Evidence map›Paper›PMID 36001247›Full record

Observational studyInternational journal of clinical oncology2022

Real-world clinical outcomes in Japanese patients with locally advanced squamous cell carcinoma of the head and neck treated with radiotherapy plus cetuximab: a prospective observational study (JROSG12-2).

Yosuke Ota, Takeshi Kodaira, Hirofumi Fujii, Mototsugu Shimokawa, Tomoya Yokota, Torahiko Nakashima, Nobuya Monden, Akihiro Homma, Shinya Ueda, Tetsuo Akimoto

Abstract readObservational Study
PubMed Publisher
In one paragraph

Observational study in International journal of clinical oncology, 2022. 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
1.0field-weighted citation impact, top 24% 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

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Association between geriatric 8 (G8) scores and self-care decline in elderly patients with head and neck squamous cell carcinoma undergoing radiotherapy.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    Article
  2. Article
  3. Review
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

10 authors at 9 institutions in 1 country.

Yosuke OtaDepartment of Radiation Oncology, Hyogo Cancer Center, 13-70 Kitaouji-cho, Akashi City, Hyogo, 673-8558, Japan. yosukeota@hyogo-cc.jp.ORCID http://orcid.org/0000-0001-5853-0977
Takeshi KodairaDepartment of Radiation Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Hirofumi FujiiDepartment of Clinical Oncology, Jichi Medical University, Shimotsuke, Japan.
Mototsugu ShimokawaDepartment of Biostatistics, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan.
Tomoya YokotaDivision of Gastrointestinal Oncology, Shizuoka Cancer Center, Sunto, Japan.
Torahiko NakashimaDepartment of Otolaryngology, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.
Nobuya MondenDepartment of Head and Neck Surgery, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.
Akihiro HommaDepartment of Otolaryngology-Head and Neck Surgery, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.
Shinya UedaDepartment of Gastroenterology-Medical Oncology, Iseikai Hospital, Osaka, Japan.
Tetsuo AkimotoDepartment of Radiation Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Aichi Cancer Center · JPHokkaido University · JPHyogo Prefectural Cancer Center · JPJichi Medical University · JPNational Cancer Center Hospital East · JPNational Kyushu Medical Center · JPShikoku Cancer Center · JPShizuoka Cancer Center · JPYamaguchi University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRadiotherapy plus cetuximab (bioradiotherapy: BRT) is a standard option in the treatment of locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN). Published data on its safety and efficacy in real-world settings is limited. Here, we conducted a prospective multi-institutional observational study to evaluate clinical outcomes of BRT in patients with LA-SCCHN.

methodsWe analyzed real-world data of all patients who underwent BRT from 2013 to 2016. The primary endpoint was 1-year progression-free survival (PFS). Secondary endpoints were 1-year locoregional PFS (LPFS), treatment completion rate (TCR), and adverse events (AEs).

resultsA total of 171 patients with a minimum 1-year follow-up were analyzed. Median age was 67 (36-85) years, and 37 patients (21.6%) were aged 75 years or older. 1-year PFS and LPFS were 51.5 and 56.1%, respectively. N stage (p = 0.049) was significantly associated with PFS. TCR was 77.2%. Cetuximab was definitively discontinued in 30 patients (17.5%), in 15 cases due to severe mucositis. N stage, T stage, and comorbidity were significantly associated with TCR. Major AEs of grade 3 or higher were pharyngeal mucositis (48.5%), radiation dermatitis (45.6%), and oral mucositis (40.4%). Pneumonitis was observed in 12 patients (7.0%); 6 cases (3.5%) were grades 3-4 and 2 (1.2%) were grade 5.

conclusionAs a result of the large number of elderly patients in clinical practice, toxicity reduced TCR. BRT-induced pneumonitis, which is sometimes fatal, was found to be more frequent than with chemotherapy plus cetuximab.

Indexed as

Antineoplastic AgentsCarcinoma, Squamous CellHead and Neck NeoplasmsMucositisAgedAntineoplastic Combined Chemotherapy ProtocolsCetuximabChemoradiotherapyHumansJapanProspective StudiesReceptors, Antigen, T-CellSquamous Cell Carcinoma of Head and NeckAntineoplastic AgentsCetuximabReceptors, Antigen, T-CellBioradiotherapyCetuximabPneumonitisReal worldSquamous cell carcinoma of the head and neck

Identifiers

PMID36001247
OpenAlexW4293168941

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.