Evidence map›Paper›PMID 32145825›Full record

Trial reportLancet (London, England)2020

Adjuvant chemotherapy in upper tract urothelial carcinoma (the POUT trial): a phase 3, open-label, randomised controlled trial.

Alison Birtle, Mark Johnson, John Chester, Robert Jones, David Dolling, Richard T Bryan, Christopher Harris, Andrew Winterbottom, Anthony Blacker, James W F Catto and 14 more

3 registry-linked trialsAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Lancet (London, England), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 268 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
268citing 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.

NCT01993979 phase3unknown statusnot on this map

A Phase III Randomised Trial of Peri-Operative Chemotherapy Versus sUrveillance in Upper Tract Urothelial Cancer

TypeinterventionalSponsorInstitute of Cancer Research, United KingdomRan2012 to 2022Enrolled261ConditionsTransitional Cell Carcinoma of UreterArmsChemotherapy, Surveillance
NCT04944550 completednot on this mapstarted 2021, after this paper: background citation

Development of New Models for the Evaluation of Preclinical Treatment for Urothelial Carcinomas of the Upper Excretory Tract.

TypeobservationalSponsorCentre Hospitalier Universitaire de NīmesRan2021 to 2023Enrolled20ConditionsUpper Urinary Tract Urothelial Carcinoma, Nephroureterectomy, Tumor, Xenograft Model
NCT06120374 recruitingnot on this mapstarted 2022, after this paper: background citation

Safety and Efficacy of Adjuvant Radioimmunotherapy Compared With Adjuvant Chemotherapy for Upper Tract Urothelial Carcinoma: An Ambispective Cohort Study

TypeobservationalSponsorPeking University First HospitalRan2022 to 2029Enrolled178ConditionsUrothelial CarcinomaArmsRadiotherapy, Chemotherapy, Immunotherapy
3 · Its place in the literature

Who cites it

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

  1. Pooled it
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  3. SEOM-SOGUG clinical guideline for urothelial cancer (2025).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025
    Guideline
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  5. Improved Disease-Free Survival With Adjuvant Chemotherapy After Nephroureterectomy for Upper Tract Urothelial Cancer: Final Results of the POUT Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024
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208 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

24 authors.

Alison BirtleLancashire Teaching Hospitals NHS Foundation Trust, Preston, UK; University of Manchester, Manchester, UK. Electronic address: alison.birtle@lthtr.nhs.uk.
Mark JohnsonNewcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle, UK.
John ChesterCardiff University, Cardiff, UK.
Robert JonesUniversity of Glasgow, Glasgow, UK.
David DollingThe Institute of Cancer Research, Clinical Trials and Statistics Unit, London, UK.
Richard T BryanUniversity of Birmingham, Birmingham, UK.
Christopher HarrisPatient and Public Involvement Representative, London, UK.
Andrew WinterbottomPatient and Public Involvement Representative, Fight Bladder Cancer, Chinnor, UK.
Anthony BlackerUniversity Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.
James W F CattoUniversity of Sheffield, Sheffield, UK.
Prabir ChakrabortiDerby Hospitals NHS Foundation Trust, Derby, UK.
Jenny L DonovanUniversity of Bristol, Bristol, UK.
Paul Anthony ElliottThe Christie NHS Foundation Trust, Manchester, UK.
Ann FrenchSouthend University Hospital NHS Foundation Trust, Southend, UK.
Satinder JagdevThe Leeds Teaching Hospitals NHS Trust, Leeds, UK.
Benjamin JenkinsThe Institute of Cancer Research, Clinical Trials and Statistics Unit, London, UK.
Francis Xavier KeeleyNorth Bristol NHS Trust, Bristol, UK.
Roger KockelberghUniversity Hospitals of Leicester NHS Trust, Leicester, UK.
Thomas PowlesBarts Cancer Institute, London, UK.
John WagstaffSingleton Hospital, Swansea, UK.
Caroline WilsonUniversity of Bristol, Bristol, UK.
Rachel ToddThe Institute of Cancer Research, Clinical Trials and Statistics Unit, London, UK.
Rebecca LewisThe Institute of Cancer Research, Clinical Trials and Statistics Unit, London, UK.
Emma HallThe Institute of Cancer Research, Clinical Trials and Statistics Unit, London, UK.

Funding

Cancer Research UK 16781Department of Health NIHR300047
6 · The paper itself

Abstract

backgroundUrothelial carcinomas of the upper urinary tract (UTUCs) are rare, with poorer stage-for-stage prognosis than urothelial carcinomas of the urinary bladder. No international consensus exists on the benefit of adjuvant chemotherapy for patients with UTUCs after nephroureterectomy with curative intent. The POUT (Peri-Operative chemotherapy versus sUrveillance in upper Tract urothelial cancer) trial aimed to assess the efficacy of systemic platinum-based chemotherapy in patients with UTUCs.

methodsWe did a phase 3, open-label, randomised controlled trial at 71 hospitals in the UK. We recruited patients with UTUC after nephroureterectomy staged as either pT2-T4 pN0-N3 M0 or pTany N1-3 M0. We randomly allocated participants centrally (1:1) to either surveillance or four 21-day cycles of chemotherapy, using a minimisation algorithm with a random element. Chemotherapy was either cisplatin (70 mg/m

findingsBetween June 19, 2012, and Nov 8, 2017, we enrolled 261 participants from 57 of 71 open study sites. 132 patients were assigned chemotherapy and 129 surveillance. One participant allocated chemotherapy withdrew consent for data use after randomisation and was excluded from analyses. Adjuvant chemotherapy significantly improved disease-free survival (hazard ratio 0·45, 95% CI 0·30-0·68; p=0·0001) at a median follow-up of 30·3 months (IQR 18·0-47·5). 3-year event-free estimates were 71% (95% CI 61-78) and 46% (36-56) for chemotherapy and surveillance, respectively. 55 (44%) of 126 participants who started chemotherapy had acute grade 3 or worse treatment-emergent adverse events, which accorded with frequently reported events for the chemotherapy regimen. Five (4%) of 129 patients managed by surveillance had acute grade 3 or worse emergent adverse events. No treatment-related deaths were reported.

interpretationGemcitabine-platinum combination chemotherapy initiated within 90 days after nephroureterectomy significantly improved disease-free survival in patients with locally advanced UTUC. Adjuvant platinum-based chemotherapy should be considered a new standard of care after nephroureterectomy for this patient population.

fundingCancer Research UK.

Indexed as

Administration, IntravenousAdultAgedAged, 80 and overAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCarcinoma, Transitional CellChemotherapy, AdjuvantCisplatinDeoxycytidineDisease-Free SurvivalFemaleGemcitabineHumansMaleAntineoplastic AgentsCarboplatinCisplatinDeoxycytidineGemcitabine

Identifiers

PMID32145825
PMCPMC7181180

What OpenQuestion holds

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LicenceCC BY-NC-ND
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.