Evidence map›Paper›PMID 26186556›Full record

Trial reportPloS one2015

Prognostic Role of Circulating Tumor Cells during Induction Chemotherapy Followed by Curative Surgery Combined with Postoperative Radiotherapy in Patients with Locally Advanced Oral and Oropharyngeal Squamous Cell Cancer.

Johanna Inhestern, Katrin Oertel, Viola Stemmann, Harald Schmalenberg, Andreas Dietz, Nicole Rotter, Johannes Veit, Martin Görner, Holger Sudhoff, Christian Junghanß and 3 more

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

Trial report in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01108042 (Phase I/II Study of Split-dose TPF-Induction Chemotherapy Before Surgery of Oropharyngeal and Cavity of the Mouth Cancer), which is not on this map. Cited by 40 papers.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed
3.0field-weighted citation impact, top 7% 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.

NCT01108042 phase1 / phase2completednot on this map

Phase I/II Study of Split-dose TPF-Induction Chemotherapy Before Surgery of Oropharyngeal and Cavity of the Mouth Cancer

TypeinterventionalSponsorOrlando Guntinas-Lichius, Prof. Dr. med.Ran2009 to 2016Enrolled71ConditionsOropharynx Cancer, Squamous Cell Carcinoma of the Oral CavityArmsTaxotere, Cisplatin, 5-Fluorouracil (5-FU)
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 70 citations in OpenAlex.

  1. Article
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  9. Article
  10. Artificial intelligence to predict outcomes of head and neck radiotherapy.Clinical and translational radiation oncology · 2023
    Article
  11. Article
  12. Detection of Circulating Tumor Cells Using the Attune NxT.International journal of molecular sciences · 2022
    Article
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  15. 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

13 authors at 5 institutions in 1 country.

Johanna InhesternDepartment of Otorhinolaryngology, Jena University Hospital, Jena, Germany.
Katrin OertelDepartment of Otorhinolaryngology, Jena University Hospital, Jena, Germany.
Viola StemmannDepartment of Otorhinolaryngology, Jena University Hospital, Jena, Germany.
Harald SchmalenbergUniversity Tumor Center, Jena University Hospital, Jena, Germany.
Andreas DietzDepartment of ENT Surgery, University Medical Center Leipzig, Leipzig, Germany.
Nicole RotterDepartment of Otorhinolaryngology, Head and Neck Surgery, Ulm University Medical Center, Ulm, Germany.
Johannes VeitDepartment of Otorhinolaryngology, Head and Neck Surgery, Ulm University Medical Center, Ulm, Germany.
Martin GörnerDepartment of Hematology and Oncology, Academic Teaching Hospital Bielefeld, Bielefeld, Germany.
Holger SudhoffDepartment of Otorhinolaryngology, Head and Neck Surgery, Academic Teaching Hospital Bielefeld, Bielefeld, Germany.
Christian JunghanßDivision of Medicine, Department of Hematology, Oncology and Palliative Medicine, University of Rostock, Rostock, Germany.
Claus WittekindtDepartment of Otorhinolaryngology, Head and Neck Surgery, University Hospital Giessen and Marburg, Giessen, Germany.
Katharina PachmannClinic of Internal Medicine II, Division of Hematology and Internal Oncology, Jena University Hospital, Erlanger Allee 101, Jena, Germany.
Orlando Guntinas-LichiusDepartment of Otorhinolaryngology, Jena University Hospital, Jena, Germany.
Jena University Hospital · DEKlinikum Bielefeld · DELeipzig University · DEUniversitätsklinikum Gießen und Marburg · DEUniversity of Rostock · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe prognostic role of circulating tumor cells (CTCs) after induction chemotherapy using docetaxel, cisplatin and fluorouracil (TPF) prior to surgery and adjuvant (chemo)radiation in locally advanced oral squamous cell cancer (OSCC) was evaluated.

methodsIn this prospective study, peripheral blood samples from 40 patients of the phase II study TISOC-1 (NCT01108042) with OSCC before, during, and after treatment were taken. CTCs were quantified using laser scanning cytometry of anti- epithelial cell adhesion molecule-stained epithelial cells. Their detection was correlated with clinical risk factors, recurrence-free (RFS) and overall survival (OS).

resultsBefore starting the treatment CTCs were detected in 32 of 40 patients (80%). The median number at baseline was 3295 CTCs/ml. The median maximal number of CTCs during treatment was 5005 CTCs/ml. There was a significant increase of CTCs before postoperative radiotherapy compared to baseline before 1st cycle of IC (p = 0.011), 2nd cycle of IC (p = 0.001), 3rd cycle of IC (p = 0.004), and before surgery (p = 0.002), but not compared to end of therapy (p = 0.118). CTCs at baseline >median was also associated to risk of recurrence (p = 0.014). Maximal CTCs during therapy >median was more frequently observed in tumors of the oral cavity (p=0.022) and related to higher risk of death during follow-up (p = 0.028). Patients with CTCs at baseline >median value had significant lower RFS than patients with CTCs at baseline <median value (p = 0.025). Patients with maximal CTCs values >median during the complete course of therapy had a significantly lower OS than patients with values <median (p = 0.049). Finally, the multivariate analysis revealed that OS was significantly lower in patients with maximal CTCs during treatment higher than the median value (HR=6.151; CI: 1.244-30.420).

conclusionsBaseline CTCs and maximal CTCs during therapy both seem to be good prognostic markers for OSCC when treated by TPF induction chemotherapy, surgery, and postoperative (chemo)radiation.

Indexed as

Induction ChemotherapyPostoperative CareCarcinoma, Squamous CellCell CountDisease-Free SurvivalFemaleHumansKaplan-Meier EstimateMaleMiddle AgedMouth NeoplasmsMultivariate AnalysisNeoplasm Recurrence, LocalNeoplasm StagingNeoplastic Cells, CirculatingOropharyngeal Neoplasms

Identifiers

PMID26186556
PMCPMC4505900
OpenAlexW1480922274

What OpenQuestion holds

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LicenceCC BY
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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.