Evidence map›Paper›PMID 37684354›Full record

Trial reportBritish journal of cancer2023

Axitinib in patients with advanced/metastatic soft tissue sarcoma (Axi-STS): an open-label, multicentre, phase II trial in four histological strata.

Penella J Woll, Piers Gaunt, Charlotte Gaskell, Robin Young, Charlotte Benson, Ian R Judson, Beatrice M Seddon, Maria Marples, Nasim Ali, Sandra J Strauss and 5 more

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in British journal of cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
2.3field-weighted citation impact, top 10% 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

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. Article
  6. Review
  7. 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

15 authors at 7 institutions in 1 country.

Penella J WollUniversity of Sheffield, Sheffield UK and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, S10 2JF, UK.
Piers GauntCancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.
Charlotte GaskellCancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.
Robin YoungUniversity of Sheffield, Sheffield UK and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, S10 2JF, UK. r.j.young@sheffield.ac.uk.ORCID 0000-0002-5146-9074
Charlotte BensonSarcoma Unit, Royal Marsden Hospital, London, UK.
Ian R JudsonSarcoma Unit, Royal Marsden Hospital, London, UK.
Beatrice M SeddonDepartment of Oncology, University College London Hospital, London, UK.
Maria MarplesSt James's University Hospital, Leeds, UK.
Nasim AliThe Clatterbridge Cancer Centre NHS Foundation Trust, Wirral, UK.
Sandra J StraussDepartment of Oncology, University College London Hospital, London, UK.
Alexander LeeThe Christie Hospital, Manchester, UK.ORCID 0000-0003-2976-6811
Ana HughesCancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.
Baljit KaurCancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.
David HughesUniversity of Sheffield, Sheffield UK and Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, S10 2JF, UK.
Lucinda BillinghamCancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK.
Cancer Research UK Clinical Trials Unit · GBSheffield Teaching Hospitals NHS Foundation Trust · GBRoyal Marsden Hospital · GBUniversity College Hospital · GBClatterbridge Cancer Centre NHS Foundation Trust · GBSt James's University Hospital · GBThe Christie Hospital · GB

Funding

Cancer Research UK 09/009Cancer Research UK 25354
6 · The paper itself

Abstract

backgroundAxitinib is an oral vascular endothelial growth factor receptor inhibitor with anti-tumour activity in renal, thyroid, and pancreatic cancer.

methodsAxi-STS was a pathologically-stratified, non-randomised, open-label, multi-centre, phase II trial of continuous axitinib treatment in patients ≥16 years, performance status ≤2, with pathologically-confirmed advanced/metastatic soft tissue sarcoma (STS). Patients were recruited within four tumour strata, each analysed separately: angiosarcoma, leiomyosarcoma, synovial sarcoma, or other eligible STSs. The primary outcome was progression-free survival at 12 weeks (PFS12). A Simon's two-stage design with activity defined as PFS12 rate of 40% determined a sample size of 33 patients per strata.

resultsBetween 31-August-2010 and 29-January-2016, 145 patients were recruited: 38 angiosarcoma, 37 leiomyosarcoma, 36 synovial sarcoma, and 34 other subtypes. PFS12 rate for each stratum analysed was 42% (95% lower confidence interval (LCI); 29), 45% (95% LCI; 32), 57% (95% LCI; 42), and 33% (95% LCI; 21), respectively. There were 74 serious adverse events including two treatment-related deaths of pulmonary haemorrhage and gastrointestinal bleeding. Fatigue and hypertension were the most common grade 3 adverse events.

conclusionsAxitinib showed clinical activity in all STS strata investigated. The adverse event profile was acceptable, supporting further investigation in phase III trials. CLINICAL

trial registrationISRCTN 60791336.

Indexed as

HemangiosarcomaLeiomyosarcomaSarcomaSarcoma, SynovialSoft Tissue NeoplasmsAngiogenesis InhibitorsAxitinibHumansTreatment OutcomeVascular Endothelial Growth Factor AAngiogenesis InhibitorsAxitinibVascular Endothelial Growth Factor A

Identifiers

PMID37684354
PMCPMC10628187
OpenAlexW4386543713

What OpenQuestion holds

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LicenceCC BY
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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.