Hematologic and Molecular Responses to Generic Imatinib in Patients With Chronic Myeloid Leukemia

Abstract

Background: Imatinib mesylate is a drug used in treating chronic myeloid leukemia (CML). It induces apoptosis and inhibits cell proliferation. This study aimed to evaluate hematologic and molecular responses to Imatib (Cipla Limited, Mumbai, India) in 30 chronic phase CML patients. Methods: Physical examination, CBC test, and peripheral blood smear were performed in order to assess the hematologic response in patients. Molecular response was evaluated through quantitative assessment of BCR-ABL fusion gene expression by real-time reverse transcriptase polymerase chain reaction (RT-PCR). The correlation of molecular and hematologic responses with the patient’s age and sex and also with dosage and duration of Imatib consumption was analyzed statistically. Results: Ninety percent of the patients showed some sort of hematologic response that had no significant correlation with a patient’s age or sex, dosage, or duration of Imatib consumption ( P >0.05). Overall, 46.7% of patients showed complete molecular response (CMR), 43.3% showed partial molecular response, and 10% showed no molecular response (NMR) to Imatib. A reverse significant correlation was noted between the type of molecular response and patient’s age ( P 0.05). Conclusion: Our study results indicate that molecular and hematologic responses to Imatib were acceptably good and therefore its efficacy is comparable to that of more expensive brands like Gleevec. * CML : chronic myeloid leukemia RT-PCR : reverse transcriptase polymerase chain reaction Ph : Philadelphia chromosome ATP : adenosine triphosphate CMR : complete molecular response MMR : major molecular response PMR : partial molecular response RT : reverse transcriptase SCT : stem cell transplantation NMR : no molecular response