Cited 2 times in
Efficacy and Safety of Ceritinib 450 mg/day with Food and 750 mg/day in Fasted State in Treatment-Naïve Patients with ALK+ Non-Small Cell Lung Cancer: Results from the ASCEND-8 Asian Subgroup Analysis
DC Field | Value | Language |
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dc.contributor.author | 조병철 | - |
dc.date.accessioned | 2023-04-07T01:34:56Z | - |
dc.date.available | 2023-04-07T01:34:56Z | - |
dc.date.issued | 2023-01 | - |
dc.identifier.issn | 1598-2998 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/193999 | - |
dc.description.abstract | Purpose: Previous report from the ASCEND-8 trial showed consistent efficacy with less gastrointestinal (GI) toxicity in patients with anaplastic lymphoma kinase-rearranged (ALK+) advanced/metastatic non-small cell lung cancer (NSCLC) treated with ceritinib 450-mg with food compared with 750-mg fasted. In this subgroup analysis, we report outcomes in Asian patients of the ASCEND-8 trial. Materials and methods: Key efficacy endpoints were blinded independent review committee (BIRC)-assessed overall response rate (ORR) and duration of response (DOR) evaluated per Response Evaluation Criteria in Solid Tumors v1.1. Other efficacy endpoints were investigator-assessed ORR and DOR; BIRC- and investigator-assessed progression-free survival (PFS) and disease control rate; overall survival (OS). Safety was evaluated by frequency and severity of adverse events. Results: At final data cutoff (6 March 2020), 198 treatment-naïve patients were included in efficacy analysis, of which 74 (37%) comprised the Asian subset; 450-mg fed (n=29), 600-mg fed (n=19), and 750-mg fasted (n=26). Baseline characteristics were mostly comparable across study arms. At baseline, more patients in 450-mg fed arm (44.8%) had brain metastases than in 750-mg fasted arm (26.9%). Per BIRC, patients in the 450-mg fed arm had a numerically higher ORR, 24-month DOR rate and 24-month PFS rate than the 750-mg fasted arm. The 36-month OS rate was 93.1% in 450-mg fed arm and 70.9% in 750-mg fasted arm. Any-grade GI toxicity occurred in 82.8% and 96.2% of patients in the 450-mg fed and 750-mg fasted arms, respectively. Conclusion: Asian patients with ALK+ advanced/metastatic NSCLC treated with ceritinib 450-mg fed showed numerically higher efficacy and lower GI toxicity than 750-mg fasted patients. | - |
dc.description.statementOfResponsibility | open | - |
dc.format | application/pdf | - |
dc.language | English, Korean | - |
dc.publisher | Official journal of Korean Cancer Association | - |
dc.relation.isPartOf | CANCER RESEARCH AND TREATMENT | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Anaplastic Lymphoma Kinase / genetics | - |
dc.subject.MESH | Carcinoma, Non-Small-Cell Lung* / drug therapy | - |
dc.subject.MESH | Carcinoma, Non-Small-Cell Lung* / genetics | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Lung Neoplasms* / drug therapy | - |
dc.subject.MESH | Lung Neoplasms* / genetics | - |
dc.subject.MESH | Protein Kinase Inhibitors / adverse effects | - |
dc.subject.MESH | Receptor Protein-Tyrosine Kinases | - |
dc.title | Efficacy and Safety of Ceritinib 450 mg/day with Food and 750 mg/day in Fasted State in Treatment-Naïve Patients with ALK+ Non-Small Cell Lung Cancer: Results from the ASCEND-8 Asian Subgroup Analysis | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Byoung Chul Cho | - |
dc.contributor.googleauthor | Dong-Wan Kim | - |
dc.contributor.googleauthor | Ullas Batra | - |
dc.contributor.googleauthor | Keunchil Park | - |
dc.contributor.googleauthor | Sang-We Kim | - |
dc.contributor.googleauthor | Cheng-Ta Yang | - |
dc.contributor.googleauthor | Pei-Jye Voon | - |
dc.contributor.googleauthor | Virote Sriuranpong | - |
dc.contributor.googleauthor | K Govind Babu | - |
dc.contributor.googleauthor | Khalid Amin | - |
dc.contributor.googleauthor | Yingbo Wang | - |
dc.contributor.googleauthor | Paramita Sen | - |
dc.contributor.googleauthor | Khemaies Slimane | - |
dc.contributor.googleauthor | Sarayut Geater | - |
dc.identifier.doi | 10.4143/crt.2021.1571 | - |
dc.contributor.localId | A03822 | - |
dc.relation.journalcode | J00453 | - |
dc.identifier.eissn | 2005-9256 | - |
dc.identifier.pmid | 35344649 | - |
dc.subject.keyword | ALK-activated | - |
dc.subject.keyword | ALK-inhibitors | - |
dc.subject.keyword | Ceritinib | - |
dc.subject.keyword | Non-small-cell lung carcinoma | - |
dc.contributor.alternativeName | Cho, Byoung Chul | - |
dc.contributor.affiliatedAuthor | 조병철 | - |
dc.citation.volume | 55 | - |
dc.citation.number | 1 | - |
dc.citation.startPage | 83 | - |
dc.citation.endPage | 93 | - |
dc.identifier.bibliographicCitation | CANCER RESEARCH AND TREATMENT, Vol.55(1) : 83-93, 2023-01 | - |
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