Background and Objectives: Chronic myeloid leukemia (CML) accounts for\napproximately 15% of newly diagnosed cases of leukemia in adults. In this\nstudy, the efficacy of nilotinib at 400 mg BID is compared with imatinib at\n400 mg BID in CML patients with suboptimal molecular response after at\nleast 12 months of daily dose 400 mg of imatinib therapy. Patients and Methods:\nThis study included a total number of 50 patients, divided into two\ngroups (25 patients each). The first group (Group I): Patients received imatinib\nat 400 mg BID, second group (Group II): Patients had a suboptimal molecular\nresponse to imatinib and received nilotinib at 400 mg BID in early\nchronic phase. During the two years period of data collection, the primary\nend included median survival. The secondary end included response rate,\ntype of response, duration of response and progression free survival. Also side\neffects were recorded. Patients were followed up every month by complete\nand differential blood counts, liver function test, renal function test and\n(PCR) every three months for two year. Results: Nilotinib group had significantly\nhigher frequency of major molecular response (MMR) where 23 (92%)\npatients achieved it while only 16 (64%) patients in Imatinib group achieved\nMMR (P = 0.01). Nilotinib had better toxicities profile than Imatinib. Conclusion:\nBoth Nilotinib and high dose Imatinib achieved response in CML\npatients with suboptimal response with rapid and deeper molecular response,\nbetter survival outcomes and less side effects in nilotinib.
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