Safety and Preliminary Efficacy of Ceritinib 450 mg with Food in Chinese ALK-positive Non-small Cell Lung Cancer.
10.3779/j.issn.1009-3419.2020.102.33
- Author:
Yuke TIAN
1
;
Tian TIAN
2
;
Ping YU
1
;
Li REN
2
;
Youling GONG
2
;
Wenxiu YAO
1
;
Xi ZHANG
3
;
Jun YIN
3
;
Lang HE
4
;
Li CHEN
5
;
Ke WANG
6
;
Meijuan HUANG
2
;
Juan LI
1
Author Information
1. 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.
2. Department of Thoracic Oncology, West China Hospital, Sichuan University, Chengdu 610041, China.
3. Third People's Hospital of Chengdu, Chengdu 610041, China.
4. Fifth People's Hospital of Chengdu, Chengdu 610041, China.
5. Hospital of Traditional Medicine of Leshan, Leshan 614000, China.
6. Department of Respiratory and Critical Care Medicine, West China Hospital, Sichuan University, Chengdu 610041, China.
- Publication Type:Journal Article
- Keywords:
Anaplastic lymphoma kinase;
Ceritinib;
Efficacy;
Lung neoplasms;
Safety
- From:
Chinese Journal of Lung Cancer
2020;23(8):655-661
- CountryChina
- Language:Chinese
-
Abstract:
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.
