Evidence map›Paper›PMID 32701199›Full record

Trial reportThe oncologist2020

A Randomized, Double-Blind, Placebo-Controlled, Phase II Study of Regorafenib Versus Placebo in Advanced/Metastatic, Treatment-Refractory Liposarcoma: Results from the SARC024 Study.

Richard F Riedel, Karla V Ballman, Yao Lu, Steven Attia, Elizabeth T Loggers, Kristen N Ganjoo, Michael B Livingston, Warren Chow, Jennifer Wright, John H Ward and 10 more

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

Trial report in The oncologist, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 3 pooled it
1.4field-weighted citation impact, top 15% 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

17 citing papers in PubMed, 3 syntheses or guidelines pooled it, 25 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Randomized Double-Blind Phase II Study of Regorafenib in Patients With Metastatic Osteosarcoma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2019
    Trial
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  17. Molecular targeted therapy for advanced or metastatic soft tissue sarcoma.Cancer control : journal of the Moffitt Cancer Center
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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

20 authors at 18 institutions in 1 country.

Richard F RiedelDuke Cancer Institute, Duke University Medical Center, Durham, North Carolina, USA.ORCID 0000-0001-5412-8710
Karla V BallmanWeill Cornell Medicine, New York, New York, USA.
Yao LuWeill Cornell Medicine, New York, New York, USA.
Steven AttiaMayo Clinic, Jacksonville, Florida, USA.
Elizabeth T LoggersFred Hutchinson Cancer Research Center, Seattle, Washington, USA.
Kristen N GanjooStanford Cancer Institute, Stanford University, Stanford, California, USA.
Michael B LivingstonLevine Cancer Institute, Atrium Health, Charlotte, North Carolina, USA.
Warren ChowCity of Hope Cancer Center, Duarte, California, USA.
Jennifer WrightEli Lilly and Company, Indianapolis, Indiana, USA.
John H WardHuntsman Cancer Institute, University of Utah, Salt Lake City, Utah, USA.
Daniel RushingMelvin and Bren Simon Cancer Center, Indiana University, Indianapolis, Indiana, USA.
Scott H OkunoMayo Clinic, Rochester, Minnesota, USA.
Damon R ReedH. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA.
David A LiebnerThe Ohio State University, Columbus, Ohio, USA.
Vicki L KeedyVanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Leo MascarenhasChildren's Hospital of Los Angeles, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.
Lara E DavisKnight Cancer Institute, Oregon Health & Science University, Portland, Oregon, USA.
Christopher RyanKnight Cancer Institute, Oregon Health & Science University, Portland, Oregon, USA.
Denise K ReinkeSarcoma Alliance for Research through Collaboration (SARC), Ann Arbor, Michigan, USA.
Robert G MakiAbramson Cancer Center, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA.
Cornell University · USOregon Health & Science University · USCity Of Hope National Medical Center · USDuke Medical Center · USEli Lilly (United States) · USFred Hutch Cancer Center · USHuntsman Cancer Institute · USIndiana University Health · USLevine Cancer Institute · USMayo Clinic · USMayo Clinic in Florida · USMoffitt Cancer Center · USSarcoma Alliance for Research through Collaboration · USStanford University · USThe Ohio State University · USUniversity of Pennsylvania · USUniversity of Southern California · USVanderbilt University Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

lessons learnedThe results from the liposarcoma cohort of SARC024 confirm previously published data and do not support the routine use of regorafenib in this patient population. Continued exploration of novel therapies, including combination approaches, is warranted for a patient population in whom limited treatment options exist.

backgroundRegorafenib is a multitargeted kinase inhibitor with a kinase profile overlapping, but distinct from, pazopanib, an agent approved for recurrent and metastatic non-gastrointestinal stromal tumor (GIST), non-adipocytic soft tissue sarcoma. We conducted a randomized, phase II study of regorafenib versus placebo in refractory liposarcoma patients.

methodsPatients with advanced or metastatic, treatment-refractory liposarcoma were randomized 1:1 to receive regorafenib 160 mg or placebo once daily (3 weeks on, 1 week off). Patients with well-differentiated liposarcoma only were excluded. Crossover for placebo was allowed upon progression. The primary endpoint was progression-free survival (PFS), according to RECIST version 1.1.

resultsForty-eight subjects with liposarcoma (34 dedifferentiated, 12 myxoid/round cell, 2 pleomorphic) were enrolled. Median PFS was 1.87 (95% confidence interval [CI], 0.92-3.67) months for regorafenib versus 2.07 (95% CI, 1.64-3.44) months for placebo; stratified hazard ratio [HR], 0.85 (95% CI, 0.46, 1.58), p = .62. No responses were seen on regorafenib. One PR was observed on placebo. Median overall survival was 6.46 (95% CI, 4.16-23.48) months for regorafenib and 4.89 (95% CI, 3.02-9.77) months for placebo, stratified HR, 0.66 (95% CI, 0.31-1.40), p = .28). Treatment-related adverse events were similar to the known safety profile of regorafenib.

conclusionRegorafenib did not appear to improve PFS in treatment-refractory liposarcoma. No new significant safety signals were observed.

Indexed as

LiposarcomaPhenylurea CompoundsPyridinesAdultAgedDouble-Blind MethodFemaleHumansMaleMiddle AgedProtein Kinase InhibitorsTreatment OutcomePhenylurea CompoundsProtein Kinase InhibitorsPyridinesregorafenib

Identifiers

PMID32701199
PMCPMC7648334
OpenAlexW3045044516

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.