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|Title:||Regorafenib for the treatment of advanced gastric cancer (INTEGRATE): a multinational placebo-controlled phase II tria|
|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|
|Citation:||Journal of Clinical Oncology 2016; 34(23): 2728-2735|
|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.|
Antineoplastic agents/therapeutic use
Phenylurea compounds/therapeutic use
Stomach neoplasms/drug therapy
|Type of Clinical Study or Trial:||Clinical Trial|
|Appears in Collections:||Journal articles|
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