenia (4%), while the most common non-hematological adverse effects were superficial edema and weight gain (51.5%), followed by musculoskeletal pain (35.5%), then gastro-intestinal symptoms (vomiting, diarrhea) (19%). Fluid retention was the commonest side effect, which responded to low-dose diuretics. The drug was safe and well tolerated. There were no deaths due to toxicity.Conclusion: Imatinib mesylate a well-tolerated drug, and all undesirable effects could be ameliorated easily. The most common hematological and non-hematological side effects were anemia and fluid retention, respectivelyConflict of interest:None declared.
Highlights
Chronic myeloid leukemia (CML) arises as the result of a mutation in a pluripotent stem cell and is characterized by progressive granulocytosis, marrow hypercellularity, and splenomegaly [1,2,3]
CML accounts for about 20% of newly diagnosed cases of leukemia in adults [2,4]
The diagnostic hallmark is the Philadelphia chromosome [5], which is present in all dividing cells of hematopoietic lineage, as well as in B and T cells in some patients, but is absent in all other cells
Summary
Chronic myeloid leukemia (CML) arises as the result of a mutation in a pluripotent stem cell and is characterized by progressive granulocytosis, marrow hypercellularity, and splenomegaly [1,2,3]. The essential role of BCR-ABL tyrosine kinase activity for cellular transformation provides the rationale for targeting this function therapeutically [6]. Imatinib selectively inhibits the proliferation and induces apoptosis in BCR-ABL–positive cell lines as well as fresh leukemic cells from patients with Philadelphia chromosomepositive CML and Philadelphia chromosome-positive acute lymphoblastic leukemia [7,8]. Growth inhibition of the CML cell line K562 occurred at micromolar concentrations and was associated with inhibition of BCR-ABL tyrosine kinase activity [9]. Imatinib inhibits the receptor tyrosine kinases for platelet-derived growth factors (PDGFs), stem cell factor (SCF), and c-kit and inhibit PDGF receptor and SCF-mediated cellular events [10]
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