PMID- 35678158
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220716
IS  - 2287-979X (Print)
IS  - 2288-0011 (Electronic)
IS  - 2287-979X (Linking)
VI  - 57
IP  - 2
DP  - 2022 Jun 30
TI  - Safety and efficacy of nilotinib in adult patients with chronic myeloid leukemia: 
      a post-marketing surveillance study in Korea.
PG  - 144-151
LID - 10.5045/br.2022.2021137 [doi]
AB  - BACKGROUND: Nilotinib is a tyrosine kinase inhibitor approved by the Ministry of 
      Food and Drug Safety for frontline and 2nd line treatment of Philadelphia 
      chromosome-positive chronic myeloid leukemia (Ph+ CML). This study aimed to 
      confirm the safety and efficacy of nilotinib in routine clinical practice within 
      South Korea. METHODS: An open-label, multicenter, single-arm, 12-week 
      observational post-marketing surveillance (PMS) study was conducted on 669 Korean 
      adult patients with Ph+ CML from December 24, 2010, to December 23, 2016. The 
      patients received nilotinib treatment in routine clinical practice settings. 
      Safety was evaluated by all types of adverse events (AEs) during the study 
      period, and efficacy was evaluated by the complete hematological response (CHR) 
      and cytogenetic response. RESULTS: During the study period, AEs occurred in 61.3% 
      (410 patients, 973 events), adverse drug reactions (ADRs) in 40.5% (271/669 
      patients, 559 events), serious AEs in 4.5% (30 patients, 37 events), and serious 
      ADRs in 0.7% (5 patients, 8 events). Furthermore, unexpected AEs occurred at a 
      rate of 6.9% (46 patients, 55 events) and unexpected ADRs at 1.2% (8 patients, 8 
      events). As for the efficacy results, CHR was achieved in 89.5% (442/494 
      patients), and minor cytogenetic response or major cytogenetic response was 
      achieved in 85.8% (139/162 patients). CONCLUSION: This PMS study shows consistent 
      results in terms of safety and efficacy compared with previous studies. Nilotinib 
      was well tolerated and efficacious in adult Korean patients with Ph+ CML in 
      routine clinical practice settings.
FAU - Ahn, Seo-Yeon
AU  - Ahn SY
AD  - Department of Hematology-Oncology, Chonnam National University Hwasun Hospital, 
      Hwasun, Korea.
FAU - Son, Sang Kyun
AU  - Son SK
AD  - Department of Hematology-Oncology, School of Medicine, Kyungpook National 
      University, Daegu, Department of Internal Medicine, Seoul, Korea.
FAU - Lee, Gyu Hyung
AU  - Lee GH
AD  - Department of Internal Medicine, University of Ulsan College of Medicine, Asan 
      Medical Center, Seoul, Korea.
FAU - Kim, Inho
AU  - Kim I
AD  - Department of Internal Medicine, Seoul National University Hospital, Cancer 
      Research Institute, Seoul National University College of Medicine, Seoul, Korea.
FAU - Cheong, June-Won
AU  - Cheong JW
AD  - Division of Hematology, Department of Internal Medicine, Yonsei University 
      College of Medicine, Seoul, Korea.
FAU - Lee, Won Sik
AU  - Lee WS
AD  - Department of Internal Medicine, Inje University Busan Paik Hospital, Busan, 
      Korea.
FAU - Kim, Byung Soo
AU  - Kim BS
AD  - Division of Hematology, Department of Internal Medicine, Korea University Anam 
      Hospital, Seoul, Korea.
FAU - Jo, Deog-Yeon
AU  - Jo DY
AD  - Department of Internal Medicine, College of Medicine, Chungnam National 
      Univeristy, Daejeon, Korea.
FAU - Jung, Chul Won
AU  - Jung CW
AD  - Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
FAU - Seong, Chu Myoung
AU  - Seong CM
AD  - Department of Hematology and Oncology, Ewha Womans University College of 
      Medicine, Seoul, Korea.
FAU - Lee, Jae Hoon
AU  - Lee JH
AD  - Division of Hematology, Gachon University Gil Medical Center, Gachon University 
      College of Medicine, Incheon, Korea.
FAU - Yuh, Young Jin
AU  - Yuh YJ
AD  - Department of Internal Medicine, Inje University, Sanggye-Paik Hospital, Seoul, 
      Korea.
FAU - Kim, Min Kyoung
AU  - Kim MK
AD  - Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, 
      Korea.
FAU - Ryoo, Hun-Mo
AU  - Ryoo HM
AD  - Division of Hematology-Oncology, Department of Internal Medicine, Daegu Catholic 
      University Medical Center, Daegu, Korea.
FAU - Park, Moo-Rim
AU  - Park MR
AD  - Department of Hematology-Oncology, Wonkwang University School of Medicine, Iksan, 
      Korea.
FAU - Cho, Su-Hee
AU  - Cho SH
AD  - Division of Hematology-Oncology, Department of Internal Medicine, Pusan National 
      University Yangsan Hospital, Yangsan, Korea.
FAU - Kim, Hoon-Gu
AU  - Kim HG
AD  - Department of Internal Medicine, Gyeongsang Institute of Health Sciences, 
      Gyeongsang National University College of Medicine and Gyeongsang National 
      University Changwon Hospital, Changwon, Korea.
FAU - Zang, Dae Young
AU  - Zang DY
AD  - Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, 
      Korea.
FAU - Park, Jinny
AU  - Park J
AD  - Division of Hematology, Gachon University Gil Medical Center, Gachon University 
      College of Medicine, Incheon, Korea.
FAU - Kim, Hawk
AU  - Kim H
AD  - Division of Hematology, Gachon University Gil Medical Center, Gachon University 
      College of Medicine, Incheon, Korea.
FAU - Lee, Seryeon
AU  - Lee S
AD  - Department of Internal Medicine, Korea University Ansan Hospital, Ansan, Korea.
FAU - Kim, Sung-Hyun
AU  - Kim SH
AD  - Department of Internal Medicine, Dong-A University College of Medicine, Busan, 
      Korea.
FAU - Chang, Myung Hee
AU  - Chang MH
AD  - Division of Oncology-Hematology, Department of Internal Medicine, National Health 
      Insurance Service Ilsan Hospital, Goyang, Korea.
FAU - Lee, Ho Sup
AU  - Lee HS
AD  - Division of Oncology-Hematology, Department of Internal Medicine, Kosin 
      University College of Medicine, Busan, Korea.
FAU - Choi, Chul Won
AU  - Choi CW
AD  - Department of Internal Medicine, Korea University Guro Hospital, Seoul, Korea.
FAU - Kwon, Jihyun
AU  - Kwon J
AD  - Department of Internal Medicine, Chungbuk National University College of 
      Medicine, Cheongju, Korea.
FAU - Lim, Sung-Nam
AU  - Lim SN
AD  - Department of Internal Medicine, Inje University College of Medicine, Haeundae 
      Paik Hospital, Busan, Korea.
FAU - Oh, Suk-Joong
AU  - Oh SJ
AD  - Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan 
      University School of Medicine, Seoul, Korea.
FAU - Joo, Inkyung
AU  - Joo I
AD  - Novartis Korea Ltd., Seoul, Korea.
FAU - Kim, Dong-Wook
AU  - Kim DW
AD  - Department of Hematology, Uijeongbu Eulji Medical Center, Leukemia Omics Research 
      Institute, Eulji University Uijeongbu Campus, Uijeongbu, Korea.
LA  - eng
PT  - Journal Article
DEP - 20220610
PL  - Switzerland
TA  - Blood Res
JT  - Blood research
JID - 101605247
PMC - PMC9242833
OTO - NOTNLM
OT  - Chronic myeloid leukemia
OT  - Nilotinib
OT  - Philadelphia chromosome positive
OT  - Post-marketing surveillance
OT  - Tyrosine kinase inhibitor
COIS- Authors' Disclosures of Potential Conflicts of Interest No potential conflicts of 
      interest relevant to this article were reported.
EDAT- 2022/06/10 06:00
MHDA- 2022/06/10 06:01
PMCR- 2022/06/30
CRDT- 2022/06/09 04:52
PHST- 2021/07/30 00:00 [received]
PHST- 2021/11/09 00:00 [revised]
PHST- 2022/05/04 00:00 [accepted]
PHST- 2022/06/10 06:00 [pubmed]
PHST- 2022/06/10 06:01 [medline]
PHST- 2022/06/09 04:52 [entrez]
PHST- 2022/06/30 00:00 [pmc-release]
AID - br.2022.2021137 [pii]
AID - br-57-2-144 [pii]
AID - 10.5045/br.2022.2021137 [doi]
PST - ppublish
SO  - Blood Res. 2022 Jun 30;57(2):144-151. doi: 10.5045/br.2022.2021137. Epub 2022 Jun 
      10.