Nilotinib as frontline therapy for patients with newly diagnosed Ph+ chronic
myeloid leukemia in chronic phase: results from the Japanese subgroup of ENESTnd.
Author(s): Nakamae H, Shibayama H, Kurokawa M, Fukuda T, Nakaseko C, Kanda Y, Nagai T,
Ohnishi K, Maeda Y, Matsuda A, Amagasaki T, Yanada M.
Affiliation(s): Hematology, Osaka City University Hospital, Osaka, Japan.
hirohisa@msic.med.osaka-cu.ac.jp
Publication date & source: 2011, Int J Hematol. , 93(5):624-32
Recent results from the phase 3 ENESTnd (Evaluating Nilotinib Efficacy and Safety
in Clinical Trials-Newly Diagnosed Patients) study have demonstrated superiority
of nilotinib over imatinib for the treatment of newly diagnosed Philadelphia
chromosome-positive chronic myeloid leukemia in the chronic phase (CML-CP). Here,
we report results from the Japanese subset of patients in ENESTnd, and assess
whether results in this subpopulation are consistent with the overall study
population. Seventy-nine Japanese patients with CML-CP were randomized to receive
nilotinib 300 mg twice daily (BID) (n = 30), nilotinib 400 mg BID (n = 24) or
imatinib 400 mg once daily (QD) (n = 25). Major molecular response rates at 12
months, the primary endpoint, were at least twice as high for nilotinib 300 mg
BID (57%) and nilotinib 400 mg BID (50%) compared with imatinib 400 mg QD (24%).
No patient on nilotinib progressed, while one patient progressed on imatinib.
Both drugs were generally well tolerated and discontinuations due to adverse
events were comparable among treatment arms. The results in the subpopulation of
Japanese patients from ENESTnd closely mirror the results of the overall
population, and support the use of nilotinib at 300 mg BID in Japanese patients
with newly diagnosed CML-CP.
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