Evidence map›Paper›PMID 31199595›Full record

Trial reportCancer medicine2019

Evaluation of EGFR inhibitor-mediated acneiform skin toxicity within the double-blind randomized EVITA trial: A thorough gender-specific analysis using the WoMo score.

Maria R Gaiser, Sylvie Lorenzen, Kirsten Merx, Jörg Trojan, Janja Ocvirk, Thomas J Ettrich, Salah-Eddin Al-Batran, Holger Schulz, Nils Homann, Hans-Peter Feustel and 7 more

Open access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Cancer medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.1field-weighted citation impact, top 23% 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

4 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. 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

17 authors at 12 institutions in 4 countries.

Maria R GaiserDepartment of Dermatology, Venereology and Allergology, University Medical Center Mannheim, Ruprecht-Karl University of Heidelberg, Mannheim, Germany.ORCID 0000-0002-7936-8865
Sylvie LorenzenMedical Clinic III, University of Munich, Munich, Germany.
Kirsten MerxInterdisciplinary Tumor Center Mannheim, University Medical Center Mannheim, Ruprecht-Karl University of Heidelberg, Mannheim, Germany.
Jörg TrojanMedical Clinic I, University Hospital Frankfurt, Frankfurt, Germany.ORCID 0000-0001-9414-378X
Janja OcvirkInstitute of Oncology, Ljubljana, Slovenia.
Thomas J EttrichMedical Clinic I, University Hospital Ulm, Ulm, Germany.
Salah-Eddin Al-BatranInstitute of Clinical Cancer Research (IKF) at Nordwest Hospital, UCT-University Cancer Center, Frankfurt, Germany.
Holger SchulzOncological Practice, Frechen, Germany.
Nils HomannMedical Clinic II Wolfsburg, Wolfsburg, Germany.
Hans-Peter FeustelHämatologisch-Onkologische Praxis, Speyer, Germany.
Michael SchatzMedizinische Klinik II, ViDia Christliche Kliniken Karlsruhe, Karlsruhe, Germany.
Melanie KrippInterdisciplinary Tumor Center Mannheim, University Medical Center Mannheim, Ruprecht-Karl University of Heidelberg, Mannheim, Germany.
Nadine SchulteInterdisciplinary Tumor Center Mannheim, University Medical Center Mannheim, Ruprecht-Karl University of Heidelberg, Mannheim, Germany.
Steffen HeegerMannheim, Germany.
Soetkin VlassakNeervelp, Belgium.
Winfried KochBDS Koch, Schwetzingen, Germany.
Ralf-Dieter HofheinzInterdisciplinary Tumor Center Mannheim, University Medical Center Mannheim, Ruprecht-Karl University of Heidelberg, Mannheim, Germany.
Heidelberg University · DEGoethe University Frankfurt · DEAngiologica (Italy) · ITCase Western Reserve University · USFraunhofer Project Centre Wolfsburg · DEGerman Cancer Research Center · DEInstitute of Oncology Ljubljana · SIMünchen Klinik · DEPraxis für Hämatologie und Onkologie · DESchwetzingen Technical Institute & Graduate Court Registrars' College · DESt. Vincentius-Kliniken · DEUniversity Hospital Ulm · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Acne-like skin reactions frequently occur in patients undergoing treatment with drugs inhibiting the epidermal growth factor receptor. Recently, the effects of vitamin K1 containing cream (Reconval K1) as prophylactic skin treatment in addition to doxycycline were explored in a double-blind randomized phase II trial (EVITA) in patients with metastatic colorectal cancer receiving cetuximab. EVITA demonstrated a trend towards less severe skin rash in Reconval K1-treated patients using the tripartite WoMo skin reaction grading score as a thorough tool for quantification of drug related skin reactions. This gender-specific analysis of the EVITA trial evaluated the application of the WoMo score for assessment of epidermal growth factor receptor (EGFR)-related skin toxicities according to treatment arm and gender. To show the robustness of results parametric and non-parametric statistical analyses were conducted. All three parts of the WoMo score independently demonstrated the superiority of the treatment arm (Reconval K1) regarding a significant reduction in acneiform skin reactions in women. Men did not benefit from Reconval K1 cream at any time point in none of the WoMo score analyses. The treatment effect in women was confirmed by the use of skin rash categories based on the final WoMo overall score and mixed effect longitudinal multiple linear regression analysis. The WoMo score represents a sensitive tool for studies exploiting treatments against EGFR mediated acne-like skin rash. Part C of the WoMo score seems to be sufficient for quantification of drug related skin toxicities in further studies. Standard WoMo skin reaction score values for future studies are provided.

Indexed as

Acneiform EruptionsAdultAgedAged, 80 and overCetuximabColorectal NeoplasmsDouble-Blind MethodErbB ReceptorsFemaleHumansMaleMiddle AgedNeoplasm MetastasisProtein Kinase InhibitorsSex CharacteristicsSkin CreamCetuximabEGFR protein, humanErbB ReceptorsProtein Kinase InhibitorsVitamin K 1acneiform skin toxicityEGFR inhibitorwomenWoMo score

Identifiers

PMID31199595
PMCPMC6675717
OpenAlexW2953327475

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.