Evidence map›Paper›PMID 23479383›Full record

Trial reportJapanese journal of clinical oncology2013

Phase II study of cetuximab plus concomitant boost radiotherapy in Japanese patients with locally advanced squamous cell carcinoma of the head and neck.

Susumu Okano, Takayuki Yoshino, Masato Fujii, Yusuke Onozawa, Takeshi Kodaira, Hirofumi Fujii, Tetsuo Akimoto, Satoshi Ishikura, Masahiko Oguchi, Sadamoto Zenda and 3 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Japanese journal of clinical oncology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00865098 (Open-label, Non-randomized, Non-controlled, Multicenter Phase II Study Investigating Cetuximab in Combination With Concomitant-boost Radiotherapy as First-line Treatment for Japanese Patients With Newly Diagnosed Locally Advanced SCCHN.), which is not on this map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
7.3field-weighted citation impact, top 2% 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.

NCT00865098 phase2completednot on this map

Open-label, Non-randomized, Non-controlled, Multicenter Phase II Study Investigating Cetuximab in Combination With Concomitant-boost Radiotherapy as First-line Treatment for Japanese Patients With Newly Diagnosed Locally Advanced SCCHN.

TypeinterventionalSponsorMerck KGaA, Darmstadt, GermanyRan2009 to 2010Enrolled27ConditionsCarcinoma of the Head and NeckArmsCetuximab
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 67 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Review
  6. Article
  7. Observational
  8. Cetuximab Concurrent with Radiotherapy in Unresectable, Locally Advanced Squamous Cell Carcinoma of Head and Neck: Real-World Evidence from a Tertiary Care Hospital.Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India · 2022
    Article
  9. Review
  10. Review
  11. Article
  12. Review
  13. Article
  14. Article
  15. Retrospective analysis of premedication, glucocorticosteroids, and HThe Journal of international medical research · 2017
    Article
  16. Retrospective evaluation of concomitant cetuximab and radiotherapy tolerance for locoregional advanced head and neck squamous cell carcinoma treatment in patients unfit for platinum-based chemotherapy.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 · 2017
    Article
  17. Article
  18. Article
  19. 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

13 authors at 9 institutions in 2 countries.

Susumu OkanoDepartment of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan.
Takayuki Yoshino
Masato Fujii
Yusuke Onozawa
Takeshi Kodaira
Hirofumi Fujii
Tetsuo Akimoto
Satoshi Ishikura
Masahiko Oguchi
Sadamoto Zenda
Barbara de Blas
Makoto Tahara
Frank Beier
National Cancer Center Hospital East · JPAichi Cancer Center · JPJichi Medical University Hospital · JPJuntendo University · JPMerck (Germany) · DEShizuoka Cancer Center · JPThe Cancer Institute Hospital · JPTokyo Medical and Dental University · JPTokyo Medical Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe investigated the tolerability of cetuximab plus radiotherapy in Japanese patients with untreated locally advanced squamous cell carcinoma of the head and neck.

methodsPatients with epidermal growth factor receptor-expressing locally advanced squamous cell carcinoma of the head and neck received cetuximab (400 mg/m(2) initial dose then 250 mg/m(2) weekly) for 7 weeks plus concomitant boost radiotherapy (weeks 2-7: once daily [1.8 Gy] for 3.6 weeks, then twice daily [1.8 Gy morning and 1.5 Gy afternoon] for 2.4 weeks). The primary endpoint was treatment completion rate (the rate of treated patients completing ≥70% of the planned cetuximab dose and the full dose of radiotherapy within 2 weeks over the planned schedule).

resultsTwenty-two patients were evaluable. The treatment completion rate was 100% (95% confidence interval 85-100). The response rate 8 weeks post-radiotherapy was 82% (95% confidence interval 60-95). The most common grade 3/4 treatment-emergent adverse events were mucosal inflammation (73%); dermatitis (27%); and infection, radiation skin injury and stomatitis (23% each).

conclusionsCetuximab plus concomitant boost radiotherapy can be safely administered to Japanese patients with locally advanced squamous cell carcinoma of the head and neck. Tolerability and efficacy were in line with those reported in the Phase III Bonner trial in a Western population of patients with locally advanced squamous cell carcinoma of the head and neck.

Indexed as

AdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAsian PeopleCarcinoma, Squamous CellCetuximabChemoradiotherapyDose Fractionation, RadiationDrug Administration ScheduleErbB ReceptorsFeasibility StudiesFemaleGene Expression Regulation, NeoplasticHead and Neck NeoplasmsHumansAntibodies, Monoclonal, HumanizedAntineoplastic AgentsCetuximabErbB ReceptorsKRAS protein, humanProto-Oncogene ProteinsProto-Oncogene Proteins p21(ras)ras Proteins

Identifiers

PMID23479383
PMCPMC3638633
OpenAlexW2171390158

What OpenQuestion holds

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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.