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Phase III Trial of Avelumab Maintenance After First-Line Induction Chemotherapy Versus Continuation of Chemotherapy in Patients With Gastric Cancers: Results From JAVELIN Gastric 100
DC Field | Value | Language |
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dc.contributor.author | Moehler, Markus | - |
dc.contributor.author | Dvorkin, Mikhail | - |
dc.contributor.author | Boku, Narikazu | - |
dc.contributor.author | Ozguroglu, Mustafa | - |
dc.contributor.author | Ryu, Min-Hee | - |
dc.contributor.author | Muntean, Alina S. | - |
dc.contributor.author | Lonardi, Sara | - |
dc.contributor.author | Nechaeva, Marina | - |
dc.contributor.author | Bragagnoli, Arinilda C. | - |
dc.contributor.author | Coskun, Hasan S. | - |
dc.contributor.author | Cubillo Gracian, Antonio | - |
dc.contributor.author | Takano, Toshimi | - |
dc.contributor.author | Wong, Rachel | - |
dc.contributor.author | Safran, Howard | - |
dc.contributor.author | Vaccaro, Gina M. | - |
dc.contributor.author | Wainberg, Zev A. | - |
dc.contributor.author | Silver, Matthew R. | - |
dc.contributor.author | Xiong, Huiling | - |
dc.contributor.author | Hong, Janet | - |
dc.contributor.author | Taieb, Julien | - |
dc.contributor.author | Bang, Yung-Jue | - |
dc.date.accessioned | 2022-04-18T09:24:04Z | - |
dc.date.available | 2022-04-18T09:24:04Z | - |
dc.date.created | 2021-06-09 | - |
dc.date.created | 2021-06-09 | - |
dc.date.issued | 2021-03-20 | - |
dc.identifier.citation | Journal of Clinical Oncology, Vol.39 No.9, pp.966-977 | - |
dc.identifier.issn | 0732-183X | - |
dc.identifier.other | 134927 | - |
dc.identifier.uri | https://hdl.handle.net/10371/178097 | - |
dc.description.abstract | PURPOSE The role of maintenance therapy for gastric (GC) or gastroesophageal junction cancer (GEJC) is unclear. We investigated avelumab (anti-programmed death ligand-1 [PD-L1]) maintenance after first-line induction chemotherapy for GC/GEJC. PATIENTS AND METHODS JAVELIN Gastric 100 was a global, open-label, phase III trial. Eligible patients had untreated, unresectable, human epidermal growth factor receptor 2-negative, locally advanced or metastatic GC or GEJC. Patients without progressive disease after 12 weeks of first-line chemotherapy with oxaliplatin plus a fluoropyrimidine were randomly assigned 1:1 to avelumab 10 mg/kg every 2 weeks or continued chemotherapy, stratified by region (Asia v non-Asia). The primary end point was overall survival (OS) after induction chemotherapy in all randomly assigned patients or the PD-L1-positive randomly assigned population (>= 1% of tumor cells; 73-10 assay). RESULTS A total of 805 patients received induction; 499 were randomly assigned to avelumab (n = 249) or continued chemotherapy (n = 250). Median OS was 10.4 months (95% CI, 9.1 to 12.0 months) versus 10.9 months (95% CI, 9.6 to 12.4 months) and 24-month OS rate was 22.1% versus 15.5% with avelumab versus chemotherapy, respectively (hazard ratio [HR], 0.91; 95% CI, 0.74 to 1.11; P = .1779). In the PD-L1-positive population (n = 54), the HR for OS was 1.13 (95% CI, 0.57 to 2.23; P = .6352). In an exploratory analysis of the PD-L1-positive population, defined as combined positive score >= 1 (22C3 assay; n = 137), median OS was 14.9 months (95% CI, 8.7 to 17.3 months) with avelumab versus 11.6 months (95% CI, 8.4 to 12.6 months) with chemotherapy (unstratified HR, 0.72; 95% CI, 0.49 to 1.05). With avelumab and chemotherapy, treatment-related adverse events (TRAEs) occurred in 149 (61.3%) and 184 (77.3%) patients, including grade >= 3 TRAEs in 31 (12.8%) and 78 (32.8%) patients, respectively. CONCLUSION JAVELIN Gastric 100 did not demonstrate superior OS with avelumab maintenance versus continued chemotherapy in patients with advanced GC or GEJC overall or in a prespecified PD-L1-positive population. | - |
dc.language | 영어 | - |
dc.publisher | American Society of Clinical Oncology | - |
dc.title | Phase III Trial of Avelumab Maintenance After First-Line Induction Chemotherapy Versus Continuation of Chemotherapy in Patients With Gastric Cancers: Results From JAVELIN Gastric 100 | - |
dc.type | Article | - |
dc.contributor.AlternativeAuthor | 방영주 | - |
dc.identifier.doi | 10.1200/JCO.20.00892 | - |
dc.citation.journaltitle | Journal of Clinical Oncology | - |
dc.identifier.wosid | 000655499200004 | - |
dc.identifier.scopusid | 2-s2.0-85103228343 | - |
dc.citation.endpage | 977 | - |
dc.citation.number | 9 | - |
dc.citation.startpage | 966 | - |
dc.citation.volume | 39 | - |
dc.identifier.sci | 000655499200004 | - |
dc.description.isOpenAccess | Y | - |
dc.contributor.affiliatedAuthor | Bang, Yung-Jue | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | DOUBLE-BLIND | - |
dc.subject.keywordPlus | OPEN-LABEL | - |
dc.subject.keywordPlus | THERAPY | - |
dc.subject.keywordPlus | CAPECITABINE | - |
dc.subject.keywordPlus | MULTICENTER | - |
dc.subject.keywordPlus | CISPLATIN | - |
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