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FältnamnIndikatorerMetadata
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001oai:gup.ub.gu.se/320131
003SwePub
008240528s2022 | |||||||||||000 ||eng|
009oai:DiVA.org:umu-194916
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024a https://gup.ub.gu.se/publication/3201312 URI
024a https://doi.org/10.1016/j.euros.2022.03.0122 DOI
024a https://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-1949162 URI
024a http://kipublications.ki.se/Default.aspx?queryparsed=id:1498406592 URI
024a https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-4785782 URI
040 a (SwePub)gud (SwePub)umud (SwePub)kid (SwePub)uu
041 a eng
042 9 SwePub
072 7a ref2 swepub-contenttype
072 7a art2 swepub-publicationtype
100a Lindskog, Magnusu Uppsala universitet,Karolinska Institutet,Cancerfarmakologi och beräkningsmedicin,Experimentell och klinisk onkologi,Uppsala Univ, Uppsala Univ Hosp, Dept Immunol Genet & Pathol, Entrance 100-101, S-751 85 Uppsala, Sweden.4 aut0 (Swepub:uu)magli409
2451 0a Ilixadencel, a Cell-based Immune Primer, plus Sunitinib Versus Sunitinib Alone in Metastatic Renal Cell Carcinoma: A Randomized Phase 2 Study
264 1b Elsevier BV,c 2022
520 a Background: The prognosis of patients with synchronous metastatic renal cell carcinoma (mRCC) is poor. Whereas single-agent tyrosine kinase inhibition (TKI) is clearly insufficient, the effects can be enhanced by combinations with immune checkpoint inhibitors. Innovative treatment options combining TKI and other immune-stimulating agents could prove beneficial. Objective: To evaluate the clinical effects on metastatic disease when two doses of allogeneic monocyte-derived dendritic cells (ilixadencel) are administrated intratumorally followed by nephrectomy and treatment with sunitinib compared with nephrectomy and sunitinib monotherapy, in patients with synchronous mRCC. Design, setting, and participants: A randomized (2:1) phase 2 multicenter trial enrolled 88 patients with newly diagnosed mRCC to treatment with the combination ilixadencel/sunitinib (ILIXA/SUN; 58 patients) or sunitinib alone (SUN; 30 patients).Outcome measurements and statistical analysis: The primary endpoints were 18mo survival rate and overall survival (OS). A secondary endpoint was objective response rate (ORR) assessed up to 18 mo after enrollment. Statistic evaluations included Kaplan-Meier estimates, log-rank tests, Cox regression, and stratified Cochran-Mantel-Haenszel tests.Results and limitations: The median OS was 35.6 mo in the ILIXA/SUN arm versus 25.3 mo in the SUN arm (hazard ratio 0.73, 95% confidence interval 0.42-1.27; p = 0.25), while the 18-mo OS rates were 63% and 66% in the ILIXA/SUN and SUN arms, respectively. The confirmed ORR in the ILIXA/SUN arm were 42.2% (19/45), including three patients with complete response, versus 24.0% (six/25) in the SUN arm (p = 0.13) without complete responses. The study was not adequately powered to detect modest differences in survival. Conclusions: The study failed to meet its primary endpoints. However, ilixadencel in combination with sunitinib was associated with a numerically higher, nonsignificant, confirmed response rate, including complete responses, compared with sunitinib monotherapy.Patient summary: We studied the effects of intratumoral vaccination with ilixadencel followed by sunitinib versus sunitinib only in a randomized phase 2 study. The combination treatment showed numerically higher numbers of confirmed responses, suggesting an immunologic effect.(c) 2022 The Author(s). Published by Elsevier B.V. on behalf of European Association of Urology. This is an open access article under the CC BY license (http://creativecommons. org/licenses/by/4.0/).
650 7a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Urologi och njurmedicin0 (SwePub)302142 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Urology and Nephrology0 (SwePub)302142 hsv//eng
650 7a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Cancer och onkologi0 (SwePub)302032 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Cancer and Oncology0 (SwePub)302032 hsv//eng
653 a Allogeneic dendritic cells
653 a Ilixadencel
653 a Intratumoral administration
653 a Metastatic renal cell carcinoma
653 a Off the shelf
653 a Phase 2 trial
653 a Randomized
653 a Sunitinib
653 a european association
653 a urology guidelines
653 a combination
653 a nivolumab
653 a Urology & Nephrology
653 a Allogeneic dendritic cells
700a Laurell, A.u Department of Oncology, Akademiska University Hospital, Uppsala, Sweden,Akadem Univ Hosp, Dept Oncol, Uppsala, Sweden.4 aut
700a Kjellman, A.u Karolinska Institutet,Karolinska Univ Hosp, Karolinska Inst, CLINTEC, Dept Urol, Stockholm, Sweden.4 aut
700a Melichar, B.u Department of Urology and Urological Oncology, Wojewodzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego, Lublin, Poland,Wojewodzki Szpital Specjalist im Stefana Kardynauc, Dept Urol & Urol Oncol, Lublin, Poland.4 aut
700a Rey, P. M.u Hospital de la Santa Creu i Sant Pau, Barcelona, Spain,Hosp Santa Creu i Sant Pau, Barcelona, Spain.4 aut
700a Zielinski, H.u Clinical Urology, Military Institute of Medicine, Warsaw, Poland,Mil Inst Med, Clin Urol, Warsaw, Poland.4 aut
700a Villacampa, F.u Urology Service, Hospital Unversitario, 12 Octubre, Madrid, Spain,Hosp Unversitario 12 Octubre, Urol Serv, Madrid, Spain.4 aut
700a Bigot, P.u Department of Urology, Centre Hospitalier Universitaire d'Angers, Angers Cedex, France,Ctr Hospitalier Univ Angers, Dept Urol, Angers, France.4 aut
700a Zoltan, B.u Szent-Györgyi Albert Klinikai Központ, Szegedi Tudomanyegyetem Altalanos Ovostudomanyi Kar Urologiai Klinika, Szeged, Hungary,Royal Preston Hosp, Rosemere Canc Ctr, Preston, Lancs, England.4 aut
700a Parikh, O.u Rosemere Cancer Centre, Royal Preston Hospital, UK, Preston, United Kingdom,Hosp Univ Puerta Hierro Majadahonda, Serv Urol, Madrid, Spain.4 aut
700a Alba, D. V.u Servicio de Urología, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain,Univ Gothenburg, Inst Clin Sci, Sahlgrenska Acad, Dept Oncol, Gothenburg, Sweden.4 aut
700a Jellvert, Åsau Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för onkologi,Institute of Clinical Sciences, Department of Oncology,Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden,Univ Debrecen, Med Sch, Dept Urol, Debrecen, Hungary.4 aut0 (Swepub:gu)xjelas
700a Flasko, T.u Department of Urology, Medical School, University of Debrecen, Debrecen, Hungary,Univ Autonoma Barcelona, Parc Tauli Hosp Universitari, Inst Invest Innovacio Parc Tauli i I3PT, Oncol Dept, Sabadell, Spain.4 aut
700a Gallardo, E.u Oncology Department, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3PT, Universitat Autònoma de Barcelona, Sabadell, Spain,Hosp Clin Barcelona, Dept Urol, Barcelona, Spain.4 aut
700a Caparros, M. J. R.u Department of Urology, Hospital Clínic Barcelona, Barcelona, Spain,Pauls Stradins Clin Univ Hosp, Oncol Clin, Riga, Latvia.4 aut
700a Purkalne, G.u Oncology Clinic, Pauls Stradins Clinical University Hospital, Rīga, Latvia,Immunicum AB, Stockholm, Sweden.4 aut
700a Suenaert, P.u Immunicum AB, Stockholm, Sweden,Uppsala Univ, Dept Immunol Genet & Pathol, Sect Clin Immunol, Uppsala, Sweden.4 aut
700a Karlsson-Parra, Alexu Uppsala universitet,Klinisk immunologi,Science for Life Laboratory, SciLifeLab,Umeå Univ, Dept Surg & Perioperat Sci, Urol & Androl, Umeå, Sweden.4 aut0 (Swepub:uu)aka12694
700a Ljungberg, Börje,c Professor,d 1949-u Umeå universitet,Urologi och andrologi,Szent Gyorgy Albert Klinika Kozpont, Szeged Tudomanyegyetem Altalan Ovostudomany Kar Ur, Szeged, Hungary.4 aut0 (Swepub:umu)bolj0001
700a Jellvert, D4 aut
710a Karolinska Institutetb Cancerfarmakologi och beräkningsmedicin4 org
773t European Urology Open Scienced : Elsevier BVg 40, s. 38-45q 40<38-45x 2666-1691x 2666-1683
856u https://doi.org/10.1016/j.euros.2022.03.012y Fulltext
856u https://umu.diva-portal.org/smash/get/diva2:1662862/FULLTEXT01.pdfx primaryx Raw objecty fulltext:print
856u https://uu.diva-portal.org/smash/get/diva2:1676621/FULLTEXT01.pdfx primaryx Raw objecty fulltext:print
8564 8u https://gup.ub.gu.se/publication/320131
8564 8u https://doi.org/10.1016/j.euros.2022.03.012
8564 8u https://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-194916
8564 8u http://kipublications.ki.se/Default.aspx?queryparsed=id:149840659
8564 8u https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-478578

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