Evidence map›Paper›PMID 33024271›Full record

Trial reportBritish journal of cancer2021

Correlative serum biomarker analyses in the phase 2 trial of lenvatinib-plus-everolimus in patients with metastatic renal cell carcinoma.

Chung-Han Lee, Robert J Motzer, Hilary Glen, M D Michaelson, James Larkin, Yukinori Minoshima, Michio Kanekiyo, Hiroki Ikezawa, Pallavi Sachdev, Corina E Dutcus and 2 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in British journal of cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01136733 (An Open-Label, Multicenter, Phase 1b/2 Study of E7080 Alone, and in Combination With Everolimus in Subjects With Unresectable Advanced or Metastatic Renal Cell Carcinoma Following One Prior VEGF-Targeted Treatment), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.5field-weighted citation impact, top 14% 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.

NCT01136733 phase1 / phase2completednot on this map

An Open-Label, Multicenter, Phase 1b/2 Study of E7080 Alone, and in Combination With Everolimus in Subjects With Unresectable Advanced or Metastatic Renal Cell Carcinoma Following One Prior VEGF-Targeted Treatment

TypeinterventionalSponsorEisai Inc.Ran2010 to 2018Enrolled173ConditionsMetastatic Renal Cell CarcinomaArmsLenvatinib, Everolimus
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 17 citations in OpenAlex.

  1. Article
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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

12 authors at 6 institutions in 3 countries.

Chung-Han LeeDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA. leec4@mskcc.org.
Robert J MotzerDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Hilary GlenMedical Oncology, Beatson West of Scotland Cancer Center, Glasgow, UK.
M D MichaelsonMassachusetts General Hospital Cancer Center, Boston, MA, USA.
James LarkinDepartment of Medical Oncology, Royal Marsden NHS Foundation Trust, London, UK.
Yukinori MinoshimaEisai Co., Ltd, Ibaraki, Japan.
Michio KanekiyoEisai Inc., Woodcliff Lake, NJ, USA.
Hiroki IkezawaEisai, Co., Ltd, Tokyo, Japan.
Pallavi SachdevEisai Inc., Woodcliff Lake, NJ, USA.
Corina E DutcusEisai Inc., Woodcliff Lake, NJ, USA.
Yasuhiro FunahashiEisai Co., Ltd, Ibaraki, Japan.
Martin H VossDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.ORCID http://orcid.org/0000-0003-0551-5807
Eisai (Japan) · JPEisai (United States) · USMemorial Sloan Kettering Cancer Center · USBeatson West of Scotland Cancer Centre · GBMassachusetts General Hospital · USRoyal Marsden NHS Foundation Trust · GB

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundNo biomarkers have been established to predict treatment efficacy in renal cell carcinoma (RCC). In an exploratory retrospective analysis of a Phase 2 study, we constructed composite biomarker scores (CBSs) to predict progression-free survival (PFS) and overall survival (OS) in patients with metastatic RCC randomised to receive lenvatinib-plus-everolimus.

methodsOf 40 biomarkers tested, the 5 most strongly associated with PFS (HGF, MIG, IL-18BP, IL-18, ANG-2) or OS (TIMP-1, M-CSF, IL-18BP, ANG-2, VEGF) were used to make a 5-factor PFS-CBS or OS-CBS, respectively. A 2-factor CBS was generated with biomarkers common to PFS-CBS and OS-CBS. Patients were divided into groups accordingly (5-factor-CBS high: 3-5, CBS-low: 0-2; 2-factor-CBS high: 1-2, CBS-low: 0).

resultsPFS/OS with lenvatinib-plus-everolimus were significantly longer in the 5-factor CBS-high group versus the CBS-low group (P = 0.0022/P < 0.0001, respectively). In the CBS-high group, PFS/OS were significantly longer with lenvatinib-plus-everolimus versus everolimus (P < 0.001/P = 0.0079, respectively); PFS was also significantly longer with lenvatinib-plus-everolimus versus lenvatinib (P = 0.0046). The 5-factor-CBS had a predictive role in PFS and OS after multivariate analysis. Similar trends were observed with the 2-factor-CBS for PFS (i.e., lenvatinib-plus-everolimus versus everolimus).

conclusionsThe 5-factor CBS may identify patients with metastatic RCC who would benefit from lenvatinib-plus-everolimus versus everolimus; additional validation is required. CLINICAL

trial registrationThe clinical trial registration number is NCT01136733.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorCarcinoma, Renal CellEverolimusFemaleHumansKidney NeoplasmsMaleMiddle AgedPhenylurea CompoundsProgression-Free SurvivalQuinolinesTreatment OutcomeBiomarkers, TumorEverolimuslenvatinibPhenylurea CompoundsQuinolines

Identifiers

PMID33024271
PMCPMC7782770
OpenAlexW3092500559

What OpenQuestion holds

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LicenceCC BY
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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.