Evidence map›Paper›PMID 31883418›Full record

Trial reportCancer science2020

Avelumab plus axitinib vs sunitinib for advanced renal cell carcinoma: Japanese subgroup analysis from JAVELIN Renal 101.

Motohide Uemura, Yoshihiko Tomita, Hideaki Miyake, Shingo Hatakeyama, Hiro-Omi Kanayama, Kazuyuki Numakura, Toshio Takagi, Tomoyuki Kato, Masatoshi Eto, Wataru Obara and 8 more

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

Trial report in Cancer science, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 1 pooled it
4.5field-weighted citation impact, top 4% 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

28 citing papers in PubMed, 1 synthesis or guideline pooled it, 43 citations in OpenAlex.

  1. Pooled it
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  15. PD-L1: expression regulation.Blood science (Baltimore, Md.) · 2023
    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

18 authors at 16 institutions in 3 countries.

Motohide UemuraDepartment of Urology, Osaka University Graduate School of Medicine, Osaka, Japan.
Yoshihiko TomitaDepartment of Urology, Department of Molecular Oncology, Niigata University Graduate School of Medicine, Niigata, Japan.
Hideaki MiyakeDepartment of Urology, Hamamatsu University School of Medicine, Hamamatsu, Japan.
Shingo HatakeyamaDepartment of Urology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.ORCID https://orcid.org/0000-0002-0026-4079
Hiro-Omi KanayamaDepartment of Urology, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan.
Kazuyuki NumakuraDepartment of Urology, Akita University Graduate School of Medicine, Akita, Japan.
Toshio TakagiDepartment of Urology, Tokyo Women's Medical University, Tokyo, Japan.
Tomoyuki KatoDepartment of Urology, Faculty of Medicine, Yamagata University, Yamagata, Japan.ORCID https://orcid.org/0000-0001-9530-4901
Masatoshi EtoDepartment of Urology, Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan.
Wataru ObaraDepartment of Urology, Iwate Medical University School of Medicine, Morioka, Japan.ORCID https://orcid.org/0000-0003-2720-9640
Hirotsugu UemuraDepartment of Urology, Faculty of Medicine, Kindai University, Osaka, Japan.
Toni K ChoueiriLank Center for Genitourinary Oncology at Dana-Farber Cancer Institute, Brigham and Women's Hospital, Boston, Massachusetts, USA.
Robert J MotzerMemorial Sloan Kettering Cancer Center, New York, New York, USA.
Yosuke FujiiPfizer R&D Japan, Tokyo, Japan.
Yoichi KameiPfizer R&D Japan, Tokyo, Japan.
Yoshiko UmeyamaPfizer R&D Japan, Tokyo, Japan.ORCID https://orcid.org/0000-0003-4967-0382
Alessandra di PietroPfizer, Lombardia, Italy.
Mototsugu OyaDepartment of Urology, Keio University School of Medicine, Tokyo, Japan.
Pfizer (Japan) · JPAkita University · JPBrigham and Women's Hospital · USHamamatsu University School of Medicine · JPHirosaki University · JPIwate Medical University · JPKeio University · JPKindai University · JPKyushu University · JPMemorial Sloan Kettering Cancer Center · USNiigata University · JPPfizer (Italy) · ITThe University of Osaka · JPTokushima University · JPTokyo Women's Medical University · JPYamagata University · JP

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
Merck KGaANCI NIH HHS P30 CA008748Pfizer
6 · The paper itself

Abstract

The phase 3 JAVELIN Renal 101 trial of avelumab + axitinib vs sunitinib in patients with treatment-naive advanced renal cell carcinoma (RCC) demonstrated significantly improved progression-free survival (PFS) and higher objective response rate (ORR) with the combination vs sunitinib. Japanese patients enrolled in the study (N = 67) were randomized to receive avelumab + axitinib (N = 33) or sunitinib (N = 34); 67% vs 59% had PD-L1+ tumors (≥1% of immune cells) and 6%/64%/27% vs 6%/82%/12% had International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) favorable/intermediate/poor risk status. In patients who received avelumab + axitinib vs sunitinib, median PFS (95% confidence interval [CI]) was not estimable (8.1 months, not estimable) vs 11.2 months (1.6 months, not estimable) (hazard ratio [HR], 0.49; 95% CI, 0.152, 1.563) in patients with PD-L1+ tumors and 16.6 months (8.1 months, not estimable) vs 11.2 months (4.2 months, not estimable) (HR, 0.66; 95% CI, 0.296, 1.464) in patients irrespective of PD-L1 expression. Median overall survival (OS) has not been reached in either arm in patients with PD-L1+ tumors and irrespective of PD-L1 expression. ORR (95% CI) was 60.6% (42.1%, 77.1%) vs 17.6% (6.8%, 34.5%) in patients irrespective of PD-L1 expression. Common treatment-emergent adverse events (all grade; grade ≥3) in each arm were hand-foot syndrome (64%; 9% vs 71%; 9%), hypertension (55%; 30% vs 44%; 18%), hypothyroidism (55%; 0% vs 24%; 0%), dysgeusia (21%; 0% vs 56%; 0%) and platelet count decreased (3%; 0% vs 65%; 32%). Avelumab + axitinib was efficacious and tolerable in treatment-naive Japanese patients with advanced RCC, which is consistent with results in the overall population.

Indexed as

AdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsAsian PeopleAxitinibB7-H1 AntigenCarcinoma, Renal CellFemaleHumansKidneyKidney NeoplasmsMaleMiddle AgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedavelumabAxitinibB7-H1 AntigenSunitinibavelumabaxitinibJapanphase 3 JAVELIN Renal 101 clinical trialrenal cell carcinoma

Identifiers

PMID31883418
PMCPMC7060483
OpenAlexW2997586762

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.