Evidence map›Paper›PMID 36037566›Full record

Trial reportESMO open2022

Association of C-reactive protein with efficacy of avelumab plus axitinib in advanced renal cell carcinoma: long-term follow-up results from JAVELIN Renal 101.

Y Tomita, J Larkin, B Venugopal, J Haanen, H Kanayama, M Eto, M-O Grimm, Y Fujii, Y Umeyama, B Huang and 3 more

Open access · goldAbstract readClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in ESMO open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
2.4field-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

13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 17 citations in OpenAlex.

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  7. Early kinetics of C-reactive protein as prognosticator for survival in a real-world cohort of patients with metastatic renal cell cancer under first-line therapy with immune checkpoint inhibitors.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024
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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

13 authors at 10 institutions in 6 countries.

Y TomitaDepartment of Urology, Department of Molecular Oncology, Niigata University Graduate School of Medicine, Niigata, Japan. Electronic address: ytomita@med.niigata-u.ac.jp.
J LarkinDepartment of Medical Oncology, Royal Marsden NHS Foundation Trust, London, UK.
B VenugopalInstitute of Cancer Sciences, University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow, UK.
J HaanenDivision of Medical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.
H KanayamaDepartment of Urology, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.
M EtoDepartment of Urology, Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan.
M-O GrimmDepartment of Urology, Jena University Hospital, Jena, Germany.
Y FujiiPfizer R&D Japan, Tokyo, Japan.
Y UmeyamaPfizer R&D Japan, Tokyo, Japan.
B HuangPfizer, Groton, USA.
M MarianiPfizer SRL, Milan, Italy.
A di PietroPfizer SRL, Milan, Italy.
T K ChoueiriLank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Boston, USA.
Pfizer (Italy) · ITPfizer (Japan) · JPDana-Farber Cancer Institute · USJena University Hospital · DEKyushu University · JPPfizer (United States) · USRoyal Marsden NHS Foundation Trust · GBThe Netherlands Cancer Institute · NLTokushima University · JPUniversity of Glasgow · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundC-reactive protein (CRP) is an important prognostic and predictive factor in advanced renal cell carcinoma (aRCC). We report the association of CRP levels at baseline and early after treatment with efficacy of avelumab plus axitinib or sunitinib from the phase III JAVELIN Renal 101 trial. PATIENTS AND

methodsPatients were categorized into normal (baseline CRP <10 mg/l), normalized (baseline CRP ≥10 mg/l and ≥1 CRP value decreased to <10 mg/l during 6-week treatment), and non-normalized (CRP ≥10 mg/l at baseline and during 6-week treatment) CRP groups. Progression-free survival and best overall response from the second interim analysis and overall survival (OS) from the third interim analysis were assessed.

resultsIn the avelumab plus axitinib and sunitinib arms, respectively, 234, 51, and 108 patients and 232, 36, and 128 patients were categorized into normal, normalized, and non-normalized CRP groups. In respective CRP groups, objective response rates [95% confidence interval (CI)] were 56.0% (49.4% to 62.4%), 66.7% (52.1% to 79.2%), and 45.4% (35.8% to 55.2%) with avelumab plus axitinib and 30.6% (24.7% to 37.0%), 41.7% (25.5% to 59.2%), and 19.5% (13.1% to 27.5%) with sunitinib; complete response rates were 3.8%, 11.8%, and 0.9% and 3.0%, 0%, and 1.6%, respectively. Median progression-free survival (95% CI) was 15.2 months (12.5-21.0 months), not reached (NR) [11.1 months-not estimable (NE)], and 7.0 months (5.6-9.9 months) with avelumab plus axitinib and 11.2 months (8.4-13.9 months), 11.2 months (6.7-13.8 months), and 4.2 months (2.8-5.6 months) with sunitinib; median OS (95% CI) was NR (42.2 months-NE), NR (30.4 months-NE), and 23.0 months (18.4-33.1 months) and NR (39.0 months-NE), 39.8 months (21.7-NE), and 19.1 months (16.3-25.3 months), respectively. Multivariate analyses demonstrated that normalized or non-normalized CRP levels were independent factors for the prediction of objective response rate or OS, respectively, with avelumab plus axitinib.

conclusionsIn patients with aRCC, CRP levels at baseline and early after treatment may predict efficacy with avelumab plus axitinib.

Indexed as

Carcinoma, Renal CellKidney NeoplasmsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsAxitinibC-Reactive ProteinFollow-Up StudiesHumansSunitinibAntibodies, Monoclonal, HumanizedavelumabAxitinibC-Reactive ProteinSunitinibavelumab plus axitinibC-reactive proteinimmune checkpoint inhibitorphase III clinical trialpredictive markerrenal cell carcinoma

Identifiers

PMID36037566
PMCPMC9588905
OpenAlexW4293375179

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.