Evidence map›Paper›PMID 37536940›Full record

Trial reportJournal for immunotherapy of cancer2023

Adjuvant dendritic cell-based immunotherapy after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy in patients with malignant peritoneal mesothelioma: a phase II clinical trial.

Michelle V Dietz, Katrien L A Quintelier, Job P van Kooten, Nadine L de Boer, Madelief Vink, Alexandra R M Brandt-Kerkhof, Cornelis Verhoef, Yvan Saeys, Joachim G J V Aerts, Marcella Willemsen and 2 more

Open access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
4.4field-weighted citation impact, top 5% 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, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

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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

12 authors at 2 institutions in 2 countries.

Michelle V DietzDepartment of Surgical oncology, Erasmus Medical Center, Rotterdam, The Netherlands.ORCID 0000-0002-4304-3022
Katrien L A QuintelierData Mining and Modeling for Biomedicine Group, VIB-UGent Center for Inflammation Research Elewaut Unit Molecular Immunology and Inflammatory Unit, Gent, Oost-Vlaanderen, Belgium.ORCID 0000-0001-5306-5615
Job P van KootenDepartment of Surgical oncology, Erasmus Medical Center, Rotterdam, The Netherlands.
Nadine L de BoerDepartment of Surgical oncology, Erasmus Medical Center, Rotterdam, The Netherlands.
Madelief VinkDepartment of Pulmonary Medicine, Erasmus Medical Center, Rotterdam, Zuid-Holland, The Netherlands.
Alexandra R M Brandt-KerkhofDepartment of Surgical oncology, Erasmus Medical Center, Rotterdam, The Netherlands.
Cornelis VerhoefDepartment of Surgical oncology, Erasmus Medical Center, Rotterdam, The Netherlands.
Yvan SaeysData Mining and Modeling for Biomedicine Group, VIB-UGent Center for Inflammation Research Elewaut Unit Molecular Immunology and Inflammatory Unit, Gent, Oost-Vlaanderen, Belgium.
Joachim G J V AertsDepartment of Pulmonary Medicine, Erasmus Medical Center, Rotterdam, Zuid-Holland, The Netherlands.ORCID 0000-0001-6662-2951
Marcella WillemsenDepartment of Pulmonary Medicine, Erasmus Medical Center, Rotterdam, Zuid-Holland, The Netherlands.
Sofie Van GassenData Mining and Modeling for Biomedicine Group, VIB-UGent Center for Inflammation Research Elewaut Unit Molecular Immunology and Inflammatory Unit, Gent, Oost-Vlaanderen, Belgium.
Eva V E MadsenDepartment of Surgical oncology, Erasmus Medical Center, Rotterdam, The Netherlands e.madsen@erasmusmc.nl.
Erasmus MC · NLGhent University · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMalignant peritoneal mesothelioma (MPM) is an aggressive malignancy with a poor prognosis. Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) improves survival outcomes, but recurrence rates remain high. Dendritic cell-based immunotherapy (DCBI) showed promising results in patients with pleural mesothelioma. The primary aim of this trial was to determine feasibility of adjuvant DCBI after CRS-HIPEC.

methodsThis open-label, single-center, phase II clinical trial, performed in the Erasmus MC Cancer Institute Rotterdam, the Netherlands, included patients with epithelioid MPM. 4-6 weeks before CRS-HIPEC leukapheresis was performed. 8-10 weeks after surgery, DCBI was administered three times biweekly. Feasibility was defined as administration of at least three adjuvant vaccinations in 75% of patients. Comprehensive immune cell profiling was performed on peripheral blood samples prior to and during treatment.

resultsAll patients who received CRS-HIPEC (n=16) were successfully treated with adjuvant DCBI. No severe toxicity related to DCBI was observed. Median progression-free survival (PFS) was 12 months (IQR 5-23) and median overall survival was not reached. DCBI was associated with increased proliferation of circulating natural killer cells and CD4+ T-helper (Th) cells. Co-stimulatory molecules, including ICOS, HLA-DR, and CD28 were upregulated predominantly on memory or proliferating Th-cells and minimally on CD8+ cytotoxic T-lymphocytes (CTLs) after treatment. However, an increase in CD8+ terminally differentiated effector memory (Temra) cells positively correlated with PFS, whereas co-expression of ICOS and Ki67 on CTLs trended towards a positive correlation.

conclusionsAdjuvant DCBI after CRS-HIPEC in patients with MPM was feasible and safe, and showed promising survival outcomes. DCBI had an immune modulatory effect on lymphoid cells and induced memory T-cell activation. Moreover, an increase of CD8+ Temra cells was more pronounced in patients with longer PFS. These data provide rationale for future combination treatment strategies. TRIAL REGISTRATION NUMBER: NTR7060; Dutch Trial Register (NTR).

Indexed as

Hyperthermia, InducedMesotheliomaMesothelioma, MalignantPeritoneal NeoplasmsAdjuvants, ImmunologicAntineoplastic Combined Chemotherapy ProtocolsCytoreduction Surgical ProceduresDendritic CellsHumansHyperthermic Intraperitoneal ChemotherapyImmunotherapyAdjuvants, ImmunologicCD4-positive T-lymphocytesCD8-positive T-lymphocytesclinical trials, phase II as topicdendritic cellsimmunotherapy

Identifiers

PMID37536940
PMCPMC10401259
OpenAlexW4385532328

What Socratic holds

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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 Socratic graph.