ASSESSMENT OF ADVERSE EFFECTS OF IMATINIB IN CHRONIC MYELOID LEUKEMIA PATIENTS AT CIVIL HOSPITAL OF KARACHI, PAKISTAN

Abstract

Background:
The original etiologic agent, imatinib mesylate, the first-in-class tyrosine kinase inhibitor (TKI), remains the leading therapeutic weapon in Chronic Myeloid Leukemia (CML) especially in the low- and middle-income countries. Despite the unquestionable effectiveness, the negative effects of the long-term use of this agent are often characterized by all the factors that can reduce patient compliance and decrease the quality of life. Based on this, the current study aimed to establish the frequency, typology as well as severity of imatinib related adverse events in patients with CML who are under the care of a publicly funded tertiary referral centre in Karachi, Pakistan.

Methods:
The design was cross-sectional descriptive and used in Civil Hospital Karachi in the period between January and December 2023. A total of 385 patients with CML diagnosed and put under imatinib treatment of ≥ six months were recruited. A structured proforma was used to record demographic data, disease stage, period of therapy and adverse events that had been documented. The grading was based on the Common Terminology Criteria of Adverse Events (CTCAE v5.0). Statistical examinations were conducted using SPSS v26.0, and Chi-square and t-tests were conducted to evaluate the relationships (p below 0.05 was taken to be significant).

Results:
Among all the 385 participants, 94% stated that they had had at least one adverse event. The most frequent non-hematologic toxicity were fatigue (67.8%), peripheral oedema (58.2%), and nausea (50.1%). Hematologic toxicities were reported as anemia (29.6%) thrombocytopenia (14.5%) neutropenia (8.8%)). Patients with elevated levels of alanine aminotransferase (ALT) were reported 21.3%. The significant predictive factors of increased toxicity were female gender, high disease stage and treatment duration over three years. The proportion of adverse events that affected daily functioning was 39.2% and several concurrent toxicities were found in 56.1% of the cohort.

Conclusion:
The use of imatinib in the treatment of CML has a high rate of hematologic, as well as non-hematologic side effects. Other independent predictors of toxicity include female sex, long term exposure, and advanced stage of the disease. Frequent monitoring and personalized intervention plans are a necessity to maximize treatment and make sure the patients have a good quality of life.