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Open-Label, Multicenter, Randomized, Biomarker-Integrated Umbrella Trial for Second-Line Treatment of Advanced Gastric Cancer: K-Umbrella Gastric Cancer Study

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dc.contributor.author김현기-
dc.contributor.author김효송-
dc.contributor.author남정모-
dc.contributor.author라선영-
dc.contributor.author이충근-
dc.contributor.author정민규-
dc.contributor.author정현철-
dc.contributor.author정희철-
dc.date.accessioned2024-03-22T06:35:44Z-
dc.date.available2024-03-22T06:35:44Z-
dc.date.issued2024-01-
dc.identifier.issn0732-183X-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/198575-
dc.description.abstractPurpose: This study aimed to screen targeted agents as second-line treatment with a standard-of-care (SOC) controlled umbrella trial design in advanced gastric cancer (AGC). Patients and methods: Patients with HER2-negative AGC from eight Korean cancer centers were screened for druggable targets using immunohistochemistry (IHC) and in situ hybridization, and randomly assigned to the biomarker versus control group at a 4:1 ratio. In the biomarker group, patients were treated with specific targeted agent plus paclitaxel: pan-ERBB inhibitor for epidermal growth factor receptor (EGFR) 2+/3+ patients (afatinib; EGFR cohort), PIK3Cβ inhibitor for phosphatase and tensin homolog (PTEN) loss/null patients (GSK2636771; PTEN cohort), and anti-PD-1 inhibitor for PD-L1+, deficient mismatch repair/microsatellite instability-high, or Epstein-Barr virus-related cases (nivolumab; NIVO cohort). NONE cohort in the biomarker group without predefined biomarkers and control group received SOC (paclitaxel with or without ramucirumab). The primary end point was progression-free survival (PFS), and the secondary end points were efficacy and safety. Results: A total of 318 patients were randomly assigned into the control (n = 64) and biomarker (n = 254; EGFR, n = 67; PTEN, n = 37; NIVO, n = 48; NONE, n = 102) groups. Median follow-up was 35 months. Median PFS and overall survival (OS) were 3.7 (95% CI, 3.1 to 4.1) and 8.6 (95% CI, 7.6 to 9.8) months in the biomarker group and 4.0 (95% CI, 3.0 to 4.6) and 8.7 (95% CI, 7.1 to 9.9) months in the control group. Afatinib addition led to marginal survival benefits to patients with EGFR 3+ compared with SOC (PFS, 4.0 v 2.2 months; P = .09), but GSK2636771 did not prolong the survival of patients with PTEN loss. Addition of nivolumab showed a durable survival benefit (median OS, 12.0 v 7.6 months; P = .08). Conclusion: Although biomarker group did not show better survival than the control group, IHC-based screening and allocation of patients with AGC to the second-line treatment in an umbrella design were feasible for effective early screening of novel agents-
dc.description.statementOfResponsibilityrestriction-
dc.languageEnglish-
dc.publisherAmerican Society of Clinical Oncology-
dc.relation.isPartOfJOURNAL OF CLINICAL ONCOLOGY-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.subject.MESHAfatinib-
dc.subject.MESHAntineoplastic Agents* / therapeutic use-
dc.subject.MESHAntineoplastic Combined Chemotherapy Protocols / adverse effects-
dc.subject.MESHBiomarkers, Tumor-
dc.subject.MESHEpstein-Barr Virus Infections* / etiology-
dc.subject.MESHErbB Receptors-
dc.subject.MESHHerpesvirus 4, Human-
dc.subject.MESHHumans-
dc.subject.MESHNivolumab / therapeutic use-
dc.subject.MESHPaclitaxel / therapeutic use-
dc.subject.MESHStomach Neoplasms* / drug therapy-
dc.subject.MESHTreatment Outcome-
dc.titleOpen-Label, Multicenter, Randomized, Biomarker-Integrated Umbrella Trial for Second-Line Treatment of Advanced Gastric Cancer: K-Umbrella Gastric Cancer Study-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Pathology (병리학교실)-
dc.contributor.googleauthorChoong-Kun Lee-
dc.contributor.googleauthorHyo Song Kim-
dc.contributor.googleauthorMinkyu Jung-
dc.contributor.googleauthorHyunki Kim-
dc.contributor.googleauthorWoo Kyun Bae-
dc.contributor.googleauthorDong-Hoe Koo-
dc.contributor.googleauthorHei Cheul Jeung-
dc.contributor.googleauthorSook Ryun Park-
dc.contributor.googleauthorIn Gyu Hwang-
dc.contributor.googleauthorDae Young Zang-
dc.contributor.googleauthorHyun Woo Lee-
dc.contributor.googleauthorSejung Park-
dc.contributor.googleauthorChung Mo Nam-
dc.contributor.googleauthorHyun Cheol Chung-
dc.contributor.googleauthorSun Young Rha-
dc.identifier.doi10.1200/jco.23.00971-
dc.contributor.localIdA01108-
dc.contributor.localIdA01202-
dc.contributor.localIdA01264-
dc.contributor.localIdA01316-
dc.contributor.localIdA03259-
dc.contributor.localIdA03606-
dc.contributor.localIdA03773-
dc.contributor.localIdA03794-
dc.relation.journalcodeJ01331-
dc.identifier.eissn1527-7755-
dc.identifier.pmid37883723-
dc.identifier.urlhttps://ascopubs.org/doi/10.1200/JCO.23.00971-
dc.contributor.alternativeNameKim, Hyunki-
dc.contributor.affiliatedAuthor김현기-
dc.contributor.affiliatedAuthor김효송-
dc.contributor.affiliatedAuthor남정모-
dc.contributor.affiliatedAuthor라선영-
dc.contributor.affiliatedAuthor이충근-
dc.contributor.affiliatedAuthor정민규-
dc.contributor.affiliatedAuthor정현철-
dc.contributor.affiliatedAuthor정희철-
dc.citation.volume42-
dc.citation.number3-
dc.citation.startPage348-
dc.citation.endPage357-
dc.identifier.bibliographicCitationJOURNAL OF CLINICAL ONCOLOGY, Vol.42(3) : 348-357, 2024-01-
Appears in Collections:
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) > Dept. of Preventive Medicine (예방의학교실) > 1. Journal Papers

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