Evidence map›Paper›PMID 27325864›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2016

Regorafenib for the Treatment of Advanced Gastric Cancer (INTEGRATE): A Multinational Placebo-Controlled Phase II Trial.

Nick Pavlakis, Katrin M Sjoquist, Andrew J Martin, Eric Tsobanis, Sonia Yip, Yoon-Koo Kang, Yung-Jue Bang, Thierry Alcindor, Christopher J O'Callaghan, Margot J Burnell and 11 more

Open access · greenAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 133 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
133citing papers in PubMed, 13 pooled it
23.3field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

133 citing papers in PubMed, 13 syntheses or guidelines pooled it, 241 citations in OpenAlex.

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  14. Health-related quality-of-life outcomes with regorafenib in advanced gastric and esophagogastric junction cancer: results from the INTEGRATE trials.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2025
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73 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 1 institution in 1 country.

Nick PavlakisNick Pavlakis, Niall C. Tebbutt, Lara R. Lipton, John R. Zalcberg, John Simes, and David Goldstein, Australasian Gastro-Intestinal Trials Group; Nick Pavlakis, Royal North Shore Hospital, University of Sydney; Katrin M. Sjoquist, Andrew J. Martin, Eric Tsobanis, Sonia Yip, and John Simes, National Health and Medical Research Council Clinical Trials Centre, University of Sydney; Katrin M. Sjoquist, Cancer Care Centre, St George Hospital; Sonia Yip, Sydney Catalyst Translational Cancer Research Centre; Mark Wong, Westmead Hospital; David Goldstein, Prince of Wales Hospital, Sydney, New South Wales; Niall C. Tebbutt, Austin Health; Lara R. Lipton, Western Health; Andrew Strickland, Monash Medical Centre; John R. Zalcberg, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia; Yoon-Koo Kang, Asan Medical Center, University of Ulsan College of Medicine; Yung-Jue Bang, Seoul National University Hospital; Sun Young Rha, Yonsei University College of Medicine; Jeeyun Lee, Samsung Medical Center, Sungkyunkwan University School of Medicine; Jae-Yong Cho, Gangnam Severance Cancer Hospital, Yonsei University College of Medicine, Seoul; Jin Won Kim, Seoul National University Bundang Hospital, Seongnam, South Korea; Thierry Alcindor, McGill University Health Centre, Montreal, Quebec; Christopher J. O'Callaghan, National Cancer Institute of Canada Clinical Trials Group, Kingston, Ontario; and Margot J. Burnell, Saint John Regional Hospital, Saint John, New Brunswick, Canada. nick.pavlakis@sydney.edu.au.
Katrin M SjoquistNick Pavlakis, Niall C. Tebbutt, Lara R. Lipton, John R. Zalcberg, John Simes, and David Goldstein, Australasian Gastro-Intestinal Trials Group; Nick Pavlakis, Royal North Shore Hospital, University of Sydney; Katrin M. Sjoquist, Andrew J. Martin, Eric Tsobanis, Sonia Yip, and John Simes, National Health and Medical Research Council Clinical Trials Centre, University of Sydney; Katrin M. Sjoquist, Cancer Care Centre, St George Hospital; Sonia Yip, Sydney Catalyst Translational Cancer Research Centre; Mark Wong, Westmead Hospital; David Goldstein, Prince of Wales Hospital, Sydney, New South Wales; Niall C. Tebbutt, Austin Health; Lara R. Lipton, Western Health; Andrew Strickland, Monash Medical Centre; John R. Zalcberg, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia; Yoon-Koo Kang, Asan Medical Center, University of Ulsan College of Medicine; Yung-Jue Bang, Seoul National University Hospital; Sun Young Rha, Yonsei University College of Medicine; Jeeyun Lee, Samsung Medical Center, Sungkyunkwan University School of Medicine; Jae-Yong Cho, Gangnam Severance Cancer Hospital, Yonsei University College of Medicine, Seoul; Jin Won Kim, Seoul National University Bundang Hospital, Seongnam, South Korea; Thierry Alcindor, McGill University Health Centre, Montreal, Quebec; Christopher J. O'Callaghan, National Cancer Institute of Canada Clinical Trials Group, Kingston, Ontario; and Margot J. Burnell, Saint John Regional Hospital, Saint John, New Brunswick, Canada.
Andrew J MartinNick Pavlakis, Niall C. Tebbutt, Lara R. Lipton, John R. Zalcberg, John Simes, and David Goldstein, Australasian Gastro-Intestinal Trials Group; Nick Pavlakis, Royal North Shore Hospital, University of Sydney; Katrin M. Sjoquist, Andrew J. Martin, Eric Tsobanis, Sonia Yip, and John Simes, National Health and Medical Research Council Clinical Trials Centre, University of Sydney; Katrin M. Sjoquist, Cancer Care Centre, St George Hospital; Sonia Yip, Sydney Catalyst Translational Cancer Research Centre; Mark Wong, Westmead Hospital; David Goldstein, Prince of Wales Hospital, Sydney, New South Wales; Niall C. Tebbutt, Austin Health; Lara R. Lipton, Western Health; Andrew Strickland, Monash Medical Centre; John R. Zalcberg, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia; Yoon-Koo Kang, Asan Medical Center, University of Ulsan College of Medicine; Yung-Jue Bang, Seoul National University Hospital; Sun Young Rha, Yonsei University College of Medicine; Jeeyun Lee, Samsung Medical Center, Sungkyunkwan University School of Medicine; Jae-Yong Cho, Gangnam Severance Cancer Hospital, Yonsei University College of Medicine, Seoul; Jin Won Kim, Seoul National University Bundang Hospital, Seongnam, South Korea; Thierry Alcindor, McGill University Health Centre, Montreal, Quebec; Christopher J. O'Callaghan, National Cancer Institute of Canada Clinical Trials Group, Kingston, Ontario; and Margot J. Burnell, Saint John Regional Hospital, Saint John, New Brunswick, Canada.
Eric TsobanisNick Pavlakis, Niall C. Tebbutt, Lara R. Lipton, John R. Zalcberg, John Simes, and David Goldstein, Australasian Gastro-Intestinal Trials Group; Nick Pavlakis, Royal North Shore Hospital, University of Sydney; Katrin M. Sjoquist, Andrew J. Martin, Eric Tsobanis, Sonia Yip, and John Simes, National Health and Medical Research Council Clinical Trials Centre, University of Sydney; Katrin M. Sjoquist, Cancer Care Centre, St George Hospital; Sonia Yip, Sydney Catalyst Translational Cancer Research Centre; Mark Wong, Westmead Hospital; David Goldstein, Prince of Wales Hospital, Sydney, New South Wales; Niall C. Tebbutt, Austin Health; Lara R. Lipton, Western Health; Andrew Strickland, Monash Medical Centre; John R. Zalcberg, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia; Yoon-Koo Kang, Asan Medical Center, University of Ulsan College of Medicine; Yung-Jue Bang, Seoul National University Hospital; Sun Young Rha, Yonsei University College of Medicine; Jeeyun Lee, Samsung Medical Center, Sungkyunkwan University School of Medicine; Jae-Yong Cho, Gangnam Severance Cancer Hospital, Yonsei University College of Medicine, Seoul; Jin Won Kim, Seoul National University Bundang Hospital, Seongnam, South Korea; Thierry Alcindor, McGill University Health Centre, Montreal, Quebec; Christopher J. O'Callaghan, National Cancer Institute of Canada Clinical Trials Group, Kingston, Ontario; and Margot J. Burnell, Saint John Regional Hospital, Saint John, New Brunswick, Canada.
Sonia YipNick Pavlakis, Niall C. Tebbutt, Lara R. Lipton, John R. Zalcberg, John Simes, and David Goldstein, Australasian Gastro-Intestinal Trials Group; Nick Pavlakis, Royal North Shore Hospital, University of Sydney; Katrin M. Sjoquist, Andrew J. Martin, Eric Tsobanis, Sonia Yip, and John Simes, National Health and Medical Research Council Clinical Trials Centre, University of Sydney; Katrin M. Sjoquist, Cancer Care Centre, St George Hospital; Sonia Yip, Sydney Catalyst Translational Cancer Research Centre; Mark Wong, Westmead Hospital; David Goldstein, Prince of Wales Hospital, Sydney, New South Wales; Niall C. Tebbutt, Austin Health; Lara R. Lipton, Western Health; Andrew Strickland, Monash Medical Centre; John R. Zalcberg, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia; Yoon-Koo Kang, Asan Medical Center, University of Ulsan College of Medicine; Yung-Jue Bang, Seoul National University Hospital; Sun Young Rha, Yonsei University College of Medicine; Jeeyun Lee, Samsung Medical Center, Sungkyunkwan University School of Medicine; Jae-Yong Cho, Gangnam Severance Cancer Hospital, Yonsei University College of Medicine, Seoul; Jin Won Kim, Seoul National University Bundang Hospital, Seongnam, South Korea; Thierry Alcindor, McGill University Health Centre, Montreal, Quebec; Christopher J. O'Callaghan, National Cancer Institute of Canada Clinical Trials Group, Kingston, Ontario; and Margot J. Burnell, Saint John Regional Hospital, Saint John, New Brunswick, Canada.
Yoon-Koo KangNick Pavlakis, Niall C. Tebbutt, Lara R. Lipton, John R. Zalcberg, John Simes, and David Goldstein, Australasian Gastro-Intestinal Trials Group; Nick Pavlakis, Royal North Shore Hospital, University of Sydney; Katrin M. Sjoquist, Andrew J. Martin, Eric Tsobanis, Sonia Yip, and John Simes, National Health and Medical Research Council Clinical Trials Centre, University of Sydney; Katrin M. Sjoquist, Cancer Care Centre, St George Hospital; Sonia Yip, Sydney Catalyst Translational Cancer Research Centre; Mark Wong, Westmead Hospital; David Goldstein, Prince of Wales Hospital, Sydney, New South Wales; Niall C. Tebbutt, Austin Health; Lara R. Lipton, Western Health; Andrew Strickland, Monash Medical Centre; John R. Zalcberg, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia; Yoon-Koo Kang, Asan Medical Center, University of Ulsan College of Medicine; Yung-Jue Bang, Seoul National University Hospital; Sun Young Rha, Yonsei University College of Medicine; Jeeyun Lee, Samsung Medical Center, Sungkyunkwan University School of Medicine; Jae-Yong Cho, Gangnam Severance Cancer Hospital, Yonsei University College of Medicine, Seoul; Jin Won Kim, Seoul National University Bundang Hospital, Seongnam, South Korea; Thierry Alcindor, McGill University Health Centre, Montreal, Quebec; Christopher J. O'Callaghan, National Cancer Institute of Canada Clinical Trials Group, Kingston, Ontario; and Margot J. Burnell, Saint John Regional Hospital, Saint John, New Brunswick, Canada.
Yung-Jue BangNick Pavlakis, Niall C. Tebbutt, Lara R. Lipton, John R. Zalcberg, John Simes, and David Goldstein, Australasian Gastro-Intestinal Trials Group; Nick Pavlakis, Royal North Shore Hospital, University of Sydney; Katrin M. Sjoquist, Andrew J. Martin, Eric Tsobanis, Sonia Yip, and John Simes, National Health and Medical Research Council Clinical Trials Centre, University of Sydney; Katrin M. Sjoquist, Cancer Care Centre, St George Hospital; Sonia Yip, Sydney Catalyst Translational Cancer Research Centre; Mark Wong, Westmead Hospital; David Goldstein, Prince of Wales Hospital, Sydney, New South Wales; Niall C. Tebbutt, Austin Health; Lara R. Lipton, Western Health; Andrew Strickland, Monash Medical Centre; John R. Zalcberg, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia; Yoon-Koo Kang, Asan Medical Center, University of Ulsan College of Medicine; Yung-Jue Bang, Seoul National University Hospital; Sun Young Rha, Yonsei University College of Medicine; Jeeyun Lee, Samsung Medical Center, Sungkyunkwan University School of Medicine; Jae-Yong Cho, Gangnam Severance Cancer Hospital, Yonsei University College of Medicine, Seoul; Jin Won Kim, Seoul National University Bundang Hospital, Seongnam, South Korea; Thierry Alcindor, McGill University Health Centre, Montreal, Quebec; Christopher J. O'Callaghan, National Cancer Institute of Canada Clinical Trials Group, Kingston, Ontario; and Margot J. Burnell, Saint John Regional Hospital, Saint John, New Brunswick, Canada.
Thierry AlcindorNick Pavlakis, Niall C. Tebbutt, Lara R. Lipton, John R. Zalcberg, John Simes, and David Goldstein, Australasian Gastro-Intestinal Trials Group; Nick Pavlakis, Royal North Shore Hospital, University of Sydney; Katrin M. Sjoquist, Andrew J. Martin, Eric Tsobanis, Sonia Yip, and John Simes, National Health and Medical Research Council Clinical Trials Centre, University of Sydney; Katrin M. Sjoquist, Cancer Care Centre, St George Hospital; Sonia Yip, Sydney Catalyst Translational Cancer Research Centre; Mark Wong, Westmead Hospital; David Goldstein, Prince of Wales Hospital, Sydney, New South Wales; Niall C. Tebbutt, Austin Health; Lara R. Lipton, Western Health; Andrew Strickland, Monash Medical Centre; John R. Zalcberg, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia; Yoon-Koo Kang, Asan Medical Center, University of Ulsan College of Medicine; Yung-Jue Bang, Seoul National University Hospital; Sun Young Rha, Yonsei University College of Medicine; Jeeyun Lee, Samsung Medical Center, Sungkyunkwan University School of Medicine; Jae-Yong Cho, Gangnam Severance Cancer Hospital, Yonsei University College of Medicine, Seoul; Jin Won Kim, Seoul National University Bundang Hospital, Seongnam, South Korea; Thierry Alcindor, McGill University Health Centre, Montreal, Quebec; Christopher J. O'Callaghan, National Cancer Institute of Canada Clinical Trials Group, Kingston, Ontario; and Margot J. Burnell, Saint John Regional Hospital, Saint John, New Brunswick, Canada.
Christopher J O'CallaghanNick Pavlakis, Niall C. Tebbutt, Lara R. Lipton, John R. Zalcberg, John Simes, and David Goldstein, Australasian Gastro-Intestinal Trials Group; Nick Pavlakis, Royal North Shore Hospital, University of Sydney; Katrin M. Sjoquist, Andrew J. Martin, Eric Tsobanis, Sonia Yip, and John Simes, National Health and Medical Research Council Clinical Trials Centre, University of Sydney; Katrin M. Sjoquist, Cancer Care Centre, St George Hospital; Sonia Yip, Sydney Catalyst Translational Cancer Research Centre; Mark Wong, Westmead Hospital; David Goldstein, Prince of Wales Hospital, Sydney, New South Wales; Niall C. Tebbutt, Austin Health; Lara R. Lipton, Western Health; Andrew Strickland, Monash Medical Centre; John R. Zalcberg, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia; Yoon-Koo Kang, Asan Medical Center, University of Ulsan College of Medicine; Yung-Jue Bang, Seoul National University Hospital; Sun Young Rha, Yonsei University College of Medicine; Jeeyun Lee, Samsung Medical Center, Sungkyunkwan University School of Medicine; Jae-Yong Cho, Gangnam Severance Cancer Hospital, Yonsei University College of Medicine, Seoul; Jin Won Kim, Seoul National University Bundang Hospital, Seongnam, South Korea; Thierry Alcindor, McGill University Health Centre, Montreal, Quebec; Christopher J. O'Callaghan, National Cancer Institute of Canada Clinical Trials Group, Kingston, Ontario; and Margot J. Burnell, Saint John Regional Hospital, Saint John, New Brunswick, Canada.
Margot J BurnellNick Pavlakis, Niall C. Tebbutt, Lara R. Lipton, John R. Zalcberg, John Simes, and David Goldstein, Australasian Gastro-Intestinal Trials Group; Nick Pavlakis, Royal North Shore Hospital, University of Sydney; Katrin M. Sjoquist, Andrew J. Martin, Eric Tsobanis, Sonia Yip, and John Simes, National Health and Medical Research Council Clinical Trials Centre, University of Sydney; Katrin M. Sjoquist, Cancer Care Centre, St George Hospital; Sonia Yip, Sydney Catalyst Translational Cancer Research Centre; Mark Wong, Westmead Hospital; David Goldstein, Prince of Wales Hospital, Sydney, New South Wales; Niall C. Tebbutt, Austin Health; Lara R. Lipton, Western Health; Andrew Strickland, Monash Medical Centre; John R. Zalcberg, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia; Yoon-Koo Kang, Asan Medical Center, University of Ulsan College of Medicine; Yung-Jue Bang, Seoul National University Hospital; Sun Young Rha, Yonsei University College of Medicine; Jeeyun Lee, Samsung Medical Center, Sungkyunkwan University School of Medicine; Jae-Yong Cho, Gangnam Severance Cancer Hospital, Yonsei University College of Medicine, Seoul; Jin Won Kim, Seoul National University Bundang Hospital, Seongnam, South Korea; Thierry Alcindor, McGill University Health Centre, Montreal, Quebec; Christopher J. O'Callaghan, National Cancer Institute of Canada Clinical Trials Group, Kingston, Ontario; and Margot J. Burnell, Saint John Regional Hospital, Saint John, New Brunswick, Canada.
Niall C TebbuttNick Pavlakis, Niall C. Tebbutt, Lara R. Lipton, John R. Zalcberg, John Simes, and David Goldstein, Australasian Gastro-Intestinal Trials Group; Nick Pavlakis, Royal North Shore Hospital, University of Sydney; Katrin M. Sjoquist, Andrew J. Martin, Eric Tsobanis, Sonia Yip, and John Simes, National Health and Medical Research Council Clinical Trials Centre, University of Sydney; Katrin M. Sjoquist, Cancer Care Centre, St George Hospital; Sonia Yip, Sydney Catalyst Translational Cancer Research Centre; Mark Wong, Westmead Hospital; David Goldstein, Prince of Wales Hospital, Sydney, New South Wales; Niall C. Tebbutt, Austin Health; Lara R. Lipton, Western Health; Andrew Strickland, Monash Medical Centre; John R. Zalcberg, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia; Yoon-Koo Kang, Asan Medical Center, University of Ulsan College of Medicine; Yung-Jue Bang, Seoul National University Hospital; Sun Young Rha, Yonsei University College of Medicine; Jeeyun Lee, Samsung Medical Center, Sungkyunkwan University School of Medicine; Jae-Yong Cho, Gangnam Severance Cancer Hospital, Yonsei University College of Medicine, Seoul; Jin Won Kim, Seoul National University Bundang Hospital, Seongnam, South Korea; Thierry Alcindor, McGill University Health Centre, Montreal, Quebec; Christopher J. O'Callaghan, National Cancer Institute of Canada Clinical Trials Group, Kingston, Ontario; and Margot J. Burnell, Saint John Regional Hospital, Saint John, New Brunswick, Canada.
Sun Young RhaNick Pavlakis, Niall C. Tebbutt, Lara R. Lipton, John R. Zalcberg, John Simes, and David Goldstein, Australasian Gastro-Intestinal Trials Group; Nick Pavlakis, Royal North Shore Hospital, University of Sydney; Katrin M. Sjoquist, Andrew J. Martin, Eric Tsobanis, Sonia Yip, and John Simes, National Health and Medical Research Council Clinical Trials Centre, University of Sydney; Katrin M. Sjoquist, Cancer Care Centre, St George Hospital; Sonia Yip, Sydney Catalyst Translational Cancer Research Centre; Mark Wong, Westmead Hospital; David Goldstein, Prince of Wales Hospital, Sydney, New South Wales; Niall C. Tebbutt, Austin Health; Lara R. Lipton, Western Health; Andrew Strickland, Monash Medical Centre; John R. Zalcberg, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia; Yoon-Koo Kang, Asan Medical Center, University of Ulsan College of Medicine; Yung-Jue Bang, Seoul National University Hospital; Sun Young Rha, Yonsei University College of Medicine; Jeeyun Lee, Samsung Medical Center, Sungkyunkwan University School of Medicine; Jae-Yong Cho, Gangnam Severance Cancer Hospital, Yonsei University College of Medicine, Seoul; Jin Won Kim, Seoul National University Bundang Hospital, Seongnam, South Korea; Thierry Alcindor, McGill University Health Centre, Montreal, Quebec; Christopher J. O'Callaghan, National Cancer Institute of Canada Clinical Trials Group, Kingston, Ontario; and Margot J. Burnell, Saint John Regional Hospital, Saint John, New Brunswick, Canada.
Jeeyun LeeNick Pavlakis, Niall C. Tebbutt, Lara R. Lipton, John R. Zalcberg, John Simes, and David Goldstein, Australasian Gastro-Intestinal Trials Group; Nick Pavlakis, Royal North Shore Hospital, University of Sydney; Katrin M. Sjoquist, Andrew J. Martin, Eric Tsobanis, Sonia Yip, and John Simes, National Health and Medical Research Council Clinical Trials Centre, University of Sydney; Katrin M. Sjoquist, Cancer Care Centre, St George Hospital; Sonia Yip, Sydney Catalyst Translational Cancer Research Centre; Mark Wong, Westmead Hospital; David Goldstein, Prince of Wales Hospital, Sydney, New South Wales; Niall C. Tebbutt, Austin Health; Lara R. Lipton, Western Health; Andrew Strickland, Monash Medical Centre; John R. Zalcberg, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia; Yoon-Koo Kang, Asan Medical Center, University of Ulsan College of Medicine; Yung-Jue Bang, Seoul National University Hospital; Sun Young Rha, Yonsei University College of Medicine; Jeeyun Lee, Samsung Medical Center, Sungkyunkwan University School of Medicine; Jae-Yong Cho, Gangnam Severance Cancer Hospital, Yonsei University College of Medicine, Seoul; Jin Won Kim, Seoul National University Bundang Hospital, Seongnam, South Korea; Thierry Alcindor, McGill University Health Centre, Montreal, Quebec; Christopher J. O'Callaghan, National Cancer Institute of Canada Clinical Trials Group, Kingston, Ontario; and Margot J. Burnell, Saint John Regional Hospital, Saint John, New Brunswick, Canada.
Jae-Yong ChoNick Pavlakis, Niall C. Tebbutt, Lara R. Lipton, John R. Zalcberg, John Simes, and David Goldstein, Australasian Gastro-Intestinal Trials Group; Nick Pavlakis, Royal North Shore Hospital, University of Sydney; Katrin M. Sjoquist, Andrew J. Martin, Eric Tsobanis, Sonia Yip, and John Simes, National Health and Medical Research Council Clinical Trials Centre, University of Sydney; Katrin M. Sjoquist, Cancer Care Centre, St George Hospital; Sonia Yip, Sydney Catalyst Translational Cancer Research Centre; Mark Wong, Westmead Hospital; David Goldstein, Prince of Wales Hospital, Sydney, New South Wales; Niall C. Tebbutt, Austin Health; Lara R. Lipton, Western Health; Andrew Strickland, Monash Medical Centre; John R. Zalcberg, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia; Yoon-Koo Kang, Asan Medical Center, University of Ulsan College of Medicine; Yung-Jue Bang, Seoul National University Hospital; Sun Young Rha, Yonsei University College of Medicine; Jeeyun Lee, Samsung Medical Center, Sungkyunkwan University School of Medicine; Jae-Yong Cho, Gangnam Severance Cancer Hospital, Yonsei University College of Medicine, Seoul; Jin Won Kim, Seoul National University Bundang Hospital, Seongnam, South Korea; Thierry Alcindor, McGill University Health Centre, Montreal, Quebec; Christopher J. O'Callaghan, National Cancer Institute of Canada Clinical Trials Group, Kingston, Ontario; and Margot J. Burnell, Saint John Regional Hospital, Saint John, New Brunswick, Canada.
Lara R LiptonNick Pavlakis, Niall C. Tebbutt, Lara R. Lipton, John R. Zalcberg, John Simes, and David Goldstein, Australasian Gastro-Intestinal Trials Group; Nick Pavlakis, Royal North Shore Hospital, University of Sydney; Katrin M. Sjoquist, Andrew J. Martin, Eric Tsobanis, Sonia Yip, and John Simes, National Health and Medical Research Council Clinical Trials Centre, University of Sydney; Katrin M. Sjoquist, Cancer Care Centre, St George Hospital; Sonia Yip, Sydney Catalyst Translational Cancer Research Centre; Mark Wong, Westmead Hospital; David Goldstein, Prince of Wales Hospital, Sydney, New South Wales; Niall C. Tebbutt, Austin Health; Lara R. Lipton, Western Health; Andrew Strickland, Monash Medical Centre; John R. Zalcberg, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia; Yoon-Koo Kang, Asan Medical Center, University of Ulsan College of Medicine; Yung-Jue Bang, Seoul National University Hospital; Sun Young Rha, Yonsei University College of Medicine; Jeeyun Lee, Samsung Medical Center, Sungkyunkwan University School of Medicine; Jae-Yong Cho, Gangnam Severance Cancer Hospital, Yonsei University College of Medicine, Seoul; Jin Won Kim, Seoul National University Bundang Hospital, Seongnam, South Korea; Thierry Alcindor, McGill University Health Centre, Montreal, Quebec; Christopher J. O'Callaghan, National Cancer Institute of Canada Clinical Trials Group, Kingston, Ontario; and Margot J. Burnell, Saint John Regional Hospital, Saint John, New Brunswick, Canada.
Mark WongNick Pavlakis, Niall C. Tebbutt, Lara R. Lipton, John R. Zalcberg, John Simes, and David Goldstein, Australasian Gastro-Intestinal Trials Group; Nick Pavlakis, Royal North Shore Hospital, University of Sydney; Katrin M. Sjoquist, Andrew J. Martin, Eric Tsobanis, Sonia Yip, and John Simes, National Health and Medical Research Council Clinical Trials Centre, University of Sydney; Katrin M. Sjoquist, Cancer Care Centre, St George Hospital; Sonia Yip, Sydney Catalyst Translational Cancer Research Centre; Mark Wong, Westmead Hospital; David Goldstein, Prince of Wales Hospital, Sydney, New South Wales; Niall C. Tebbutt, Austin Health; Lara R. Lipton, Western Health; Andrew Strickland, Monash Medical Centre; John R. Zalcberg, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia; Yoon-Koo Kang, Asan Medical Center, University of Ulsan College of Medicine; Yung-Jue Bang, Seoul National University Hospital; Sun Young Rha, Yonsei University College of Medicine; Jeeyun Lee, Samsung Medical Center, Sungkyunkwan University School of Medicine; Jae-Yong Cho, Gangnam Severance Cancer Hospital, Yonsei University College of Medicine, Seoul; Jin Won Kim, Seoul National University Bundang Hospital, Seongnam, South Korea; Thierry Alcindor, McGill University Health Centre, Montreal, Quebec; Christopher J. O'Callaghan, National Cancer Institute of Canada Clinical Trials Group, Kingston, Ontario; and Margot J. Burnell, Saint John Regional Hospital, Saint John, New Brunswick, Canada.
Andrew StricklandNick Pavlakis, Niall C. Tebbutt, Lara R. Lipton, John R. Zalcberg, John Simes, and David Goldstein, Australasian Gastro-Intestinal Trials Group; Nick Pavlakis, Royal North Shore Hospital, University of Sydney; Katrin M. Sjoquist, Andrew J. Martin, Eric Tsobanis, Sonia Yip, and John Simes, National Health and Medical Research Council Clinical Trials Centre, University of Sydney; Katrin M. Sjoquist, Cancer Care Centre, St George Hospital; Sonia Yip, Sydney Catalyst Translational Cancer Research Centre; Mark Wong, Westmead Hospital; David Goldstein, Prince of Wales Hospital, Sydney, New South Wales; Niall C. Tebbutt, Austin Health; Lara R. Lipton, Western Health; Andrew Strickland, Monash Medical Centre; John R. Zalcberg, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia; Yoon-Koo Kang, Asan Medical Center, University of Ulsan College of Medicine; Yung-Jue Bang, Seoul National University Hospital; Sun Young Rha, Yonsei University College of Medicine; Jeeyun Lee, Samsung Medical Center, Sungkyunkwan University School of Medicine; Jae-Yong Cho, Gangnam Severance Cancer Hospital, Yonsei University College of Medicine, Seoul; Jin Won Kim, Seoul National University Bundang Hospital, Seongnam, South Korea; Thierry Alcindor, McGill University Health Centre, Montreal, Quebec; Christopher J. O'Callaghan, National Cancer Institute of Canada Clinical Trials Group, Kingston, Ontario; and Margot J. Burnell, Saint John Regional Hospital, Saint John, New Brunswick, Canada.
Jin Won KimNick Pavlakis, Niall C. Tebbutt, Lara R. Lipton, John R. Zalcberg, John Simes, and David Goldstein, Australasian Gastro-Intestinal Trials Group; Nick Pavlakis, Royal North Shore Hospital, University of Sydney; Katrin M. Sjoquist, Andrew J. Martin, Eric Tsobanis, Sonia Yip, and John Simes, National Health and Medical Research Council Clinical Trials Centre, University of Sydney; Katrin M. Sjoquist, Cancer Care Centre, St George Hospital; Sonia Yip, Sydney Catalyst Translational Cancer Research Centre; Mark Wong, Westmead Hospital; David Goldstein, Prince of Wales Hospital, Sydney, New South Wales; Niall C. Tebbutt, Austin Health; Lara R. Lipton, Western Health; Andrew Strickland, Monash Medical Centre; John R. Zalcberg, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia; Yoon-Koo Kang, Asan Medical Center, University of Ulsan College of Medicine; Yung-Jue Bang, Seoul National University Hospital; Sun Young Rha, Yonsei University College of Medicine; Jeeyun Lee, Samsung Medical Center, Sungkyunkwan University School of Medicine; Jae-Yong Cho, Gangnam Severance Cancer Hospital, Yonsei University College of Medicine, Seoul; Jin Won Kim, Seoul National University Bundang Hospital, Seongnam, South Korea; Thierry Alcindor, McGill University Health Centre, Montreal, Quebec; Christopher J. O'Callaghan, National Cancer Institute of Canada Clinical Trials Group, Kingston, Ontario; and Margot J. Burnell, Saint John Regional Hospital, Saint John, New Brunswick, Canada.
John R ZalcbergNick Pavlakis, Niall C. Tebbutt, Lara R. Lipton, John R. Zalcberg, John Simes, and David Goldstein, Australasian Gastro-Intestinal Trials Group; Nick Pavlakis, Royal North Shore Hospital, University of Sydney; Katrin M. Sjoquist, Andrew J. Martin, Eric Tsobanis, Sonia Yip, and John Simes, National Health and Medical Research Council Clinical Trials Centre, University of Sydney; Katrin M. Sjoquist, Cancer Care Centre, St George Hospital; Sonia Yip, Sydney Catalyst Translational Cancer Research Centre; Mark Wong, Westmead Hospital; David Goldstein, Prince of Wales Hospital, Sydney, New South Wales; Niall C. Tebbutt, Austin Health; Lara R. Lipton, Western Health; Andrew Strickland, Monash Medical Centre; John R. Zalcberg, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia; Yoon-Koo Kang, Asan Medical Center, University of Ulsan College of Medicine; Yung-Jue Bang, Seoul National University Hospital; Sun Young Rha, Yonsei University College of Medicine; Jeeyun Lee, Samsung Medical Center, Sungkyunkwan University School of Medicine; Jae-Yong Cho, Gangnam Severance Cancer Hospital, Yonsei University College of Medicine, Seoul; Jin Won Kim, Seoul National University Bundang Hospital, Seongnam, South Korea; Thierry Alcindor, McGill University Health Centre, Montreal, Quebec; Christopher J. O'Callaghan, National Cancer Institute of Canada Clinical Trials Group, Kingston, Ontario; and Margot J. Burnell, Saint John Regional Hospital, Saint John, New Brunswick, Canada.
John SimesNick Pavlakis, Niall C. Tebbutt, Lara R. Lipton, John R. Zalcberg, John Simes, and David Goldstein, Australasian Gastro-Intestinal Trials Group; Nick Pavlakis, Royal North Shore Hospital, University of Sydney; Katrin M. Sjoquist, Andrew J. Martin, Eric Tsobanis, Sonia Yip, and John Simes, National Health and Medical Research Council Clinical Trials Centre, University of Sydney; Katrin M. Sjoquist, Cancer Care Centre, St George Hospital; Sonia Yip, Sydney Catalyst Translational Cancer Research Centre; Mark Wong, Westmead Hospital; David Goldstein, Prince of Wales Hospital, Sydney, New South Wales; Niall C. Tebbutt, Austin Health; Lara R. Lipton, Western Health; Andrew Strickland, Monash Medical Centre; John R. Zalcberg, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia; Yoon-Koo Kang, Asan Medical Center, University of Ulsan College of Medicine; Yung-Jue Bang, Seoul National University Hospital; Sun Young Rha, Yonsei University College of Medicine; Jeeyun Lee, Samsung Medical Center, Sungkyunkwan University School of Medicine; Jae-Yong Cho, Gangnam Severance Cancer Hospital, Yonsei University College of Medicine, Seoul; Jin Won Kim, Seoul National University Bundang Hospital, Seongnam, South Korea; Thierry Alcindor, McGill University Health Centre, Montreal, Quebec; Christopher J. O'Callaghan, National Cancer Institute of Canada Clinical Trials Group, Kingston, Ontario; and Margot J. Burnell, Saint John Regional Hospital, Saint John, New Brunswick, Canada.
David GoldsteinNick Pavlakis, Niall C. Tebbutt, Lara R. Lipton, John R. Zalcberg, John Simes, and David Goldstein, Australasian Gastro-Intestinal Trials Group; Nick Pavlakis, Royal North Shore Hospital, University of Sydney; Katrin M. Sjoquist, Andrew J. Martin, Eric Tsobanis, Sonia Yip, and John Simes, National Health and Medical Research Council Clinical Trials Centre, University of Sydney; Katrin M. Sjoquist, Cancer Care Centre, St George Hospital; Sonia Yip, Sydney Catalyst Translational Cancer Research Centre; Mark Wong, Westmead Hospital; David Goldstein, Prince of Wales Hospital, Sydney, New South Wales; Niall C. Tebbutt, Austin Health; Lara R. Lipton, Western Health; Andrew Strickland, Monash Medical Centre; John R. Zalcberg, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia; Yoon-Koo Kang, Asan Medical Center, University of Ulsan College of Medicine; Yung-Jue Bang, Seoul National University Hospital; Sun Young Rha, Yonsei University College of Medicine; Jeeyun Lee, Samsung Medical Center, Sungkyunkwan University School of Medicine; Jae-Yong Cho, Gangnam Severance Cancer Hospital, Yonsei University College of Medicine, Seoul; Jin Won Kim, Seoul National University Bundang Hospital, Seongnam, South Korea; Thierry Alcindor, McGill University Health Centre, Montreal, Quebec; Christopher J. O'Callaghan, National Cancer Institute of Canada Clinical Trials Group, Kingston, Ontario; and Margot J. Burnell, Saint John Regional Hospital, Saint John, New Brunswick, Canada.
Saint John's Hospital · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeWe evaluated the activity of regorafenib, an oral multikinase inhibitor, in advanced gastric adenocarcinoma. PATIENTS AND

methodsWe 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.

resultsA 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.

conclusionIn 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.

Indexed as

AdenocarcinomaAdultAgedAged, 80 and overAntineoplastic AgentsAustraliaCanadaDisease-Free SurvivalDisease ProgressionDouble-Blind MethodFemaleHumansMaleMiddle AgedNew ZealandPhenylurea CompoundsAntineoplastic AgentsPhenylurea CompoundsPlacebosPyridinesregorafenib

Identifiers

PMID27325864
PMCPMC5019744
OpenAlexW2472847770

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.