Determining the efficiency of the Imatinib mesylate and monitoring of relapse and emergence of IM resistance in Algerian adult patients with Chronic Myeloid Leukaemia

Abstract

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Imatinib mesylate (IM) shows remarkable clinical activity in patients with Chronic Myeloid Leukaemia (CML). Patients who fail to respond to IM or those who lose their response should be treated with second-generation tyrosine kinase inhibitors (TKIs). The aim of this study was to determine the efficiency of the Indian IM generic (Imatib*CIPLA), and to monitor relapse and emergence of IM resistance. Two hundred and seven adult patients from the Northwestern region of Algeria were diagnosed as CML in chronic phase (CP) and were treated with an Indian generic of IM at 400 mg/day. The IM 600 mg treatment and second-line therapy were prescribed after failure of treatment. Molecular Analysis was performed and BCR-ABL/ABL ratios were determined and standardised according to the international scale using 0.47 as conversion factor. Our findings showed a significant difference in major molecular response (MMR) for patients treated with IM 600 mg compared to IM 400 mg (51.7% vs. 37.6%, p<0.001). In the second line therapy group, there was a significant improvement of MR^4.5 compared to the IM group (7.7% vs. 32.6%, p=0.039). Likewise, no significant relationship was found between the median duration of second-generation TKIs deep response and IM 400 mg/day regarding the MR⁴ (11 vs. 26.5 months, p=0.107) and MR^4.5 (20 vs. 32.5 months, p=0.203). The Indian IM generic molecule (Imatib*CIPLA), has shown its efficiency in achieving major and deep molecular responses. Patients treated with the second-generation TKIs showed deep molecular responses with fewer relapses in a shorter median time than those treated with IM.