Evidence map›Paper›PMID 35254550›Full record

ArticleGastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association2022

A multicenter, open-label, single-arm phase I trial of neoadjuvant nivolumab monotherapy for resectable gastric cancer.

Hirotaka Hasegawa, Kohei Shitara, Shuji Takiguchi, Noriaki Takiguchi, Seiji Ito, Mitsugu Kochi, Hidehito Horinouchi, Takahiro Kinoshita, Takaki Yoshikawa, Kei Muro and 3 more

Open access · hybridAbstract readClinical Trial, Phase IMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 5 pooled it
5.0field-weighted citation impact, top 4% 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

29 citing papers in PubMed, 5 syntheses or guidelines pooled it, 36 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

13 authors at 9 institutions in 1 country.

Hirotaka Hasegawa *Department of Gastroenterological Surgery, Nagoya University School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8560, Japan.
Kohei Shitara *Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Shuji TakiguchiDepartment of Gastroenterological Surgery, Graduate School of Medical Sciences, Nagoya City University, Nagoya, Japan.
Noriaki TakiguchiDepartment of Surgery, Tsuchiura Kyodo General Hospital, Tsuchiura, Japan.
Seiji ItoDepartment of Gastroenterological Surgery, Aichi Cancer Center Hospital, Nagoya, Japan.
Mitsugu KochiDepartment of Digestive Surgery, Nihon University Itabashi Hospital, Tokyo, Japan.
Hidehito HorinouchiDepartment of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.
Takahiro KinoshitaDepartment of Gastric Surgery, National Cancer Center Hospital East, Kashiwa, Japan.
Takaki YoshikawaDepartment of Gastric Surgery, National Cancer Center Hospital, Tokyo, Japan.
Kei MuroDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Hiroyoshi NishikawaDivision of Cancer Immunology, Research Institute/Exploratory Oncology Research and Clinical Trial Center, National Cancer Center, Tokyo, Japan.
Hideaki SunaClinical Development Planning Division, Ono Pharmaceutical Co., Ltd., Osaka, Japan.
Yasuhiro KoderaDepartment of Gastroenterological Surgery, Nagoya University School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8560, Japan. ykodera@med.nagoya-u.ac.jp.ORCID 0000-0002-6173-7474
Aichi Cancer Center · JPNagoya University · JPNational Cancer Center Hospital East · JPNagoya City University · JPNagoya University Hospital · JPNihon University Itabashi Hospital · JPOno Pharmaceutical (Japan) · JPTokyo National Hospital · JPTsuchiura Kyodo General Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNivolumab monotherapy has demonstrated superior efficacy in advanced unresectable gastric cancer (GC), but its impact on resectable GC remains unknown. This phase I study aimed to evaluate safety, feasibility, and potential biomarkers of neoadjuvant nivolumab monotherapy in resectable GC.

methodsUntreated, resectable, cT2 or more advanced gastric adenocarcinomas with clinical stage I, II, or III were treated with two doses of nivolumab before gastrectomy. Patients were excluded if their tumors may be applicable to neoadjuvant chemotherapy. The primary endpoint was the incidence of adverse event (AE) categories of special interest.

resultsAll of the 31 enrolled patients completed 2 doses of nivolumab monotherapy. While 30 (97%) patients underwent surgery with curative intent, 1 patient discontinued before the planned surgical intervention because of a newly emerging liver metastasis. Seven patients (23%) had nivolumab treatment-related AEs, and one patient had a treatment-related AE of grade 3-4. The incidences of treatment-related AE categories of special interest ranged from 0 to 6%. Notable surgical complications included two cases of grade 3 anastomotic leakage and two cases of pancreatic fistula. The major pathologic response (MPR) assessed by the independent pathology review committee was achieved in five (16%) patients, of which one patient had a pathologic complete response. The MPR was mostly observed in patients with positive PD-L1 expression, high microsatellite instability, and/or high tumor mutation burden.

conclusionsNeoadjuvant nivolumab monotherapy is feasible with an acceptable safety profile and induces a MPR in certain patients with resectable GC. (Registration: clinicaltrials.jp, JapicCTI-183895).

Indexed as

AdenocarcinomaNivolumabStomach NeoplasmsHumansMicrosatellite InstabilityNeoadjuvant TherapyNivolumabBiomarkerGastric cancerNeoadjuvant therapyNivolumabPD-L1

Identifiers

PMID35254550
PMCPMC9013329
OpenAlexW4220785579

What OpenQuestion holds

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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.