Evidence map›Paper›PMID 39549218›Full record

Observational studyInternational journal of clinical oncology2025

Real-world outcomes of avelumab plus axitinib in patients with advanced renal cell carcinoma in Japan: long-term follow-up from the J-DART2 retrospective study.

Taigo Kato, Junya Furukawa, Nobuyuki Hinata, Kosuke Ueda, Isao Hara, Fumiya Hongo, Ryuichi Mizuno, Teppei Okamoto, Hiroshi Okuno, Takayuki Ito and 6 more

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in International journal of clinical oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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

3 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
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

16 authors.

Taigo KatoDepartment of Urology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Oska, 565-0871, Japan.
Junya FurukawaDepartment of Urology, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan.
Nobuyuki HinataDepartment of Urology, Graduate School of Biomedical and Health Sciences, Hiroshima University, Kasumi 1-2-3, Minami-ku, Hiroshima, 734-8551, Japan.
Kosuke UedaDepartment of Urology, Kurume University School of Medicine, Asahi-Machi 67, Kurume-shi, Fukuoka, 830-0011, Japan.
Isao HaraDepartment of Urology, Wakayama Medical University, 811-1 Kimiidera, Wakayama, 641-8509, Japan.
Fumiya HongoDepartment of Urology, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, 602-8566, Japan.
Ryuichi MizunoDepartment of Urology, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.
Teppei OkamotoDepartment of Urology, Hirosaki University Graduate School of Medicine, 5 Zaifu-cho, Hirosaki, Aomori, 036-8562, Japan.
Hiroshi OkunoDepartment of Urology, National Hospital Organization Kyoto Medical Center, 1-1 Fukakusa-Mukaihatacho, Fushimiku, Kyoto, 612-8555, Japan.
Takayuki ItoMedical Department, Merck Biopharma Co., Ltd., Tokyo, Japan, an affiliate of Merck KGaA, 1-8-1 Shimomeguro, Meguro-ku, Tokyo, 153-8926, Japan.
Masahiro KajitaMedical Department, Merck Biopharma Co., Ltd., Tokyo, Japan, an affiliate of Merck KGaA, 1-8-1 Shimomeguro, Meguro-ku, Tokyo, 153-8926, Japan.
Mototsugu OyaDepartment of Urology, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.
Yoshihiko TomitaDepartments of Urology and Molecular Oncology, Niigata University Graduate School of Medical and Dental Sciences, 1-757 Asahimachi Street, Chuo Ward, Niigata, 951-8510, Japan.
Nobuo ShinoharaDepartment of Renal and Genitourinary Surgery, Graduate School of Medicine, Hokkaido University, Kita15, Nishi7, Kita-Ku, Sapporo, Hokkaido, 060-8638, Japan.
Masatoshi EtoDepartment of Urology, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.
Hirotsugu UemuraDepartment of Urology, Kindai University Faculty of Medicine, 377-2 Ohno-Higashi, Osakasayama, Osaka, 589-8511, Japan. huemura@med.kindai.ac.jp.ORCID http://orcid.org/0000-0002-3665-9523

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAvelumab + axitinib was approved for advanced renal cell carcinoma (aRCC) in Japan in December 2019. We report long-term real-world outcomes with first-line avelumab + axitinib from the J-DART2 study in Japan.

methodsJ-DART2 was a multicenter, noninterventional, retrospective study examining clinical data from patients with curatively unresectable locally advanced or metastatic RCC who started treatment with first-line avelumab + axitinib in Japan between December 2019 and October 2022. Endpoints included patient characteristics, treatment patterns, and outcomes.

resultsData from 150 patients across 19 sites were analyzed; median follow-up was 18.7 months (95% CI, 16.3-20.6 months). Median age was 70.5 years; 26.0% of patients were aged ≤64 years, 42.7% were aged 65-74 years, and 31.3% were aged ≥75 years. International Metastatic RCC Database Consortium risk was favorable in 26.0%, intermediate in 54.7% (1 risk factor in 30.7%; 2 risk factors in 24.0%), and poor in 19.3% of patients. Median progression-free survival (PFS) was 17.1 months, with 1- and 2-year PFS rates of 57.7% and 37.5%, respectively. Median overall survival (OS) was not reached, with 1- and 2-year OS rates of 90.6% and 84.7%, respectively. Objective response rate was 53.3%; disease control rate was 88.9%. Outcomes were similar across age groups, including patients aged ≥75 years.

conclusionsJ-DART2 is the largest retrospective study to report long-term real-world outcomes in patients with aRCC treated with avelumab + axitinib in Japan. Findings were similar to those observed in previous studies and support the benefit of avelumab + axitinib in clinical practice in Japan.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsAxitinibCarcinoma, Renal CellKidney NeoplasmsAdultAgedAged, 80 and overFemaleFollow-Up StudiesHumansJapanMaleMiddle AgedRetrospective StudiesAntibodies, Monoclonal, HumanizedavelumabAxitinibAvelumabAxitinibJapanReal worldRenal cell carcinomaRetrospective

Identifiers

PMID39549218
PMCPMC11700049

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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.