Evidence map›Paper›PMID 30962963›Full record

ArticleESMO open2019

Phase I clinical trial of decitabine (5-aza-2'-deoxycytidine) administered by hepatic arterial infusion in patients with unresectable liver-predominant metastases.

Yanina J L Jansen, Gontran Verset, Kelly Schats, Pieter-Jan Van Dam, Teofila Seremet, Mark Kockx, Jean-Luc B Van Laethem, Bart Neyns

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in ESMO open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02316028 (A Phase I Clinical Trial on Decitabine), which is not on this map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
2.3field-weighted citation impact, top 10% 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.

NCT02316028 phase1 / phase2completednot on this map

A Phase I Clinical Trial on Decitabine (5-aza-2'-Deoxycytidine) Administered by Hepatic Arterial Infusion in Patients With Unresectable Liver-predominant Metastases From Colorectal Cancer

TypeinterventionalSponsorUniversitair Ziekenhuis BrusselRan2014 to 2017Enrolled11ConditionsLiver Metastasis, Colorectal CancerArmsDecitabine
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 35 citations in OpenAlex.

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  17. Targeting Epigenetic Modifications in Uveal Melanoma.International journal of molecular sciences · 2020
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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

8 authors at 4 institutions in 2 countries.

Yanina J L JansenOncology, Universitair ziekenhuis Brussel, Brussel, Belgium.
Gontran VersetOncology, Hopital Erasme, Bruxelles, Belgium.
Kelly SchatsAnatomopathology, Histogenex, Antwerp, Belgium.
Pieter-Jan Van DamHistoGeneX NV, Edegem, Belgium.
Teofila SeremetOncology, Universitair ziekenhuis Brussel, Brussel, Belgium.
Mark KockxHistoGeneX NV, Edegem, Belgium.
Jean-Luc B Van LaethemEpidemiology, Netherlands Cancer Institute, Amsterdam, The Netherlands.
Bart NeynsOncology, Universitair ziekenhuis Brussel, Brussel, Belgium.
HistoGeneX (Belgium) · BEUniversitair Ziekenhuis Brussel · BEErasmus Hospital · BEThe Netherlands Cancer Institute · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

DNA demethylating agents may increase the immunogenicity of malignant tumours and increase the efficacy of subsequent treatment with immune check point inhibitors. We investigated the safety of administrating the demethylating agent decitabine by hepatic arterial infusionin patients with unresectable liver meta stases from solid tumours in a dose escalation phase I clinical trial. A total of nine eligible patients were enrolled and initiated study treatment at three different dose levels (two patients at 10, four at 15 and six at a dose level of 20mg decitabine/m2/day) (per protocol there was no intent to escalate the dose above the median tolerated intravenous dose level). Decitabine was administered as a 1-hour hepatic arterial infusion on five consecutive days every 4 weeks. Intrapatient dose escalation was applied in five patients. Grades 1 and 2 haematological toxicity was the most frequent treatment-related adverse event. None of the patients experienced treatment-limiting adverse events. Expression analysis of 30 cancer test is antigens (CTA) in pretreatment and post-treatment biopsies from patients indicated an increased expression of 21 CTAs after treatment. There were no objective tumour responses on study treatment or during post study exposure to immune checkpoint therapy in four patients with uveal melanoma liver metastases. We conclude that the investigate d hepatic arterial administration regimen for decitabine can be safely applied, and a dose level of 20 mg/m2/day on five consecutive days every 4 weeks can be considered for further investigation in combinatorial immunotherapy regimens. TRIAL REGISTRATION NUMBER: NCT02316028.

Indexed as

decitabinehepatic arterial infusionliver metastases

Identifiers

PMID30962963
PMCPMC6435241
OpenAlexW2921351676

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.