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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.authorLee, CK-
dc.contributor.authorKim, HS-
dc.contributor.authorJung, M-
dc.contributor.authorKim, H-
dc.contributor.authorBae, WK-
dc.contributor.authorKoo, DH-
dc.contributor.authorJeung, HC-
dc.contributor.authorPark, SR-
dc.contributor.authorHwang, IG-
dc.contributor.authorZang, DY-
dc.contributor.authorLee, HW-
dc.contributor.authorPark, S-
dc.contributor.authorNam, CM-
dc.contributor.authorChung, HC-
dc.contributor.authorRha, SY-
dc.date.accessioned2024-02-13T23:27:02Z-
dc.date.available2024-02-13T23:27:02Z-
dc.date.issued2024-
dc.identifier.issn0732-183X-
dc.identifier.urihttp://repository.ajou.ac.kr/handle/201003/32183-
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.language.isoen-
dc.subject.MESHAfatinib-
dc.subject.MESHAntineoplastic Agents-
dc.subject.MESHAntineoplastic Combined Chemotherapy Protocols-
dc.subject.MESHBiomarkers, Tumor-
dc.subject.MESHEpstein-Barr Virus Infections-
dc.subject.MESHErbB Receptors-
dc.subject.MESHHerpesvirus 4, Human-
dc.subject.MESHHumans-
dc.subject.MESHNivolumab-
dc.subject.MESHPaclitaxel-
dc.subject.MESHStomach Neoplasms-
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.identifier.pmid37883723-
dc.contributor.affiliatedAuthorLee, HW-
dc.type.localJournal Papers-
dc.identifier.doi10.1200/JCO.23.00971-
dc.citation.titleJournal of clinical oncology-
dc.citation.volume42-
dc.citation.number3-
dc.citation.date2024-
dc.citation.startPage348-
dc.citation.endPage357-
dc.identifier.bibliographicCitationJournal of clinical oncology, 42(3). : 348-357, 2024-
dc.embargo.liftdate9999-12-31-
dc.embargo.terms9999-12-31-
dc.identifier.eissn1527-7755-
dc.relation.journalidJ00732183X-
Appears in Collections:
Journal Papers > School of Medicine / Graduate School of Medicine > Hematology-Oncology
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