Evidence map›Paper›PMID 30523411›Full record

ArticleEuropean 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 Surgery2019

Benefit of cetuximab addition to a platinum-fluorouracil-based chemotherapy according to KRAS-LCS6 variant in an unselected population of recurrent and/or metastatic head and neck cancers.

Vianney Bastit, Nicolas Bon-Mardion, Jean-Michel Picquenot, Vinciane Rainville, Cristian Moldovan, Arnaud François, Agnès Loeb, Sébastien Thureau, Dorel Manu, Fabrice Jardin and 3 more

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In one paragraph

Article in 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, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 44% 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

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. 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

13 authors at 4 institutions in 2 countries.

Vianney BastitDepartment of Head and Neck Surgery, Henri Becquerel Centre, rue d'Amiens, 76000, Rouen, France. v.bastit@baclesse.unicancer.fr.ORCID http://orcid.org/0000-0001-7394-1301
Nicolas Bon-MardionDepartment of Head and Neck Surgery, Rouen University Hospital, rue de Germont, 76000, Rouen, France.
Jean-Michel PicquenotDepartment of Biopathology, Henri Becquerel Centre, rue d'Amiens, 76000, Rouen, France.
Vinciane RainvilleIRON Group, Normandy Centre for Genomic and Personalized Medicine, Rouen University Hospital, UNIROUEN, Inserm U1245, rue de Germont, Normandie Université, 76000, Rouen, France.
Cristian MoldovanDepartment of Medical Oncology, Henri Becquerel Centre, rue d'Amiens, 76000, Rouen, France.
Arnaud FrançoisDepartment of Biopathology, Rouen University Hospital, rue de Germont, 76000, Rouen, France.
Agnès LoebDepartment of Biomedical Informatics, Henri Becquerel Centre, rue d'Amiens, 76000, Rouen, France.
Sébastien ThureauDepartment of Radiation therapy, Henri Becquerel Centre, rue d'Amiens, 76000, Rouen, France.
Dorel ManuDepartment of Head and Neck Surgery, Henri Becquerel Centre, rue d'Amiens, 76000, Rouen, France.
Fabrice JardinIRON Group, Normandy Centre for Genomic and Personalized Medicine, Rouen University Hospital, UNIROUEN, Inserm U1245, rue de Germont, Normandie Université, 76000, Rouen, France.
Jean-Paul MarieDepartment of Head and Neck Surgery, Rouen University Hospital, rue de Germont, 76000, Rouen, France.
Fréderic Di FioreIRON Group, Normandy Centre for Genomic and Personalized Medicine, Rouen University Hospital, UNIROUEN, Inserm U1245, rue de Germont, Normandie Université, 76000, Rouen, France.
Florian ClatotIRON Group, Normandy Centre for Genomic and Personalized Medicine, Rouen University Hospital, UNIROUEN, Inserm U1245, rue de Germont, Normandie Université, 76000, Rouen, France.
Inserm · FRLaboratoire National Henri Becquerel · FRUniversité de Rouen Normandie · FRCentre François Baclesse · LU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo evaluate the benefit of cetuximab (Cx) addition to platinum-based and 5-fluorouracil chemotherapy (PFU) in unselected recurrent and/or metastatic head and neck cancer patients (R/MHNC) according to KRAS-LCS6 variant status.

methodsAll patients who received at least two PFU ± Cx cycles from 2004 to 2014 were retrospectively included into to two distinct study periods according to Cx implementation: patients treated by PFU alone before 2009 and those treated by PFU + Cx from 2009. Primary objective was to evaluate the progression-free survival (PFS) between the two groups. Secondary objectives were to analyze the overall survival (OS) between the two groups and the prognostic impact of KRAS-LCS6 variant. Factors associated with survival were determined by a Cox multivariate analysis including age, WHO performance status (PS), type of treatment, KRAS-LCS6 variant, Charlson's score and p16 status.

resultsOverall, 134 patients were included: 59 (44%) in PFU group and 75 (56%) in PFU + Cx group. Baseline characteristics were well balanced including 30% of patients with 2-3 PS. Median PFS was significantly improved in PFU + Cx group compared to PFU group (6.1 vs 4.4 months, respectively, HR 0.68, p = 0.02) and with a trend for better OS. A KRAS-LCS6 variant was found in 27 (25%) of samples without prognostic impact neither in whole population nor according to treatment. In multivariate analysis, addition of Cx to PFU was the only factor significantly associated with a better PFS (p = 0.01, HR 0.6).

conclusionOur results suggest that PFU + Cx combination may be effective in unselected population of R/MHNC regardless the KRAS-LCS6 variant status.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCarboplatinCetuximabCisplatinFemaleFluorouracilHead and Neck NeoplasmsHumansMaleMiddle AgedNeoplasm Recurrence, LocalProgression-Free SurvivalProto-Oncogene Proteins p21(ras)Retrospective StudiesCarboplatinCetuximabCisplatinFluorouracilKRAS protein, humanProto-Oncogene Proteins p21(ras)CetuximabKRAS-LCS6PrognosisRecurrent and/or metastatic head and neck cancersRs61764370Unselected population

Identifiers

PMID30523411
OpenAlexW2904559102

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.