title: Nilotinib as frontline therapy for patients with newly diagnosed Ph+ chronic myeloid leukemia in chronic phase: results from the Japanese subgroup of ENESTnd.
abstract: 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.
authors.affiliation: Hematology, Osaka City University Hospital, Osaka, Japan. hirohisa@msic.med.osaka-cu.ac.jp.
authors.forename: Hirohisa
authors.initials: H
authors.lastname: Nakamae
authors.affiliation: Department of Hematology and Oncology, Osaka University Hospital, Osaka, Japan.
authors.forename: Hirohiko
authors.initials: H
authors.lastname: Shibayama
authors.affiliation: Department of Hematology and Oncology, The University of Tokyo Hospital, Tokyo, Japan.
authors.forename: Mineo
authors.initials: M
authors.lastname: Kurokawa
authors.affiliation: Department of Hematology, Tokyo Medical and Dental University Hospital of Medicine, Tokyo, Japan.
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Fukuda
authors.affiliation: Department of Hematology, Chiba University Hospital, Chiba, Japan.
authors.forename: Chiaki
authors.initials: C
authors.lastname: Nakaseko
authors.affiliation: Division of Hematology, Saitama Medical Center, Jichi Medical University, Saitama, Japan.
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Kanda
authors.affiliation: Division of Hematology, Jichi Medical University Hospital, Tochigi, Japan.
authors.forename: Tadashi
authors.initials: T
authors.lastname: Nagai
authors.affiliation: Oncology Center, Hamamatsu University School of Medicine, Shizuoka, Japan.
authors.forename: Kazunori
authors.initials: K
authors.lastname: Ohnishi
authors.affiliation: Department of Hematology, Kinki University Hospital, Osaka, Japan.
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Maeda
authors.affiliation: Department of Hematology, Saitama International Medical Center, Saitama Medical University, Saitama, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Matsuda
authors.affiliation: Novartis Pharma KK, Tokyo, Japan.
authors.forename: Taro
authors.initials: T
authors.lastname: Amagasaki
authors.affiliation: Novartis Pharma KK, Tokyo, Japan.
authors.forename: Masamitsu
authors.initials: M
authors.lastname: Yanada
mesh_terms: D001549:Benzamides; D018450:Disease Progression; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D005260:Female; D016044:Fusion Proteins, bcr-abl / Q000037:antagonists & inhibitors* / Q000097:blood / Q000235:genetics; D006801:Humans; D000068877:Imatinib Mesylate; D007564:Japan / Q000453:epidemiology; D015466:Leukemia, Myeloid, Chronic-Phase / Q000097:blood* / Q000188:drug therapy* / Q000208:ethnology / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000097:blood; D010879:Piperazines / Q000008:administration & dosage*; D047428:Protein Kinase Inhibitors / Q000008:administration & dosage*; D011505:Protein-Tyrosine Kinases / Q000037:antagonists & inhibitors* / Q000097:blood / Q000235:genetics; D011743:Pyrimidines / Q000008:administration & dosage*; D012074:Remission Induction / Q000379:methods; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D001549:Benzamides; D010879:Piperazines; D047428:Protein Kinase Inhibitors; D011743:Pyrimidines; D000068877:Imatinib Mesylate; D011505:Protein-Tyrosine Kinases; D016044:Fusion Proteins, bcr-abl; C498826:nilotinib