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Regorafenib for the treatment of advanced gastric cancer (INTEGRATE): A multinational placebo-controlled phase II Trial

Cited 114 time in Web of Science Cited 119 time in Scopus
Authors
Pavlakis, Nick; Sjoquist, Katrin M.; Martin, Andrew J.; Tsobanis, Eric; Yip, Sonia; Kang, Yoon-Koo; Bang, Yung-Jue; Alcindor, Thierry; O'Callaghan, Christopher J.; Burnell, Margot J.; Tebbutt, Niall C.; Rha, Sun Young; Lee, Jeeyun; Cho, Jae-Yong; Lipton, Lara R.; Wong, Mark; Strickland, Andrew; Kim, Jin Won; Zalcberg, John R.; Simes, John; Goldstein, David
Issue Date
2016-08
Citation
Journal of Clinical Oncology, Vol.34 No.23, pp.2728-2728
Abstract
Purpose 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. (C) 2016 by American Society of Clinical Oncology
ISSN
0732-183X
URI
https://hdl.handle.net/10371/173087
DOI
https://doi.org/10.1200/JCO.2015.65.1901
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College of Medicine/School of Medicine (의과대학/대학원)Internal Medicine (내과학전공)Journal Papers (저널논문_내과학전공)
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