Evidence map›Paper›PMID 27456941›Full record

Trial reportCancer research and treatment2017

Efficacy and Safety of Regorafenib in Korean Patients with Advanced Gastrointestinal Stromal Tumor after Failure of Imatinib and Sunitinib: A Multicenter Study Based on the Management Access Program.

Myoung Kyun Son, Min-Hee Ryu, Joon Oh Park, Seock-Ah Im, Tae-Yong Kim, Su Jin Lee, Baek-Yeol Ryoo, Sook Ryun Park, Yoon-Koo Kang

Abstract readClinical Trial, Phase III
In one paragraph

Trial report in Cancer research and treatment, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 3 pooled it
–field-weighted citation impact
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

21 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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  18. Response letter onTranslational gastroenterology and hepatology · 2018
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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

9 authors.

Myoung Kyun SonDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Min-Hee RyuDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Joon Oh ParkDivision of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Seock-Ah ImDepartment of Internal Medicine, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.
Tae-Yong KimDepartment of Internal Medicine, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.
Su Jin LeeDivision of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Baek-Yeol RyooDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Sook Ryun ParkDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Yoon-Koo KangDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe aim of this study was to confirm the efficacy and safety of regorafenib for advanced gastrointestinal stromal tumors (GISTs) reported in the GRID phase III trial in Korean patients. MATERIALS AND

methodsFifty-seven Korean patientswith advanced GISTwho experienced both imatinib and sunitinib failure were enrolled in the management access program between December 2012 and November 2013 and treated with regorafenib (160 mg orally once daily in a 3 weeks on/1 week off).

resultsNone of the patients achieved a complete or partial response while 25 patients (44%) showed stable disease for ≥ 12 weeks. With a median follow-up of 12.7 months (range, 0.2 to 27.6 months), the median progression-free survival and overall survival were 4.5 months (95% confidence interval [CI], 3.8 to 5.3) and 12.9 months (95% CI, 8.1 to 17.7), respectively. Interestingly, 15 patients (26%) experienced an exacerbation of their cancer-related symptoms (abdominal pain in eight and abdominal distension in five) during the rest period for regorafenib, but all were ameliorated upon the resumption of regorafenib. The most common grade 3 or 4 adverse event was a hand-foot skin reaction (25%). The regorafenib dose was reduced in 44 patients (77%) due to toxicity, which manifested mainly as a hand-foot skin reaction (n=31).

conclusionThis study confirmed the efficacy and safety of regorafenib for advanced GIST after imatinib and sunitinib failure in Korean patients. Considering the exacerbation of the cancer-related symptoms observed during the rest periods, further exploration of the continuous dosing schedule of regorafenib is warranted in future clinical trials.

Indexed as

Angiogenesis InhibitorsAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsDrug Resistance, NeoplasmFemaleFollow-Up StudiesGastrointestinal Stromal TumorsHumansImatinib MesylateIndolesKaplan-Meier EstimateMaleMiddle AgedNeoplasm MetastasisNeoplasm StagingPhenylurea CompoundsAngiogenesis InhibitorsAntineoplastic AgentsImatinib MesylateIndolesPhenylurea CompoundsProtein Kinase InhibitorsPyridinesPyrrolesregorafenibSunitinibFailure to imatinibGastrointestinal stromal tumorsManagement access programRegorafenibSunitinib

Identifiers

PMID27456941
PMCPMC5398393

What OpenQuestion holds

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Registered trials

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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.