dc.contributor.author | Gulley, JL | |
dc.contributor.author | Borre, M | |
dc.contributor.author | Vogelzang, NJ | |
dc.contributor.author | Ng, S | |
dc.contributor.author | Agarwal, N | |
dc.contributor.author | Parker, CC | |
dc.contributor.author | Pook, DW | |
dc.contributor.author | Rathenborg, P | |
dc.contributor.author | Flaig, TW | |
dc.contributor.author | Carles, J | |
dc.contributor.author | Saad, F | |
dc.contributor.author | Shore, ND | |
dc.contributor.author | Chen, L | |
dc.contributor.author | Heery, CR | |
dc.contributor.author | Gerritsen, WR | |
dc.contributor.author | Priou, F | |
dc.contributor.author | Langkilde, NC | |
dc.contributor.author | Novikov, A | |
dc.contributor.author | Kantoff, PW | |
dc.date.accessioned | 2019-06-24T08:46:25Z | |
dc.date.issued | 2019-05 | |
dc.identifier.citation | Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2019, 37 (13), pp. 1051 - 1061 | |
dc.identifier.issn | 0732-183X | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/3265 | |
dc.identifier.eissn | 1527-7755 | |
dc.identifier.doi | 10.1200/jco.18.02031 | |
dc.description.abstract | PURPOSE: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.format | Print-Electronic | |
dc.format.extent | 1051 - 1061 | |
dc.language | eng | |
dc.language.iso | eng | |
dc.rights.uri | https://creativecommons.org/licenses/by/4.0 | |
dc.subject | Humans | |
dc.subject | Neoplasm Metastasis | |
dc.subject | Granulocyte-Macrophage Colony-Stimulating Factor | |
dc.subject | Cancer Vaccines | |
dc.subject | HLA-A2 Antigen | |
dc.subject | Survival Rate | |
dc.subject | Double-Blind Method | |
dc.subject | Aged | |
dc.subject | Male | |
dc.subject | Prostatic Neoplasms, Castration-Resistant | |
dc.title | Phase III Trial of PROSTVAC in Asymptomatic or Minimally Symptomatic Metastatic Castration-Resistant Prostate Cancer. | |
dc.type | Journal Article | |
rioxxterms.versionofrecord | 10.1200/jco.18.02031 | |
rioxxterms.licenseref.uri | https://creativecommons.org/licenses/by/4.0 | |
rioxxterms.licenseref.startdate | 2019-05 | |
rioxxterms.type | Journal Article/Review | |
dc.relation.isPartOf | Journal of clinical oncology : official journal of the American Society of Clinical Oncology | |
pubs.issue | 13 | |
pubs.notes | Not known | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/Royal Marsden Clinical Units | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/Royal Marsden Clinical Units | |
pubs.publication-status | Published | |
pubs.volume | 37 | |
pubs.embargo.terms | Not known | |
dc.contributor.icrauthor | Parker, Chris | |