Evidence map›Paper›PMID 35763178›Full record

Trial reportInvestigational new drugs2022

Phase II study of Disulfiram and Cisplatin in Refractory Germ Cell Tumors. The GCT-SK-006 phase II trial.

M Mego, D Svetlovska, De Angelis V, K Kalavska, P Lesko, M Makovník, J Obertova, Z Orszaghova, P Palacka, M Rečková and 4 more

Abstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Investigational new drugs, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
4.6field-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

18 citing papers in PubMed, 23 citations in OpenAlex.

  1. Trial
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  13. Targeting cuproplasia and cuproptosis in cancer.Nature reviews. Clinical oncology · 2024
    Review
  14. Science advances · 2024
    Article
  15. Article
  16. Review
  17. Review
  18. Disulfiram: Mechanisms, Applications, and Challenges.Antibiotics (Basel, Switzerland) · 2023
    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

14 authors at 2 institutions in 1 country.

M MegoTranslational Research Unit, Faculty of Medicine, Comenius University, National Cancer Institute, Bratislava, Slovakia. misomego@gmail.com.
D SvetlovskaTranslational Research Unit, Faculty of Medicine, Comenius University, National Cancer Institute, Bratislava, Slovakia.
De Angelis VNational Cancer Institute, Bratislava, Slovakia.
K KalavskaTranslational Research Unit, Faculty of Medicine, Comenius University, National Cancer Institute, Bratislava, Slovakia.
P Lesko2nd Department of Oncology, Faculty of Medicine, Comenius University and National Cancer Institute, Klenova 1, 833 10, Bratislava, Slovakia.
M Makovník2nd Department of Oncology, Faculty of Medicine, Comenius University and National Cancer Institute, Klenova 1, 833 10, Bratislava, Slovakia.
J Obertova2nd Department of Oncology, Faculty of Medicine, Comenius University and National Cancer Institute, Klenova 1, 833 10, Bratislava, Slovakia.
Z Orszaghova2nd Department of Oncology, Faculty of Medicine, Comenius University and National Cancer Institute, Klenova 1, 833 10, Bratislava, Slovakia.
P Palacka2nd Department of Oncology, Faculty of Medicine, Comenius University and National Cancer Institute, Klenova 1, 833 10, Bratislava, Slovakia.
M RečkováNational Cancer Institute, Bratislava, Slovakia.
K Rejlekova2nd Department of Oncology, Faculty of Medicine, Comenius University and National Cancer Institute, Klenova 1, 833 10, Bratislava, Slovakia.
Sycova-Mila ZNational Cancer Institute, Bratislava, Slovakia.
J Mardiak2nd Department of Oncology, Faculty of Medicine, Comenius University and National Cancer Institute, Klenova 1, 833 10, Bratislava, Slovakia.
M Chovanec2nd Department of Oncology, Faculty of Medicine, Comenius University and National Cancer Institute, Klenova 1, 833 10, Bratislava, Slovakia.
National Institute of Cardiovascular Diseases · SKComenius University Bratislava · SK

Funding

Ministry of Health, Slovakia MZ SR 2018/39-LFUK-13Slovak Research and Development Agency APVV-20-0158VEGA VEGA 1/0349/21
6 · The paper itself

Abstract

backgroundMultiple relapsed/refractory germ cell tumor (GCT) patients have extremely poor prognosis. Cisplatin resistant testicular GCTs overexpress aldehyde-dehydrogenase (ALDH) isoforms and inhibition of ALDH activity by disulfiram is associated with reconstitution of cisplatin sensitivity in vitro as well as in animal model. This study aimed to determine the efficacy and toxicity of ALDH inhibitor disulfiram in combination with cisplatin in patients with multiple relapsed/refractory GCTs.

methodsDisulfiram was administered at a dose of 400 mg daily until progression or unacceptable toxicity, cisplatin was administered at dose 50 mg/m

resultsTwelve patients with multiple relapsed/refractory GCTs were enrolled in the phase II study from May 2019 to September 2021. Median number of treatment cycles was 2 (range 1-6). None of patients achieved objective response to treatment, therefore the study was terminated in first stage. Median progression-free survival was 1.4 months, 95% CI (0.7-1.5 months), and median overall survival was 2.9 months 95% CI (1.5-4.7 months). Disease stabilization for at least 3 months was observed in 2 (16.7%) patients. Treatment was well tolerated, however, 5 (41.7%) of patients experienced grade 3/4 fatigue, 4 (33.3%) thrombocytopenia, 3 (25.0%) anemia, while 2 (16.7%) experienced neutropenia, nausea and infection.

conclusionsThis study failed to achieve its primary endpoint and our data suggest limited efficacy of disulfiram in restoring sensitivity to cisplatin in multiple relapsed/refractory GCTs.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsNeoplasms, Germ Cell and EmbryonalTesticular NeoplasmsCisplatinDisulfiramDrug Resistance, NeoplasmHumansMaleCisplatinDisulfiramALDHCisplatinDisulfiramGerm cell tumoursRefractory

Identifiers

PMID35763178
OpenAlexW4283662511

What OpenQuestion holds

Textmetadata
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.