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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 | Cho, Byoung Chul | - |
dc.contributor.author | Kim, Dong-Wan | - |
dc.contributor.author | Batra, Ullas | - |
dc.contributor.author | Park, Keunchil | - |
dc.contributor.author | Kim, Sang-We | - |
dc.contributor.author | Yang, Cheng-Ta | - |
dc.contributor.author | Voon, Pei-Jye | - |
dc.contributor.author | Sriuranpong, Virote | - |
dc.contributor.author | Babu, K Govind | - |
dc.contributor.author | Amin, Khalid | - |
dc.contributor.author | Wang, Yingbo | - |
dc.contributor.author | Sen, Paramita | - |
dc.contributor.author | Slimane, Khemaies | - |
dc.contributor.author | Geater, Sarayut | - |
dc.date.accessioned | 2023-05-10T01:22:41Z | - |
dc.date.available | 2023-05-10T01:22:41Z | - |
dc.date.created | 2023-04-13 | - |
dc.date.created | 2023-04-13 | - |
dc.date.created | 2023-04-13 | - |
dc.date.created | 2023-04-13 | - |
dc.date.created | 2023-04-13 | - |
dc.date.created | 2023-04-13 | - |
dc.date.created | 2023-04-13 | - |
dc.date.created | 2023-04-13 | - |
dc.date.issued | 2023-01 | - |
dc.identifier.citation | Cancer Research and Treatment, Vol.55 No.1, pp.83-93 | - |
dc.identifier.issn | 1598-2998 | - |
dc.identifier.uri | https://hdl.handle.net/10371/192263 | - |
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.language | 영어 | - |
dc.publisher | 대한암학회 | - |
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.identifier.doi | 10.4143/crt.2021.1571 | - |
dc.citation.journaltitle | Cancer Research and Treatment | - |
dc.identifier.wosid | 000957087400008 | - |
dc.identifier.scopusid | 2-s2.0-85146364976 | - |
dc.citation.endpage | 93 | - |
dc.citation.number | 1 | - |
dc.citation.startpage | 83 | - |
dc.citation.volume | 55 | - |
dc.identifier.kciid | ART002922896 | - |
dc.description.isOpenAccess | Y | - |
dc.contributor.affiliatedAuthor | Kim, Dong-Wan | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | OPEN-LABEL | - |
dc.subject.keywordPlus | PHASE-II | - |
dc.subject.keywordPlus | CRIZOTINIB | - |
dc.subject.keywordPlus | CHEMOTHERAPY | - |
dc.subject.keywordPlus | SURVIVAL | - |
dc.subject.keywordPlus | DIAGNOSIS | - |
dc.subject.keywordPlus | BRAIN | - |
dc.subject.keywordPlus | MULTICENTER | - |
dc.subject.keywordPlus | ALECTINIB | - |
dc.subject.keywordAuthor | ALK-activated | - |
dc.subject.keywordAuthor | ALK-inhibitors | - |
dc.subject.keywordAuthor | Ceritinib | - |
dc.subject.keywordAuthor | Non-small-cell lung carcinoma | - |
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