Study on Efficacy and Safety of Dasatinib 50 Mg in Newly Diagnosed Patients of Chronic Myeloid Leukemia (CML) in Chronic Phase (CP): Experience From a Tertiary Care Hospital
摘要
Imatinib & Dasatinib Are Two Most Commonly Used Tyrosine Kinase Inhibitor (TKI) for Chronic Myeloid Leukemia (CML) in Chronic Phase (CP). Dasatinib at Approved Dose of 100 Mg Causes Myelosuppression & pleuro-pulmonary Toxicity Leading To Drug Discontinuation & Treatment Failure, so 50 Mg Is an Option. Therefore, this Study Was Undertaken To Determine the Cytogenetic & Molecular Response with Dasatinib 50 Mg & To Assess its Adverse Effects. It is a prospective study from July 2021 to December 2022 with a sample size of 58. Newly diagnosed patients of CML CP, after considering the inclusion & exclusion criteria, were evaluated at baseline. They were started on 50 mg of Dasatinib & followed up weekly for first 4weeks, then monthly for two months, at 3 month & at 6 month with CBC & monitoring of toxicities. Quantitative reverse transcriptase polymerase chain reaction (RT-PCR) for BCR: :ABL1 transcript from peripheral blood was performed at 3 & 6 month. Median age of the study population was 37(thirty-seven). 61% & 65% patients attained optimum molecular milestone at 3 month & 6 month respectively. 27% patients achieved major molecular response (MMR) (BCR::ABL < 0.1%) at 6 month. we found a statistically significant correlation between baseline total leucocyte count (TLC) & achievement of BCR::ABL < 10% at 3 month. Total 26(45%) adverse events noted, most common being neutropenia. Median duration of dose interruption was 29 days with a range of 10–70 days. 27% attained MMR at 6 month. One (1) patient developed grade 3 pleural effusion & succumbed to complication. 20% patients failed to achieve optimum molecular response at 6 month with most common adverse effect being neutropenia.