PMID- 34508295
OWN - NLM
STAT- MEDLINE
DCOM- 20220221
LR  - 20221207
IS  - 1865-3774 (Electronic)
IS  - 0925-5710 (Linking)
VI  - 115
IP  - 1
DP  - 2022 Jan
TI  - Nilotinib vs. imatinib in Japanese patients with newly diagnosed chronic myeloid 
      leukemia in chronic phase: 10-year follow‑up of the Japanese subgroup of the 
      randomized ENESTnd trial.
PG  - 33-42
LID - 10.1007/s12185-021-03216-5 [doi]
AB  - In the 10-year analysis of Japanese patients with newly diagnosed CML-CP in the 
      ENESTnd trial, nilotinib yielded higher cumulative response rates. There were no 
      new occurrences of disease progression or deaths since the 5-year analysis. 
      Cumulative 10-year rates of MMR and MR(4.5) were higher in the nilotinib arms 
      [300 mg twice daily (BID), 86.2% and 69.0%, respectively; 400 mg BID, 78.3% and 
      69.6%, respectively] than the imatinib arm (400 mg once daily, 60.0% and 48.0%, 
      respectively). Nasopharyngitis (85.7%, 77.3%, 79.2%), rash (50.0%, 68.2%, 37.5%), 
      headache (39.3%, 45.5%, 25.0%), and back pain (39.3%, 50.0%, 29.2%) were the most 
      frequently reported all-grade adverse events (AEs) for nilotinib 300 and 400 mg 
      BID and imatinib, respectively. Cardiovascular AEs were more common with 
      nilotinib than with imatinib. More patients on nilotinib had pre-diabetic and 
      diabetic levels of HbA1c (300 mg BID, 17.9% and 10.7%, respectively; 400 mg BID, 
      22.7% and 18.2%, respectively) compared with imatinib (4.2% each). Overall, 
      10-year results from the Japanese cohort are consistent with prior results from 
      the full ENESTnd cohort and the Japanese subgroup, and continue to support the 
      long-term use of nilotinib in Japanese patients with newly diagnosed CML-CP, but 
      with proper monitoring and management of comorbidities.
CI  - (c) 2021. Japanese Society of Hematology.
FAU - Nakamae, Hirohisa
AU  - Nakamae H
AUID- ORCID: 0000-0003-4203-990X
AD  - Hematology, Graduate School of Medicine, Osaka City University, 1-4-3 
      Asahi-machi, Abeno-ku, Osaka, 545-8585, Japan. hirohisa@med.osaka-cu.ac.jp.
FAU - Yamamoto, Masahide
AU  - Yamamoto M
AD  - Department of Hematology, Medical Hospital of Tokyo Medical and Dental 
      University, Tokyo, Japan.
FAU - Sakaida, Emiko
AU  - Sakaida E
AD  - Department of Hematology, Chiba University Hospital, Chiba, Japan.
FAU - Kanda, Yoshinobu
AU  - Kanda Y
AD  - Division of Hematology, Jichi Medical University Saitama Medical Center, Saitama, 
      Japan.
FAU - Ohmine, Ken
AU  - Ohmine K
AD  - Division of Hematology, Jichi Medical University Hospital, Tochigi, Japan.
FAU - Ono, Takaaki
AU  - Ono T
AD  - Division of Hematology, Hamamatsu University School of Medicine, Shizuoka, Japan.
FAU - Matsumura, Itaru
AU  - Matsumura I
AD  - Department of Hematology, Kindai University Hospital, Osaka, Japan.
FAU - Ishikawa, Maho
AU  - Ishikawa M
AD  - Department of Hemato-Oncology, Saitama Medical University International Medical 
      Center, Saitama, Japan.
FAU - Aoki, Makoto
AU  - Aoki M
AD  - Novartis Pharma KK, Tokyo, Japan.
FAU - Maki, Akio
AU  - Maki A
AD  - Novartis Pharma KK, Tokyo, Japan.
FAU - Shibayama, Hirohiko
AU  - Shibayama H
AD  - Department of Hematology and Oncology, Osaka University Graduate School of 
      Medicine, Osaka, Japan.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20210911
PL  - Japan
TA  - Int J Hematol
JT  - International journal of hematology
JID - 9111627
RN  - 0 (Protein Kinase Inhibitors)
RN  - 0 (Pyrimidines)
RN  - 8A1O1M485B (Imatinib Mesylate)
RN  - EC 2.7.10.1 (Protein-Tyrosine Kinases)
RN  - F41401512X (nilotinib)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Asian People
MH  - Blast Crisis
MH  - Disease Progression
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Imatinib Mesylate/*adverse effects
MH  - Leukemia, Myelogenous, Chronic, BCR-ABL Positive/diagnosis/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Protein Kinase Inhibitors/*administration & dosage
MH  - Protein-Tyrosine Kinases/antagonists & inhibitors
MH  - Pyrimidines/*adverse effects
MH  - Time Factors
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - CML-CP
OT  - ENESTnd
OT  - Japanese
OT  - Long term
OT  - Nilotinib
EDAT- 2021/09/12 06:00
MHDA- 2022/02/22 06:00
CRDT- 2021/09/11 06:08
PHST- 2021/04/27 00:00 [received]
PHST- 2021/09/01 00:00 [accepted]
PHST- 2021/09/01 00:00 [revised]
PHST- 2021/09/12 06:00 [pubmed]
PHST- 2022/02/22 06:00 [medline]
PHST- 2021/09/11 06:08 [entrez]
AID - 10.1007/s12185-021-03216-5 [pii]
AID - 10.1007/s12185-021-03216-5 [doi]
PST - ppublish
SO  - Int J Hematol. 2022 Jan;115(1):33-42. doi: 10.1007/s12185-021-03216-5. Epub 2021 
      Sep 11.