PMID- 33033286
OWN - NLM
STAT- MEDLINE
DCOM- 20210104
LR  - 20240329
IS  - 2045-2322 (Electronic)
IS  - 2045-2322 (Linking)
VI  - 10
IP  - 1
DP  - 2020 Oct 8
TI  - Ceritinib in Japanese patients with anaplastic lymphoma kinase (ALK)+ non-small 
      cell lung cancer: interim analysis results of a post-marketing surveillance 
      study.
PG  - 16773
LID - 10.1038/s41598-020-72863-1 [doi]
LID - 16773
AB  - Ceritinib is a selective anaplastic lymphoma kinase (ALK) inhibitor approved for 
      the treatment of patients with unresectable advanced and/or recurrent ALK fusion 
      gene-positive non-small cell lung cancer (NSCLC). As per the approval condition 
      in Japan, this post-marketing surveillance (PMS) study evaluated the clinical 
      safety (including adverse events [AEs], adverse drug reactions [ADRs] and 
      priority investigation items) and efficacy (including ORR and PFS) of ceritinib 
      in Japanese patients. Interim analysis was conducted ~ 2 years after the start of 
      this non-interventional, multicentre, uncontrolled, open-label, special drug-use 
      investigation and results are reported from March 28, 2016 to April 28, 2018. 
      Each patient was followed up for 1 year. Most patients started treatment with 
      750 mg ceritinib. Safety profile was similar to that observed at the time of 
      approval. No new AEs or ADRs with incidences higher than that at approval were 
      identified. The rate of gastrointestinal ADRs (nausea, vomiting and diarrhoea) 
      was 73.64%. Meaningful efficacy was observed in both post-crizotinib and 
      post-alectinib settings, with ORR of 29.55% (95% CI 20.29-40.22) and disease 
      control rate of 53.41% (95% CI 42.46-64.12). No concerns regarding the safety and 
      efficacy of ceritinib were identified. No new measures, including modification of 
      the PMS study protocol, are considered necessary.
FAU - Kaneda, Hiroyasu
AU  - Kaneda H
AD  - Osaka City University, Osaka, Japan.
FAU - Kizaki, Minako
AU  - Kizaki M
AD  - Novartis Pharma K.K., Tokyo, Japan.
FAU - Ochi, Masami
AU  - Ochi M
AD  - Novartis Pharma K.K., Tokyo, Japan.
FAU - Shiraiwa, Naoko
AU  - Shiraiwa N
AD  - Novartis Pharma K.K., Tokyo, Japan.
FAU - Akatsu, Shigemi
AU  - Akatsu S
AD  - Novartis Pharma K.K., Tokyo, Japan. shigemi.akatsu@novartis.com.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20201008
PL  - England
TA  - Sci Rep
JT  - Scientific reports
JID - 101563288
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Pyrimidines)
RN  - 0 (Sulfones)
RN  - EC 2.7.10.1 (Anaplastic Lymphoma Kinase)
RN  - K418KG2GET (ceritinib)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anaplastic Lymphoma Kinase/*antagonists & inhibitors/metabolism
MH  - Antineoplastic Agents/adverse effects/*therapeutic use
MH  - Carcinoma, Non-Small-Cell Lung/*drug therapy/enzymology/mortality
MH  - Female
MH  - Humans
MH  - Japan
MH  - Kaplan-Meier Estimate
MH  - Lung Neoplasms/*drug therapy/enzymology/mortality
MH  - Male
MH  - Middle Aged
MH  - Product Surveillance, Postmarketing
MH  - Progression-Free Survival
MH  - Pyrimidines/adverse effects/*therapeutic use
MH  - Sulfones/adverse effects/*therapeutic use
PMC - PMC7544686
COIS- MK, MO, NS and SA are employees of Novartis Pharma K.K., Japan. HK has declare no 
      competing interests.
EDAT- 2020/10/10 06:00
MHDA- 2021/01/05 06:00
PMCR- 2020/10/08
CRDT- 2020/10/09 05:34
PHST- 2020/02/10 00:00 [received]
PHST- 2020/09/03 00:00 [accepted]
PHST- 2020/10/09 05:34 [entrez]
PHST- 2020/10/10 06:00 [pubmed]
PHST- 2021/01/05 06:00 [medline]
PHST- 2020/10/08 00:00 [pmc-release]
AID - 10.1038/s41598-020-72863-1 [pii]
AID - 72863 [pii]
AID - 10.1038/s41598-020-72863-1 [doi]
PST - epublish
SO  - Sci Rep. 2020 Oct 8;10(1):16773. doi: 10.1038/s41598-020-72863-1.