Evidence map›Paper›PMID 39264379›Full record

ArticleInternational journal of clinical oncology2024

Efficacy and safety of adjuvant nivolumab after radical surgery for high-risk urothelial carcinoma: a preliminary report of real-world data from a single institution.

Yosuke Yasuda, Noboru Numao, Tetsuya Urasaki, Ryosuke Oki, Tomohiko Oguchi, Ryo Fujiwara, Yusuke Yoneoka, Kosuke Takemura, Junji Yonese, Takeshi Yuasa

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Article in International journal of clinical oncology, 2024. 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

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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.

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4 · The record

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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

10 authors.

Yosuke YasudaDepartment of Genitourinary Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
Noboru NumaoDepartment of Genitourinary Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan. noboru.numao@jfcr.or.jp.
Tetsuya UrasakiDepartment of Medical Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
Ryosuke OkiDepartment of Medical Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
Tomohiko OguchiDepartment of Genitourinary Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
Ryo FujiwaraDepartment of Genitourinary Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
Yusuke YoneokaDepartment of Genitourinary Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
Kosuke TakemuraDepartment of Genitourinary Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
Junji YoneseDepartment of Genitourinary Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
Takeshi YuasaDepartment of Genitourinary Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe phase 3 CheckMate 274 trial demonstrated superiority of adjuvant nivolumab over placebo after radical surgery in patients with high-risk urothelial carcinoma (UC). However, real-world data on the efficacy and safety profile of adjuvant nivolumab in Japan have not been reported.

methodsThis retrospective study enrolled patients with high-risk UC who received adjuvant nivolumab therapy following radical surgery between 2022 and 2024 at our institution. We evaluated immune-related adverse events (irAEs) according to the Common Terminology Criteria for Adverse Events, version 5.0. Kaplan-Meier curves were used to assess disease-free survival (DFS) and overall survival (OS).

resultsThirty-three patients with high-risk UC receiving adjuvant nivolumab therapy following radical surgery were identified, and median follow-up was 11 months. Three patients experienced grade 3 irAEs, and 8 discontinued adjuvant nivolumab therapy due to irAEs. No grade 4 or 5 irAEs were observed. Eight patients have completed 1 year of treatment, and nine are currently on treatment. Nine patients had recurrences and one died of cancer. Of the nine patients with recurrences, six relapsed while on adjuvant nivolumab therapy, two relapsed after completing 1 year of treatment, and one relapsed after discontinuation of irAE. The 1- and 2-year OS rates were 100% and 90%, respectively, and median OS was not reached. The 1- and 2-year DFS rates were 70% and 60%, respectively, and median DFS was 26 months.

conclusionsAdjuvant nivolumab appears to have some efficacy in Japanese patients. Since this is a postoperative adjuvant therapy, careful patient selection is warranted.

Indexed as

NivolumabAgedAged, 80 and overAntineoplastic Agents, ImmunologicalCarcinoma, Transitional CellChemotherapy, AdjuvantDisease-Free SurvivalFemaleHumansJapanMaleMiddle AgedNeoplasm Recurrence, LocalRetrospective StudiesUrinary Bladder NeoplasmsAntineoplastic Agents, ImmunologicalNivolumabAdjuvant nivolumabHigh-risk urothelial carcinomaReal-world data

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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.