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