Evidence map›Paper›PMID 38722221›Full record

ArticleInternational journal of urology : official journal of the Japanese Urological Association2024

J-AVENUE: A retrospective, real-world study evaluating patient characteristics and outcomes in patients with advanced urothelial carcinoma treated with avelumab first-line maintenance therapy in Japan.

Eiji Kikuchi, Nozomi Hayakawa, Masashi Nakayama, Masahiro Uno, Hiroomi Nakatsu, Chiyoe Kitagawa, Hideaki Miyake, Takeshi Yamada, Kazutoshi Fujita, Hideaki Shimoyama and 10 more

Registry-linked trialAbstract readMulticenter Study
In one paragraph

Article 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. It is linked to trial NCT05431777 (Retrospective, Multicenter, Observational Study to Evaluate Current Treatment Patterns and Outcomes in Japanese Patients With Locally Advanced or Metastatic Urothelial Carcinoma Treated With First-line Avelumab Maintenance), which is not on this map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing 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.

NCT05431777 completednot on this map

Retrospective, Multicenter, Observational Study to Evaluate Current Treatment Patterns and Outcomes in Japanese Patients With Locally Advanced or Metastatic Urothelial Carcinoma Treated With First-line Avelumab Maintenance

TypeobservationalSponsorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyRan2022 to 2023Enrolled79ConditionsUrothelial CarcinomaArmsAvelumab
3 · Its place in the literature

Who cites it

18 citing papers in PubMed.

  1. Trial
  2. Observational
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  6. Review
  7. Article
  8. Avelumab maintenance in advanced urothelial carcinoma: real-world data from Northern Spain (AVEBLADDER study).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025
    Article
  9. Observational
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Review
  17. Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors.

Eiji KikuchiDepartment of Urology, St. Marianna University School of Medicine, Kanagawa, Japan.ORCID 0000-0002-1624-6676
Nozomi HayakawaDepartment of Urology, St. Marianna University School of Medicine, Kanagawa, Japan.
Masashi NakayamaDepartment of Urology, Osaka International Cancer Institute, Osaka, Japan.
Masahiro UnoDepartment of Urology, Ogaki Municipal Hospital, Gifu, Japan.
Hiroomi NakatsuDepartment of Urology, Asahi General Hospital, Chiba, Japan.
Chiyoe KitagawaDepartment of Medical Oncology, National Hospital Organization Nagoya Medical Center, Aichi, Japan.
Hideaki MiyakeDepartment of Urology, Hamamatsu University School of Medicine, Shizuoka, Japan.
Takeshi YamadaDepartment of Urology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Kazutoshi FujitaDepartment of Urology, Kindai University Faculty of Medicine, Osaka, Japan.
Hideaki ShimoyamaDepartment of Urology, Showa University Fujigaoka Hospital, Kanagawa, Japan.
Kiyoaki NishiharaDepartment of Urology, Kurume University School of Medicine, Fukuoka, Japan.
Mizuki KobayashiDepartment of Urology, Akita University Hospital, Akita, Japan.ORCID 0000-0002-4135-6789
Motonobu NakamuraDepartment of Urology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Kiyohide FujimotoDepartment of Urology, Nara Medical University Hospital, Nara, Japan.ORCID 0000-0003-1507-2464
Takeshi SanoDepartment of Urology, Kyoto University Graduate School of Medicine, Kyoto, Japan.ORCID 0000-0001-5854-6258
Naotaka NishiyamaDepartment of Urology, Graduate School of Medicine and Pharmaceutical Sciences for Research, University of Toyama, Toyama, Japan.
Takayuki ItoMedical Department, Merck Biopharma Co., Ltd. (an affiliate of Merck KGaA), Tokyo, Japan.
Masahiro KajitaOncology Medical Affairs, Merck Biopharma Co., Ltd. (an affiliate of Merck KGaA), Tokyo, Japan.
Takashi KobayashiDepartment of Urology, Kyoto University Graduate School of Medicine, Kyoto, Japan.ORCID 0000-0003-1069-2816
Hiroshi KitamuraDepartment of Urology, Graduate School of Medicine and Pharmaceutical Sciences for Research, University of Toyama, Toyama, Japan.

Funding

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaAPfizer
6 · The paper itself

Abstract

objectivesThe JAVELIN Bladder 100 phase 3 trial showed that avelumab first-line maintenance + best supportive care significantly prolonged overall survival and progression-free survival versus best supportive care alone in patients with advanced urothelial carcinoma who were progression-free following first-line platinum-based chemotherapy. We report findings from J-AVENUE (NCT05431777), a real-world study of avelumab first-line maintenance therapy in Japan.

methodsMedical charts of patients with advanced urothelial carcinoma without disease progression following first-line platinum-based chemotherapy, who received avelumab maintenance between February and November 2021, were reviewed. Patients were followed until June 2022. The primary endpoint was patient characteristics; secondary endpoints included time to treatment failure and progression-free survival.

resultsIn 79 patients analyzed, median age was 72 years (range, 44-86). Primary tumor site was upper tract in 45.6% and bladder in 54.4%. The most common first-line chemotherapy regimen was cisplatin + gemcitabine (63.3%). Median number of chemotherapy cycles received was four. Best response to chemotherapy was complete response in 10.1%, partial response in 58.2%, and stable disease in 31.6%. Median treatment-free interval before avelumab was 4.9 weeks. With avelumab first-line maintenance therapy, the disease control rate was 58.2%, median time to treatment failure was 4.6 months (95% CI, 3.3-6.4), and median progression-free survival was 6.1 months (95% CI, 3.6-9.7).

conclusionsFindings from J-AVENUE show the effectiveness of avelumab first-line maintenance in patients with advanced urothelial carcinoma in Japan in clinical practice, with similar progression-free survival to JAVELIN Bladder 100 and previous real-world studies, supporting its use as a standard of care.

Indexed as

Antibodies, Monoclonal, HumanizedCarcinoma, Transitional CellMaintenance ChemotherapyAdultAgedAged, 80 and overAntineoplastic Agents, ImmunologicalAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansJapanMaleMiddle AgedProgression-Free SurvivalRetrospective StudiesTreatment OutcomeAntibodies, Monoclonal, HumanizedAntineoplastic Agents, Immunologicalavelumabavelumabimmunotherapyreal world clinical trialstreatment outcomeurothelial carcinoma

Identifiers

PMID38722221
PMCPMC11524101

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Registered trials

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.