Evidence map›Paper›PMID 36271420›Full record

Trial reportJournal of hematology & oncology2022

Randomized phase 2 trial of intravenous oncolytic virus JX-594 combined with low-dose cyclophosphamide in patients with advanced soft-tissue sarcoma.

Maud Toulmonde, Sophie Cousin, Michèle Kind, Jean-Philippe Guegan, Alban Bessede, Francois Le Loarer, Raul Perret, Coralie Cantarel, Carine Bellera, Antoine Italiano

Open access · goldAbstract readRandomized Controlled TrialClinical Trial, Phase IILetter
In one paragraph

Trial report in Journal of hematology & oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 1 pooled it
8.8field-weighted citation impact, top 2% 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

35 citing papers in PubMed, 1 synthesis or guideline pooled it, 49 citations in OpenAlex.

  1. Pooled it
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  6. Review
  7. Article
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  15. Oncolytic viruses as cancer therapeutics: From mechanistic insights to clinical translation.Molecular therapy : the journal of the American Society of Gene Therapy · 2025
    Review
  16. Article
  17. Cancer vaccines: current status and future directions.Journal of hematology & oncology · 2025
    Review
  18. Review
  19. Review
  20. Translation of oncolytic viruses in sarcoma.Molecular therapy. Oncology · 2024
    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

10 authors at 3 institutions in 1 country.

Maud ToulmondeEarly Phase Trials and Sarcoma Units, Department of Medical Oncology, Institut Bergonié, 229 Cours de l'Argonne, Bordeaux, France.
Sophie CousinEarly Phase Trials and Sarcoma Units, Department of Medical Oncology, Institut Bergonié, 229 Cours de l'Argonne, Bordeaux, France.
Michèle KindDepartment of Medical Imaging, Institut Bergonié, Bordeaux, France.
Jean-Philippe GueganExplicyte, Bordeaux, France.
Alban BessedeExplicyte, Bordeaux, France.
Francois Le LoarerDepartment of Pathology, Institut Bergonié, Bordeaux, France.
Raul PerretDepartment of Pathology, Institut Bergonié, Bordeaux, France.
Coralie CantarelInserm, Bordeaux Population Health Research Center, Epicene Team, UMR 1219, Univ. Bordeaux, 33000, Bordeaux, France.
Carine BelleraInserm, Bordeaux Population Health Research Center, Epicene Team, UMR 1219, Univ. Bordeaux, 33000, Bordeaux, France.
Antoine ItalianoEarly Phase Trials and Sarcoma Units, Department of Medical Oncology, Institut Bergonié, 229 Cours de l'Argonne, Bordeaux, France. a.italiano@bordeaux.unicancer.fr.
Institut Bergonié · FRUniversité de Bordeaux · FRBordeaux Population Health · FR

Funding

Institut National Du Cancer CLIP2
6 · The paper itself

Abstract

JX-594 is an oncolytic vaccinia virus genetically modified to replicate selectively in tumor cells. Metronomic chemotherapy has shown preclinical synergy with oncolytic viruses. We report here the results of the METROMAJX which is a randomized phase II clinical trial investigating the combination of JX-594 combined with metronomic cyclophosphamide (arm 1) or metronomic cyclophosphamide (arm 2) in patients with advanced STS. A two-stage Simon design was used. JX-594 was administered intra-venously at the dose 1.109 every 2 weeks for the first 3 injections and then every 3 weeks. Cyclophosphamide was given orally at the dose of 50 mg BID 1 week on 1 week off. The primary endpoint was the 6-month non progression rate. 20 patients were included (arm 1:15, arm 2:5). The two most frequent toxicities were grade 1 fatigue and fever and grade 2 fatigue and grade 2 lymphopenia in arms 1 and 2, respectively. In arm 1, 12 patients were assessable for the efficacy analysis. None of them were progression-free at 6 months indicating that the first stage of the Simon's design was not satisfied. One patient out 4 assessable for efficacy was progression-free at 6 months in arm 2. High throughput analysis of sequential plasma samples revealed an upregulation of protein biomarkers reflecting immune induction such as CXCL10 and soluble CD8 antigen in arm 1. Systemic treatment with JX-594 is safe in patients with advanced STS. Further investigations are needed to improve immune response to oncolytic viruses and define their therapeutic potential in patients with STS.

Indexed as

Oncolytic VirusesSarcomaAntineoplastic Combined Chemotherapy ProtocolsCD8 AntigensCyclophosphamideFatigueHumansTreatment OutcomeCD8 AntigensCyclophosphamideJX-594Low-dose cyclophosphamideSoft-tissue sarcomaVirus oncolytics

Identifiers

PMID36271420
PMCPMC9585864
OpenAlexW4306973499

What OpenQuestion holds

Textmetadata
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.