Evidence map›Paper›PMID 37866029›Full record

ArticleESMO open2023

Efficacy of avelumab plus axitinib versus sunitinib by numbers of IMDC risk factors and target tumor sites at baseline in advanced renal cell carcinoma: long-term follow-up results from JAVELIN Renal 101.

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

Open access · goldAbstract read
In one paragraph

Article in ESMO open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
2.3field-weighted citation impact, top 11% 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

8 citing papers in PubMed, 9 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 TomitaDepartments of Urology and 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, NY, USA.
T K ChoueiriThe Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
B I RiniHematology Oncology, Vanderbilt-Ingram Cancer Center, Nashville, TN, USA.
H MiyakeDepartment of Urology, Hamamatsu University School of Medicine, Hamamatsu, Japan.
M OyaDepartment of Urology, Keio University School of Medicine, Tokyo, Japan.
L AlbigesDepartment of Oncology, Institut Gustave Roussy, Villejuif, France.
M AizawaPfizer R&D Japan, Tokyo, Japan.
Y UmeyamaPfizer R&D Japan, Tokyo, Japan.
J WangPfizer, Cambridge, MA, USA.
A di PietroPfizer srl, Milan, Italy.
M SchmidingerDepartment of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.
Pfizer (Japan) · JPComprehensive Cancer Center Vienna · ATDana-Farber Cancer Institute · USHamamatsu University School of Medicine · JPInstitut Gustave Roussy · FRKeio University · JPMemorial Sloan Kettering Cancer Center · USNiigata University · JPPfizer (Italy) · ITPfizer (United States) · USVanderbilt University · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI SELWYN M VICKERS · 1985 to 2026
$347.4M
VectorP30CA006516 · NCI · DANA-FARBER CANCER INSTITUTE · PI Irene M. Ghobrial · 1985 to 2026
$330.6M
Treating the P13-Kinase/AKTP50CA101942 · NCI · BETH ISRAEL DEACONESS MEDICAL CENTER · PI David McDermott · 2003 to 2026
$53.4M
NCI NIH HHS P30 CA006516NCI NIH HHS P30 CA008748NCI NIH HHS P50 CA101942
6 · The paper itself

Abstract

backgroundIn the phase III JAVELIN Renal 101 trial, first-line avelumab + axitinib improved progression-free survival (PFS) and objective response rate versus sunitinib in patients with advanced renal cell carcinoma across all International Metastatic RCC Database Consortium (IMDC) risk groups (favorable, intermediate, and poor); analyses of overall survival (OS) remain immature. Here, we report post hoc analyses of efficacy from the third interim analysis (data cut-off, April 2020) by the numbers of IMDC risk factors and target tumor sites at baseline.

methodsEfficacy endpoints assessed were PFS, objective response, and best overall response per investigator assessment (RECIST v1.1) and OS. Best percentage change and percentage change from baseline in target tumor size over time during the study were also assessed.

resultsIn patients with 0, 1, 2, 3, or 4-6 IMDC risk factors, hazard ratios [HRs; 95% confidence interval (CIs)] for OS with avelumab + axitinib versus sunitinib were 0.660 (0.356-1.223), 0.745 (0.524-1.059), 0.973 (0.668-1.417), 0.718 (0.414-1.248), and 0.443 (0.237-0.829), and HRs (95% CIs) for PFS were 0.706 (0.490-1.016), 0.709 (0.540-0.933), 0.711 (0.527-0.960), 0.501 (0.293-0.854), and 0.395 (0.214-0.727), respectively. In patients with 1, 2, 3, or ≥4 target tumor sites, HRs (95% CIs) for OS with avelumab + axitinib versus sunitinib were 0.912 (0.640-1.299), 0.715 (0.507-1.006), 0.679 (0.442-1.044), and 0.747 (0.346-1.615), and HRs (95% CIs) for PFS were 0.706 (0.548-0.911), 0.552 (0.422-0.723), 0.856 (0.589-1.244), and 0.662 (0.329-1.332), respectively. Across all subgroups, analyses of objective response rate and complete response rate favored avelumab + axitinib versus sunitinib, and a greater proportion of patients treated with avelumab + axitinib had tumor shrinkage.

conclusionsIn post hoc analyses, first-line treatment with avelumab + axitinib was generally associated with efficacy benefits versus treatment with sunitinib in patients with advanced renal cell carcinoma across subgroups defined by different numbers of IMDC risk factors or target tumor sites.

Indexed as

Antineoplastic AgentsCarcinoma, Renal CellKidney NeoplasmsAntibodies, Monoclonal, HumanizedAxitinibFollow-Up StudiesHumansRisk FactorsSunitinibAntibodies, Monoclonal, HumanizedAntineoplastic AgentsavelumabAxitinibSunitinibavelumabaxitinibrenal cell carcinomarisk factortumor site

Identifiers

PMID37866029
PMCPMC10774904
OpenAlexW4387834934

What OpenQuestion holds

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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.