Evidence map›Paper›PMID 32993574›Full record

Trial reportBMC cancer2020

Treatment response lowers tumor symptom burden in recurrent and/or metastatic head and neck cancer.

Markus Hecht, Dennis Hahn, Philipp Wolber, Matthias G Hautmann, Dietmar Reichert, Steffi Weniger, Claus Belka, Tobias Bergmann, Thomas Göhler, Manfred Welslau and 8 more

Registry-linked trialAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in BMC cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00122460 (Cetuximab in Combination With Cisplatin or Carboplatin and 5-Fluorouracil in the First Line Treatment of Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT00122460 phase3completednot on this map

Cetuximab in Combination With Cisplatin or Carboplatin and 5-Fluorouracil in the First Line Treatment of Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck

TypeinterventionalSponsorMerck KGaA, Darmstadt, GermanyRan2004 to 2011Enrolled442ConditionsHead and Neck CancerArmsCetuximab + Platinum (Cisplatin or Carboplatin) + 5Fluorouracil (5-FU), Platinum (Cisplatin or Carboplatin) + 5-FU
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Long-term Survival and Molecular Biomarker Evaluation of a Phase II Cetuximab and Nivolumab Clinical Trial in Recurrent/Metastatic Head and Neck Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Trial
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  6. Review
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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

18 authors.

Markus HechtDepartment of Radiation Oncology, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Universitätsstraße 27, 91054, Erlangen, Germany. markus.hecht@uk-erlangen.de.ORCID http://orcid.org/0000-0003-2082-216X
Dennis HahnKlinikum Stuttgart, Klinik für Onkologie, Stuttgart, Germany.
Philipp WolberUniversitätsklinikum Köln, Klinik für Hals-, Nasen- und Ohrenheilkunde, Köln, Germany.
Matthias G HautmannUniversitätsklinikum Regensburg, Klinik und Poliklinik für Strahlentherapie, Regensburg, Germany.
Dietmar ReichertMedizinische Studiengesellschaft NORD-WEST GmbH, Westerstede, Germany.
Steffi WenigerGemeinschaftspraxis Dres. Weniger/Bittrich, Erfurt, Germany.
Claus BelkaKlinikum der Universität München (A.ö.R.), Klinik für Strahlentherapie und Radioonkologie, Munich, Germany.
Tobias BergmannSRH Wald-Klinikum Gera GmbH, II. Medizinische Klinik, Gera, Germany.
Thomas GöhlerOnkozentrum Dresden/Freiberg, Dresden, Germany.
Manfred WelslauKlinikum Aschaffenburg, Hämato-Onkologische Schwerpunktpraxis, Aschaffenburg, Germany.
Christina Große-ThieUniversitätsmedizin Rostock, Zentrum Innere Medizin Klinik III - Hämatologie, Onkologie, Palliativmedizin, Rostock, Germany.
Orlando Guntinas-LichiusUniversitätsklinikum Jena, Klinik für Hals-Nasen- und Ohrenheilkunde, Jena, Germany.
Jens von der GrünKlinikum der J.-W. Goethe-Universität Frankfurt a.M., Klinik für Strahlentherapie und Onkologie, Frankfurt, Germany.
Panagiotis BalermpasKlinikum der J.-W. Goethe-Universität Frankfurt a.M., Klinik für Strahlentherapie und Onkologie, Frankfurt, Germany.
Katrin OrlowskiMerck Serono GmbH, Medical Affairs Oncology, Darmstadt, Germany.
Diethelm MessingerPrometris GmbH, Mannheim, Germany.
Karsten G StenzelMerck Serono GmbH, Medical Affairs Oncology, Darmstadt, Germany.
Rainer FietkauDepartment of Radiation Oncology, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Universitätsstraße 27, 91054, Erlangen, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHead and neck squamous cell cancer (HNSCC) frequently causes severe symptoms that may be reduced, when the tumor is successfully treated. The SOCCER trial studied the association of treatment response with patient reported tumor symptom burden in first line treatment of recurrent and/or metastatic HNSCC.

methodsIn this prospective, multi-center, non-interventional trial patients were treated either with platinum-based chemotherapy and cetuximab or radiotherapy and cetuximab. Tumor symptom burden was assessed every four weeks with a questionnaire containing ten visual analogue scales (VAS, range 0-100), which were summarized to the overall VAS score.

resultsFourhundred seventy patients were registered in 97 German centers. A total of 315 patients with at least the baseline and one subsequent questionnaire were available for analysis. Changes in the VAS score were rated as absolute differences from baseline. Negative values indicate improvement of symptoms. The overall VAS score improved significantly at the first post-baseline assessment in responders (- 2.13 vs. non-responders + 1.15, p = 0.048), and even more for the best post-baseline assessment (- 7.82 vs. non-responders - 1.97, p = 0.0005). The VAS for pain (- 16.37 vs. non-responders - 8.89, p = 0.001) and swallowing of solid food (- 16.67 vs. non-responders - 5.06, p = 0.002) improved significantly more in responders (best post-baseline assessment). In the multivariable Cox regression analysis, worse overall VAS scores were associated with worse overall survival (hazard ratio for death 1.12 per 10 points increment on the overall VAS scale, 95% CI 1.05-1.20, p = 0.0009).

conclusionIn unselected patients beyond randomized controlled trials, treatment response lowers tumor symptom burden in recurrent and/or metastatic HNSCC.

trial registrationClinicalTrials.gov, NCT00122460 . Registered 22 Juli 2005.

Indexed as

AdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCetuximabCisplatinCombined Modality TherapyDisease-Free SurvivalFemaleHumansMaleMiddle AgedNeoplasm MetastasisNeoplasm Recurrence, LocalPlatinumProgression-Free SurvivalAntibodies, Monoclonal, HumanizedCetuximabCisplatinPlatinumCetuximabChemotherapyHNSCCResponseSymptom

Identifiers

PMID32993574
PMCPMC7526421

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.