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Phase III, randomised trial of avelumab versus physician's choice of chemotherapy as third-line treatment of patients with advanced gastric or gastro-oesophageal junction cancer: Primary analysis of JAVELIN Gastric 300
DC Field | Value | Language |
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dc.contributor.author | Bang, Y. -J. | - |
dc.contributor.author | Ruiz, E. Yanez | - |
dc.contributor.author | Van Cutsem, E. | - |
dc.contributor.author | Lee, K. -W. | - |
dc.contributor.author | Wyrwicz, L. | - |
dc.contributor.author | Schenker, M. | - |
dc.contributor.author | Alsina, M. | - |
dc.contributor.author | Ryu, M. -H. | - |
dc.contributor.author | Chung, H. -C. | - |
dc.contributor.author | Evesque, L. | - |
dc.contributor.author | Al-Batran, S. -E. | - |
dc.contributor.author | Park, S. H. | - |
dc.contributor.author | Lichinitser, M. | - |
dc.contributor.author | Boku, N. | - |
dc.contributor.author | Moehler, M. H. | - |
dc.contributor.author | Hong, J. | - |
dc.contributor.author | Xiong, H. | - |
dc.contributor.author | Hallwachs, R. | - |
dc.contributor.author | Conti, I. | - |
dc.contributor.author | Taieb, J. | - |
dc.date.accessioned | 2021-01-31T11:58:59Z | - |
dc.date.available | 2021-01-31T11:58:59Z | - |
dc.date.created | 2019-05-09 | - |
dc.date.created | 2019-05-09 | - |
dc.date.issued | 2018-10 | - |
dc.identifier.citation | Annals of Oncology, Vol.29 No.10, pp.2052-2060 | - |
dc.identifier.issn | 0923-7534 | - |
dc.identifier.other | 73503 | - |
dc.identifier.uri | https://hdl.handle.net/10371/173182 | - |
dc.description.abstract | Background: There currently are no internationally recognised treatment guidelines for patients with advanced gastric cancer/gastro-oesophageal junction cancer (GC/GEJC) in whom two prior lines of therapy have failed. The randomised, phase III JAVELIN Gastric 300 trial compared avelumab versus physician's choice of chemotherapy as third-line therapy in patients with advanced GC/GEJC. Patients and methods: Patients with unresectable, recurrent, locally advanced, or metastatic GC/GEJC were recruited at 147 sites globally. All patients were randomised to receive either avelumab 10 mg/kg by intravenous infusion every 2 weeks or physician's choice of chemotherapy (paclitaxel 80 mg/m(2) on days 1, 8, and 15 or irinotecan 150 mg/m(2) on days 1 and 15, each of a 4-week treatment cycle); patients ineligible for chemotherapy received best supportive care. The primary end point was overall survival (OS). Secondary end points included progression-free survival (PFS), objective response rate (ORR), and safety. Results: A total of 371 patients were randomised. The trial did not meet its primary end point of improving OS {median, 4.6 versus 5.0 months; hazard ratio (HR)=1.1 [95% confidence interval (CI) 0.9-1.4]; P=0.81} or the secondary end points of PFS [median, 1.4 versus 2.7 months; HR=1.73 (95% CI 1.4-2.2); P > 0.99] or ORR (2.2% versus 4.3%) in the avelumab versus chemotherapy arms, respectively. Treatment-related adverse events (TRAEs) of any grade occurred in 90 patients (48.9%) and 131 patients (74.0%) in the avelumab and chemotherapy arms, respectively. Grade >= 3 TRAEs occurred in 17 patients (9.2%) in the avelumab arm and in 56 patients (31.6%) in the chemotherapy arm. Conclusions: Treatment of patients with GC/GEJC with single-agent avelumab in the third-line setting did not result in an improvement in OS or PFS compared with chemotherapy. Avelumab showed a more manageable safety profile than chemotherapy. | - |
dc.language | 영어 | - |
dc.publisher | Oxford University Press | - |
dc.title | Phase III, randomised trial of avelumab versus physician's choice of chemotherapy as third-line treatment of patients with advanced gastric or gastro-oesophageal junction cancer: Primary analysis of JAVELIN Gastric 300 | - |
dc.type | Article | - |
dc.contributor.AlternativeAuthor | 방영주 | - |
dc.identifier.doi | 10.1093/annonc/mdy264 | - |
dc.citation.journaltitle | Annals of Oncology | - |
dc.identifier.wosid | 000455165100007 | - |
dc.identifier.scopusid | 2-s2.0-85055128316 | - |
dc.citation.endpage | 2060 | - |
dc.citation.number | 10 | - |
dc.citation.startpage | 2052 | - |
dc.citation.volume | 29 | - |
dc.identifier.sci | 000455165100007 | - |
dc.description.isOpenAccess | Y | - |
dc.contributor.affiliatedAuthor | Bang, Y. -J. | - |
dc.contributor.affiliatedAuthor | Lee, K. -W. | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | DEATH-LIGAND 1 | - |
dc.subject.keywordAuthor | PD-L1 | - |
dc.subject.keywordAuthor | avelumab | - |
dc.subject.keywordAuthor | chemotherapy | - |
dc.subject.keywordAuthor | gastric cancer | - |
dc.subject.keywordAuthor | gastro-oesophageal junction cancer | - |
dc.subject.keywordAuthor | phase III | - |
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