Evidence map›Paper›PMID 33125596›Full record

ArticleInternational journal of clinical oncology2021

Real-world clinical outcomes and prognostic factors in Japanese patients with recurrent or metastatic squamous cell carcinoma of head and neck treated with chemotherapy plus cetuximab: a prospective observation study (JROSG12-2).

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

Abstract read
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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. Cited by 5 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 2 pooled it
1.2field-weighted citation impact, top 19% 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

5 citing papers in PubMed, 2 syntheses or guidelines pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Review
  4. Article
  5. Article
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 10 institutions in 1 country.

Tomoya YokotaDivision of Gastrointestinal Oncology, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi, Sunto-gun, Shizuoka, 411-8777, Japan. t.yokota@scchr.jp.ORCID http://orcid.org/0000-0001-7327-7949
Yosuke OtaDepartment of Radiation Oncology, Hyogo Cancer Center Hospital, Akashi, Hyogo, Japan.
Hirofumi FujiiDepartment of Clinical Oncology, Jichi Medical University, Shimotsuke, Tochigi, Japan.
Takeshi KodairaDepartment of Radiation Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Mototsugu ShimokawaDepartment of Biostatistics, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan.
Torahiko NakashimaDepartment of Otolaryngology, Kyushu Medical Center, Fukuoka, Japan.
Nobuya MondenDepartment of Head and Neck Surgery, National Hospital Organization Shikoku Cancer Center, Matsuyama, Ehime, Japan.
Akihiro HommaDepartment of Otolaryngology-Head and Neck Surgery, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.
Shinya UedaDepartment of Medical Oncology, Kindai University Nara Hospital, Ikoma, 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 · JPNara Medical University Hospital · 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

backgroundThe aims of this study are to evaluate the efficacy and safety of first-line treatment with chemotherapy plus cetuximab in real-world patients with recurrent or metastatic squamous cell carcinoma of the head and neck (RM-SCCHN) and to identify prognostic factors for overall survival (OS).

methodsThis is a prospective observation study involving 20 oncology institutions in Japan. Patients with RM-SCCHN treated with a first-line therapy consisting of cetuximab plus any chemotherapy regimen between December 2013 and February 2017 were enrolled. The primary objective of the study was 1-year OS. Secondary objectives included response rate and adverse events.

resultsOf 120 patients recruited, 114 patients were analyzed. Median age was 64 years. Cetuximab in combination with platinum plus 5-FU (EXTREME regimen) was chosen in 86 patients (75.4%). The median OS was 12.4 months. A point estimate of the 1-year survival rate was 51.1%. Overall response rate was 26.3%. Grade 3 or worse adverse events included neutropenia (22.8%), hypokalemia (9.6%), acneiform rash (7.0%), pneumonitis (1.8%), and infusion-related reaction (0.9%). On multivariate analysis, regional lymph node metastasis, absence of intervention by dermatologists, lack of response to therapy, skin metastasis, and non-EXTREME regimen were identified as independent unfavorable prognostic factors for OS.

conclusionThe combination of cetuximab plus chemotherapy was tolerable and efficacious in patients with RM-SCCHN in a real-world setting. Clinical outcomes and prognostic factors extracted from this study provide a reference of the current clinical practice as well as for the future development of novel therapy in RM-SCCHN.

Indexed as

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and NeckAntineoplastic Combined Chemotherapy ProtocolsAsian PeopleCetuximabHumansJapanMiddle AgedNeoplasm Recurrence, LocalPrognosisProspective StudiesTreatment OutcomeCetuximabCetuximabCombination therapyObservation studyPrognostic factorsReal-world dataSquamous cell carcinoma of the head and neck

Identifiers

PMID33125596
OpenAlexW3095782069

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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.