Evidence map›Paper›PMID 35397432›Full record

Trial reportESMO open2022

Efficacy and safety of avelumab plus axitinib in elderly patients with advanced renal cell carcinoma: extended follow-up results from JAVELIN Renal 101.

Y Tomita, R J Motzer, T K Choueiri, B I Rini, H Miyake, H Uemura, L Albiges, Y Fujii, Y Umeyama, J Wang and 2 more

Open access · goldAbstract readRandomized Controlled Trial
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 33 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 1 pooled it
6.7field-weighted citation impact, top 2% 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

33 citing papers in PubMed, 1 synthesis or guideline pooled it, 48 citations in OpenAlex.

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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 11 institutions in 5 countries.

Y TomitaDepartment of Urology, Niigata University Graduate School of Medicine, Niigata, Japan; Department of Molecular Oncology, Niigata University Graduate School of Medicine, Niigata, Japan. Electronic address: ytomita@med.niigata-u.ac.jp.
R J MotzerDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, USA.
T K ChoueiriThe Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Boston, USA.
B I RiniDepartment of Hematology and Medical Oncology, Vanderbilt University, Nashville, USA.
H MiyakeDepartment of Urology, Hamamatsu University School of Medicine, Hamamatsu, Japan.
H UemuraDepartment of Urology, Faculty of Medicine, Kindai University, Osaka, Japan.
L AlbigesDepartment of Cancer Medicine, Institut Gustave Roussy, Villejuif, France.
Y FujiiPfizer R&D Japan, Tokyo, Japan.
Y UmeyamaPfizer R&D Japan, Tokyo, Japan.
J WangPfizer, Cambridge, USA.
M MarianiPfizer srl, Milan, Italy.
M SchmidingerDepartment of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.
Pfizer (Japan) · JPBoston University · USComprehensive Cancer Center Vienna · ATHamamatsu University School of Medicine · JPInstitut Gustave Roussy · FRKindai University · JPMemorial Sloan Kettering Cancer Center · USNiigata University · JPPfizer (Italy) · ITPfizer (United States) · USVanderbilt University Medical Center · US

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

backgroundIn the phase III JAVELIN Renal 101 trial, first-line avelumab plus axitinib demonstrated a progression-free survival (PFS) and objective response rate (ORR) benefit versus sunitinib in patients with advanced renal cell carcinoma (aRCC). However, efficacy in elderly patients remains unclear. We report efficacy and safety by age group from the second interim analysis of overall survival (OS). PATIENTS AND

methodsPFS and ORR as per blinded independent central review (RECIST 1.1), OS, and safety were assessed in patient groups aged <65, ≥65 to <75, and ≥75 years.

resultsIn the avelumab plus axitinib and sunitinib arms, 271/138/33 and 275/128/41 patients aged <65, ≥65 to <75, and ≥75 years, respectively, were randomized. At data cut-off (January 2019), median PFS [95% confidence interval (CI)] with avelumab plus axitinib versus sunitinib in these respective age groups was 11.6 (8.4-19.4) versus 6.9 (5.6-8.4) months [hazard ratio (HR), 0.63; 95% CI 0.501-0.786], 13.8 (11.1-18.0) versus 11.0 (7.8-16.6) months (HR, 0.88; 95% CI 0.627-1.231), and 13.8 [7.0-not estimable (NE)] versus 9.8 (4.3-NE) months (HR, 0.76; 95% CI 0.378-1.511). Median OS (95% CI) in the respective age groups was not reached (NR) (NE-NE) versus 28.6 (25.5-NE) months (HR, 0.74; 95% CI 0.541-1.022), 30.0 (30.0-NE) versus NR (NE-NE) months (HR, 0.89; 95% CI 0.546-1.467), and 25.3 (19.9-NE) versus NR (19.4-NE) months (HR, 0.87; 95% CI 0.359-2.106). ORR (95% CI) in the respective age groups was 49.4% (43.3% to 55.6%) versus 27.3% (22.1% to 32.9%), 60.9% (52.2% to 69.1%) versus 28.9% (21.2% to 37.6%), and 42.4% (25.5% to 60.8%) versus 22.0% (10.6% to 37.6%). In the avelumab plus axitinib arm, grade ≥3 adverse events (AEs) and immune-related AEs occurred in 76.9%/81.2%/72.7% and 45.5%/48.1%/36.4% in the respective age groups.

conclusionsFirst-line avelumab plus axitinib demonstrated favorable efficacy across age groups, including patients aged ≥75 years. OS data were still immature; follow-up is ongoing. The safety profile was generally consistent across age groups.

Indexed as

Carcinoma, Renal CellKidney NeoplasmsAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsAxitinibFemaleFollow-Up StudiesHumansMaleSunitinibAntibodies, Monoclonal, HumanizedavelumabAxitinibSunitinibavelumab plus axitinibelderlyimmune checkpoint inhibitorphase IIIrenal cell carcinoma

Identifiers

PMID35397432
PMCPMC9058903
OpenAlexW4223447219

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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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.