Evidence map›Paper›PMID 38110838›Full record

Observational studyInternational journal of urology : official journal of the Japanese Urological Association2024

Real-world outcomes of avelumab plus axitinib as first-line therapy in patients with advanced renal cell carcinoma in Japan: A multicenter, retrospective, observational study (J-DART).

Taigo Kato, Yuzo Nakano, Fumiya Hongo, Hidenori Katano, Tomoaki Miyagawa, Kosuke Ueda, Haruhito Azuma, Masahiro Nozawa, Nobuyuki Hinata, Junichi Hori and 10 more

Open access · hybridAbstract readMulticenter StudyObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in International journal of urology : official journal of the Japanese Urological Association, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
2.1field-weighted citation impact, top 12% 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

6 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Article
  3. Role of Cytoreductive Nephrectomy in the Immune Checkpoint Inhibitor Era: A Multicenter Collaborative Study.International journal of urology : official journal of the Japanese Urological Association · 2025
    Article
  4. Article
  5. Observational
  6. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 17 institutions in 1 country.

Taigo KatoDepartment of Urology, Osaka University Graduate School of Medicine, Suita, Japan.ORCID 0000-0002-8681-1407
Yuzo NakanoDepartment of Urology, Kobe University Graduate School of Medicine, Kobe, Japan.
Fumiya HongoDepartment of Urology, Kyoto Prefectural University of Medicine, Kyoto, Japan.ORCID 0000-0002-1991-4166
Hidenori KatanoDepartment of Urology, Iwamizawa Municipal General Hospital, Iwamizawa, Japan.
Tomoaki MiyagawaDepartment of Urology, Jichi Medical University Saitama Medical Center, Saitama, Japan.
Kosuke UedaDepartment of Urology, Kurume University School of Medicine, Kurume, Japan.ORCID 0000-0002-8154-6616
Haruhito AzumaDepartment of Urology, Osaka Medical and Pharmaceutical University, Takatsuki, Japan.
Masahiro NozawaDepartment of Urology, Kindai University Faculty of Medicine, Osakasayama, Japan.
Nobuyuki HinataDepartment of Urology, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.ORCID 0000-0001-7014-6812
Junichi HoriDepartment of Renal and Urologic Surgery, Asahikawa Medical University, Asahikawa, Japan.
Taiyo OtoshiDepartment of Urology, Osaka Metropolitan University Graduate School of Medicine, Osaka, Japan.
Nobuaki ShimizuDepartment of Urology, Gunma Prefectural Cancer Center, Ota, Japan.
Mana AizawaBiometrics and Data Management, Pfizer R&D Japan, Tokyo, Japan.
Shingo OsadaOncology Medical Affairs, Pfizer Japan, Inc., Tokyo, Japan.
Akiko MatsuiOncology Medical Affairs, Pfizer Japan, Inc., Tokyo, Japan.
Mototsugu OyaDepartment of Urology, Keio University School of Medicine, Tokyo, Japan.
Masatoshi EtoDepartment of Urology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Yoshihiko TomitaDepartments of Urology and Molecular Oncology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.ORCID 0000-0002-7465-9591
Nobuo ShinoharaDepartment of Urology, Graduate School of Medicine, Hokkaido University, Sapporo, Japan.
Hirotsugu UemuraDepartment of Urology, Kindai University Faculty of Medicine, Osakasayama, Japan.ORCID 0000-0002-3665-9523
Pfizer (Japan) · JPKindai University · JPAsahikawa Medical University · JPGunma Prefectural Cardiovascular Center · JPHiroshima University · JPHokkaido University · JPJichi Medical University · JPKeio University · JPKobe University · JPKurume University · JPKyoto Prefectural University of Medicine · JPKyushu University · JPMiwa Hospital · JPNiigata University · JPOsaka Metropolitan University · JPOsaka University of Pharmaceutical Sciences · JPThe University of Osaka · JP

Funding

Merck (CrossRef Funder ID: 10.13039/100009945)Pfizer
6 · The paper itself

Abstract

objectivesIn the phase 3 JAVELIN Renal 101 trial in patients with advanced renal cell carcinoma (aRCC), objective response rate (ORR) and progression-free survival (PFS) were significantly improved in patients treated with first-line avelumab plus axitinib vs sunitinib. Here we evaluate real-world outcomes with first-line avelumab plus axitinib in Japanese patients with aRCC.

methodsIn this multicenter, noninterventional, retrospective study, clinical data from patients with aRCC treated with first-line avelumab plus axitinib between December 2019 and December 2020 in Japan were reviewed. Endpoints included ORR and PFS per investigator assessment, and time to treatment discontinuation (TTD).

resultsData from 48 patients (median age, 69 years) from 12 sites were analyzed. Median follow-up was 10.4 months (range, 2.6-16.5), and median duration of treatment was 7.4 months (range, 0.5-16.5). International Metastatic RCC Database Consortium risk category was favorable, intermediate, or poor in 16.7%, 54.2%, and 29.2% of patients, respectively. The ORR was 48.8% (95% CI, 33.3%-64.5%), including complete response in 3/43 patients (7.0%). Thirteen patients (27.1%) had disease progression or died, and median PFS was 15.3 months (95% CI, 9.7 months - not estimable). At data cutoff, 24 patients (50.0%) were still receiving avelumab plus axitinib, and median TTD was 15.2 months (95% CI, 7.4 months - not estimable). Three patients (6.3%) received high-dose corticosteroid treatment for immune-related adverse events, and 8 (16.7%) received treatment for infusion-related reactions.

conclusionsWe report the first real-world evidence of the effectiveness and tolerability of first-line avelumab plus axitinib in Japanese patients with aRCC. Results were comparable with the JAVELIN Renal 101 trial.

Indexed as

Antibodies, Monoclonal, HumanizedCarcinoma, Renal CellKidney NeoplasmsAgedAntineoplastic Combined Chemotherapy ProtocolsAxitinibClinical Trials, Phase III as TopicHumansJapanRetrospective StudiesAntibodies, Monoclonal, HumanizedavelumabAxitinibaxitinibimmunotherapyJapanrenal cell carcinomaretrospective study

Identifiers

PMID38110838
PMCPMC11524108
OpenAlexW4389953159

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.