Evidence map›Paper›PMID 28500491›Full record

Trial reportStrahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al]2017

Hyperfractionated accelerated radiation therapy plus cetuximab plus cisplatin chemotherapy in locally advanced inoperable squamous cell carcinoma of the head and neck : Final 5‑year results of a phase II study.

Thomas Kuhnt, Andreas Schreiber, Anett Pirnasch, Matthias G Hautmann, Peter Hass, Frank P Sieker, Rita Engenhart-Cabillic, Michael Richter, Kathrin Dellas, Jürgen Dunst

Abstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al], 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 28% 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

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Addition of chemotherapy to hyperfractionated radiotherapy in advanced head and neck cancer-a meta-analysis.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2019
    Pooled it
  2. Article
  3. Review
  4. 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 6 institutions in 1 country.

Thomas KuhntDepartment of Imaging and Radiation Medicine, Clinic of Radiooncology, University of Leipzig, Stephanstr. 9a, 04103, Leipzig, Germany. Thomas.Kuhnt@medizin.uni-leipzig.de.
Andreas SchreiberPrivate Praxis for Radio Oncology Dresden, Dresden, Germany.
Anett PirnaschDepartment of Radiation Oncology, University of Rostock, Rostock, Germany.
Matthias G HautmannDepartment of Radiotherapy, University of Regensburg, Regensburg, Germany.
Peter HassDepartment of Radiotherapy, Otto von Guericke University of Magdeburg, Magdeburg, Germany.
Frank P SiekerDepartment of Radiotherapy, Martin Luther University of Halle-Wittenberg, Halle (Saale), Germany.
Rita Engenhart-CabillicDepartment of Radiotherapy, Philipps University Marburg, Marburg, Germany.
Michael RichterCoordination Centre for Clinical Trials Halle, Halle (Saale), Germany.
Kathrin DellasDepartment of Radiation Oncology, University of Kiel, Kiel, Germany.
Jürgen DunstDepartment of Radiation Oncology, University of Kiel, Kiel, Germany.
Kiel University · DEMartin Luther University Halle-Wittenberg · DEOtto-von-Guericke University Magdeburg · DEPhilipps University of Marburg · DEUniversity of Regensburg · DEUniversity of Rostock · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCetuximab (CET) is a potent inhibitor of the epidermal growth factor receptor and has been shown to have activity in squamous cell carcinoma of the head and neck (SCCHN). We conducted a single-arm phase II trial of a combination therapy comprising cisplatin (CIS), CET and hyperfractionated accelerated radiotherapy (HART). PATIENTS AND

methodsPatients with UICC stage III or IVA/B, M0 SCCHN were enrolled and treated with an initial dose of CET (400 mg/m

resultsBetween November 2007 and November 2010, a total of 74 patients were enrolled in the study, of whom 65 were evaluable (83% were men). Median age was 56 years (range 37-69 years). An Oropharyngeal primary tumour was diagnosed in 49%, T4a,b in 65% and N2/3 in 96% of the patients. Of these patients, 85% were smokers or ex-smokers. Complete remission (CR) was observed in 23 patients (35%). The most common toxicity grade was ≥3, including mucositis (58%) and dysphagia (52%). The 2‑ and 5‑year overall survival rates were 64 and 41%, the 2‑ and 5‑year PFS rates were 45 and 32%, and the 2‑ and 5‑year locoregional control rates were 47 and 33%, respectively.

conclusionThe combination of weekly CIS with HART plus CET is a feasible regimen for these unfavourable smoking-induced cancers. However, the parallel US study (RTOG 0522) showed no advantage of the enhanced triple therapy compared to chemoradiotherapy alone.

Indexed as

Dose Fractionation, RadiationAdultAgedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Squamous CellCetuximabCisplatinCombined Modality TherapyDisease-Free SurvivalDrug Administration ScheduleFemaleFollow-Up StudiesHumansMaleMiddle AgedNeoplasm StagingCetuximabCisplatinChemoradiotherapyMucositisSmokingSurvivalToxicity

Identifiers

PMID28500491
OpenAlexW2612330257

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.