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dc.contributor.authorPavlakis, Nick-
dc.contributor.authorSjoquist, Katrin M-
dc.contributor.authorMartin, Andrew J-
dc.contributor.authorTsobanis, Eric-
dc.contributor.authorYip, Sonia-
dc.contributor.authorKang, Yoon-Koo-
dc.contributor.authorBang, Yung-Jue-
dc.contributor.authorAlcindor, Thierry-
dc.contributor.authorO’Callaghan, Christopher J-
dc.contributor.authorBurnell, Margot J-
dc.contributor.authorTebbutt, Niall C-
dc.contributor.authorRha, Sun Young-
dc.contributor.authorLee, Jeeyun-
dc.contributor.authorCho, Jae-Yong-
dc.contributor.authorLipton, Lara R-
dc.contributor.authorWong, Mark-
dc.contributor.authorStrickland, Andrew-
dc.contributor.authorKim, Jin Won-
dc.contributor.authorZalcberg, John R-
dc.contributor.authorSimes, John-
dc.contributor.authorGoldstein, David-
dc.identifier.citationJournal of Clinical Oncology 2016; 34(23): 2728-2735en_US
dc.description.abstractPURPOSE: We evaluated the activity of regorafenib, an oral multikinase inhibitor, in advanced gastric adenocarcinoma. PATIENTS AND METHODS: We conducted an international (Australia and New Zealand, South Korea, and Canada) randomized phase II trial in which patients were randomly assigned at a two-to-one ratio and stratified by lines of prior chemotherapy for advanced disease (one v two) and region. Eligible patients received best supportive care plus regorafenib 160 mg or matching placebo orally on days 1 to 21 of each 28-day cycle until disease progression or prohibitive adverse events occurred. The primary end point was progression-free survival (PFS). Final analysis included data to December 31, 2014. RESULTS: A total of 152 patients were randomly assigned from November 7, 2012, to February 25, 2014, yielding 147 evaluable patients (regorafenib, n = 97; placebo, n = 50). Baseline characteristics were balanced. Median PFS significantly differed between groups (regorafenib, 2.6 months; 95% CI, 1.8 to 3.1 and placebo, 0.9 months; 95% CI, 0.9 to 0.9; hazard ratio [HR], 0.40; 95% CI, 0.28 to 0.59; P < .001). The effect was greater in South Korea than in Australia, New Zealand, and Canada combined (HR, 0.12 v 0.61; interaction P < .001) but consistent across age, neutrophil-to-lymphocyte ratio, primary site, lines of chemotherapy, peritoneal metastasis presence, number of metastatic sites, and plasma vascular endothelial growth factor A. A survival trend in favor of regorafenib was seen (median, 5.8 months; 95% CI, 4.4 to 6.8 v 4.5 months; 95% CI, 3.4 to 5.2; HR, 0.74; P = .147). Twenty-nine patients assigned to placebo received open-label regorafenib after disease progression. Regorafenib toxicity was similar to that previously reported. CONCLUSION: In this phase II trial, regorafenib was effective in prolonging PFS in refractory advanced gastric adenocarcinoma. Regional differences were found, but regorafenib was effective in both regional groups. A phase III trial is planned.en_US
dc.subjectAdenocarcinoma/drug therapyen_US
dc.subjectAntineoplastic agents/therapeutic useen_US
dc.subjectPhenylurea compounds/therapeutic useen_US
dc.subjectPyridines/therapeutic useen_US
dc.subjectStomach neoplasms/drug therapyen_US
dc.titleRegorafenib for the treatment of advanced gastric cancer (INTEGRATE): a multinational placebo-controlled phase II triaen_US
dc.typeJournal Articleen_US
dc.identifier.journaltitleJournal of Clinical Oncologyen_US
dc.identifier.affiliationAustin Health, Heidelberg, Victoria, Australiaen_US
dc.identifier.affiliationRoyal North Shore Hospital, University of Sydney, Sydney, NSW, Australiaen_US
dc.identifier.affiliationNational Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, NSW, Australiaen_US
dc.identifier.affiliationCancer Care Centre, St George Hospital, NSW, Australiaen_US
dc.identifier.affiliationSydney Catalyst Translational Cancer Research Centre, NSW, Australiaen_US
dc.identifier.affiliationWestmead Hospital, NSW, Australiaen_US
dc.identifier.affiliationPrince of Wales Hospital, Sydney, New South Wales, Australiaen_US
dc.identifier.affiliationWestern Health, Victoria, Australiaen_US
dc.identifier.affiliationMonash Medical Centre, Victoria, Australiaen_US
dc.identifier.affiliationPeter MacCallum Cancer Centre, Melbourne, Victoria, Australiaen_US
dc.identifier.affiliationAsan Medical Center, University of Ulsan College of Medicine, South Koreaen_US
dc.identifier.affiliationSeoul National University Hospital, Seoul, South Koreaen_US
dc.identifier.affiliationYonsei University College of Medicine, Seoul, South Koreaen_US
dc.identifier.affiliationSamsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Koreaen_US
dc.identifier.affiliationGangnam Severance Cancer Hospital, Yonsei University College of Medicine, Seoul, South Koreaen_US
dc.identifier.affiliationSeoul National University Bundang Hospital, Seongnam, South Koreaen_US
dc.identifier.affiliationMcGill University Health Centre, Montreal, Quebec, Canadaen_US
dc.identifier.affiliationNational Cancer Institute of Canada Clinical Trials Group, Kingston, Ontario, Canadaen_US
dc.identifier.affiliationSaint John Regional Hospital, Saint John, New Brunswick, Canadaen_US
dc.type.studyortrialClinical Trialen_US
dc.type.austinJournal Articleen_US, Niall C
item.fulltextNo Fulltext-
item.openairetypeJournal Article-
item.openairecristype Oncology- Newton-John Cancer Wellness and Research Centre-
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