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Phase II clinical and exploratory biomarker study of dacomitinib in recurrent and/or metastatic esophageal squamous cell carcinoma

DC FieldValueLanguage
dc.contributor.author김대준-
dc.contributor.author김주항-
dc.contributor.author김현기-
dc.contributor.author김혜련-
dc.contributor.author김효송-
dc.contributor.author문용화-
dc.contributor.author박준철-
dc.contributor.author백순명-
dc.contributor.author신성관-
dc.contributor.author이상길-
dc.contributor.author이용찬-
dc.contributor.author이창걸-
dc.contributor.author정현수-
dc.contributor.author조병철-
dc.contributor.author표경호-
dc.contributor.author허진-
dc.date.accessioned2018-03-26T17:07:46Z-
dc.date.available2018-03-26T17:07:46Z-
dc.date.issued2015-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/157227-
dc.description.abstractThe purpose of this study was to investigate the clinical activity, safety and predictive biomarkers of dacomitinib, an irreversible pan-HER inhibitor, in patients with recurrent or metastatic esophageal squamous cell carcinoma (R/M-ESCC). Patients, whose diseases were not amenable to curative treatment and had progressed on platinum-based chemotherapy, were treated with dacomitinib 45 mg/day. The primary endpoint was objective response rate by RECISTv 1.1. Predictive biomarker analyses included the characterization of somatic mutations and gene expression using the Ion Torrent AmpliSeq Cancer Hotspot Panel and Nanostring nCounter, and investigation of their relationship with clinical outcomes. Of the 48 evaluable patients, 6 (12.5%) achieved partial responses and 29 (60.4%) had stable disease. The median response duration was 7.1 months. The median progression free survival (PFS) and overall survival (OS) was 3.3 months (95% CI, 2.4-4.3 months) and 6.4 months (95% CI, 4.4-8.4 months). Adverse events were mostly grade 1-2. Gene set enrichment analysis revealed that ERBB signaling pathway is significantly enriched in patients with PFS ≥ 4 months (n = 12) than PFS < 4 months (n = 21) (p < 0.001). Upregulation of ERBB signaling pathway was significantly associated with longer PFS (5.0 vs. 2.9 months, P = 0.016) and OS (10.0 vs. 4.8 months, P = 0.022). The most frequent mutations were TP53 (61%) followed by CDKN2A (8%), MLH1 (8%), FLT3 (8%) and EGFR (8%). Dacomitinib demonstrated clinical efficacy with manageable toxicity in platinum-failed R/M-ESCC. Screening of ERBB pathway-related gene expression profiles may help identify patients who are most likely benefit from dacomitinib.-
dc.description.statementOfResponsibilityopen-
dc.languageEnglish-
dc.publisherImpact Journals-
dc.relation.isPartOfONCOTARGET-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.rightshttps://creativecommons.org/licenses/by-nc-nd/2.0/kr/-
dc.subject.MESHAged-
dc.subject.MESHAged, 80 and over-
dc.subject.MESHAntineoplastic Agents/adverse effects-
dc.subject.MESHAntineoplastic Agents/therapeutic use*-
dc.subject.MESHBiomarkers, Tumor/antagonists & inhibitors-
dc.subject.MESHBiomarkers, Tumor/genetics*-
dc.subject.MESHCarcinoma, Squamous Cell/drug therapy*-
dc.subject.MESHCarcinoma, Squamous Cell/genetics-
dc.subject.MESHCarcinoma, Squamous Cell/mortality-
dc.subject.MESHCarcinoma, Squamous Cell/pathology-
dc.subject.MESHDNA Mutational Analysis-
dc.subject.MESHDisease Progression-
dc.subject.MESHDisease-Free Survival-
dc.subject.MESHEsophageal Neoplasms/drug therapy*-
dc.subject.MESHEsophageal Neoplasms/genetics-
dc.subject.MESHEsophageal Neoplasms/mortality-
dc.subject.MESHEsophageal Neoplasms/pathology-
dc.subject.MESHFemale-
dc.subject.MESHHumans-
dc.subject.MESHKaplan-Meier Estimate-
dc.subject.MESHMale-
dc.subject.MESHMiddle Aged-
dc.subject.MESHMutation-
dc.subject.MESHNeoplasm Recurrence, Local*-
dc.subject.MESHPatient Selection-
dc.subject.MESHPrecision Medicine-
dc.subject.MESHProtein Kinase Inhibitors/adverse effects-
dc.subject.MESHProtein Kinase Inhibitors/therapeutic use*-
dc.subject.MESHQuinazolinones/adverse effects-
dc.subject.MESHQuinazolinones/therapeutic use*-
dc.subject.MESHReceptor, Epidermal Growth Factor/antagonists & inhibitors-
dc.subject.MESHReceptor, Epidermal Growth Factor/genetics-
dc.subject.MESHRepublic of Korea-
dc.subject.MESHTime Factors-
dc.subject.MESHTreatment Outcome-
dc.titlePhase II clinical and exploratory biomarker study of dacomitinib in recurrent and/or metastatic esophageal squamous cell carcinoma-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine-
dc.contributor.departmentDept. of Thoracic & Cardiovascular Surgery-
dc.contributor.googleauthorHyo Song Kim-
dc.contributor.googleauthorSung-Moo Kim-
dc.contributor.googleauthorHyunki Kim-
dc.contributor.googleauthorKyoung-Ho Pyo-
dc.contributor.googleauthorJong-Mu Sun-
dc.contributor.googleauthorMyung-Ju Ahn-
dc.contributor.googleauthorKeunchil Park-
dc.contributor.googleauthorBhumsuk Keam-
dc.contributor.googleauthorNak-Jung Kwon-
dc.contributor.googleauthorHwan Jung Yun-
dc.contributor.googleauthorHoon-Gu Kim-
dc.contributor.googleauthorIk-Joo Chung-
dc.contributor.googleauthorJong Seok Lee-
dc.contributor.googleauthorKyung Hee Lee-
dc.contributor.googleauthorDae Joon Kim-
dc.contributor.googleauthorChang‑Geol Lee-
dc.contributor.googleauthorJin Hur-
dc.contributor.googleauthorHyunsoo Chung-
dc.contributor.googleauthorJun Chul Park-
dc.contributor.googleauthorSung Kwan Shin-
dc.contributor.googleauthorSang Kil Lee-
dc.contributor.googleauthorHye Ryun Kim-
dc.contributor.googleauthorYong Wha Moon-
dc.contributor.googleauthorYong Chan Lee-
dc.contributor.googleauthorJoo Hang Kim-
dc.contributor.googleauthorSoonmyung Paik-
dc.contributor.googleauthorByoung Chul Cho-
dc.identifier.doi10.18632/oncotarget.6056-
dc.contributor.localIdA00368-
dc.contributor.localIdA00945-
dc.contributor.localIdA01108-
dc.contributor.localIdA01166-
dc.contributor.localIdA01202-
dc.contributor.localIdA01370-
dc.contributor.localIdA01676-
dc.contributor.localIdA01823-
dc.contributor.localIdA02112-
dc.contributor.localIdA02812-
dc.contributor.localIdA02988-
dc.contributor.localIdA03240-
dc.contributor.localIdA03765-
dc.contributor.localIdA03822-
dc.contributor.localIdA04809-
dc.contributor.localIdA04370-
dc.relation.journalcodeJ02421-
dc.identifier.eissn1949-2553-
dc.identifier.pmid26462025-
dc.subject.keywordbiomarker-
dc.subject.keywordepidermal growth factor receptor-
dc.subject.keywordesophageal squamous cell carcinoma-
dc.subject.keywordtyrosine kinase inhibitor-
dc.contributor.alternativeNameKim, Dae Joon-
dc.contributor.alternativeNameKim, Joo Hang-
dc.contributor.alternativeNameKim, Hyun Ki-
dc.contributor.alternativeNameKim, Hye Ryun-
dc.contributor.alternativeNameKim, Hyo Song-
dc.contributor.alternativeNameMoon, Yong Wha-
dc.contributor.alternativeNamePark, Jun Chul-
dc.contributor.alternativeNamePaik, Soon Myung-
dc.contributor.alternativeNameShin, Sung Kwan-
dc.contributor.alternativeNameLee, Sang Kil-
dc.contributor.alternativeNameLee, Yong Chan-
dc.contributor.alternativeNameLee, Chang Geol-
dc.contributor.alternativeNameChung, Hyun Soo-
dc.contributor.alternativeNameCho, Byoung Chul-
dc.contributor.alternativeNamePyo, Kyoung Ho-
dc.contributor.alternativeNameHur, Jin-
dc.contributor.affiliatedAuthorKim, Dae Joon-
dc.contributor.affiliatedAuthorKim, Joo Hang-
dc.contributor.affiliatedAuthorKim, Hyun Ki-
dc.contributor.affiliatedAuthorKim, Hye Ryun-
dc.contributor.affiliatedAuthorKim, Hyo Song-
dc.contributor.affiliatedAuthorMoon, Yong Wha-
dc.contributor.affiliatedAuthorPark, Jun Chul-
dc.contributor.affiliatedAuthorPaik, Soon Myung-
dc.contributor.affiliatedAuthorShin, Sung Kwan-
dc.contributor.affiliatedAuthorLee, Sang Kil-
dc.contributor.affiliatedAuthorLee, Yong Chan-
dc.contributor.affiliatedAuthorLee, Chang Geol-
dc.contributor.affiliatedAuthorChung, Hyun Soo-
dc.contributor.affiliatedAuthorCho, Byoung Chul-
dc.contributor.affiliatedAuthorPyo, Kyoung Ho-
dc.contributor.affiliatedAuthorHur, Jin-
dc.citation.volume6-
dc.citation.number42-
dc.citation.startPage44971-
dc.citation.endPage44984-
dc.identifier.bibliographicCitationONCOTARGET , Vol.6(42) : 44971-44984, 2015-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Thoracic and Cardiovascular Surgery (흉부외과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Pathology (병리학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > BioMedical Science Institute (의생명과학부) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Radiation Oncology (방사선종양학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Radiology (영상의학교실) > 1. Journal Papers

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