Evidence map›Paper›PMID 33993388›Full record

Trial reportEsophagus : official journal of the Japan Esophageal Society2021

Five-year follow-up of nivolumab treatment in Japanese patients with esophageal squamous-cell carcinoma (ATTRACTION-1/ONO-4538-07).

Taroh Satoh, Ken Kato, Takashi Ura, Yasuo Hamamoto, Takashi Kojima, Takahiro Tsushima, Shuichi Hironaka, Hiroki Hara, Satoru Iwasa, Kei Muro and 7 more

Open access · hybridAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Esophagus : official journal of the Japan Esophageal Society, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 13% 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

20 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 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

17 authors at 10 institutions in 1 country.

Taroh SatohDepartment of Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, E21-19, 2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan. taroh@cfs.med.osaka-u.ac.jp.
Ken KatoDepartment of Head and Neck, Esophageal Medical Oncology / Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
Takashi UraDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Yasuo HamamotoKeio Cancer Center, Keio University School of Medicine, Tokyo, Japan.
Takashi KojimaDepartment of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Takahiro TsushimaDivision of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
Shuichi HironakaClinical Trial Promotion Department, Chiba Cancer Center, Chiba, Japan.
Hiroki HaraDepartment of Gastroenterology, Saitama Cancer Center, Saitama, Japan.
Satoru IwasaDepartment of Head and Neck, Esophageal Medical Oncology / Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
Kei MuroDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Hirofumi YasuiDivision of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
Keiko MinashiClinical Trial Promotion Department, Chiba Cancer Center, Chiba, Japan.
Kensei YamaguchiDepartment of Gastroenterology, Saitama Cancer Center, Saitama, Japan.
Atsushi OhtsuNational Cancer Center Hospital East, Kashiwa, Japan.
Yuichiro DokiDepartment of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.
Yasuhiro MatsumuraDepartment of Oncology, ONO Pharmaceutical Co., Ltd., Osaka, Japan.
Yuko KitagawaDepartment of Surgery, Keio University School of Medicine, Tokyo, Japan.
National Cancer Center Hospital East · JPKeio University · JPOsaka University · JPSaitama Cancer Center · JPShizuoka Cancer Center · JPAichi Cancer Center · JPChiba Cancer Center · JPKyoto Medical Center · JPOita University · JPOno Pharmaceutical (Japan) · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn the phase II ATTRACTION-1 study, nivolumab demonstrated a promising antitumor activity among Japanese patients with treatment-refractory advanced esophageal cancer. Here, we report the follow-up results of ATTRACTION-1 of > 5 years.

methodsWe enrolled patients with esophageal cancer that was refractory or intolerant to a standard chemotherapy. Then, nivolumab (3 mg/kg) was administered every 2 weeks. The primary endpoint was a centrally assessed objective response rate.

resultsNivolumab was administered to 65 patients with esophageal squamous-cell carcinoma (ESCC). The centrally assessed objective response rate was 17.2%. The overall survival rates at 3 and 5 years were 10.9% and 6.3%, respectively. Three-year survivors tended to have more reduced target lesions. A total of 63.1% of the patients exhibited treatment-related adverse events, and no new safety signal was observed. Patients with select adverse events tended to have better overall survival than those without. No apparent chronological order was observed between the first response and the onset of select adverse events.

conclusionOur follow-up analysis of more than 5 years is currently the longest and is the first to demonstrate that nivolumab has long-term efficacy and safety for advanced ESCC.

Indexed as

Esophageal NeoplasmsEsophageal Squamous Cell CarcinomaFollow-Up StudiesHumansJapanNivolumabNivolumabClinical trialEsophageal squamous cell carcinomaImmunotherapyNivolumab

Identifiers

PMID33993388
PMCPMC8387268
OpenAlexW3163948836

What OpenQuestion holds

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LicenceCC BY
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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.