PMID- 35212915
OWN - NLM
STAT- MEDLINE
DCOM- 20220429
LR  - 20220429
IS  - 1865-3774 (Electronic)
IS  - 0925-5710 (Linking)
VI  - 115
IP  - 5
DP  - 2022 May
TI  - NOVEL-1st: an observational study to assess the safety and efficacy of nilotinib 
      in newly diagnosed patients with Philadelphia chromosome-positive chronic myeloid 
      leukemia in chronic phase in Taiwan.
PG  - 704-712
LID - 10.1007/s12185-022-03311-1 [doi]
AB  - Nilotinib has been approved for the treatment of Philadelphia chromosome-positive 
      chronic myeloid leukemia in chronic phase (Ph(+) CML-CP). However, the real-world 
      evidence of nilotinib in newly diagnosed untreated Ph(+) CML-CP is limited in 
      Taiwan. The NOVEL-1st study was a non-interventional, multi-center study 
      collecting long-term safety and effectiveness data in patients with newly 
      diagnosed and untreated Ph(+) CML-CP receiving nilotinib. We enrolled 129 
      patients from 11 hospitals. Overall, 1,466 adverse events (AEs) were reported; 
      among these, 151 were serious and 524 were nilotinib-related. Common 
      hematological AEs were thrombocytopenia (31.0%), anemia (20.9%), and leukopenia 
      (14.0%); common nilotinib-related AEs were thrombocytopenia (29.5%), anemia 
      (14.7%), and leukopenia (12.4%). Early molecular response, defined as 
      BCR-ABL </= 10% at Month 3, was seen in 87.6% of patients. By 36 months, the 
      cumulative rates of complete hematologic response, complete cytogenetic response, 
      major molecular response, molecular response 4.0-log reduction, and molecular 
      response 4.5-log reduction were 98.5, 92.5, 85.8, 65.0, and 45.0%, respectively. 
      Nilotinib is effective and well-tolerated in patients with newly diagnosed Ph(+) 
      CML-CP in the real-world setting. Long-term holistic care and a highly tolerable 
      AE profile may contribute to good treatment outcomes in Ph(+) CML-CP under 
      first-line treatment with nilotinib.
CI  - (c) 2022. Japanese Society of Hematology.
FAU - Hwang, Wen-Li
AU  - Hwang WL
AD  - Taichung Veterans General Hospital, Taichung, Taiwan.
AD  - Asia University Hospital, Taichung, Taiwan.
FAU - Chen, Tsung-Chih
AU  - Chen TC
AD  - Taichung Veterans General Hospital, Taichung, Taiwan.
FAU - Lin, Hsuan-Yu
AU  - Lin HY
AD  - Changhua Christian Hospital, Changhua, Taiwan.
FAU - Chang, Ming-Chih
AU  - Chang MC
AD  - Mackay Memorial Hospital, Taipei, Taiwan.
FAU - Hsiao, Pei-Ching
AU  - Hsiao PC
AD  - Chung Shan Medical University Hospital, Taichung, Taiwan.
FAU - Bai, Li-Yuan
AU  - Bai LY
AD  - China Medical University Hospital, Taichung, Taiwan.
FAU - Kuo, Ching-Yuan
AU  - Kuo CY
AD  - Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan.
FAU - Chen, Yeu-Chin
AU  - Chen YC
AD  - Tri-Service General Hospital, Taipei, Taiwan.
FAU - Liu, Ta-Chih
AU  - Liu TC
AD  - Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, Taiwan.
AD  - Chang Bing Show Chwan Memorial Hospital, Changhua, Taiwan.
FAU - Gau, Jyh-Pyng
AU  - Gau JP
AD  - Taipei Veterans General Hospital, Taipei, Taiwan.
FAU - Wang, Po-Nan
AU  - Wang PN
AD  - Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan.
FAU - Hwang, Wei-Shou
AU  - Hwang WS
AD  - Chung Shan Medical University Hospital, Taichung, Taiwan.
FAU - Kuo, Ming-Chung
AU  - Kuo MC
AD  - Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan.
FAU - Liu, Chun-Yu
AU  - Liu CY
AD  - Taipei Veterans General Hospital, Taipei, Taiwan.
FAU - Liu, Yi-Chang
AU  - Liu YC
AD  - Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, Taiwan.
FAU - Ma, Ming-Chun
AU  - Ma MC
AD  - Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan.
FAU - Su, Nai-Wen
AU  - Su NW
AD  - Mackay Memorial Hospital, Taipei, Taiwan.
FAU - Wang, Chuan-Cheng
AU  - Wang CC
AD  - Changhua Christian Hospital, Changhua, Taiwan.
FAU - Wu, Yi-Ying
AU  - Wu YY
AD  - Tri-Service General Hospital, Taipei, Taiwan.
FAU - Yao, Ming
AU  - Yao M
AD  - National Taiwan University Hospital, Taipei, Taiwan.
FAU - Yeh, Su-Peng
AU  - Yeh SP
AD  - China Medical University Hospital, Taichung, Taiwan.
FAU - Cheng, Hao-Wei
AU  - Cheng HW
AD  - Novartis (Taiwan) Co. Ltd., Taipei, Taiwan.
FAU - Lee, Yee-Ming
AU  - Lee YM
AD  - Novartis (Taiwan) Co. Ltd., Taipei, Taiwan.
FAU - Ku, Fan-Chen
AU  - Ku FC
AD  - Novartis (Taiwan) Co. Ltd., Taipei, Taiwan.
FAU - Tang, Jih-Luh
AU  - Tang JL
AUID- ORCID: 0000-0003-4021-3281
AD  - National Taiwan University Hospital, Taipei, Taiwan. tangntuh@gmail.com.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
DEP - 20220225
PL  - Japan
TA  - Int J Hematol
JT  - International journal of hematology
JID - 9111627
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Protein Kinase Inhibitors)
RN  - 0 (Pyrimidines)
RN  - F41401512X (nilotinib)
SB  - IM
MH  - *Antineoplastic Agents/adverse effects
MH  - Humans
MH  - *Leukemia, Myelogenous, Chronic, BCR-ABL Positive/diagnosis/drug therapy
MH  - *Leukopenia/chemically induced
MH  - Philadelphia Chromosome
MH  - Protein Kinase Inhibitors/therapeutic use
MH  - Pyrimidines
MH  - Taiwan/epidemiology
MH  - *Thrombocytopenia/chemically induced
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Chronic myeloid leukemia
OT  - First-line treatment
OT  - Nilotinib
OT  - Real-world setting
EDAT- 2022/02/26 06:00
MHDA- 2022/04/30 06:00
CRDT- 2022/02/25 12:24
PHST- 2021/10/19 00:00 [received]
PHST- 2022/02/09 00:00 [accepted]
PHST- 2022/02/09 00:00 [revised]
PHST- 2022/02/26 06:00 [pubmed]
PHST- 2022/04/30 06:00 [medline]
PHST- 2022/02/25 12:24 [entrez]
AID - 10.1007/s12185-022-03311-1 [pii]
AID - 10.1007/s12185-022-03311-1 [doi]
PST - ppublish
SO  - Int J Hematol. 2022 May;115(5):704-712. doi: 10.1007/s12185-022-03311-1. Epub 
      2022 Feb 25.