Evidence map›Paper›PMID 28295221›Full record

Trial reportCancer2017

REGOSARC: Regorafenib versus placebo in doxorubicin-refractory soft-tissue sarcoma-A quality-adjusted time without symptoms of progression or toxicity analysis.

Vincent Berry, Laurent Basson, Emilie Bogart, Olivier Mir, Jean-Yves Blay, Antoine Italiano, François Bertucci, Christine Chevreau, Stéphanie Clisant-Delaine, Bernadette Liegl-Antzager and 7 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Cancer, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 1 pooled it
4.7field-weighted citation impact, top 5% 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.

NCT01900743 phase2completednot on this map

Activity and Safety of Regorafenib in Patients With Metastatic Soft Tissue Sarcoma Previously Treated With Anthracycline-based Chemotherapy : a Multinational, Randomized, Phase II, Placebo-controlled Trial

TypeinterventionalSponsorCentre Oscar LambretRan2013 to 2020Enrolled219ConditionsSarcomaArmsRegorafenib, Placebo
NCT05395741 phase1 / phase2completednot on this mapstarted 2022, after this paper: background citation

Evaluation of the Efficacy and Safety of Regorafenib in Patients With Refractory Primary Bone Tumors

TypeinterventionalSponsorInstitute of Mother and Child, Warsaw, PolandRan2022 to 2026Enrolled30ConditionsOsteosarcoma, Ewing Sarcoma of BoneArmsRegorafenib
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 1 synthesis or guideline pooled it, 43 citations in OpenAlex.

  1. Soft Tissue Sarcoma, Version 2.2022, NCCN Clinical Practice Guidelines in Oncology.Journal of the National Comprehensive Cancer Network : JNCCN · 2022
    Guideline
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  16. Update on systemic therapy for advanced soft-tissue sarcoma.Current oncology (Toronto, Ont.) · 2020
    Review
  17. Review
  18. Article
  19. Review
  20. Observational
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 9 institutions in 2 countries.

Vincent BerryMedical Oncology Department, Oscar Lambret Center, Lille, France.
Laurent BassonBiostatisitics and Methodology Unit, Oscar Lambret Center, Lille, France.
Emilie BogartBiostatisitics and Methodology Unit, Oscar Lambret Center, Lille, France.
Olivier MirMedical Oncology Department, Gustave Roussy, Villejuif, France.
Jean-Yves BlayMedical Oncology Department, Léon Bérard Center, Lyon, France.
Antoine ItalianoMedical Oncology Department, Bergonié Institute, Bordeaux, France.
François BertucciMedical Oncology Department, Paoli-Calmette Institute, Marseille, France.
Christine ChevreauMedical Oncology Department, University Cancer Institute of Toulouse-Oncopole, Toulouse, France.
Stéphanie Clisant-DelaineMethodology and Clinical Research Platform, SIRIC OncoLille, Lille, France.
Bernadette Liegl-AntzagerInstitute of Pathology, Medical University of Graz, Graz, Austria.
Emmanuelle Tresch-BruneelBiostatisitics and Methodology Unit, Oscar Lambret Center, Lille, France.
Jennifer WalletBiostatisitics and Methodology Unit, Oscar Lambret Center, Lille, France.
Sophie TaiebRadiology Department, Oscar Lambret Center, Lille, France.
Emilie DecoupignyMethodology and Clinical Research Platform, SIRIC OncoLille, Lille, France.
Axel Le CesneMedical Oncology Department, Gustave Roussy, Villejuif, France.
Thomas BrodowiczGeneral Hospital, Medical University of Vienna, Vienna, Austria.
Nicolas PenelMedical Oncology Department, Oscar Lambret Center, Lille, France.
Centre Oscar Lambret · FRInstitut Gustave Roussy · FROnco Lille · FRCentre Léon Bérard · FRInstitut Bergonié · FRInstitut Paoli-Calmettes · FRInstitut universitaire du cancer de Toulouse Oncopole · FRMedical University of Graz · ATMedical University of Vienna · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn a placebo-controlled, randomized phase 2 trial (ClinicalTrials.gov identifier NCT01900743), regorafenib improved progression-free survival (PFS) for patients with doxorubicin-pretreated advanced nonadipocytic sarcoma. A quality-adjusted time without symptoms of progression or toxicity (Q-TWiST) post hoc exploratory analysis was applied to provide an integrated measure of its clinical benefit.

methodsIn the base-case analysis, each patient's overall survival (OS) was partitioned into 3 mutually exclusive health states: the time with a grade 3 or 4 adverse event (TOX), the time without symptoms of disease or grade 3 or 4 toxicity from treatment, and the time after tumor progression or relapse. The time spent in each state was weighted with a health-state utility associated with that state and was summed to calculate the Q-TWiST. The stability of the base-case analysis was explored with several sensitivity analyses.

resultsIn nonadipocytic sarcoma, the PFS was (4.0 months [2.6-5.5 months] with regorafenib vs 1.0 month [0.9-1.8 months] with a placebo; hazard ratio, 0.36 [0.25-0.53]; P < .0001); the OS was 13.4 months (8.6-17.3 months) with regorafenib and 9.0 months (6.8-12.5 months) with a placebo (hazard ratio, 0.67 [0.44-1.02]). With the classic definition of TOX (including all grade 3 and 4 clinical adverse events), the Q-TWiSTs were 8.0 months (7.0-9.0 months) with regorafenib and 5.7 months (4.9-6.4 months) with a placebo (P < .001).

conclusionsFor patients with doxorubicin-pretreated soft-tissue sarcoma, regorafenib significantly improved quality-adjusted survival in comparison with a placebo. Cancer 2017;123:2294-2302. © 2017 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society. This is an open access article under the terms of the Creative Commons Attribution NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

Indexed as

AgedAlopeciaAnorexiaAntineoplastic AgentsAstheniaDiarrheaDouble-Blind MethodFecal IncontinenceFemaleHand-Foot SyndromeHospitalizationHumansHypertensionLeiomyosarcomaLiposarcomaMaleAntineoplastic AgentsPhenylurea CompoundsPyridinesregorafenibmetastatic soft-tissue sarcomaplaceboquality-adjusted survivalquality-adjusted time without symptoms of progression or toxicity (Q-TWiST)regorafenib

Identifiers

PMID28295221
PMCPMC5485075
OpenAlexW2592028643

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.