KCI등재
SCOPUS
Safety and efficacy of nilotinib in adult patients with chronic myeloid leukemia: a post-marketing surveillance study in Korea
저자
Seo-Yeon Ahn (Department of Hematology-Oncology, Chonnam National University Hwasun Hospital and Chonnam National University Medical School, Hwasun, Korea) ; Sang Kyun Son (Department of Hematology-Oncology, School of Medicine, Kyungpook National University, Daegu, Department of Internal Medicine, Seoul, Korea) ; Gyu Hyung Lee (Department of Hematology-Oncology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea) ; Inho Kim (Department of Internal Medicine, Seoul National University Hospital and Cancer Research Institute, Seoul National University College of Medicine) ; June-Won Cheong (Division of Hematology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea) ; Won Sik Lee (Department of Internal Medicine, Inje University Busan Paik Hospital, Busan, Korea) ; Byung Soo Kim (Division of Hematology, Department of Internal Medicine, Korea University Anam Hospital, Seoul, Korea) ; Deog-Yeon Jo (Department of Internal Medicine, College of Medicine, Chungnam National Univeristy, Daejeon, Korea) ; Chul Won Jung (Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea) ; Chu Myoung Seong (Department of Hematology and Oncology, Ewha Womans University College of Medicine, Seoul, Korea) ; Jae Hoon Lee (Division of Hematology, Gachon University Gil Medical Center, Gachon University College of Medicine, Incheon, Korea) ; Young Jin Yuh (Department of Internal Medicine, Inje University, Sanggye-Paik Hospital, Seoul, Korea) ; Min Kyoung Kim (Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea) ; Hun-Mo Ryoo (Division of Hematology-Oncology, Department of Internal Medicine, Daegu Catholic University Medical Center, Daegu, Korea) ; Moo-Rim Park (Department of Hematology-Oncology, Wonkwang University School of Medicine, Iksan, Korea) ; Su-Hee Cho (Division of Hematology-Oncology, Department of Internal Medicine, Pusan National University Yangsan Hospital, Yangsan, Department of Internal Medicine, Changwon, Korea) ; Hoon-Gu Kim (Gyeongsang Institute of Health Sciences, Gyeongsang National University College of Medicine and Gyeongsang National University Changwon Hospital, Changwon, Korea) ; Dae Young Zang (Hallym University Sacred Heart Hospital, Anyang, Korea) ; Jinny Park (Division of Hematology, Gachon University Gil Medical Center, Gachon University College of Medicine, Incheon, Korea) ; Hawk Kim (Division of Hematology, Gachon University Gil Medical Center, Gachon University College of Medicine, Incheon, Korea) ; Seryeon Lee (Korea University Ansan Hospital, Ansan, Korea) ; Sung-Hyun Kim (Dong-A University College of Medicine) ; Myung Hee Chang (National Health Insurance Service Ilsan Hospital, Goyang, Korea) ; Ho Sup Lee (Kosin University College of Medicine, Busan, Department of Internal Medicine, Seoul, Korea) ; Chul Won Choi (Korea University Guro Hospital, Seoul, Korea) ; Jihyun Kwon (Chungbuk National University College of Medicine, Department of Internal Medicine, Cheongju, Korea) ; Sung-Nam Lim (Inje University College of Medicine, Haeundae Paik Hospital, Busan, Korea) ; Suk-Joong Oh (Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea) ; Inkyung Joo (Novartis Korea Ltd., Seoul, Korea) ; Dong-Wook Kim (Department of Hematology, Uijeongbu Eulji Medical Center, Leukemia Omics Research Institute, Eulji University Uijeongbu Campus, Uijeongbu, Korea)
발행기관
학술지명
권호사항
발행연도
2022
작성언어
English
주제어
등재정보
KCI등재,SCOPUS,ESCI
자료형태
학술저널
수록면
144-151(8쪽)
DOI식별코드
제공처
소장기관
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.
서지정보 내보내기(Export)
닫기소장기관 정보
닫기권호소장정보
닫기오류접수
닫기오류 접수 확인
닫기음성서비스 신청
닫기음성서비스 신청 확인
닫기이용약관
닫기학술연구정보서비스 이용약관 (2017년 1월 1일 ~ 현재 적용)
학술연구정보서비스(이하 RISS)는 정보주체의 자유와 권리 보호를 위해 「개인정보 보호법」 및 관계 법령이 정한 바를 준수하여, 적법하게 개인정보를 처리하고 안전하게 관리하고 있습니다. 이에 「개인정보 보호법」 제30조에 따라 정보주체에게 개인정보 처리에 관한 절차 및 기준을 안내하고, 이와 관련한 고충을 신속하고 원활하게 처리할 수 있도록 하기 위하여 다음과 같이 개인정보 처리방침을 수립·공개합니다.
주요 개인정보 처리 표시(라벨링)
목 차
3년
또는 회원탈퇴시까지5년
(「전자상거래 등에서의 소비자보호에 관한3년
(「전자상거래 등에서의 소비자보호에 관한2년
이상(개인정보보호위원회 : 개인정보의 안전성 확보조치 기준)개인정보파일의 명칭 | 운영근거 / 처리목적 | 개인정보파일에 기록되는 개인정보의 항목 | 보유기간 | |
---|---|---|---|---|
학술연구정보서비스 이용자 가입정보 파일 | 한국교육학술정보원법 | 필수 | ID, 비밀번호, 성명, 생년월일, 신분(직업구분), 이메일, 소속분야, 웹진메일 수신동의 여부 | 3년 또는 탈퇴시 |
선택 | 소속기관명, 소속도서관명, 학과/부서명, 학번/직원번호, 휴대전화, 주소 |
구분 | 담당자 | 연락처 |
---|---|---|
KERIS 개인정보 보호책임자 | 정보보호본부 김태우 | - 이메일 : lsy@keris.or.kr - 전화번호 : 053-714-0439 - 팩스번호 : 053-714-0195 |
KERIS 개인정보 보호담당자 | 개인정보보호부 이상엽 | |
RISS 개인정보 보호책임자 | 대학학술본부 장금연 | - 이메일 : giltizen@keris.or.kr - 전화번호 : 053-714-0149 - 팩스번호 : 053-714-0194 |
RISS 개인정보 보호담당자 | 학술진흥부 길원진 |
자동로그아웃 안내
닫기인증오류 안내
닫기귀하께서는 휴면계정 전환 후 1년동안 회원정보 수집 및 이용에 대한
재동의를 하지 않으신 관계로 개인정보가 삭제되었습니다.
(참조 : RISS 이용약관 및 개인정보처리방침)
신규회원으로 가입하여 이용 부탁 드리며, 추가 문의는 고객센터로 연락 바랍니다.
- 기존 아이디 재사용 불가
휴면계정 안내
RISS는 [표준개인정보 보호지침]에 따라 2년을 주기로 개인정보 수집·이용에 관하여 (재)동의를 받고 있으며, (재)동의를 하지 않을 경우, 휴면계정으로 전환됩니다.
(※ 휴면계정은 원문이용 및 복사/대출 서비스를 이용할 수 없습니다.)
휴면계정으로 전환된 후 1년간 회원정보 수집·이용에 대한 재동의를 하지 않을 경우, RISS에서 자동탈퇴 및 개인정보가 삭제처리 됩니다.
고객센터 1599-3122
ARS번호+1번(회원가입 및 정보수정)