Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/11877
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dc.contributor.authorOhtsu, Atsushien
dc.contributor.authorAjani, Jaffer Aen
dc.contributor.authorBai, Yu-Xianen
dc.contributor.authorBang, Yung-Jueen
dc.contributor.authorChung, Hyun-Cheolen
dc.contributor.authorPan, Hong-Mingen
dc.contributor.authorSahmoud, Tareken
dc.contributor.authorShen, Linen
dc.contributor.authorYeh, Kun-Hueien
dc.contributor.authorChin, Keishoen
dc.contributor.authorMuro, Keien
dc.contributor.authorKim, Yeul Hongen
dc.contributor.authorFerry, Daviden
dc.contributor.authorTebbutt, Niall Cen
dc.contributor.authorAl-Batran, Salah-Eddinen
dc.contributor.authorSmith, Heinden
dc.contributor.authorCostantini, Chiaraen
dc.contributor.authorRizvi, Syeden
dc.contributor.authorLebwohl, Daviden
dc.contributor.authorVan Cutsem, Ericen
dc.date.accessioned2015-05-16T01:30:29Z
dc.date.available2015-05-16T01:30:29Z
dc.date.issued2013-09-16en
dc.identifier.citationJournal of Clinical Oncology 2013; 31(31): 3935-43en
dc.identifier.govdoc24043745en
dc.identifier.otherPUBMEDen
dc.identifier.urihttps://ahro.austin.org.au/austinjspui/handle/1/11877en
dc.description.abstractThe oral mammalian target of rapamycin inhibitor everolimus demonstrated promising efficacy in a phase II study of pretreated advanced gastric cancer. This international, double-blind, phase III study compared everolimus efficacy and safety with that of best supportive care (BSC) in previously treated advanced gastric cancer.Patients with advanced gastric cancer that progressed after one or two lines of systemic chemotherapy were randomly assigned to everolimus 10 mg/d (assignment schedule: 2:1) or matching placebo, both given with BSC. Randomization was stratified by previous chemotherapy lines (one v two) and region (Asia v rest of the world [ROW]). Treatment continued until disease progression or intolerable toxicity. Primary end point was overall survival (OS). Secondary end points included progression-free survival (PFS), overall response rate, and safety.Six hundred fifty-six patients (median age, 62.0 years; 73.6% male) were enrolled. Median OS was 5.4 months with everolimus and 4.3 months with placebo (hazard ratio, 0.90; 95% CI, 0.75 to 1.08; P = .124). Median PFS was 1.7 months and 1.4 months in the everolimus and placebo arms, respectively (hazard ratio, 0.66; 95% CI, 0.56 to 0.78). Common grade 3/4 adverse events included anemia, decreased appetite, and fatigue. The safety profile was similar in patients enrolled in Asia versus ROW.Compared with BSC, everolimus did not significantly improve overall survival for advanced gastric cancer that progressed after one or two lines of previous systemic chemotherapy. The safety profile observed for everolimus was consistent with that observed for everolimus in other cancers.en
dc.language.isoenen
dc.subject.otherAdenocarcinoma.drug therapy.mortalityen
dc.subject.otherAdulten
dc.subject.otherAgeden
dc.subject.otherAged, 80 and overen
dc.subject.otherDisease-Free Survivalen
dc.subject.otherDouble-Blind Methoden
dc.subject.otherFemaleen
dc.subject.otherHumansen
dc.subject.otherImmunosuppressive Agents.therapeutic useen
dc.subject.otherKaplan-Meier Estimateen
dc.subject.otherMaleen
dc.subject.otherMiddle Ageden
dc.subject.otherNeoplasm Recurrence, Local.drug therapyen
dc.subject.otherProportional Hazards Modelsen
dc.subject.otherSirolimus.analogs & derivatives.therapeutic useen
dc.subject.otherStomach Neoplasms.drug therapy.mortalityen
dc.subject.otherYoung Adulten
dc.titleEverolimus for previously treated advanced gastric cancer: results of the randomized, double-blind, phase III GRANITE-1 study.en
dc.typeJournal Articleen
dc.identifier.journaltitleJournal of Clinical Oncologyen
dc.identifier.affiliationSalah-Eddin Al-Batran, Institute for Clinical Oncology Research, Krankenhaus Nordwest, UCT University Cancer Center, Frankfurt, Germanyen
dc.identifier.affiliationChiara Costantini, Novartis Pharma AG, Basel, Switzerlanden
dc.identifier.affiliationEric Van Cutsem, University Hospitals Leuven and KU Leuven, Leuven, Belgium.en
dc.identifier.affiliationAtsushi Ohtsu, National Cancer Center Hospital East, Kashiwa; Keisho Chin, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo; Kei Muro, Aichi Cancer Center Hospital, Nagoya, Japan; Jaffer A. Ajani, University of Texas MD Anderson Cancer Center, Houston, TX; Tarek Sahmoud, Heind Smith, Syed Rizvi, David Lebwohl, Novartis Pharmaceuticals, Florham Park, NJ; Yu-Xian Bai, Tumor Hospital of Harbin Medical University, Harbin; Hong-Ming Pan, Sir Run Run Shaw Hospital, Zhejiang; Lin Shen, Peking University Cancer Hospital, Beijing, People's Republic of China; Yung-Jue Bang, Seoul National University College of Medicine; Hyun-Cheol Chung, Yonsei Cancer Center, Yonsei University College of Medicine; Yeul Hong Kim, Korea University Anam Hospital, Seoul, South Korea; Kun-Huei Yeh, National Taiwan University Hospital, Taipei, Taiwan, Republic of China; David Ferry, New Cross Hospital, Wolverhampton, United Kingdom; Niall C. Tebbutt, Austin Health, Heidelberg, Victoria, Australiaen
dc.identifier.doi10.1200/JCO.2012.48.3552en
dc.description.pages3935-43en
dc.relation.urlhttps://pubmed.ncbi.nlm.nih.gov/24043745en
dc.type.austinJournal Articleen
local.name.researcherTebbutt, Niall C
item.openairecristypehttp://purl.org/coar/resource_type/c_18cf-
item.cerifentitytypePublications-
item.fulltextNo Fulltext-
item.grantfulltextnone-
item.languageiso639-1en-
item.openairetypeJournal Article-
crisitem.author.deptMedical Oncology-
crisitem.author.deptOlivia Newton-John Cancer Wellness and Research Centre-
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