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dc.rights.licenseopenen_US
dc.contributor.authorTOULMONDE, Maud
dc.contributor.authorCOUSIN, Sophie
dc.contributor.authorKIND, Michele
dc.contributor.authorGUEGAN, Jean-Philippe
dc.contributor.authorBESSEDE, Alban
dc.contributor.authorLE LOARER, Francois
dc.contributor.authorPERRET, Raul
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorCANTAREL, Coralie
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorBELLERA, Carine
dc.contributor.authorITALIANO, Antoine
dc.date.accessioned2022-12-07T11:15:36Z
dc.date.available2022-12-07T11:15:36Z
dc.date.issued2022-10-21
dc.identifier.issn1756-8722 (Electronic) 1756-8722 (Linking)en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/170495
dc.description.abstractEnJX-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.
dc.language.isoENen_US
dc.rightsAttribution 3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by/3.0/us/*
dc.subject.enSoft-tissue sarcoma
dc.subject.enVirus oncolytics
dc.subject.enJX-594
dc.subject.enLow-dose cyclophosphamide
dc.title.enRandomized phase 2 trial of intravenous oncolytic virus JX-594 combined with low-dose cyclophosphamide in patients with advanced soft-tissue sarcoma
dc.typeArticle de revueen_US
dc.identifier.doi10.1186/s13045-022-01370-9en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed36271420en_US
bordeaux.journalJournal of Hematology and Oncologyen_US
bordeaux.page149en_US
bordeaux.volume15en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.issue1en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.teamEPICENE_BPHen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
bordeaux.identifier.funderIDInstitut National Du Canceren_US
bordeaux.identifier.funderIDAssociation pour la Recherche sur le Canceren_US
hal.identifierhal-04008638
hal.version1
hal.date.transferred2023-02-28T15:07:03Z
hal.exporttrue
dc.rights.ccPas de Licence CCen_US
bordeaux.COinSctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.jtitle=Journal%20of%20Hematology%20and%20Oncology&rft.date=2022-10-21&rft.volume=15&rft.issue=1&rft.spage=149&rft.epage=149&rft.eissn=1756-8722%20(Electronic)%201756-8722%20(Linking)&rft.issn=1756-8722%20(Electronic)%201756-8722%20(Linking)&rft.au=TOULMONDE,%20Maud&COUSIN,%20Sophie&KIND,%20Michele&GUEGAN,%20Jean-Philippe&BESSEDE,%20Alban&rft.genre=article


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