Evidence map›Paper›PMID 32111181›Full record

Trial reportBMC cancer2020

High thromboembolic event rate in patients with locally advanced oesophageal cancer during neoadjuvant therapy. An exploratory analysis of the prospective, randomised intergroup phase III trial SAKK 75/08.

Martin Fehr, Hanne Hawle, Stefanie Hayoz, Peter Thuss-Patience, Sabina Schacher, Jorge Riera Knorrenschild, Donat Dürr, Wolfram T Knoefel, Holger Rumpold, Michael Bitzer and 15 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
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 NCT01107639 (Multimodal Therapy With and Without Cetuximab in Patients With Locally Advanced Esophageal Carcinoma - An Open-Label Phase III Trial), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 41% 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.

NCT01107639 phase3completednot on this map

Multimodal Therapy With and Without Cetuximab in Patients With Locally Advanced Esophageal Carcinoma - An Open-Label Phase III Trial

TypeinterventionalSponsorSwiss Cancer InstituteRan2010 to 2018Enrolled297ConditionsAdenocarcinoma of the Gastroesophageal Junction, Esophageal CancerArmscetuximab, cisplatin, docetaxel, adjuvant therapy, neoadjuvant therapy
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  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

25 authors at 18 institutions in 3 countries.

Martin FehrDepartment of Medical Oncology and Haematology, Cantonal Hospital St. Gallen, Rorschacherstrasse 95, 9007, St. Gallen, Switzerland. Martin.Fehr@kssg.ch.ORCID http://orcid.org/0000-0003-2128-9061
Hanne HawleSAKK Coordinating Center, Bern, Switzerland.
Stefanie HayozSAKK Coordinating Center, Bern, Switzerland.
Peter Thuss-PatienceCharité - Universitätsmedizin Berlin, Berlin, Germany.
Sabina SchacherKantonsspital Winterthur, Winterthur, Switzerland.
Jorge Riera KnorrenschildUniversitätsklinikum Giessen und Marburg, Marburg, Germany.
Donat DürrStadtspital Triemli, Zürich, Switzerland.
Wolfram T KnoefelUniversitätsklinikum Düsseldorf, Düsseldorf, Germany.
Holger RumpoldKrankenhaus der barmherzigen Schwestern, Linz, Austria.
Michael BitzerUniversitätsklinikum Tübingen, Tübingen, Germany.
Martin ZweifelInselspital Bern, Bern, Switzerland.
Panagiotis SamarasUniversitätsspital Zürich, Zürich, Switzerland.
Ulrich MeyKantonsspital Graubünden, Chur, Switzerland.
Marc KüngHôpital Fribourgeois, Villars-sur-Glâne, Switzerland.
Ralph WinterhalderLuzerner Kantonsspital, Luzern, Switzerland.
Wolfgang EistererMedizinische Universität Innsbruck, Innsbruck, Austria.
Viviane HessUniversitätsspital Basel, Basel, Switzerland.
Marie-Aline GérardSAKK Coordinating Center, Bern, Switzerland.
Arnoud TempletonClaraspital Basel, Basel, Switzerland.
Michael StahlEvang. Kliniken Essen-Mitte, Essen, Germany.
Thomas RuhstallerDepartment of Medical Oncology and Haematology, Cantonal Hospital St. Gallen, Rorschacherstrasse 95, 9007, St. Gallen, Switzerland.
Swiss Group for Clinical Cancer Research (SAKK)
German Esophageal Cancer Study Group
Austrian Arbeitsgemeinschaft Medikamentöse Tumortherapie (AGMT)
Fédération Francophone de Cancérologie Digestive (FFCD) / Fédération de Recherche en Chirurgie (FRENCH)
Swiss Group For Clinical Cancer Research · CHTriemli Hospital · CHUniversitätsklinikum Gießen und Marburg · DEUniversity Hospital of Basel · CHUniversity Hospital of Bern · CHUniversity of Basel · CHCharité - Universitätsmedizin Berlin · DEDüsseldorf University Hospital · DEInnsbruck Medical University · ATKantonsspital Winterthur · CHKliniken Essen-Mitte · DEKlinikum Klagenfurt · ATLandeskrankenhaus Feldkirch · ATLuzerner Kantonsspital · CHSt. Claraspital · CHUniversitätsklinikum Tübingen · DEUniversity Hospital of Zurich · CHUniversity of St.Gallen · CH

Funding

Merck KGaA, Darmstadt, Germany No grant numer appliesStaatssekretariat für Bildung, Forschung und Innovation No grant number applies
6 · The paper itself

Abstract

backgroundHigh rates of venous thromboembolic events (VTEs), mainly in advanced disease, are reported for patients with cancer of the upper gastrointestinal tract (stomach, pancreas) and for treatment with cisplatin.

methodsExploratory analysis of VTEs reported as adverse events and serious adverse events in a prospective, randomised, multicentre, multimodal phase III trial according to VTEs reported as adverse events and severe adverse events. Patients with resectable oesophageal cancer (T2N1-3, T3-4aNx) were randomized to 2 cycles of chemotherapy with docetaxel 75 mg/m

resultsVTEs occurred in 26 of 300 patients included in the trial, resulting in an incidence rate (IR) of 8.7% [95% CI 5.7-12.4%]. A total of 29 VTEs were reported:13 (45%) VTEs were grade 2, 13 (45%) grade 3 and three (10%) fatal grade 5 events. 72% (21/29) of all VTEs occurred preoperatively (IR 6.7%): 14% (4/29) during chemotherapy and 59% (17/29) during CRT. In multivariable logistic regression only adenocarcinoma (IR 11.1%, 21/189 patients) compared to squamous cell cancer (IR 4.5%, 5/111 patients) was significantly associated with VTE-risk during treatment, OR 2.9 [95%CI 1.0-8.4], p = 0.046. Baseline Khorana risk score was 0 in 73% (19/26), 1-2 in 23% (6/26) and 3 in only 4% (1/26) of patients with VTEs.

conclusionA high incidence of VTEs during preoperative therapy of resectable oesophageal cancer is observed in this analysis, especially in patients with adenocarcinoma. The role of prophylactic anticoagulation during neoadjuvant therapy in resectable esophageal cancer should be further evaluated in prospective clinical trials. According to our data, which are in line with other analysis of VTE-risk in patients with oesophageal cancer patients treated with neoadjuvant cisplatin-based chemotherapy and CRT, prophylactic anticoagluation could be considered balanced against individual bleeding risks, especially in patients with adenocarcinoma. In addition to the established risk factors, oesophageal adenocarcinoma treated with neoadjuvant cisplatin-based therapy may be regarded as a high-risk situation for VTEs.

trial registrationRegistered at clinicaltrials.gov, NCT01107639, on 21 April 2010.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsCetuximabChemoradiotherapyCisplatinDigestive System Surgical ProceduresDocetaxelEsophageal NeoplasmsFemaleHumansIncidenceLogistic ModelsMaleMiddle AgedProspective StudiesCetuximabCisplatinDocetaxelAdenocarcinomaChemoradiotherapyCisplatinNeoadjuvant therapyOesophageal cancerPreoperative therapyThromboembolic eventsThrombosisVenous thrombosis

Identifiers

PMID32111181
PMCPMC7048062
OpenAlexW3012642228

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.