Evidence map›Paper›PMID 25655899›Full record

Trial reportInternational journal of clinical oncology2015

Regorafenib for advanced gastrointestinal stromal tumors following imatinib and sunitinib treatment: a subgroup analysis evaluating Japanese patients in the phase III GRID trial.

Yoshito Komatsu, Toshihiko Doi, Akira Sawaki, Tatsuo Kanda, Yasuhide Yamada, Iris Kuss, George D Demetri, Toshirou Nishida

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in International journal of clinical oncology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01271712 (A Randomized, Double-blind, Placebo-controlled Phase III Study of Regorafenib Plus Best Supportive Care Versus Placebo Plus Best Supportive Care for Subjects With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors), which is not on this map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
3.5field-weighted citation impact, top 8% 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.

NCT01271712 phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled Phase III Study of Regorafenib Plus Best Supportive Care Versus Placebo Plus Best Supportive Care for Subjects With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) Whose Disease Has Progressed Despite Prior Treatment With at Least Imatinib and Sunitinib

TypeinterventionalSponsorBayerRan2011 to 2019Enrolled199ConditionsGastrointestinal Stromal TumorsArmsRegorafenib (Stivarga, BAY73-4506), Placebo, Best supportive care
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 33 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Molecular Mechanisms and Clinical Implications ofCurrent issues in molecular biology · 2025
    Review
  5. Review
  6. Article
  7. Review
  8. Review
  9. Risk factor analysis for regorafenib-induced severe hypertension in metastatic colorectal cancer treatment.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2022
    Article
  10. Review
  11. Article
  12. Review
  13. Review
  14. Article
  15. Article
  16. Article
  17. Review
  18. Article
  19. Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 5 institutions in 3 countries.

Yoshito KomatsuCancer Center, Hokkaido University Hospital, Kita 14 Nishi 5, Kita-ku, Sapporo, Hokkaido, 060-8648, Japan. ykomatsu@ac.cyberhome.ne.jp.
Toshihiko DoiNational Cancer Center Hospital East, Kashiwa, Japan.
Akira SawakiDepartment of Oncology and Gastroenterology, Nagoya Second Red Cross Hospital, Nagoya, Japan.
Tatsuo KandaDivision of Digestive and General Surgery, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.
Yasuhide YamadaGastrointestinal Oncology Division, National Cancer Center Hospital, Tokyo, Japan.
Iris KussGlobal Clinical Development, Oncology, Ophthalmology and Neurology, Bayer Pharma AG, Berlin, Germany.
George D DemetriLudwig Cancer Center, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.
Toshirou NishidaDepartment of Surgery, National Cancer Center Hospital East, Kashiwa, Japan.
National Cancer Center Hospital East · JPBayer (Germany) · DEHarvard University · USHokkaido University · JPNiigata University · JP

Funding

Tissue and Pathology ResourcesP50CA127003 · NCI · DANA-FARBER CANCER INST · PI EL-BARDEESY, NABEEL, SELLERS, WILLIAM R · 2007 to 2023
$33.2M
NCI NIH HHS P50 CA127003
6 · The paper itself

Abstract

backgroundThe randomized, double-blind, placebo-controlled GRID trial tested the oral multikinase inhibitor regorafenib in 199 patients with advanced gastrointestinal stromal tumors (GIST) following failure of at least imatinib and sunitinib, and showed a significant improvement in progression-free survival (PFS) versus placebo [hazard ratio (HR) 0.27; 95 % confidence interval (CI) 0.19-0.39; p < 0.0001].

methodsA subgroup analysis of Japanese patients in the GRID study was performed to compare the efficacy and safety of oral regorafenib 160 mg once daily with matching placebo, in combination with best supportive care. The primary study endpoint was progression-free survival (PFS); safety was evaluated through the incidence of adverse events (AEs).

resultsSeventeen Japanese patients were randomized to regorafenib (n = 12) or placebo (n = 5). Patient demographics were consistent with those of the overall study population. PFS was significantly longer with regorafenib than placebo (HR 0.08; 95 % CI 0.02-0.45; p = 0.000164). Centrally assessed disease control rates were 58 % and 20 % in the regorafenib and placebo groups, respectively (p = 0.080796). Treatment-related adverse events (AEs) were reported in all regorafenib-treated patients and 60 % of placebo recipients; the most frequent AE was hand-foot skin reaction (HFSR) (92 % versus 20 %, respectively).

conclusionRegorafenib showed efficacy and a manageable safety profile in Japanese patients with advanced GIST, consistent with the overall GRID study population. AEs, such as HFSR and maculopapular rash, were observed more frequently in Japanese patients. Although dose modification was frequently reported, only one patient with hepatic failure discontinued regorafenib because of AEs.

Indexed as

AdolescentAdultAgedAged, 80 and overAntineoplastic AgentsAsian PeopleDouble-Blind MethodGastrointestinal NeoplasmsGastrointestinal Stromal TumorsHumansImatinib MesylateIndolesMiddle AgedPhenylurea CompoundsPyridinesPyrrolesAntineoplastic AgentsImatinib MesylateIndolesPhenylurea CompoundsPyridinesPyrrolesregorafenibSunitinibGastrointestinal stromal tumorHand–foot syndromeHypertensionJapaneseRegorafenib

Identifiers

PMID25655899
PMCPMC4527951
OpenAlexW2045609038

What OpenQuestion holds

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Registered trials

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.