Evidence map›Paper›PMID 32923171›Full record

Trial reportOncoimmunology2020

Adjuvant MUC vaccination with tecemotide after resection of colorectal liver metastases: a randomized, double-blind, placebo-controlled, multicenter AIO phase II trial (LICC).

Carl Christoph Schimanski, Stefan Kasper, Susanna Hegewisch-Becker, Jan Schröder, Friedrich Overkamp, Frank Kullmann, Wolf Otto Bechstein, Matthias Vöhringer, Robert Öllinger, Florian Lordick and 10 more

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

Trial report in Oncoimmunology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
1.5field-weighted citation impact, top 17% 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

14 citing papers in PubMed, 27 citations in OpenAlex.

  1. Review
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  5. Article
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  7. Article
  8. [Research Progress of Lung Cancer Vaccines].Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2023
    Review
  9. Review
  10. Review
  11. Review
  12. Nanodrugs Targeting T Cells in Tumor Therapy.Frontiers in immunology · 2022
    Review
  13. Review
  14. Review
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

20 authors at 17 institutions in 4 countries.

Carl Christoph SchimanskiMedical Department 1, Johannes Gutenberg University, Mainz, Germany.ORCID 0000-0002-0544-8969
Stefan KasperDepartment of Medical Oncology, West German Cancer Center, University Hospital Essen, Essen, Germany.
Susanna Hegewisch-BeckerHematological and Oncological Practice Eppendorf (HOPE), Practice for Oncology, Hamburg, Germany.
Jan SchröderPractice for Hematology and Oncology, Müllheim a.d.R., Germany.
Friedrich OverkampOncologianova GmbH Recklinghausen, Recklinghausen, Germany.
Frank KullmannDepartment of Medicine I, Nordoberpfalz Clinics AG, Weiden i.d.O, Germany.
Wolf Otto BechsteinDepartment of General and Visceral Surgery, Frankfurt University Hospital and Clinics, Frankfurt, Germany.
Matthias VöhringerDepartment of Hematology and Oncology, Robert Bosch Hospital, Stuttgart, Germany.
Robert ÖllingerDepartment of Surgery, Campus Charité Mitte and Campus Virchow-Klinikum, Charité-Universitätsmedizin Berlin, Berlin, Germany.
Florian LordickUniversity Cancer Center Leipzig (UCCL), University Hospital Leipzig, Leipzig, Germany.
Volker HeinemannDepartment of Medical Oncology and Comprehensive Cancer Center, University Hospital Grosshadern, Ludwig Maximilian University of Munich, Munich, Germany.
Michael GeißlerDepartment of Internal Medicine, Oncology/Hematology, Gastroenterology, Hospital Esslingen GmbH, Esslingen, Germany.
Armin Schulz-AbeliusDepartment of Hematology and Oncology, Hospital Altenburger Land GmbH, Altenburg, Germany.
Helga BernhardDepartment of Hematology/Oncology, Klinikum Darmstadt GmbH, Darmstadt, Germany.
Michael R SchönClinic of Visceral Surgery, Municipal Hospital Karlsruhe gGmbH, Karlsruhe, Germany.
Richard GreilDepartment of Internal Medicine III, Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-CCCIT, Cancer Cluster, Salzburg, Austria.
Peter GalleMedical Department 1, Johannes Gutenberg University, Mainz, Germany.
Hauke LangDepartment of General, Visceral and Transplantation Surgery, University Hospital of Mainz, Mainz, Germany.ORCID 0000-0001-9303-2148
Irene SchmidtmannInstitute for Medical Biostatistics, Epidemiology and Informatics, Johannes Gutenberg-University Mainz, Mainz, Germany.
Markus MoehlerMedical Department 1, Johannes Gutenberg University, Mainz, Germany.
Johannes Gutenberg University Mainz · DECharité - Universitätsmedizin Berlin · DEEppendorf (Germany) · DEGoethe University Frankfurt · DEKlinikum Altenburger Land · DEKlinikum Darmstadt · DEKlinikum Esslingen · DEKlinikum Weiden · DEKnappschaftskrankenhaus Recklinghausen · DELudwig-Maximilians-Universität München · DEParacelsus Medical University · ATRobert Bosch Hospital · DERuhr West University of Applied Sciences · DEStädtisches Klinikum Karlsruhe · DEUniversity Hospital Leipzig · DEUniversity of Applied Sciences Mainz · DEWest Cancer Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Resection of colorectal liver metastases (CRLM) is a potential curative treatment for patients with metastatic colorectal cancer (mCRC) with liver-limited disease (LLD). Although long-term survival improved considerably within the last decades, high recurrence rates of 50-75% after resection remain a major challenge.Tecemotide (L-BLP25) is an antigen-specific cancer vaccine inducing immunity against mucin-1 (MUC1). The LICC trial aimed to improve survival in patients with mCRC after R0/R1 resection of CRLM. LICC was a binational, randomized, double-blind, placebo-controlled, multicenter phase 2 study including patients with R0/R1 resected CRLM without evidence of metastatic disease outside the liver. Co-primary endpoints were recurrence-free survival (RFS) and 3-year overall survival (OS) rate, secondary endpoints were RFS and OS in subgroups with different MUC1 expression and safety. In total, 121 patients were 2:1 randomized between Oct 2011 and Dec 2014to receive tecemotide (N=79) or placebo (N=42). Baseline characteristics were well balanced. Median RFS was 6.1 months (95% CI 4.5-8.9) and 11.4 months (95% CI 3.7-21.2) ( Abbreviations: AE: adverse event; CP: cyclophosphamide; CRC: colorectal cancer; CT: computed tomography; ECOG: Eastern Cooperative Oncology Group; FU: follow-up; HR: hazard ratio; IHC: immunohistochemical staining; ITT: intention-to-treat; DSMB: Data Safety Monitoring Board; LLD: liver-limited disease; mCRC: metastatic colorectal cancer; MPLA: monophosphoryl lipid; AMRI: magnetic resonance imaging; MUC1: mucin 1; NA: not applicable; NCI-CTCAE: National Cancer Institute Common Terminology Criteria for Adverse Events; NS: normal saline; NSCLC: non-small-cell lung carcinoma; OS: overall surviva; lPP: per protocol; RAS: Rat sarcoma; RFS: recurrence-free survival; TEAE: treatment-emergent adverse event; UICC: Union for International Cancer Control; US: ultrasound; vs.: versus.

Indexed as

Cancer VaccinesCarcinoma, Non-Small-Cell LungColorectal NeoplasmsLiver NeoplasmsLung NeoplasmsGermanyHumansMembrane GlycoproteinsNeoplasm Recurrence, LocalVaccinationCancer VaccinesL-BLP25Membrane Glycoproteinscolorectal Neoplasmsliver-limited diseasemucin-1 (MUC1)resection of colorectal liver metastasesTecemotide (L-BLP25)

Identifiers

PMID32923171
PMCPMC7458621
OpenAlexW3080548139

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.