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A randomized phase ...
A randomized phase II trial of efficacy and safety of the immunotherapy ALECSAT as an adjunct to radiotherapy and temozolomide for newly diagnosed glioblastoma.
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- Werlenius, Katja (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för onkologi,Institute of Clinical Sciences, Department of Oncology,Sahlgrenska University Hospital,Sahlgrenska Academy
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- Stragliotto, Giuseppe (författare)
- Karolinska University Hospital
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- Strandeus, Michael (författare)
- Ryhov County Hospital, Jönköping
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- Blomstrand, Malin, 1974 (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för onkologi,Institute of Clinical Sciences, Department of Oncology,Sahlgrenska Academy,Sahlgrenska University Hospital
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- Carén, Helena, 1979 (författare)
- University of Gothenburg,Gothenburg University,Göteborgs universitet,Institutionen för biomedicin, avdelningen för laboratoriemedicin,Sahlgrenska Centrum för Cancerforskning (SCCR),Department of Laboratory Medicine,Sahlgrenska Center for Cancer Research (SCCR)
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- Jakola, Asgeir Store (författare)
- Sahlgrenska University Hospital
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- Rydenhag, Bertil, 1954 (författare)
- Sahlgrenska University Hospital
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- Dyregaard, Dorte (författare)
- Cytovac A/S
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- Dzhandzhugazyan, Karine N (författare)
- Cytovac A/S
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- Kirkin, Alexei F (författare)
- Cytovac A/S
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- Raida, Martin K (författare)
- Cytovac A/S
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- Smits, Anja (författare)
- Uppsala University,Uppsala universitet,Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för klinisk neurovetenskap,Institute of Neuroscience and Physiology, Department of Clinical Neuroscience,Landtblom: Neurovetenskap,Institute of Neuroscience and Physiology, Department of Clinical Neuroscience, Sahlgrenska Academy, University of Gothenburg , Gothenburg , Sweden
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- Kinhult, Sara (författare)
- Lund 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,Sahlgrenska Academy,Skåne University Hospital
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(creator_code:org_t)
- 2021-10-22
- 2021
- Engelska.
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Ingår i: Neuro-oncology advances. - : Oxford University Press (OUP). - 2632-2498. ; 3:1
- Relaterad länk:
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https://academic.oup...
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https://doi.org/10.1...
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https://uu.diva-port... (primary) (Raw object)
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http://dx.doi.org/10... (free)
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https://gup.ub.gu.se...
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https://doi.org/10.1...
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https://urn.kb.se/re...
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https://lup.lub.lu.s...
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Abstract
Ämnesord
Stäng
- There is an urgent need for effective treatments against glioblastoma (GBM). In this trial, we investigated the efficacy and safety of an adoptive cell-based immunotherapy.Patients with newly diagnosed GBM were recruited at 4 study sites in Sweden. The patients were randomized 1:2 to receive either radiotherapy (RT), 60 Gy/30 fractions, with concomitant and adjuvant temozolomide (TMZ) only, or RT and TMZ with the addition of Autologous Lymphoid Effector Cells Specific Against Tumor (ALECSAT) in an open-label phase II trial. The primary endpoint was investigator-assessed progression-free survival (PFS). The secondary endpoints were survival and safety of ALECSAT.Sixty-two patients were randomized to either standard of care (SOC) with RT and TMZ alone (n = 22) or SOC with ALECSAT (n = 40). Median age was 57 years (range 38-69), 95% of the patients were in good performance status (WHO 0-1). There was no significant difference between the study arms (SOC vs ALECSAT + SOC) in PFS (7.9 vs 7.8 months; hazard ratio [HR] 1.28; 95% confidence interval [CI] 0.70-2.36; P = .42) or in median overall survival (OS) (18.3 vs 19.2 months; HR 1.16, 95% CI 0.58-2.31; P = .67). The treatment groups were balanced in terms of serious adverse events (52.4% vs 52.5%), but adverse events ≥grade 3 were more common in the experimental arm (81.0% vs 92.5%).Addition of ALECSAT immunotherapy to standard treatment with radiochemotherapy was well tolerated but did not improve PFS or OS for patients with newly diagnosed GBM.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
Nyckelord
- ALECSAT
- adoptive cell therapy
- glioblastoma
- immunotherapy
- randomized trial
- ALECSAT
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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- Av författaren/redakt...
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Werlenius, Katja
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Stragliotto, Giu ...
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Strandeus, Micha ...
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Blomstrand, Mali ...
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Carén, Helena, 1 ...
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Jakola, Asgeir S ...
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Rydenhag, Bertil ...
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Dyregaard, Dorte
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Dzhandzhugazyan, ...
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Kirkin, Alexei F
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Raida, Martin K
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Smits, Anja
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Kinhult, Sara
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
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och Cancer och onkol ...
- Artiklar i publikationen
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Neuro-oncology a ...
- Av lärosätet
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Göteborgs universitet
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Uppsala universitet
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Lunds universitet