An Observational study of Non-adherence in Patients with Chronic Myeloid Leukemia on Treatment with Imatinib – Prevalence, Predictors and Outcomes.

INTRODUCTION : Chronic myeloid leukemia (CML) is a myeloproliferative neoplasm that originates in an abnormal pluripotent bone marrow stem cell(1). It is consistently associated with a fusion gene, the BCR-ABL1, which is located on the Philadelphia chromosome. The Philadelphia chromosome is formed by the translocation t(9;22)(q34;11) – which results in juxtaposition of the ABL gene from Chromosome 9 to the BCR gene in Chromosome 22. This gene codes for a fusion protein (BCR-ABL) which has constitutive tyrosine kinase activity, resulting in uncontrolled myeloid proliferation. Although the major initial laboratory abnormality noted is usually neutrophilic leukocytosis, the BCR-ABL1 is found in all myeloid lineages as well as some lymphoid cells and endothelial cells. If untreated, CML will progress from an indolent chronic phase to a more aggressive accelerated phase or blast crisis. AIMS AND OBJECTIVES : Prevalence Estimation – To determine the prevalence and severity of non-adherence to Imatinib among CML patients in the month prior to interview; provided that these patients have been on treatment for at least 6 months. • Identification of Predictors of Non-Adherence – To identify those variables which are predictive of patient non-adherence. • Non-Adherer Analysis: To assess impact of non-adherence on outcome. • To assess patient-perceived adverse effects with Imatinib • To document degree of knowledge of disease. • To document the toxicity profile of imatinib in patients with CML. MATERIALS AND METHODS : The study is designed as an observational study in patients with chronic myeloid leukemia, who are currently under follow-up in the department of Hematology, CMC Hospital Vellore, during the period May 1st 2012 – July 31st 2012. All patients with CML on Imatinib Mesylate (Glivec / Veenat) for at least 6 months were included in the study. All patients were counseled about the study and informed consent was taken from all patients prior to enrollment. In case of minors (age <18years), assent forms were signed ...