We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Safety and Preliminary Efficacy of Ceritinib 450 mg with Food in Chinese ALK-positive Non-small Cell Lung Cancer.
- Authors
Yuke TIAN; Tian TIAN; Ping YU; Li REN; Youling GONG; Wenxiu YAO; Xi ZHANG; Jun YIN; Lang HE; Li CHEN; Ke WANG; Meijuan HUANG; Juan LI
- Abstract
Background and objective 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%). Conclusion 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.
- Subjects
CHINA; CONFIDENCE intervals; HEALTH facilities; LUNG cancer; PATIENT safety; PROTEIN-tyrosine kinase inhibitors; TREATMENT effectiveness; ANAPLASTIC lymphoma kinase; DESCRIPTIVE statistics
- Publication
Chinese Journal of Lung Cancer, 2020, Vol 23, Issue 8, p655
- ISSN
1009-3419
- Publication type
Article
- DOI
10.3779/j.issn.1009-3419.2020.102.33