Evidence map›Paper›PMID 34285574›Full record

ArticleCancer management and research2021

Effect of Regorafenib in Delaying Definitive Deterioration in Health-Related Quality of Life in Patients with Advanced Cancer of Three Different Tumor Types.

Ralf-Dieter Hofheinz, Jordi Bruix, George D Demetri, Axel Grothey, Marisca Marian, Jennifer Bartsch, Dawn Odom

4 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Cancer management and research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 29% 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.

NCT01103323 phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled Phase III Study of Regorafenib Plus BSC Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy

TypeinterventionalSponsorBayerRan2010 to 2014Enrolled760ConditionsMetastatic Colorectal CancerArmsRegorafenib (Stivarga, BAY73-4506), Placebo, Best Supportive Care (BSC)
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
NCT01584830 phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled Phase III Study of Regorafenib Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Asian Subjects With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy

TypeinterventionalSponsorBayerRan2012 to 2016Enrolled204ConditionsColorectal NeoplasmsArmsRegorafenib (BAY73-4506), Placebo
NCT01774344 phase3completednot on this map

A Randomized, Double Blind, Placebo Controlled, Multicenter Phase III Study of Regorafenib in Patients With Hepatocellular Carcinoma (HCC) After Sorafenib

TypeinterventionalSponsorBayerRan2013 to 2019Enrolled573ConditionsCarcinoma, HepatocellularArmsRegorafenib (Stivarga, BAY73-4506), Placebo
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Health utility book: A systematic review and meta-analysis of health utilities in gastric cancer.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    Pooled it
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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

7 authors at 6 institutions in 4 countries.

Ralf-Dieter HofheinzInterdisciplinary Tumor Center, University of Heidelberg, Mannheim, Germany.
Jordi BruixBarcelona Clinic Liver Cancer (BCLC) Group, Hospital Clinic. IDIBAPS, University of Barcelona, CIBERehd, Barcelona, Spain.ORCID 0000-0002-9826-0753
George D DemetriLudwig Center, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA.
Axel GrotheyGastrointestinal Cancer Research, West Cancer Center, OneOncology, Germantown, TN, USA.
Marisca MarianOncology, Pharmaceuticals Division of Bayer AG, Basel, Switzerland.
Jennifer BartschDepartment of Biostatistics, RTI Health Solutions, Research Triangle Park, NC, USA.ORCID 0000-0003-1506-5715
Dawn OdomDepartment of Biostatistics, RTI Health Solutions, Research Triangle Park, NC, USA.
RTI Health Solutions · USBayer (Switzerland) · CHCentro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas · ESHarvard University · USHeidelberg University · DEWest Cancer Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe efficacy and safety of regorafenib have been demonstrated in phase 3 trials for multiple tumor types, including metastatic colorectal cancer (mCRC) (CORRECT [NCT01103323]; CONCUR [NCT01584830]), advanced gastrointestinal stromal tumor (GIST) (GRID [NCT01271712]), and hepatocellular carcinoma (HCC) (RESORCE [NCT01774344]). The objective of this post hoc exploratory analysis was to explore the impact of regorafenib on delaying health-related quality of life (HRQOL) deterioration across these tumor types. PATIENTS AND

methodsHRQOL data (assessed with EORTC QLQ-C30 and EQ-5D questionnaires) were pooled for all trials to determine time until definitive deterioration (TUDD), defined as the patient's first minimal clinically important deterioration in HRQOL score from baseline that does not resolve, using stratified Kaplan-Meier estimators and Cox proportional hazards models adjusted for relevant trial, cancer type, and baseline covariates. Additional analyses based on cancer type were conducted by pooling mCRC trials (CORRECT and CONCUR) and pooling the two mCRC trials with the HCC trial (RESORCE).

resultsA total of 1699 patients with HRQOL data were pooled across the four trials. The results showed that regorafenib significantly delayed TUDD compared with placebo across all three tumor types. Median time to deterioration across the five scales ranged from 16.3 to 24.1 weeks for regorafenib and 8.6 to 12.1 weeks for placebo. The results from the individual studies, the pooled mCRC trials, and the pooled mCRC and HCC trials were similar to the overall pooled results.

conclusionA pooled analysis of four phase 3 trials demonstrated that regorafenib delayed a clinically relevant exploratory endpoint, defined as TUDD, compared with placebo across three different tumor types (mCRC, GIST, and HCC), which supports a novel benefit of the impact of regorafenib with respect to patients with these three types of cancers by allowing initial declines in HRQOL to resolve and patients the opportunity to continue treatment.

Indexed as

gastrointestinal cancerhepatocellular cancermetastatic colorectal cancerquality of liferegorafenib

Identifiers

PMID34285574
PMCPMC8285228
OpenAlexW3181568504

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.