Phase III Trial of PROSTVAC in Asymptomatic or Minimally Symptomatic Metastatic Castration-Resistant Prostate Cancer
| Autor: | Fred Saad, James L. Gulley, Chris Parker, Niels C. Langkilde, Frank Priou, Philip W. Kantoff, Andrey Novikov, Per Rathenborg, Liddy M. Chen, Neal D. Shore, Christopher R. Heery, David Pook, Nicholas J. Vogelzang, Siobhan Ng, Joan Carles, Winald R. Gerritsen, Neeraj Agarwal, Thomas W. Flaig, Michael Borre |
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| Přispěvatelé: | Institut Català de la Salut, [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, Vall d'Hebron Barcelona Hospital Campus, Hospital Universitari Vall d'Hebron |
| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
Oncology Male Cancer Research Vacunes contra el càncer medicine.medical_treatment Phases of clinical research VACCINE PLUS PREDNISONE Prostate cancer PSA 0302 clinical medicine Neoplasm Metastasis Prostvac DOCETAXEL Neoplasms::Neoplastic Processes::Neoplasm Metastasis [DISEASES] MEN COLONY-STIMULATING FACTOR MITOXANTRONE Survival Rate Prostate-specific antigen Prostatic Neoplasms Castration-Resistant Urological cancers Radboud Institute for Health Sciences [Radboudumc 15] 030220 oncology & carcinogenesis medicine.symptom RAPID COMMUNICATION medicine.medical_specialty ENZALUTAMIDE Urology MEDLINE Castration resistant Placebo Asymptomatic Cancer Vaccines Genitourinary Cancer 03 medical and health sciences Text mining Metàstasi Double-Blind Method Internal medicine HLA-A2 Antigen medicine Humans IMMUNOTHERAPY Survival rate SURVIVAL ANALYSIS Aged business.industry Granulocyte-Macrophage Colony-Stimulating Factor Complex Mixtures::Biological Products::Vaccines::Cancer Vaccines [CHEMICALS AND DRUGS] Immunotherapy Prostate-Specific Antigen medicine.disease Pròstata - Càncer - Tractament Neoplasms::Neoplasms by Site::Urogenital Neoplasms::Genital Neoplasms Male::Prostatic Neoplasms::Prostatic Neoplasms Castration-Resistant [DISEASES] Clinical trial 030104 developmental biology neoplasias::procesos neoplásicos::metástasis neoplásica [ENFERMEDADES] neoplasias::neoplasias por localización::neoplasias urogenitales::neoplasias de los genitales masculinos::neoplasias de la próstata::neoplasias prostáticas resistentes a la castración [ENFERMEDADES] mezclas complejas::productos biológicos::vacunas::vacunas del cáncer [COMPUESTOS QUÍMICOS Y DROGAS] business |
| Zdroj: | Scientia Gulley, J L, Borre, M, Vogelzang, N J, Ng, S, Agarwal, N, Parker, C C, Pook, D W, Rathenborg, P, Flaig, T W, Carles, J, Saad, F, Shore, N D, Chen, L, Heery, C R, Gerritsen, W R, Priou, F, Langkilde, N C, Novikov, A & Kantoff, P W 2019, ' Phase III Trial of PROSTVAC in Asymptomatic or Minimally Symptomatic Metastatic Castration-Resistant Prostate Cancer ', Journal of clinical oncology : official journal of the American Society of Clinical Oncology, vol. 37, no. 13, pp. 1051-1061 . https://doi.org/10.1200/JCO.18.02031 Recercat: Dipósit de la Recerca de Catalunya Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya) Gulley, J L, Borre, M, Vogelzang, N J, Ng, S, Agarwal, N, Parker, C C, Pook, D W, Rathenborg, P, Flaig, T W, Carles, J, Saad, F, Shore, N D, Chen, L, Heery, C R, Gerritsen, W R, Priou, F, Langkilde, N C, Novikov, A & Kantoff, P W 2019, ' Phase III Trial of PROSTVAC in Asymptomatic or Minimally Symptomatic Metastatic Castration-Resistant Prostate Cancer ', Journal of clinical oncology : official journal of the American Society of Clinical Oncology, vol. 37, no. 13, JCO1802031, pp. 1051-1061 . https://doi.org/10.1200/JCO.18.02031 Journal of Clinical Oncology, 37, 13, pp. 1051-1061 Journal of Clinical Oncology, 37, 1051-1061 Recercat. Dipósit de la Recerca de Catalunya instname Journal of Clinical Oncology |
| ISSN: | 1527-7755 0732-183X |
| Popis: | Càncer de pròstata; Metàstasi neoplàsica; Immunoteràpia Cáncer de próstata; Metástasis neoplásica; Inmunoterapia Prostate cancer; Metastatic neoplasm; Immunotherapy 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. Supported 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. P30 CA008748/CA/NCI NIH HHS/United States DH_/Department of Health/United Kingdom |
| Databáze: | OpenAIRE |
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