PMID- 32838488
OWN - NLM
STAT- MEDLINE
DCOM- 20210719
LR  - 20210719
IS  - 1999-6187 (Electronic)
IS  - 1009-3419 (Print)
IS  - 1009-3419 (Linking)
VI  - 23
IP  - 8
DP  - 2020 Aug 20
TI  - [Safety and Preliminary Efficacy of Ceritinib 450 mg with Food in Chinese 
      ALK-positive Non-small Cell Lung Cancer].
PG  - 655-661
LID - 10.3779/j.issn.1009-3419.2020.102.33 [doi]
AB  - BACKGROUND: Anaplastic lymphoma kinase (ALK) rearrangement is a common driver 
      gene of non-small cell lung cancer (NSCLC). Ceritinib is a second-generation ALK 
      inhibitor, which can bring survival benefits to ALK-positive metastatic NSCLC. 
      However, few studies focus on the safety and efficacy of ceritinib in China. 
      Therefore, this study intends to investigate the safety and preliminary efficacy 
      of ceritinib 450 mg with meals in Chinese patients with ALK-positive NSCLC 
      through a real world study. METHODS: From October 2018 to December 2019, patients 
      with ALK-positive NSCLC from 8 medical centers in Sichuan province were recruited 
      in this study. All of these participants received ceritinib 450 mg/d with food. 
      The basic characteristics, adverse effects (AEs) and responses were collected and 
      analyzed in order to evaluate the safety and efficacy of ceritinib. RESULTS: A 
      total of 109 patients were included in this study. Data cutoff was January 23, 
      2020. The median duration of treatment exposure was 5.87 mon (range: 0.4 mon-15.7 
      mon). Total AEs were reported in 98 (89.9%) of 109 patients and grade 3 or 4 AEs 
      were reported in 22.9% of patients. Most common AEs (mainly grade 1 or 2) were 
      diarrhea (60.6%), elevated alanine aminotransferase (ALT)(38.5%) and aspartate 
      aminotransferase (AST)(37.6%). As of data cutoff, 45 patients discontinued 
      ceritinib. The overall response rate (ORR) was 37.6% (95%CI: 28.5%-47.4%) and 
      disease control rate (DCR) was 86.2% (95%CI: 78.3%-92.1%). CONCLUSIONS: The 
      treatment of ceritinib 450 mg with food for Chinese ALK-positive NSCLC patients 
      had a good safety profile and favorable DCR in real-world setting. However, this 
      conclusion needs to be further verified by large sample, prospective trials.
FAU - Tian, Yuke
AU  - Tian Y
AD  - Department of Medical Oncology, Sichuan Cancer Hospital and Institute, Sichuan 
      Cancer Center, School of Medicine, University of Electronic Science and 
      Technology of China, Chengdu 610041, China.
FAU - Tian, Tian
AU  - Tian T
AD  - Department of Thoracic Oncology, West China Hospital, Sichuan University, Chengdu 
      610041, China.
FAU - Yu, Ping
AU  - Yu P
AD  - Department of Medical Oncology, Sichuan Cancer Hospital and Institute, Sichuan 
      Cancer Center, School of Medicine, University of Electronic Science and 
      Technology of China, Chengdu 610041, China.
FAU - Ren, Li
AU  - Ren L
AD  - Department of Thoracic Oncology, West China Hospital, Sichuan University, Chengdu 
      610041, China.
FAU - Gong, Youling
AU  - Gong Y
AD  - Department of Thoracic Oncology, West China Hospital, Sichuan University, Chengdu 
      610041, China.
FAU - Yao, Wenxiu
AU  - Yao W
AD  - Department of Medical Oncology, Sichuan Cancer Hospital and Institute, Sichuan 
      Cancer Center, School of Medicine, University of Electronic Science and 
      Technology of China, Chengdu 610041, China.
FAU - Zhang, Xi
AU  - Zhang X
AD  - Third People's Hospital of Chengdu, Chengdu 610041, China.
FAU - Yin, Jun
AU  - Yin J
AD  - Third People's Hospital of Chengdu, Chengdu 610041, China.
FAU - He, Lang
AU  - He L
AD  - Fifth People's Hospital of Chengdu, Chengdu 610041, China.
FAU - Chen, Li
AU  - Chen L
AD  - Hospital of Traditional Medicine of Leshan, Leshan 614000, China.
FAU - Wang, Ke
AU  - Wang K
AD  - Department of Respiratory and Critical Care Medicine, West China Hospital, 
      Sichuan University, Chengdu 610041, China.
FAU - Huang, Meijuan
AU  - Huang M
AD  - Department of Thoracic Oncology, West China Hospital, Sichuan University, Chengdu 
      610041, China.
FAU - Li, Juan
AU  - Li J
AD  - Department of Medical Oncology, Sichuan Cancer Hospital and Institute, Sichuan 
      Cancer Center, School of Medicine, University of Electronic Science and 
      Technology of China, Chengdu 610041, China.
LA  - chi
PT  - Journal Article
PL  - China
TA  - Zhongguo Fei Ai Za Zhi
JT  - Zhongguo fei ai za zhi = Chinese journal of lung cancer
JID - 101126433
RN  - 0 (Protein Kinase Inhibitors)
RN  - 0 (Pyrimidines)
RN  - 0 (Sulfones)
RN  - EC 2.7.10.1 (ALK protein, human)
RN  - EC 2.7.10.1 (Anaplastic Lymphoma Kinase)
RN  - K418KG2GET (ceritinib)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Anaplastic Lymphoma Kinase/antagonists & inhibitors/genetics/*metabolism
MH  - Carcinoma, Non-Small-Cell Lung/*drug therapy
MH  - Female
MH  - Humans
MH  - Lung Neoplasms/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Protein Kinase Inhibitors/*adverse effects/*therapeutic use
MH  - Pyrimidines/*adverse effects/*therapeutic use
MH  - Retrospective Studies
MH  - Sulfones/*adverse effects/*therapeutic use
PMC - PMC7467981
OTO - NOTNLM
OT  - Anaplastic lymphoma kinase
OT  - Ceritinib
OT  - Efficacy
OT  - Lung neoplasms
OT  - Safety
COIS- The authors declare that they have no competing interests.
EDAT- 2020/08/26 06:00
MHDA- 2021/07/20 06:00
PMCR- 2020/08/20
CRDT- 2020/08/26 06:00
PHST- 2020/08/26 06:00 [entrez]
PHST- 2020/08/26 06:00 [pubmed]
PHST- 2021/07/20 06:00 [medline]
PHST- 2020/08/20 00:00 [pmc-release]
AID - zgfazz-23-8-655 [pii]
AID - 10.3779/j.issn.1009-3419.2020.102.33 [doi]
PST - ppublish
SO  - Zhongguo Fei Ai Za Zhi. 2020 Aug 20;23(8):655-661. doi: 
      10.3779/j.issn.1009-3419.2020.102.33.