Evidence map›Paper›PMID 29594250›Full record

ArticleClinical and translational radiation oncology2018

Anti PD-L1 DUrvalumab combined with Cetuximab and RadiOtherapy in locally advanced squamous cell carcinoma of the head and neck: A phase I/II study (DUCRO).

Pierluigi Bonomo, Isacco Desideri, Mauro Loi, Monica Mangoni, Mariangela Sottili, Livia Marrazzo, Cinzia Talamonti, Daniela Greto, Stefania Pallotta, Lorenzo Livi

Erratum issuedOpen access · goldAbstract read
In one paragraph

Article in Clinical and translational radiation oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
4.9field-weighted citation impact, top 4% 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

18 citing papers in PubMed, 33 citations in OpenAlex.

  1. Review
  2. Observational
  3. Review
  4. Review
  5. Role of HPV status and PD-L1 expression in prognosis of laryngeal squamous cell carcinoma.International journal of clinical and experimental pathology · 2021
    Article
  6. Review
  7. Review
  8. Review
  9. Article
  10. Article
  11. Review
  12. Article
  13. Immune Modulation of Head and Neck Squamous Cell Carcinoma and the Tumor Microenvironment by Conventional Therapeutics.Clinical cancer research : an official journal of the American Association for Cancer Research · 2019
    Review
  14. Review
  15. Article
  16. Article
  17. Review
  18. DNA damage response and potential biomarkers of radiosensitivity in head and neck cancers: clinical implications.Romanian journal of morphology and embryology = Revue roumaine de morphologie et embryologie
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 1 institution in 1 country.

Pierluigi BonomoRadiation Oncology, Azienda Ospedaliero - Universitaria Careggi, University of Florence, Florence, Italy.
Isacco DesideriRadiation Oncology, Azienda Ospedaliero - Universitaria Careggi, University of Florence, Florence, Italy.
Mauro LoiRadiation Oncology, Azienda Ospedaliero - Universitaria Careggi, University of Florence, Florence, Italy.
Monica MangoniRadiation Oncology, Azienda Ospedaliero - Universitaria Careggi, University of Florence, Florence, Italy.
Mariangela SottiliRadiation Oncology, Azienda Ospedaliero - Universitaria Careggi, University of Florence, Florence, Italy.
Livia MarrazzoMedical Physics, Azienda Ospedaliero - Universitaria Careggi, University of Florence, Florence, Italy.
Cinzia TalamontiMedical Physics, Azienda Ospedaliero - Universitaria Careggi, University of Florence, Florence, Italy.
Daniela GretoRadiation Oncology, Azienda Ospedaliero - Universitaria Careggi, University of Florence, Florence, Italy.
Stefania PallottaMedical Physics, Azienda Ospedaliero - Universitaria Careggi, University of Florence, Florence, Italy.
Lorenzo LiviRadiation Oncology, Azienda Ospedaliero - Universitaria Careggi, University of Florence, Florence, Italy.
Azienda Ospedaliero-Universitaria Careggi · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

INTRODUCTION AND

backgroundHead and neck squamous cell carcinoma (HNSCC) has been increasingly recognized as an immune suppressive malignancy. The efficacy of immune checkpoint inhibitors (ICI's) in the context of recurrent/metastatic (R/M) setting anticipates the possible integration of immunotherapy into the therapeutic armamentarium of locally advanced disease. Durvalumab (DUR) is a humanized monoclonal IgG1, anti-PD-L1 antibody with promising data in R/M HNSCC. The aim of our study is to test the antitumor activity of a combined regimen incorporating an immune checkpoint inhibitor into a conventional bio-radiation strategy for the cure of unfavorable locally advanced HNSCC. METHODS/

designIn this open label, multi-center, single-arm, phase I/II study, enrolled patients will receive Radiotherapy (RT) (69.9 Gy/2.12 Gy in 33 fractions) with concurrent Cetuximab (CTX) (400 mg/m DISCUSSION: Conventional intensification strategies failed to provide any benefit for the cure of locally advanced HNSCC. For the still prevalent HPV-negative population and the high risk-HPV positive disease, there is an unmet need for alternative treatment paradigms. Potentially, the inhibition of the PD-1/PD-L1 checkpoint may synergize with both CTX and RT through immunologic interplay, ultimately aiming to reverse the HNSCC-induced immune suppression. The DUCRO study will seek to demonstrate if such a strategy may be safe and active.

trial registrationNCT number: NCT03051906Eudract number: 2016-004668-20.

Indexed as

CetuximabDurvalumabHead and neck cancerImmunotherapyRadiotherapy

Identifiers

PMID29594250
PMCPMC5862684
OpenAlexW2793139049

What OpenQuestion holds

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Registered trials

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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.