Evidence map›Paper›PMID 31249394›Full record

Trial reportBritish journal of cancer2019

Urine protein:creatinine ratio vs 24-hour urine protein for proteinuria management: analysis from the phase 3 REFLECT study of lenvatinib vs sorafenib in hepatocellular carcinoma.

Thomas R Jeffry Evans, Masatoshi Kudo, Richard S Finn, Kwang-Hyub Han, Ann-Lii Cheng, Masafumi Ikeda, Silvija Kraljevic, Min Ren, Corina E Dutcus, Fabio Piscaglia and 1 more

Erratum issued Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in British journal of cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT01761266 (A Multicenter, Randomized, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib), which is not on this map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
2.8field-weighted citation impact, top 9% 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.

NCT01761266 phase3completednot on this map

A Multicenter, Randomized, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-Line Treatment of Subjects With Unresectable Hepatocellular Carcinoma

TypeinterventionalSponsorEisai LimitedRan2013 to 2021Enrolled954ConditionsHepatocellular Carcinoma (HCC)ArmsLenvatinib, Sorafenib
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.

  1. Guideline
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  11. Observational
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 10 institutions in 6 countries.

Thomas R Jeffry EvansUniversity of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow, UK. j.evans@beatson.gla.ac.uk.
Masatoshi KudoDepartment of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka, Japan.
Richard S FinnDavid Geffen School of Medicine, UCLA Medical Center, Los Angeles, CA, USA.
Kwang-Hyub HanSeverance Hospital, Yonsei University, Seoul, South Korea.
Ann-Lii ChengNational Taiwan University Hospital and National Taiwan University Cancer Center, Taipei, Taiwan.
Masafumi IkedaDepartment of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Silvija KraljevicFormer employee of Eisai Ltd, Hatfield, UK.
Min RenEisai Inc., Woodcliff Lake, NJ, USA.
Corina E DutcusEisai Inc., Woodcliff Lake, NJ, USA.
Fabio PiscagliaUnit of Internal Medicine, University of Bologna, S.Orsola-Malpighi Hospital, Bologna, Italy.
Max W SungTisch Cancer Institute at Mount Sinai, New York, NY, USA.
Eisai (United States) · USEisai (United Kingdom) · GBKindai University · JPNational Cancer Center Hospital East · JPNational Taiwan University Hospital · TWOlive View-UCLA Medical Center · USSeverance Hospital · KRTisch Cancer InstituteUniversity of Bologna · ITUniversity of Glasgow · GB

Funding

Cancer Research UK 11650Cancer Research UK 20409Cancer Research UK 26813
6 · The paper itself

Abstract

backgroundProteinuria monitoring is required in patients receiving lenvatinib, however, current methodology involves burdensome overnight urine collection.

methodsTo determine whether the simpler urine protein:creatinine ratio (UPCR) calculated from spot urine samples could be accurately used for proteinuria monitoring in patients receiving lenvatinib, we evaluated the correlation between UPCR and 24-hour urine protein results from the phase 3 REFLECT study. Paired data (323 tests, 154 patients) were analysed.

resultsRegression analysis showed a statistically significant correlation between UPCR and 24-hour urine protein (R

conclusionIncorporation of UPCR into the current algorithm for proteinuria management can enable optimisation of lenvatinib treatment, while minimising patient inconvenience. CLINICAL

trial registrationNCT01761266.

Indexed as

Carcinoma, HepatocellularCreatinineHumansLiver NeoplasmsPhenylurea CompoundsProteinuriaQuinolinesSorafenibCreatininelenvatinibPhenylurea CompoundsQuinolinesSorafenib

Identifiers

PMID31249394
PMCPMC6738107
OpenAlexW2954340933

What OpenQuestion holds

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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.