TITLE:
Efficacy of Nilotinib versus Imatinib in Philadelphia Positive Patients with Chronic Myeloid Leukemia in Early Chronic Phase Who Have a Warning Molecular Response to Imatinib
AUTHORS:
Amen Hamdy Zaky Aly, Ahmed EL Sayed Mohammed Khalifa, Esraa Abdallah Abdelkariem Gadallah
KEYWORDS:
Nilotinib, Imatinib, Philadelphia Positive Chronic Myeloid Leukemia Patients, Warning Molecular Response
JOURNAL NAME:
Journal of Cancer Therapy,
Vol.9 No.11,
November
16,
2018
ABSTRACT: 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.