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Title: Regorafenib for the treatment of advanced gastric cancer (INTEGRATE): a multinational placebo-controlled phase II tria
Austin 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
Affiliation: Austin Health, Heidelberg, Victoria, Australia
Royal North Shore Hospital, University of Sydney, Sydney, NSW, Australia
National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia
Cancer Care Centre, St George Hospital, NSW, Australia
Sydney Catalyst Translational Cancer Research Centre, NSW, Australia
Westmead Hospital, NSW, Australia
Prince of Wales Hospital, Sydney, New South Wales, Australia
Western Health, Victoria, Australia
Monash Medical Centre, Victoria, Australia
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
Asan Medical Center, University of Ulsan College of Medicine, South Korea
Seoul National University Hospital, Seoul, South Korea
Yonsei University College of Medicine, Seoul, South Korea
Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea
Gangnam Severance Cancer Hospital, Yonsei University College of Medicine, Seoul, South Korea
Seoul National University Bundang Hospital, Seongnam, South Korea
McGill University Health Centre, Montreal, Quebec, Canada
National Cancer Institute of Canada Clinical Trials Group, Kingston, Ontario, Canada
Saint John Regional Hospital, Saint John, New Brunswick, Canada
Issue Date: 10-Aug-2016
Date: 2016-06-20
Publication information: 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.
DOI: 10.1200/JCO.2015.65.1901
Journal: Journal of Clinical Oncology
PubMed URL:
Type: Journal Article
Subjects: Adenocarcinoma/drug therapy
Antineoplastic agents/therapeutic use
Phenylurea compounds/therapeutic use
Pyridines/therapeutic use
Stomach neoplasms/drug therapy
Type of Clinical Study or Trial: Clinical Trial
Appears in Collections:Journal articles

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