PMID- 35645123
OWN - NLM
STAT- MEDLINE
DCOM- 20220603
LR  - 20220606
IS  - 1998-4138 (Electronic)
IS  - 1998-4138 (Linking)
VI  - 18
IP  - 2
DP  - 2022 Apr
TI  - Clinical data from the real world: Efficacy analysis of ceritinib (450mg) in 
      ALK-rearrangement non-small-cell lung cancer patients with brain metastases in 
      China.
PG  - 516-524
LID - 10.4103/jcrt.jcrt_1453_21 [doi]
AB  - OBJECTIVES: The real-world intracranial efficacy data of ceritinib at a dose of 
      450 mg quaque die (QD) are currently unavailable. Therefore, we evaluated the 
      intracranial efficacy of ceritinib (450 mg QD) in anaplastic lymphoma kinase 
      (ALK)-rearrangement NSCLC patients in China. MATERIALS AND METHODS: In total, 57 
      ALK-rearrangement NSCLC patients with brain metastases (BM) were enrolled 
      retrospectively in this real-world study. Of these, 53 patients experienced 
      progression at baseline during or after prior crizotinib administration, and 24 
      patients received prior brain radiotherapy. Patients received ceritinib (450 mg 
      QD) treatment. Intracranial efficacy [objective response rate (ORR) and disease 
      control rate (DCR)] was evaluated according to the Response Assessment in 
      Neuro-Oncology (RANO) standard; progression-free survival (PFS) and adverse 
      events (AEs) data were obtained through follow-ups. RESULTS: The intracranial ORR 
      and DCR of ceritinib were 73.7% and 93.0%, respectively. The median intracranial 
      PFS in patients reaching the endpoint was 8.75 months, whereas the median 
      intracranial PFS in all patients was not reached and predicted to be not 
      evaluable (NE) (95% CI: 12.9-NE). The estimated 12-month event-free probability 
      (EFP) of intracranial lesions was 68.1%. A subgroup analysis revealed that the 
      estimated 12-month EFP of intracranial lesions was relatively higher in patients 
      with prior brain radiotherapy (93.8% vs. 47.1%, P = 0.0006). CONCLUSION: 
      Ceritinib administered at 450 mg QD to ALK-rearrangement NSCLC patients with BM 
      in China exhibited superior ORR and DCR, as well as PFS and event free 
      probability. The estimated 12-month EFP for intracranial lesions improved in 
      patients with prior brain radiotherapy.
FAU - Qiu, Zhixin
AU  - Qiu Z
AD  - Department of Respiratory and Critical Care Medicine, West China Hospital, 
      Sichuan University, Sichuan Province, Chengdu, P.R. China.
FAU - Xian, Xinhong
AU  - Xian X
AD  - West China Clinical Medical College, Sichuan University, Sichuan Province, 
      Chengdu, P.R. China.
FAU - Liu, Chunrong
AU  - Liu C
AD  - Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, 
      Sichuan Province, Chengdu, P.R. China.
FAU - Yu, Min
AU  - Yu M
AD  - Department of Chest Oncology, West China Hospital, Sichuan University, Sichuan 
      Province, Chengdu, P.R. China.
FAU - Lin, Feng
AU  - Lin F
AD  - Department of Thoracic Surgery, West China Hospital, Sichuan University, Sichuan 
      Province, Chengdu, P.R. China.
FAU - Huang, Meijuan
AU  - Huang M
AD  - Department of Chest Oncology, West China Hospital, Sichuan University, Sichuan 
      Province, Chengdu, P.R. China.
FAU - Wang, Ke
AU  - Wang K
AD  - Department of Respiratory and Critical Care Medicine; Lung Cancer Treatment 
      Center, West China Hospital, Sichuan University, Sichuan Province, Chengdu, P.R. 
      China.
LA  - eng
PT  - Journal Article
PL  - India
TA  - J Cancer Res Ther
JT  - Journal of cancer research and therapeutics
JID - 101249598
RN  - 0 (Pyrimidines)
RN  - 0 (Sulfones)
RN  - EC 2.7.10.1 (Anaplastic Lymphoma Kinase)
RN  - K418KG2GET (ceritinib)
SB  - IM
MH  - Anaplastic Lymphoma Kinase/genetics
MH  - *Brain Neoplasms/drug therapy/secondary
MH  - *Carcinoma, Non-Small-Cell Lung/drug therapy/pathology
MH  - Chromosome Aberrations
MH  - Humans
MH  - *Lung Neoplasms/drug therapy/pathology
MH  - Pyrimidines
MH  - Retrospective Studies
MH  - Sulfones
OTO - NOTNLM
OT  - ALK
OT  - NSCLC
OT  - ceritinib
OT  - main metastases
OT  - real world
COIS- None
EDAT- 2022/06/02 06:00
MHDA- 2022/06/07 06:00
CRDT- 2022/06/01 11:05
PHST- 2022/06/01 11:05 [entrez]
PHST- 2022/06/02 06:00 [pubmed]
PHST- 2022/06/07 06:00 [medline]
AID - JCanResTher_2022_18_2_516_345525 [pii]
AID - 10.4103/jcrt.jcrt_1453_21 [doi]
PST - ppublish
SO  - J Cancer Res Ther. 2022 Apr;18(2):516-524. doi: 10.4103/jcrt.jcrt_1453_21.