Evidence map›Paper›PMID 37046849›Full record

ArticleCancers2023

Perioperative Cetuximab with Cisplatin and 5-Fluorouracil in Esogastric Adenocarcinoma: A Phase II Study.

Caroline Gronnier, Christophe Mariette, Come Lepage, Carole Monterymard, Marine Jary, Aurélie Ferru, Mathieu Baconnier, Xavier Adhoute, David Tavan, Hervé Perrier and 17 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Cancers, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01360086 (Trial Evaluating the Efficacy and Tolerance of Perioperative Chemotherapy With 5FU-Cisplatin-Cetuximab in Adenocarcinomas of the Stomach and Gastroesophageal Junction. Phase II Single Arm, Multicenter.), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 31% 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.

NCT01360086 phase2completednot on this map

Trial Evaluating the Efficacy and Tolerance of Perioperative Chemotherapy With 5FU-Cisplatin-Cetuximab in Adenocarcinomas of the Stomach and Gastroesophageal Junction. Phase II Single Arm, Multicenter.

TypeinterventionalSponsorFederation Francophone de Cancerologie DigestiveRan2011 to 2013Enrolled65ConditionsAdenocarcinoma of the Gastroesophageal Junction, Gastric CancerArmscetuximab, cisplatin, fluorouracil, leucovorin calcium, adjuvant therapy
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 2 citations in OpenAlex.

  1. Pooled it
  2. 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

27 authors at 16 institutions in 1 country.

Caroline GronnierDepartment of Digestive Surgery, Magellan Center, Bordeaux University Hospital, 33600 Pessac, France.ORCID 0000-0002-7836-8134
Christophe MarietteDepartment of Digestive and Oncological Surgery, CHU Lille, Claude Huriez University Hospital, 59000 Lille, France.
Come LepageFFCD EPICAD INSERM LNC-UMR 1231, University of Burgundy and Franche-Comté, 21000 Dijon, France.ORCID 0000-0001-9211-4707
Carole MonterymardFederation Francophone de Cancérologie Digestive (FFCD), EPICAD INSERM LNC-UMR 1231, University of Burgundy and Franche Comté, 21000 Dijon, France.
Marine JaryDepartment of Digestive Oncology, University Hospital, 63100 Clermont-Ferrand, France.
Aurélie FerruDepartment of Oncology, University Hospital, 86000 Poitiers, France.
Mathieu BaconnierDepartment of Gastroenterology, General Hospital, 74960 Annecy, France.
Xavier AdhouteDepartment of Gastroenterology, St Joseph General Hospital, 13000 Marseille, France.ORCID 0000-0001-5977-800X
David TavanDepartment of Gastroenterology, Lyon Protestant Infirmary Clinic, 69300 Lyon, France.
Hervé PerrierDepartment of Hepato-Gastroenterology, Saint Joseph Hospital, 13000 Marseille, France.
Véronique Guerin-MeyerInstitut de Cancérologie de l'Ouest Paul Papin, 49000 Angers, France.
Cédric LecailleDepartment of Hepato-Gastroenterology, Polyclinic Bordeaux Nord, 33000 Bordeaux, France.
Nathalie Bonichon-LamichhaneMedical Oncology, Clinique Tivoli Ducos, 33000 Bordeaux, France.
Didier PillonDepartment of Hepato-Gastroenterology, Centre Hospitalier de Bourg en Bresse, 01053 Bourg-en-Bresse, France.
Oana CojocarasuOnco-Hematology Department, Centre Hospitalier du Mans, 72000 Le Mans, France.
Joëlle EgreteauRadiotherapy and Oncology Department, Centre Hospitalier Bretagne Sud, 56100 Lorient, France.
Xavier Benoit D'journoDepartment of Thoracic Surgery, North Hospital, Aix-Marseille University, 13000 Marseille, France.
Laétitia DahanService d'Oncologie Digestive, CHU Timone, 13000 Marseille, France.
Christophe LocherHepato-Gastroenterology Unit, Meaux Hospital, 77100 Meaux, France.
Patrick TexereauGastroenterology, Centre Hospitalier de Mont-de-Marsan, 40000 Mont-de-Marsan, France.
Denis ColletDepartment of Digestive Surgery, Magellan Center, Bordeaux University Hospital, 33600 Pessac, France.
Pierre MichelIron Group, Normandy Centre for Genomic and Personalized Medicine and Department of Hepatogastroenterology, Rouen University Hospital, Normandie University, 76000 Rouen, France.
Meher Ben AbdelghaniDepartment of Oncology, Centre Paul Strauss, 67100 Strasbourg, France.
Rosine GuimbaudCentre Hospitalier Universitaire de Toulouse, 31400 Toulouse, France.
Marie MullerDepartment of Gastroenterology, CHU Nancy, 54500 Vandoeuvre-les-Nancy, France.ORCID 0000-0001-6412-932X
Olivier BouchéDepartment of Digestive Oncology, CHU Reims, 51100 Reims, France.ORCID 0000-0002-8284-3743
Guillaume PiessenDepartment of Digestive and Oncological Surgery, CHU Lille, Claude Huriez University Hospital, 59000 Lille, France.ORCID 0000-0001-8243-8310
Centre Hospitalier Universitaire de Lille · FRInserm · FRUniversité de Bordeaux · FRAix-Marseille Université · FRCentre Hospitalier de Bretagne Sud · FRCentre Hospitalier du Mans · FRCentre Hospitalier Régional et Universitaire de Nancy · FRCentre Hospitalier Universitaire de Reims · FRCentre Hospitalier Universitaire de Toulouse · FRHôpital de la Timone · FRHôpital Saint Joseph · FRInfirmerie Protestante · FRInstitut de Cancérologie de l'Ouest · FRInt'Air Medical (France) · FRNormandie Université · FRPolyclinique de Bordeaux-Tondu · FR

Funding

Merck (France) NCT 01360086
6 · The paper itself

Abstract

purposeWhile perioperative chemotherapy provides a survival benefit over surgery alone in gastric and gastroesophageal junction (G/GEJ) adenocarcinomas, the results need to be improved. This study aimed to evaluate the efficacy and safety of perioperative cetuximab combined with 5-fluorouracil and cisplatin. PATIENTS AND

methodsPatients received six cycles of cetuximab, cisplatin, and simplified LV5FU2 before and after surgery. The primary objective was a combined evaluation of the tumor objective response (TOR), assessed by computed tomography, and the absence of major toxicities resulting in discontinuation of neoadjuvant chemotherapy (NCT) (45% and 90%, respectively).

resultsFrom 2011 to 2013, 65 patients were enrolled. From 64 patients evaluable for the primary endpoint, 19 (29.7%) had a morphological TOR and 61 (95.3%) did not stop NCT prematurely due to major toxicity. Sixty patients (92.3%) underwent resection. Sixteen patients (/56 available, 28.5%) had histological responses (Mandard tumor regression grade ≤3). After a median follow-up of 44.5 months, median disease-free and overall survival were 24.4 [95% CI: 16.4-39.4] and 40.3 months [95% CI: 27.5-NA], respectively.

conclusionAdding cetuximab to the NCT regimen in operable G/GEJ adenocarcinomas is safe, but did not show enough efficacy in the present study to meet the primary endpoint (NCT01360086).

Indexed as

cetuximabefficacyEGFR-1esogastric adenocarcinomaneoadjuvant chemotherapysafetysurgery

Identifiers

PMID37046849
PMCPMC10093434
OpenAlexW4362699301

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.