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dc.contributorVall d'Hebron Barcelona Hospital Campus
dc.contributor.authorGulley, James L.
dc.contributor.authorBorre, Michael
dc.contributor.authorVogelzang, Nicholas J.
dc.contributor.authorNg, Siobhan
dc.contributor.authorParker, Chris C.
dc.contributor.authorCarles Galceran, Joan
dc.contributor.authorAgarwal, Neeraj
dc.date.accessioned2021-03-11T14:25:03Z
dc.date.available2021-03-11T14:25:03Z
dc.date.issued2019-05-01
dc.identifier.citationGulley JL, Borre M, Vogelzang NJ, Ng S, Agarwal N, Parker CC, et al. Phase III Trial of PROSTVAC in asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer. J Clin Oncol. 2019;37(13):1051–61.
dc.identifier.issn1527-7755
dc.identifier.urihttps://hdl.handle.net/11351/5751
dc.descriptionCàncer de pròstata; Metàstasi neoplàsica; Immunoteràpia
dc.description.abstractPURPOSE PROSTVAC, a viral vector–based immunotherapy, prolonged median overall survival (OS) by 8.5 months versus placebo in metastatic castration-resistant prostate cancer in a phase II study. This phase III study further investigated those findings. PATIENTS AND METHODS Patients were randomly assigned to PROSTVAC (Arm V; n = 432), PROSTVAC plus granulocyte-macrophage colony-stimulating factor (Arm VG; n = 432), or placebo (Arm P; n = 433), stratified by prostate-specific antigen (less than 50 ng/mL v 50 ng/mL or more) and lactate dehydrogenase (less than 200 v 200 U/L or more). Primary end point was OS. Secondary end points were patients alive without events (AWE)—namely, radiographic progression, pain progression, chemotherapy initiation, or death—at 6 months and safety. The study design was a superiority trial of PROSTVAC (Arm V or Arm VG) versus Arm P. Three interim analyses were planned. RESULTS At the third interim analysis, criteria for futility were met and the trial was stopped early. Neither active treatment had an effect on median OS (Arm V, 34.4 months; hazard ratio, 1.01; 95% CI, 0.84 to 1.20; P = .47; Arm VG, 33.2 months; hazard ratio, 1.02; 95% CI, 0.86 to 1.22; P = .59; Arm P, 34.3 months). Likewise, AWE at 6 months was similar (Arm V, 29.4%; odds ratio, 0.96; 95% CI, 0.71 to 1.29; Arm VG, 28.0%; odds ratio, 0.89; 95% CI, 0.66 to 1.20; placebo, 30.3%). Adverse events were similar for the treatment and placebo groups, with the most common being injection site reactions (62% to 72%) and fatigue (21% to 24%). Arrhythmias were the most common cardiac-related events (1.4% to 3.5%). There were no reports of either myocarditis or pericarditis. Serious treatment-related events occurred in less than 1% of all patients. CONCLUSION Whereas PROSTVAC was safe and well tolerated, it had no effect on OS or AWE in metastatic castration-resistant prostate cancer. Combination therapy is currently being explored in clinical trials.
dc.description.sponsorshipSupported by Bavarian Nordic, the National Institute for Health Research Biomedical Research Centre at the Royal Marsden National Health Service Foundation Trust, and the Institute of Cancer Research. Funded in part by National Cancer Institute Cancer Center Support Grant No. P30-CA008748 and the Center for Cancer Research, National Cancer Institute.
dc.description.sponsorshipP30 CA008748/CA/NCI NIH HHS/United States DH_/Department of Health/United Kingdom
dc.language.isoeng
dc.publisherAmerican Society of Clinical Oncology
dc.relation.ispartofseriesJournal of Clinical Oncology;37(13)
dc.rightsAttribution 4.0 International
dc.rightsAttribution 4.0 International
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.sourceScientia
dc.subjectPròstata - Càncer - Tractament
dc.subjectVacunes contra el càncer
dc.subjectMetàstasi
dc.subject.meshProstatic Neoplasms, Castration-Resistant
dc.subject.meshNeoplasm Metastasis
dc.subject.meshCancer Vaccines
dc.titlePhase III Trial of PROSTVAC in Asymptomatic or Minimally Symptomatic Metastatic Castration-Resistant Prostate Cancer
dc.typeinfo:eu-repo/semantics/article
dc.identifier.doi10.1200/JCO.18.02031
dc.subject.decsneoplasias prostáticas resistentes a la castración
dc.subject.decsmetástasis neoplásica
dc.subject.decsvacunas del cáncer
dc.relation.publishversionhttps://ascopubs.org/doi/10.1200/JCO.18.02031
dc.type.versioninfo:eu-repo/semantics/publishedVersion
dc.audienceProfessionals
dc.contributor.organismesInstitut Català de la Salut
dc.contributor.authoraffiliation[Gulley JL] National Institutes of Health, Bethesda, MD. [Borre M] Aarhus Universitetshospital, Åarhus, Denmark. [Vogelzang NJ] Comprehensive Cancer Centers of Nevada, Las Vegas, NV. [Ng S] St John of God Subiaco Hospital, Subiaco, Western Australia, Australia. [Agarwal N] University of Utah Huntsman Cancer Institute, Salt Lake City, UT. [Carles J] Genitourinary, CNS and Sarcoma Tumors Program, Vall d’Hebron Institute of Oncology, Barcelona, Spain. Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain
dc.identifier.pmid30817251
dc.identifier.wos000468265100005
dc.rights.accessrightsinfo:eu-repo/semantics/openAccess


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