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Efficacy and Safety of Ceritinib (450 mg/d or 600 mg/d) With Food Versus 750-mg/d Fasted in Patients With ALK Receptor Tyrosine Kinase (ALK)-Positive NSCLC: Primary Efficacy Results From the ASCEND-8 Study

DC Field Value Language
dc.contributor.author조병철-
dc.date.accessioned2022-08-19T06:27:12Z-
dc.date.available2022-08-19T06:27:12Z-
dc.date.issued2019-07-
dc.identifier.issn1556-0864-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/189187-
dc.description.abstractIntroduction: In an earlier report of the ASCEND-8 study (open-label, phase I, three-arm study, treatment-naive patients and pre-treated patients with advanced/metastatic NSCLC), it was shown that ceritinib 450 mg with food had comparable exposure and better gastrointestinal tolerability than 750-mg fasted. Methods: Here, we report efficacy and updated safety data from primary efficacy analysis of the ASCEND-8 study. Key secondary endpoints were overall response rate and duration of response, assessed by blinded independent review committee (BIRC) using Response Evaluation Criteria in Solid Tumors 1.1. Results: In total, 306 patients were randomized to ceritinib 450-mg fed (n = 108) or 600-mg fed (n = 87) or 750-mg fasted (n = 111), of which 304 patients were included in safety analysis and 198 treatment-naive patients (ALK receptor tyrosine kinase [ALK]-positive by immunohistochemistry) were included in the efficacy analysis (450-mg fed [n = 73], 600-mg fed [n = 51], and 750-mg fasted [n = 74]). The BIRC-assessed overall response rate was 78.1% (95% confidence interval [CI]: 66.9-86.9), 72.5% (95% CI: 58.3-84.1), and 75.7% (95% CI: 64.3-84.9), respectively; and the median duration of response (months) by BIRC was not estimable (NE) (95% CI: 11.2-NE), 20.7 (95% CI: 15.8-NE), and 15.4 (95% CI: 8.3-NE), respectively. Based on the safety analysis (n = 304), the 450-mg fed arm showed the highest median relative dose intensity (100% versus 78.5% versus 83.7%), lowest proportion of patients with dose reductions (24.1% versus 65.1% versus 60.9%), and lowest proportion of patients with gastrointestinal toxicities (75.9% versus 82.6% versus 91.8%). Conclusion: Ceritinib at a dose of 450 mg with food compared to 750-mg fasted showed consistent efficacy and less gastrointestinal toxicity. (C) 2019 International Association for the Study of Lung Cancer. Published by Elsevier Inc.-
dc.description.statementOfResponsibilityopen-
dc.languageEnglish-
dc.publisherElsevier-
dc.relation.isPartOfJOURNAL OF THORACIC ONCOLOGY-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.subject.MESHAdult-
dc.subject.MESHAged-
dc.subject.MESHAged, 80 and over-
dc.subject.MESHAnaplastic Lymphoma Kinase / genetics*-
dc.subject.MESHAntineoplastic Agents / therapeutic use*-
dc.subject.MESHBone Neoplasms / drug therapy-
dc.subject.MESHBone Neoplasms / genetics-
dc.subject.MESHBone Neoplasms / secondary-
dc.subject.MESHBrain Neoplasms / drug therapy-
dc.subject.MESHBrain Neoplasms / genetics-
dc.subject.MESHBrain Neoplasms / secondary-
dc.subject.MESHCarcinoma, Non-Small-Cell Lung / drug therapy*-
dc.subject.MESHCarcinoma, Non-Small-Cell Lung / genetics-
dc.subject.MESHCarcinoma, Non-Small-Cell Lung / pathology-
dc.subject.MESHFasting*-
dc.subject.MESHFemale-
dc.subject.MESHFollow-Up Studies-
dc.subject.MESHFood*-
dc.subject.MESHGene Rearrangement-
dc.subject.MESHHumans-
dc.subject.MESHLiver Neoplasms / drug therapy-
dc.subject.MESHLiver Neoplasms / genetics-
dc.subject.MESHLiver Neoplasms / secondary-
dc.subject.MESHLung Neoplasms / drug therapy*-
dc.subject.MESHLung Neoplasms / genetics-
dc.subject.MESHLung Neoplasms / pathology-
dc.subject.MESHMale-
dc.subject.MESHMaximum Tolerated Dose-
dc.subject.MESHMiddle Aged-
dc.subject.MESHPrognosis-
dc.subject.MESHPyrimidines / therapeutic use*-
dc.subject.MESHResponse Evaluation Criteria in Solid Tumors-
dc.subject.MESHSulfones / therapeutic use*-
dc.subject.MESHYoung Adult-
dc.titleEfficacy and Safety of Ceritinib (450 mg/d or 600 mg/d) With Food Versus 750-mg/d Fasted in Patients With ALK Receptor Tyrosine Kinase (ALK)-Positive NSCLC: Primary Efficacy Results From the ASCEND-8 Study-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학교실)-
dc.contributor.googleauthorByoung Chul Cho-
dc.contributor.googleauthorRadka Obermannova-
dc.contributor.googleauthorAlessandra Bearz-
dc.contributor.googleauthorMark McKeage-
dc.contributor.googleauthorDong-Wang Kim-
dc.contributor.googleauthorUllas Batra-
dc.contributor.googleauthorGloria Borra-
dc.contributor.googleauthorSergey Orlov-
dc.contributor.googleauthorSang-We Kim-
dc.contributor.googleauthorSarayut L Geater-
dc.contributor.googleauthorPieter E Postmus-
dc.contributor.googleauthorScott A Laurie-
dc.contributor.googleauthorKeunchil Park-
dc.contributor.googleauthorCheng-Ta Yang-
dc.contributor.googleauthorAndrea Ardizzoni-
dc.contributor.googleauthorAnna C Bettini-
dc.contributor.googleauthorGilberto de Castro Jr-
dc.contributor.googleauthorFlavia Kiertsman-
dc.contributor.googleauthorZhe Chen-
dc.contributor.googleauthorYvonne Y Lau-
dc.contributor.googleauthorKalyanee Viraswami-Appanna-
dc.contributor.googleauthorVanessa Q Passos-
dc.contributor.googleauthorRafal Dziadziuszko-
dc.identifier.doi10.1016/j.jtho.2019.03.002-
dc.contributor.localIdA03822-
dc.relation.journalcodeJ01909-
dc.identifier.eissn1556-1380-
dc.identifier.pmid30851442-
dc.subject.keywordCeritinib-
dc.subject.keywordALK receptor tyrosine kinase-
dc.subject.keywordNSCLC-
dc.subject.keywordFood effect-
dc.contributor.alternativeNameCho, Byoung Chul-
dc.contributor.affiliatedAuthor조병철-
dc.citation.volume14-
dc.citation.number7-
dc.citation.startPage1255-
dc.citation.endPage1265-
dc.identifier.bibliographicCitationJOURNAL OF THORACIC ONCOLOGY, Vol.14(7) : 1255-1265, 2019-07-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

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