Evidence map›Paper›PMID 33219460›Full record

ArticleInternational journal of clinical oncology2021

Effectiveness and safety of nivolumab in patients with head and neck cancer in Japanese real-world clinical practice: a multicenter retrospective clinical study.

Nobuhiro Hanai, Yasushi Shimizu, Shin Kariya, Ryuji Yasumatsu, Tomoya Yokota, Takashi Fujii, Kiyoaki Tsukahara, Masafumi Yoshida, Kenji Hanyu, Tsutomu Ueda and 16 more

Erratum issued Registry-linked trialOpen access · hybridAbstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in International journal of clinical oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03569436 (Efficacy and Safety of Nivolumab in Recurrent or Metastatic Head and Neck Cancer), which is not on this map. Cited by 26 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 2 pooled it
3.4field-weighted citation impact, top 6% 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.

NCT03569436 completednot on this map

Efficacy and Safety of Nivolumab in Recurrent or Metastatic Head and Neck Cancer (HNC) Patients - Japanese Real-world Data Through Clinical Chart Review

TypeobservationalSponsorBristol-Myers SquibbRan2018 to 2020Enrolled262ConditionsCancer of Head and Neck, Cancer of the Head, Cancer of the Neck
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 2 syntheses or guidelines pooled it, 54 citations in OpenAlex.

  1. Pooled it
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  3. Prognostic impact of immune-related adverse events in recurrent or metastatic sinonasal squamous cell carcinoma treated with immune checkpoint inhibitors.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2026
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  7. Sequential RAS mutations evaluation in cell-free DNA of patients with tissue RAS wild-type metastatic colorectal cancer: the PERSEIDA (Cohort 2) study.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

26 authors at 20 institutions in 1 country.

Nobuhiro HanaiDepartment of Head and Neck Surgery, Aichi Cancer Center Hospital, Nagoya, Japan.
Yasushi ShimizuDepartment of Medical Oncology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.
Shin KariyaDepartment of Otolaryngology, Head and Neck Surgery, Okayama University Hospital, Okayama, Japan.
Ryuji YasumatsuDepartment of Otolaryngology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Tomoya YokotaDivision of Gastrointestinal Oncology, Shizuoka Cancer Center, Nagaizumi, Japan.
Takashi FujiiDepartment of Head and Neck Surgery, Osaka International Cancer Institute, Osaka, Japan.
Kiyoaki TsukaharaDepartment of Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University, Tokyo, Japan.
Masafumi YoshidaOtorhinolaryngology and Head and Neck Surgery, The University of Tokyo Hospital, Tokyo, Japan.
Kenji HanyuHead and Neck Oncology Center, International University of Health and Welfare, Mita Hospital, Tokyo, Japan.
Tsutomu UedaDepartment of Otorhinolaryngology, Head and Neck Surgery, Hiroshima University Hospital, Hiroshima, Japan.
Hitoshi HirakawaDepartment of Otorhinolaryngology, Head and Neck Surgery, University of the Ryukyu Hospital, Nishihara, Japan.
Shunji TakahashiDepartment of Medical Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
Takeharu OnoDepartment of Otolaryngology, Head and Neck Surgery, Kurume University Hospital, Kurume, Japan.
Daisuke SanoDepartment of Otolaryngology, Head and Neck Surgery, Yokohama City University Hospital, Yokohama, Japan.
Moriyasu YamauchiDepartment of Otolaryngology, Head and Neck Surgery, Saga University Hospital, Saga, Japan.
Akihito WatanabeDepartment of Otolaryngology, Head and Neck Surgery, Keiyukai Sapporo Hospital, Sapporo, Japan.
Koichi OmoriDepartment of Otolaryngology, Head and Neck Surgery, Kyoto University Hospital, Kyoto, Japan.
Tomoko YamazakiDivision of Head and Neck Cancer Oncology, Miyagi Cancer Center, Sendai, Japan.
Nobuya MondenDepartment of Head and Neck Surgery, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.
Naomi KudoDepartment of Otorhinolaryngology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.
Makoto AraiDepartment of Medical Oncology, Chiba University Hospital, Chiba, Japan.
Daiju SakuraiDepartment of Otorhinolaryngology, Head and Neck Surgery, Chiba University Hospital, Chiba, Japan.
Takahiro AsakageDepartment of Head and Neck Surgery, Tokyo Medical and Dental University Medical Hospital, Tokyo, Japan.
Issei DoiMedical Affairs, ONO Pharmaceutical Co., Ltd, Osaka, Japan.
Takayuki YamadaJapan Medical and Development, Bristol-Myers Squibb K.K., Tokyo, Japan.
Akihiro HommaDepartment of Otolaryngology, Head and Neck Surgery, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Kita15 Nishi7, Kita-Ku, Sapporo, Hokkaido, 060-8638, Japan. ak-homma@med.hokudai.ac.jp.ORCID http://orcid.org/0000-0003-1488-0646
Chiba University Hospital · JPAichi Cancer Center · JPBristol-Myers Squibb (Japan) · JPHirosaki University · JPHiroshima University Hospital · JPHokkaido University · JPKeiyukai Sapporo Hospital · JPKurume University Hospital · JPKyoto University Hospital · JPKyushu University · JPMita Hospital · JPMiyagi Prefectural Hospital Organization · JPOkayama University Hospital · JPOno Pharmaceutical (Japan) · JPOsaka International Cancer Institute · JPSaga University · JPSapporo Medical University · JPShikoku Cancer Center · JPShizuoka Cancer Center · JPThe Cancer Institute Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo fill the data gap between clinical trials and real-world settings, this study assessed the overall effectiveness and safety of nivolumab in patients with head and neck cancer (HNC) during Japanese real-world clinical practice.

methodsThis was a multicenter, retrospective study in Japanese patients with recurrent or metastatic HNC who received nivolumab for the first time between July and December 2017. Data on the clinical use, effectiveness, and safety of nivolumab were extracted from patient medical records.

resultsOverall, 256 patients were enrolled in this study. The median duration of nivolumab treatment was 72.5 days, with patients receiving a median of 6.0 (range 1-27) doses. Median overall survival (OS) was 9.5 (95% confidence interval [CI] 8.2-12.0) months and the estimated 12-month OS rate was 43.2%. The objective response rate (ORR) was 15.7% overall and 21.1%, 7.1%, and 13.6% in patients with primary nasopharynx, maxillary sinus, and salivary gland tumors, respectively, who had been excluded from CheckMate 141. Grade ≥ 3 immune-related adverse events occurred in 5.9% of patients. No new safety signals were identified compared with adverse events noted in CheckMate 141.

conclusionsThe effectiveness and safety of nivolumab in real-world clinical practice are consistent with data from the CheckMate 141 clinical trial. Therapeutic response was also observed in the groups of patients excluded from CheckMate 141. TRIAL REGISTRATION NUMBER: UMIN-CTR (UMIN000032600), Clinicaltrials.gov (NCT03569436).

Indexed as

Head and Neck NeoplasmsHumansJapanNivolumabRetrospective StudiesSurvival RateNivolumabMulticenter retrospective studyNivolumabReal-world clinical practiceRecurrent or metastatic head and neck cancer

Identifiers

PMID33219460
PMCPMC7895797
OpenAlexW3100953153

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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.