Evidence map›Paper›PMID 34789480›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2022

Association of Neutrophil-to-Lymphocyte Ratio with Efficacy of First-Line Avelumab plus Axitinib vs. Sunitinib in Patients with Advanced Renal Cell Carcinoma Enrolled in the Phase 3 JAVELIN Renal 101 Trial.

Mehmet A Bilen, Brian I Rini, Martin H Voss, James Larkin, John B A G Haanen, Laurence Albiges, Lance C Pagliaro, Eric G Voog, Elaine T Lam, Nikolay Kislov and 7 more

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

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02684006 (A PHASE 3, MULTINATIONAL, RANDOMIZED, OPEN-LABEL, PARALLEL-ARM STUDY OF AVELUMAB), which is not on this map. Cited by 24 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 2 pooled it
3.8field-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.

NCT02684006 phase3completednot on this map

A phase 3, multinational, randomized, open-label, parallel-arm study of avelumab (msb0010718c) in combination with axitinib (inlyta(registered)) versus sunitinib (sutent(registered)) monotherapy in the first-line treatment of patients with advanced renal cell carcinoma

TypeinterventionalSponsorPfizerRan2016 to 2024Enrolled886ConditionsRenal Cell CancerArmsAvelumab (MSB0010718C), Axitinib (AG-013736), Sunitinib
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 34 citations in OpenAlex.

  1. Pooled it
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  3. Article
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  5. Navigating advanced renal cell carcinoma in the era of artificial intelligence.Cancer imaging : the official publication of the International Cancer Imaging Society · 2025
    Review
  6. Article
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  9. Overview on biomarkers for immune oncology drugs.Exploration of targeted anti-tumor therapy · 2025
    Review
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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

17 authors at 16 institutions in 7 countries.

Mehmet A BilenDepartment of Hematology and Medical Oncology, Winship Cancer Institute of Emory University, Atlanta, Georgia.
Brian I RiniVanderbilt University Medical Center, Nashville, Tennessee.
Martin H VossMemorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0003-0551-5807
James LarkinRoyal Marsden NHS Foundation Trust, London, United Kingdom.
John B A G HaanenDepartment of Medical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.
Laurence AlbigesDepartment of Cancer Medicine, Institut Gustave Roussy, Villejuif, and Université Paris-Saclay, Paris, France.
Lance C PagliaroMayo Clinic, Rochester, Minnesota.
Eric G VoogClinique Victor Hugo, Le Mans, France.
Elaine T LamUniversity of Colorado Cancer Center, Anschutz Medical Campus, Aurora, Colorado.
Nikolay KislovYaroslavl Regional Clinical Oncological Hospital, Yaroslavl, Russia.ORCID 0000-0002-0077-4909
Bradley A McGregorDana-Farber Cancer Institute, Boston, Massachusetts.ORCID 0000-0002-8298-0289
Aly-Khan A LalaniJuravinski Cancer Center, Hamilton, Ontario, Canada.ORCID 0000-0002-9907-9112
Bo HuangPfizer, Groton, Connecticut.ORCID 0000-0002-3088-9328
Alessandra di PietroPfizer SRL, Lombardia, Italy.
Stan KrulewiczPfizer, Collegeville, Pennsylvania.ORCID 0000-0001-6123-8950
Paul B RobbinsPfizer, La Jolla, California.
Toni K ChoueiriDana-Farber Cancer Institute, Boston, Massachusetts.
Dana-Farber Cancer Institute · USAssociazione Regionale Allevatori della Lombardia · ITClinical Hospital No. 8 · RUClinique Victor Hugo · FRConnecticut Sea Grant · USEmory University · USJuravinski Cancer Centre · CAKettering University · USLa Jolla Alcohol Research · USMayo Clinic · USOncode Institute · NLPitzer College · USRoyal Marsden NHS Foundation Trust · GBUniversité Paris-Saclay · FRUniversity of Colorado Cancer Center · USVanderbilt University Medical Center · US

Funding

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

Abstract

purposeTo evaluate the association between neutrophil-to-lymphocyte ratio (NLR) and efficacy of avelumab plus axitinib or sunitinib. EXPERIMENTAL

designAdult patients with untreated advanced renal cell carcinoma (RCC) with a clear-cell component, ≥1 measurable lesions, Eastern Cooperative Oncology Group performance status of 0 or 1, fresh or archival tumor specimen, and adequate renal, cardiac, and hepatic function were included. Retrospective analyses of the association between baseline NLR and progression-free survival (PFS) and overall survival (OS) in the avelumab plus axitinib or sunitinib arms were performed using the first interim analysis of the phase 3 JAVELIN Renal 101 trial (NCT02684006). Multivariate Cox regression analyses of PFS and OS were conducted. Translational data were assessed to elucidate the underlying biology associated with differences in NLR.

resultsPatients with below-median NLR had longer observed PFS with avelumab plus axitinib [stratified HR, 0.85; 95% confidence interval (CI), 0.634-1.153] or sunitinib (HR, 0.56; 95% CI, 0.415-0.745). In the avelumab plus axitinib or sunitinib arms, respectively, median PFS was 13.8 and 11.2 months in patients with below-median NLR, and 13.3 and 5.6 months in patients with median-or-higher NLR. Below-median NLR was also associated with longer observed OS in the avelumab plus axitinib (HR, 0.51; 95% CI, 0.300-0.871) and sunitinib arms (HR, 0.30; 95% CI, 0.174-0.511). Tumor analyses showed an association between NLR and key biological characteristics, suggesting a role of NLR in underlying mechanisms influencing clinical outcome.

conclusionsCurrent data support NLR as a prognostic biomarker in patients with advanced RCC receiving avelumab plus axitinib or sunitinib.

Indexed as

Carcinoma, Renal CellKidney NeoplasmsAdultAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsAxitinibHumansLymphocytesNeutrophilsRetrospective StudiesSunitinibAntibodies, Monoclonal, HumanizedavelumabAxitinibSunitinib

Identifiers

PMID34789480
PMCPMC9377757
OpenAlexW3211458171

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.