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  • Werlenius, KatjaGothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för onkologi,Institute of Clinical Sciences, Department of Oncology,Department of Oncology, Sahlgrenska University Hospital, Gothenburg, Sweden; Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden,Sahlgrens Univ Hosp, Dept Oncol, Gothenburg, Sweden.;Univ Gothenburg, Sahlgrenska Acad, Inst Clin Sci, Dept Oncol, Gothenburg, Sweden. (författare)

Effect of Disulfiram and Copper Plus Chemotherapy vs Chemotherapy Alone on Survival in Patients With Recurrent Glioblastoma: A Randomized Clinical Trial.

  • Artikel/kapitelEngelska2023

Förlag, utgivningsår, omfång ...

  • 2023-03-31
  • American Medical Association (AMA),2023

Nummerbeteckningar

  • LIBRIS-ID:oai:gup.ub.gu.se/325259
  • https://gup.ub.gu.se/publication/325259URI
  • https://doi.org/10.1001/jamanetworkopen.2023.4149DOI
  • https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-105313URI
  • https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-520223URI
  • https://lup.lub.lu.se/record/434b5399-d57d-4f9f-91b5-0d3352a184bdURI
  • https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-198092URI
  • http://kipublications.ki.se/Default.aspx?queryparsed=id:153679759URI

Kompletterande språkuppgifter

  • Språk:engelska

Ingår i deldatabas

Klassifikation

  • Ämneskategori:ref swepub-contenttype
  • Ämneskategori:art swepub-publicationtype

Anmärkningar

  • Funding agencies:AG foundationSahlgrenska FoundationNordic Cancer UnionSwedish county councils concerning economic support of research and education of doctors (ALF-agreement) ALFGBG-716671 ALFGBG-933972
  • Funding Agencies|Swedish government [ALFGBG-716671, ALFGBG-933972]; AG foundation; Sahlgrenska Foundation; Nordic Cancer Union; Swedish Society of Medicine [SLS-681721]; Swedish Cancer Society [CAN 2018/452]; Swedish county councils concerning economic support of research and education of doctors (ALF-agreement) [ALFGBG-716671, ALFGBG-933972]
  • Disulfiram has demonstrated broad antitumoral effect in several preclinical studies. One of the proposed indications is for the treatment of glioblastoma.To evaluate the efficacy and safety of disulfiram and copper as add-on to alkylating chemotherapy in patients with recurrent glioblastoma.This was a multicenter, open-label, randomized phase II/III clinical trial with parallel group design. Patients were recruited at 7 study sites in Sweden and 2 sites in Norway between January 2017 and November 2020. Eligible patients were 18 years or older, had a first recurrence of glioblastoma, and indication for treatment with alkylating chemotherapy. Patients were followed up until death or a maximum of 24 months. The date of final follow-up was January 15, 2021. Data analysis was performed from February to September 2022.Patients were randomized 1:1 to receive either standard-of-care (SOC) alkylating chemotherapy alone, or SOC with the addition of disulfiram (400 mg daily) and copper (2.5 mg daily).The primary end point was survival at 6 months. Secondary end points included overall survival, progression-free survival, adverse events, and patient-reported quality of life.Among the 88 patients randomized to either SOC (n=45) or SOC plus disulfiram and copper (n=43), 63 (72%) were male; the mean (SD) age was 55.4 (11.5) years. There was no significant difference between the study groups (SOC vs SOC plus disulfiram and copper) in 6 months survival (62% [26 of 42] vs 44% [19 of 43]; P=.10). Median overall survival was 8.2 months (95% CI, 5.4-10.2 months) with SOC and 5.5 months (95% CI, 3.9-9.3 months) with SOC plus disulfiram and copper, and median progression-free survival was 2.6 months (95% CI, 2.4-4.6 months) vs 2.3 months (95% CI, 1.7-2.6 months), respectively. More patients in the SOC plus disulfiram and copper group had adverse events grade 3 or higher (34% [14 of 41] vs 11% [5 of 44]; P=.02) and serious adverse events (41% [17 of 41] vs 16% [7 of 44]; P=.02), and 10 patients (24%) discontinued disulfiram treatment because of adverse effects.This randomized clinical trial found that among patients with recurrent glioblastoma, the addition of disulfiram and copper to chemotherapy, compared with chemotherapy alone, resulted in significantly increased toxic effects, but no significant difference in survival. These findings suggest that disulfiram and copper is without benefit in patients with recurrent glioblastoma.ClinicalTrials.gov Identifier: NCT02678975; EUDRACT Identifier: 2016-000167-16.

Ämnesord och genrebeteckningar

Biuppslag (personer, institutioner, konferenser, titlar ...)

  • Kinhult, SaraLund University,Lunds universitet,Tumörmikromiljö,Sektion I,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,LUCC: Lunds universitets cancercentrum,Övriga starka forskningsmiljöer,Tumor microenvironment,Section I,Department of Clinical Sciences, Lund,Faculty of Medicine,LUCC: Lund University Cancer Centre,Other Strong Research Environments,Lund Univ, Sweden(Swepub:lu)onk-sk0 (författare)
  • Solheim, Tora SkeidsvollDepartment of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway; Cancer Clinic, St Olavs Hospital, Trondheim, Norway,Norwegian Univ Sci & Technol, Dept Clin & Mol Med, Fac Med & Hlth Sci, Trondheim, Norway.;St Olavs Hosp, Canc Clin, Trondheim, Norway. (författare)
  • Magelssen, HenrietteDepartment of Oncology, Oslo University Hospital, Oslo, Norway,Oslo Univ Hosp, Dept Oncol, Oslo, Norway. (författare)
  • Löfgren, David,1977-Örebro universitet,Institutionen för medicinska vetenskaper,Department of Oncology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden,Örebro Univ, Fac Med & Hlth, Dept Oncol, Örebro, Sweden.(Swepub:oru)dln (författare)
  • Mudaisi, MunilaKarolinska Institutet,Linköpings universitet,Avdelningen för kirurgi, ortopedi och onkologi,Medicinska fakulteten,Region Östergötland, Onkologiska kliniken US,Finnmark Hosp, Norway(Swepub:liu)munmu89 (författare)
  • Hylin, SofiaDepartment of Neurology, Karolinska University Hospital, Stockholm, Sweden,Karolinska Univ Hosp, Dept Neurol, Stockholm, Sweden. (författare)
  • Bartek, JiriKarolinska Institutet,Karolinska Institute,Karolinska University Hospital,Copenhagen University Hospital,Danish Cancer Society,Karolinska Univ Hosp, Sweden; Karolinska Inst, Sweden; Rigshosp, Denmark; Karolinska Inst, Sweden; Danish Canc Soc Res Ctr, Denmark (författare)
  • Strandéus, MichaelDepartment of Oncology, County Hospital Ryhov, Jönköping, Sweden,Cty Hosp Ryhov, Dept Oncol, Jönköping, Sweden. (författare)
  • Lindskog, MagnusUppsala University,Uppsala universitet,Cancerprecisionsmedicin,Karolinska Univ Hosp, Dept Pelv Canc, Sect Genitourinary Oncol, Stockholm, Sweden.,Karolinska University Hospital,Uppsala Univ, Sweden; Karolinska Univ Hosp, Sweden(Swepub:uu)magli409 (författare)
  • Rashid, Havyan BahrozSahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden,Univ Gothenburg, Sahlgrenska Acad, Gothenburg, Sweden. (författare)
  • Carstam, LouiseGothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för klinisk neurovetenskap,Institute of Neuroscience and Physiology, Department of Clinical Neuroscience,Department of Neurosurgery, Sahlgrenska University Hospital, Gothenburg, Sweden; Institute of Neuroscience and Physiology, Department of Clinical Neuroscience, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden,Sahlgrens Univ Hosp, Dept Neurosurg, Gothenburg, Sweden.;Univ Gothenburg, Inst Neurosci & Physiol, Sahlgrenska Acad, Dept Clin Neurosci, Gothenburg, Sweden.(Swepub:gu)xcarsl (författare)
  • Gulati, SashaDepartment of Neurosurgery, St Olavs Hospital, Trondheim, Norway; Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology, Trondheim, Norway,St Olavs Hosp, Dept Neurosurg, Trondheim, Norway.;Norwegian Univ Sci & Technol, Dept Neuromed & Movement Sci, Trondheim, Norway. (författare)
  • Solheim, OleDepartment of Neurosurgery, St Olavs Hospital, Trondheim, Norway; Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology, Trondheim, Norway,St Olavs Hosp, Dept Neurosurg, Trondheim, Norway.;Norwegian Univ Sci & Technol, Dept Neuromed & Movement Sci, Trondheim, Norway. (författare)
  • Bartek, Jiri (författare)
  • Salvesen, ØyvindDepartment of Public Health and Nursing, Norwegian University of Science and Technology, Trondheim, Norway,Norwegian Univ Sci & Technol, Dept Publ Hlth & Nursing, Trondheim, Norway. (författare)
  • Jakola, Asgeir StoreGothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för klinisk neurovetenskap,Institute of Neuroscience and Physiology, Department of Clinical Neuroscience,Department of Neurosurgery, Sahlgrenska University Hospital, Gothenburg, Sweden; Institute of Neuroscience and Physiology, Department of Clinical Neuroscience, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Neurosurgery, St Olavs Hospital, Trondheim, Norway,Sahlgrens Univ Hosp, Dept Neurosurg, Gothenburg, Sweden.;Univ Gothenburg, Inst Neurosci & Physiol, Sahlgrenska Acad, Dept Clin Neurosci, Gothenburg, Sweden.;St Olavs Hosp, Dept Neurosurg, Trondheim, Norway.(Swepub:gu)xjakas (författare)
  • Salvesen, O (författare)
  • Göteborgs universitetInstitutionen för kliniska vetenskaper, Avdelningen för onkologi (creator_code:org_t)

Sammanhörande titlar

  • Ingår i:JAMA network open: American Medical Association (AMA)6:32574-3805

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