Evidence map›Paper›PMID 32519026›Full record

ArticleInternational journal of clinical oncology2020

A multicenter retrospective study of nivolumab monotherapy in previously treated metastatic renal cell carcinoma patients: interim analysis of Japanese real-world data.

Nobuyuki Hinata, Junji Yonese, Satoru Masui, Yasutomo Nakai, Suguru Shirotake, Katsunori Tatsugami, Teruo Inamoto, Masahiro Nozawa, Kosuke Ueda, Toru Etsunaga and 10 more

Open access · hybridAbstract readMulticenter Study
In one paragraph

Article in International journal of clinical oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
1.8field-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

13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 25 citations in OpenAlex.

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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

20 authors at 19 institutions in 1 country.

Nobuyuki HinataDivision of Urology, Department of Surgery Related, Kobe University Graduate School of Medicine, Kobe, Japan.
Junji YoneseDepartment of Urology, Cancer Institute Hospital of JFCR, Tokyo, Japan.
Satoru MasuiDivision of Reparative and Regenerative Medicine, Nephro-Urologic Surgery and Andrology, Institute of Medical Life Science, Mie University Graduate School of Medicine, Mie, Japan.
Yasutomo NakaiDepartment of Urology, Osaka International Cancer Institute, Osaka, Japan.
Suguru ShirotakeDepartment of Uro-Oncology, Saitama Medical University International Medical Center, Saitama, Japan.
Katsunori TatsugamiDepartment of Urology, Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan.
Teruo InamotoDepartment of Urology, Osaka Medical College, Osaka, Japan.
Masahiro NozawaDepartment of Urology, Kindai University, Faculty of Medicine, 377-2, OhnoHigashi, Osakasayama-shi, Osaka, 589-8511, Japan.
Kosuke UedaDepartment of Urology, Kurume University School of Medicine, Fukuoka, Japan.
Toru EtsunagaDepartment of Urology, Isesaki Municipal Hospital, Gunma, Japan.
Takahiro OsawaDepartment of Urology, Hokkaido University Graduate School of Medicine, Hokkaido, Japan.
Motohide UemuraDepartment of Urology, Osaka University Graduate School of Medicine, Osaka, Japan.
Go KimuraDepartment of Urology, Nippon Medical School Hospital, Tokyo, Japan.
Kazuyuki NumakuraDepartment of Urology, Akita University Graduate School of Medicine, Akita, Japan.
Kazutoshi YamanaDepartment of Urology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.
Hideaki MiyakeDepartment of Urology, Hamamatsu University School of Medicine, Shizuoka, Japan.
Satoshi FukasawaProstate Center and Division of Urology, Chiba Cancer Center, Chiba, Japan.
Kenya OchiOno Pharmaceutical Co., Ltd, Osaka, Japan.
Hirokazu KanekoBristol-Myers Squibb K.K, Tokyo, Japan.
Hirotsugu UemuraDepartment of Urology, Kindai University, Faculty of Medicine, 377-2, OhnoHigashi, Osakasayama-shi, Osaka, 589-8511, Japan. huemura@med.kindai.ac.jp.ORCID http://orcid.org/0000-0002-3665-9523
Kindai University · JPAkita University · JPBristol-Myers Squibb (Japan) · JPChiba Cancer Center · JPHamamatsu University School of Medicine · JPHokkaido University · JPIsesaki Fukushima Hospital · JPKobe University · JPKurume University · JPKyushu University · JPMie University · JPNiigata University · JPNippon Medical School Hospital · JPOno Pharmaceutical (Japan) · JPOsaka International Cancer Institute · JPOsaka Medical and Pharmaceutical University · JPSaitama Medical University · JPThe Cancer Institute Hospital · JPThe University of Osaka · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn a phase III clinical trial, CheckMate 025, treatment of metastatic renal cell carcinoma (mRCC) with nivolumab demonstrated superior efficacy over everolimus. However, as the clinical trial excluded patients with specific complications and poor performance status (PS), the effectiveness and safety of nivolumab in clinical practice, in which patients with various clinical complications are treated, is unclear. This study explored real-world nivolumab treatment in Japanese mRCC patients.

methodsThis is an interim analysis of a multicenter, non-interventional, medical record review study (minimum follow-up: 9 months). All eligible Japanese mRCC patients who first received nivolumab between February and October 2017 were included; data cut-off was April 2019. We analyzed nivolumab treatment patterns, efficacy (including overall survival, progression-free survival, objective response rate, and duration of response) and safety (including immune-related adverse events).

resultsOf 208 evaluable patients, 31.7% received nivolumab as fourth- or later line of treatment. At data cut-off, 26.9% of patients were continuing nivolumab treatment. The major reason for discontinuation was disease progression (n = 100, 65.8%). Median overall survival was not reached; the 12-month survival rate was 75.6%. Median progression-free survival was 7.1 months, the objective response rate was 22.6%, and median duration of response was 13.3 months. Patients who were excluded or limited in number in CheckMate 025, such as those with non-clear cell RCC or poor PS, also received benefits from nivolumab treatment. Immune-related adverse events occurred in 27.4% of patients (grade ≥ 3, 10.1%).

conclusionNivolumab was effective and well-tolerated in real-world Japanese mRCC patients.

trial registrationUMIN000033312.

Indexed as

AgedAntineoplastic Agents, ImmunologicalAsian PeopleCarcinoma, Renal CellFemaleHumansKidney NeoplasmsMaleMiddle AgedNivolumabProgression-Free SurvivalRegistriesRetrospective StudiesSurvival RateTreatment OutcomeAntineoplastic Agents, ImmunologicalNivolumabEfficacyJapanMetastatic renal cell carcinomaNivolumabReal-worldSafety

Identifiers

PMID32519026
PMCPMC7392942
OpenAlexW3033436222

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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.