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Everolimus for previously treated advanced gastric cancer: results of the randomized, double-blind, phase III GRANITE-1 study.

ABSTRACT: PURPOSE:The 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 AND METHODS: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. RESULTS: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. CONCLUSION: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.

SUBMITTER: Ohtsu A

PROVIDER: S-EPMC5950503 | biostudies-literature | 2013 Nov

REPOSITORIES: biostudies-literature

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Everolimus for previously treated advanced gastric cancer: results of the randomized, double-blind, phase III GRANITE-1 study.

Ohtsu Atsushi A Ajani Jaffer A JA Bai Yu-Xian YX Bang Yung-Jue YJ Chung Hyun-Cheol HC Pan Hong-Ming HM Sahmoud Tarek T Shen Lin L Yeh Kun-Huei KH Chin Keisho K Muro Kei K Kim Yeul Hong YH Ferry David D Tebbutt Niall C NC Al-Batran Salah-Eddin SE Smith Heind H Costantini Chiara C Rizvi Syed S Lebwohl David D Van Cutsem Eric E

Journal of clinical oncology : official journal of the American Society of Clinical Oncology 20130916 31

<h4>Purpose</h4>The 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.<h4>Patients and methods</h4>Patients with advanced gastric cancer that progressed after one or two lines of systemic chemotherapy were randomly assigned to ...[more]

PMID: 24043745

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Everolimus for previously treated advanced gastric cancer: results of the randomized, double-blind, phase III GRANITE-1 study.

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Everolimus for previously treated advanced gastric cancer: results of the randomized, double-blind, phase III GRANITE-1 study.

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