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DC Field | Value | Language |
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dc.contributor | Sistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSP | - |
dc.contributor.author | PARKER, C. | - |
dc.contributor.author | NILSSON, S. | - |
dc.contributor.author | HEINRICH, D. | - |
dc.contributor.author | HELLE, S. I. | - |
dc.contributor.author | O'SULLIVAN, J. M. | - |
dc.contributor.author | FOSSA, S. D. | - |
dc.contributor.author | CHODACKI, A. | - |
dc.contributor.author | WIECHNO, P. | - |
dc.contributor.author | LOGUE, J. | - |
dc.contributor.author | SEKE, M. | - |
dc.contributor.author | WIDMARK, A. | - |
dc.contributor.author | JOHANNESSEN, D. C. | - |
dc.contributor.author | HOSKIN, P. | - |
dc.contributor.author | BOTTOMLEY, D. | - |
dc.contributor.author | JAMES, N. D. | - |
dc.contributor.author | SOLBERG, A. | - |
dc.contributor.author | SYNDIKUS, I. | - |
dc.contributor.author | KLIMENT, J. | - |
dc.contributor.author | WEDEL, S. | - |
dc.contributor.author | BOEHMER, S. | - |
dc.contributor.author | DALL'OGLIO, M. | - |
dc.contributor.author | FRANZEN, L. | - |
dc.contributor.author | COLEMAN, R. | - |
dc.contributor.author | VOGELZANG, N. J. | - |
dc.contributor.author | O'BRYAN-TEAR, C. G. | - |
dc.contributor.author | STAUDACHER, K. | - |
dc.contributor.author | GARCIA-VARGAS, J. | - |
dc.contributor.author | SHAN, M. | - |
dc.contributor.author | BRULAND, O. S. | - |
dc.contributor.author | SARTOR, O. | - |
dc.date.accessioned | 2013-09-23T16:30:02Z | - |
dc.date.available | 2013-09-23T16:30:02Z | - |
dc.date.issued | 2013 | - |
dc.identifier.citation | NEW ENGLAND JOURNAL OF MEDICINE, v.369, n.3, p.213-223, 2013 | - |
dc.identifier.issn | 0028-4793 | - |
dc.identifier.uri | https://observatorio.fm.usp.br/handle/OPI/1671 | - |
dc.description.abstract | Background Radium-223 dichloride (radium-223), an alpha emitter, selectively targets bone metastases with alpha particles. We assessed the efficacy and safety of radium-223 as compared with placebo, in addition to the best standard of care, in men with castration-resistant prostate cancer and bone metastases. Methods In our phase 3, randomized, double-blind, placebo-controlled study, we randomly assigned 921 patients who had received, were not eligible to receive, or declined docetaxel, in a 2:1 ratio, to receive six injections of radium-223 (at a dose of 50 kBq per kilogram of body weight intravenously) or matching placebo; one injection was administered every 4 weeks. In addition, all patients received the best standard of care. The primary end point was overall survival. The main secondary efficacy end points included time to the first symptomatic skeletal event and various biochemical end points. A prespecified interim analysis, conducted when 314 deaths had occurred, assessed the effect of radium-223 versus placebo on survival. An updated analysis, when 528 deaths had occurred, was performed before crossover from placebo to radium-223. Results At the interim analysis, which involved 809 patients, radium-223, as compared with placebo, significantly improved overall survival (median, 14.0 months vs. 11.2 months; hazard ratio, 0.70; 95% confidence interval [CI], 0.55 to 0.88; two-sided P=0.002). The updated analysis involving 921 patients confirmed the radium-223 survival benefit (median, 14.9 months vs. 11.3 months; hazard ratio, 0.70; 95% CI, 0.58 to 0.83; P<0.001). Assessments of all main secondary efficacy end points also showed a benefit of radium-233 as compared with placebo. Radium-223 was associated with low myelosuppression rates and fewer adverse events. Conclusions In this study, which was terminated for efficacy at the prespecified interim analysis, radium-223 improved overall survival. (Funded by Algeta and Bayer HealthCare Pharmaceuticals; ALSYMPCA ClinicalTrials.gov number, NCT00699751.) | - |
dc.description.sponsorship | Amgen | - |
dc.description.sponsorship | Astellas | - |
dc.description.sponsorship | Bayer | - |
dc.description.sponsorship | Janssen | - |
dc.description.sponsorship | Bristol-Myers Squibb | - |
dc.description.sponsorship | BN ImmunoTherapeutics | - |
dc.description.sponsorship | Takeda | - |
dc.description.sponsorship | Sanofi-Aventis | - |
dc.description.sponsorship | Pfizer | - |
dc.description.sponsorship | Novartis | - |
dc.description.sponsorship | Sanofi | - |
dc.description.sponsorship | Janssen-Cilag | - |
dc.description.sponsorship | Medivation | - |
dc.description.sponsorship | Pierre Fabre | - |
dc.description.sponsorship | Roche | - |
dc.description.sponsorship | Debiopharm | - |
dc.description.sponsorship | Novartis Biociencias | - |
dc.description.sponsorship | AstraZeneca | - |
dc.description.sponsorship | Dendreon | - |
dc.description.sponsorship | Johnson Johnson | - |
dc.description.sponsorship | Aragon | - |
dc.description.sponsorship | Bavarian Nordic | - |
dc.description.sponsorship | Bellicum | - |
dc.description.sponsorship | OncoGeneX | - |
dc.description.sponsorship | Algeta | - |
dc.description.sponsorship | Bayer HealthCare Pharmaceuticals | - |
dc.language.iso | eng | - |
dc.publisher | MASSACHUSETTS MEDICAL SOC | - |
dc.relation.ispartof | New England Journal of Medicine | - |
dc.rights | restrictedAccess | - |
dc.subject.other | bone metastases | - |
dc.subject.other | skeletal metastases | - |
dc.subject.other | phase-ii | - |
dc.subject.other | targeted therapy | - |
dc.subject.other | clinical-trials | - |
dc.subject.other | ra-223 | - |
dc.subject.other | multicenter | - |
dc.subject.other | bisphosphonates | - |
dc.subject.other | chemotherapy | - |
dc.subject.other | mitoxantrone | - |
dc.title | Alpha Emitter Radium-223 and Survival in Metastatic Prostate Cancer | - |
dc.type | article | - |
dc.rights.holder | Copyright MASSACHUSETTS MEDICAL SOC | - |
dc.contributor.groupauthor | ALSYMPCA Investigators | - |
dc.identifier.doi | 10.1056/NEJMoa1213755 | - |
dc.identifier.pmid | 23863050 | - |
dc.subject.wos | Medicine, General & Internal | - |
dc.type.category | original article | - |
dc.type.version | publishedVersion | - |
hcfmusp.author.external | PARKER, C.:Royal Marsden Natl Hlth Serv Fdn Trust, Sutton, Surrey, England; Inst Canc Res, Sutton, Surrey, England | - |
hcfmusp.author.external | NILSSON, S.:Karolinska Univ Hosp, Stockholm, Sweden | - |
hcfmusp.author.external | HEINRICH, D.:Akershus Univ Hosp, Lorenskog, Norway | - |
hcfmusp.author.external | HELLE, S. I.:Haukeland Hosp, N-5021 Bergen, Norway | - |
hcfmusp.author.external | O'SULLIVAN, J. M.:Queens Univ Belfast, Ctr Canc Res & Cell Biol, Belfast, Antrim, North Ireland | - |
hcfmusp.author.external | FOSSA, S. D.:Radiumhospitalet, Oslo, Norway | - |
hcfmusp.author.external | CHODACKI, A.:Hosp Kochova, Chomutov, Czech Republic | - |
hcfmusp.author.external | WIECHNO, P.:Maria Sklodowska Curie Inst Oncol, Warsaw, Poland | - |
hcfmusp.author.external | LOGUE, J.:Christie Hosp, Manchester, Lancs, England | - |
hcfmusp.author.external | SEKE, M.:Cent Lasarettet Vaxjo, Vaxjo, Sweden | - |
hcfmusp.author.external | WIDMARK, A.:Umea Univ, Umea, Sweden | - |
hcfmusp.author.external | JOHANNESSEN, D. C.:Ullevaal Univ Hosp, Oslo, Norway | - |
hcfmusp.author.external | HOSKIN, P.:Mt Vernon Hosp, Ctr Canc, Northwood HA6 2RN, Middx, England | - |
hcfmusp.author.external | BOTTOMLEY, D.:St James Univ Hosp, Leeds, W Yorkshire, England | - |
hcfmusp.author.external | JAMES, N. D.:Canc Res UK Clin Trials Unit, Sch Canc Sci, Birmingham, W Midlands, England | - |
hcfmusp.author.external | SOLBERG, A.:St Olavs Hosp, Trondheim, Norway | - |
hcfmusp.author.external | SYNDIKUS, I.:Clatterbridge Ctr Oncol, Wirral, Merseyside, England | - |
hcfmusp.author.external | KLIMENT, J.:Univ Hosp, Jessenius Sch Med, Martin, Slovakia | - |
hcfmusp.author.external | WEDEL, S.:Ortenau Klinikum Offenburg Gengenbach, Klin Urol & Kinderurol, Offenburg, Germany | - |
hcfmusp.author.external | FRANZEN, L.:Umea Univ Hosp, S-90185 Umea, Sweden; Lanssjukhuset Sundsvall Harnosand Cty Hosp, Sundsvall, Sweden | - |
hcfmusp.author.external | COLEMAN, R.:Weston Pk Hosp, Sheffield, S Yorkshire, England | - |
hcfmusp.author.external | VOGELZANG, N. J.:Comprehens Canc Ctr Nevada, Las Vegas, NV USA | - |
hcfmusp.author.external | O'BRYAN-TEAR, C. G.:Algeta, Oslo, Norway | - |
hcfmusp.author.external | STAUDACHER, K.:Algeta, Oslo, Norway | - |
hcfmusp.author.external | GARCIA-VARGAS, J.:Bayer HealthCare Pharmaceut, Montville, NJ USA | - |
hcfmusp.author.external | SHAN, M.:Bayer HealthCare Pharmaceut, Montville, NJ USA | - |
hcfmusp.author.external | BRULAND, O. S.:Univ Oslo, Norwegian Radium Hosp, Oslo, Norway; Univ Oslo, Fac Med, Oslo, Norway | - |
hcfmusp.author.external | SARTOR, O.:Tulane Canc Ctr, New Orleans, LA USA | - |
hcfmusp.description.beginpage | 213 | - |
hcfmusp.description.endpage | 223 | - |
hcfmusp.description.issue | 3 | - |
hcfmusp.description.volume | 369 | - |
hcfmusp.origem | WOS | - |
hcfmusp.origem.id | 2-s2.0-84880428467 | - |
hcfmusp.origem.id | WOS:000321945800007 | - |
hcfmusp.publisher.city | WALTHAM | - |
hcfmusp.publisher.country | USA | - |
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dc.description.index | MEDLINE | - |
hcfmusp.remissive.sponsorship | AstraZeneca | - |
hcfmusp.remissive.sponsorship | Bayer | - |
hcfmusp.remissive.sponsorship | Bristol-Myers Squibb | - |
hcfmusp.remissive.sponsorship | Janssen | - |
hcfmusp.remissive.sponsorship | Novartis | - |
hcfmusp.remissive.sponsorship | Pfizer | - |
hcfmusp.remissive.sponsorship | Roche | - |
hcfmusp.remissive.sponsorship | Sanofi-Aventis | - |
hcfmusp.remissive.sponsorship | Johnson and Johnson | - |
hcfmusp.citation.scopus | 2596 | - |
hcfmusp.scopus.lastupdate | 2024-04-12 | - |
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