Alpha Emitter Radium-223 and Survival in Metastatic Prostate Cancer

Página do item simplificado
dc.contributorSistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSP
dc.contributor.authorPARKER, C.
dc.contributor.authorNILSSON, S.
dc.contributor.authorHEINRICH, D.
dc.contributor.authorHELLE, S. I.
dc.contributor.authorO'SULLIVAN, J. M.
dc.contributor.authorFOSSA, S. D.
dc.contributor.authorCHODACKI, A.
dc.contributor.authorWIECHNO, P.
dc.contributor.authorLOGUE, J.
dc.contributor.authorSEKE, M.
dc.contributor.authorWIDMARK, A.
dc.contributor.authorJOHANNESSEN, D. C.
dc.contributor.authorHOSKIN, P.
dc.contributor.authorBOTTOMLEY, D.
dc.contributor.authorJAMES, N. D.
dc.contributor.authorSOLBERG, A.
dc.contributor.authorSYNDIKUS, I.
dc.contributor.authorKLIMENT, J.
dc.contributor.authorWEDEL, S.
dc.contributor.authorBOEHMER, S.
dc.contributor.authorDALL'OGLIO, M.
dc.contributor.authorFRANZEN, L.
dc.contributor.authorCOLEMAN, R.
dc.contributor.authorVOGELZANG, N. J.
dc.contributor.authorO'BRYAN-TEAR, C. G.
dc.contributor.authorSTAUDACHER, K.
dc.contributor.authorGARCIA-VARGAS, J.
dc.contributor.authorSHAN, M.
dc.contributor.authorBRULAND, O. S.
dc.contributor.authorSARTOR, O.
dc.contributor.groupauthorALSYMPCA Investigators
dc.date.accessioned2013-09-23T16:30:02Z
dc.date.available2013-09-23T16:30:02Z
dc.date.issued2013
dc.description.abstractBackground 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.indexMEDLINE
dc.description.sponsorshipAmgen
dc.description.sponsorshipAstellas
dc.description.sponsorshipBayer
dc.description.sponsorshipJanssen
dc.description.sponsorshipBristol-Myers Squibb
dc.description.sponsorshipBN ImmunoTherapeutics
dc.description.sponsorshipTakeda
dc.description.sponsorshipSanofi-Aventis
dc.description.sponsorshipPfizer
dc.description.sponsorshipNovartis
dc.description.sponsorshipSanofi
dc.description.sponsorshipJanssen-Cilag
dc.description.sponsorshipMedivation
dc.description.sponsorshipPierre Fabre
dc.description.sponsorshipRoche
dc.description.sponsorshipDebiopharm
dc.description.sponsorshipNovartis Biociencias
dc.description.sponsorshipAstraZeneca
dc.description.sponsorshipDendreon
dc.description.sponsorshipJohnson Johnson
dc.description.sponsorshipAragon
dc.description.sponsorshipBavarian Nordic
dc.description.sponsorshipBellicum
dc.description.sponsorshipOncoGeneX
dc.description.sponsorshipAlgeta
dc.description.sponsorshipBayer HealthCare Pharmaceuticals
dc.identifier.citationNEW ENGLAND JOURNAL OF MEDICINE, v.369, n.3, p.213-223, 2013
dc.identifier.doi10.1056/NEJMoa1213755
dc.identifier.issn0028-4793
dc.identifier.urihttps://observatorio.fm.usp.br/handle/OPI/1671
dc.language.isoeng
dc.publisherMASSACHUSETTS MEDICAL SOC
dc.relation.ispartofNew England Journal of Medicine
dc.rightsrestrictedAccess
dc.rights.holderCopyright MASSACHUSETTS MEDICAL SOC
dc.subject.otherbone metastases
dc.subject.otherskeletal metastases
dc.subject.otherphase-ii
dc.subject.othertargeted therapy
dc.subject.otherclinical-trials
dc.subject.otherra-223
dc.subject.othermulticenter
dc.subject.otherbisphosphonates
dc.subject.otherchemotherapy
dc.subject.othermitoxantrone
dc.subject.wosMedicine, General & Internal
dc.titleAlpha Emitter Radium-223 and Survival in Metastatic Prostate Cancer
dc.typearticle
dc.type.categoryoriginal article
dc.type.versionpublishedVersion
dspace.entity.typePublication
hcfmusp.affiliation.countryInglaterra
hcfmusp.affiliation.countrySuécia
hcfmusp.affiliation.countryNoruega
hcfmusp.affiliation.countryIrlanda
hcfmusp.affiliation.countryRepública Tcheca
hcfmusp.affiliation.countryPolônia
hcfmusp.affiliation.countryEslováquia
hcfmusp.affiliation.countryAlemanha
hcfmusp.affiliation.countryEstados Unidos
hcfmusp.affiliation.countryisous
hcfmusp.affiliation.countryisono
hcfmusp.affiliation.countryisogb
hcfmusp.affiliation.countryisose
hcfmusp.affiliation.countryisoie
hcfmusp.affiliation.countryisocz
hcfmusp.affiliation.countryisopl
hcfmusp.affiliation.countryisosk
hcfmusp.affiliation.countryisode
hcfmusp.author.externalPARKER, C.:Royal Marsden Natl Hlth Serv Fdn Trust, Sutton, Surrey, England; Inst Canc Res, Sutton, Surrey, England
hcfmusp.author.externalNILSSON, S.:Karolinska Univ Hosp, Stockholm, Sweden
hcfmusp.author.externalHEINRICH, D.:Akershus Univ Hosp, Lorenskog, Norway
hcfmusp.author.externalHELLE, S. I.:Haukeland Hosp, N-5021 Bergen, Norway
hcfmusp.author.externalO'SULLIVAN, J. M.:Queens Univ Belfast, Ctr Canc Res & Cell Biol, Belfast, Antrim, North Ireland
hcfmusp.author.externalFOSSA, S. D.:Radiumhospitalet, Oslo, Norway
hcfmusp.author.externalCHODACKI, A.:Hosp Kochova, Chomutov, Czech Republic
hcfmusp.author.externalWIECHNO, P.:Maria Sklodowska Curie Inst Oncol, Warsaw, Poland
hcfmusp.author.externalLOGUE, J.:Christie Hosp, Manchester, Lancs, England
hcfmusp.author.externalSEKE, M.:Cent Lasarettet Vaxjo, Vaxjo, Sweden
hcfmusp.author.externalWIDMARK, A.:Umea Univ, Umea, Sweden
hcfmusp.author.externalJOHANNESSEN, D. C.:Ullevaal Univ Hosp, Oslo, Norway
hcfmusp.author.externalHOSKIN, P.:Mt Vernon Hosp, Ctr Canc, Northwood HA6 2RN, Middx, England
hcfmusp.author.externalBOTTOMLEY, D.:St James Univ Hosp, Leeds, W Yorkshire, England
hcfmusp.author.externalJAMES, N. D.:Canc Res UK Clin Trials Unit, Sch Canc Sci, Birmingham, W Midlands, England
hcfmusp.author.externalSOLBERG, A.:St Olavs Hosp, Trondheim, Norway
hcfmusp.author.externalSYNDIKUS, I.:Clatterbridge Ctr Oncol, Wirral, Merseyside, England
hcfmusp.author.externalKLIMENT, J.:Univ Hosp, Jessenius Sch Med, Martin, Slovakia
hcfmusp.author.externalWEDEL, S.:Ortenau Klinikum Offenburg Gengenbach, Klin Urol & Kinderurol, Offenburg, Germany
hcfmusp.author.externalFRANZEN, L.:Umea Univ Hosp, S-90185 Umea, Sweden; Lanssjukhuset Sundsvall Harnosand Cty Hosp, Sundsvall, Sweden
hcfmusp.author.externalCOLEMAN, R.:Weston Pk Hosp, Sheffield, S Yorkshire, England
hcfmusp.author.externalVOGELZANG, N. J.:Comprehens Canc Ctr Nevada, Las Vegas, NV USA
hcfmusp.author.externalO'BRYAN-TEAR, C. G.:Algeta, Oslo, Norway
hcfmusp.author.externalSTAUDACHER, K.:Algeta, Oslo, Norway
hcfmusp.author.externalGARCIA-VARGAS, J.:Bayer HealthCare Pharmaceut, Montville, NJ USA
hcfmusp.author.externalSHAN, M.:Bayer HealthCare Pharmaceut, Montville, NJ USA
hcfmusp.author.externalBRULAND, O. S.:Univ Oslo, Norwegian Radium Hosp, Oslo, Norway; Univ Oslo, Fac Med, Oslo, Norway
hcfmusp.author.externalSARTOR, O.:Tulane Canc Ctr, New Orleans, LA USA
hcfmusp.citation.scopus2596
hcfmusp.contributor.author-fmusphcMARCOS FRANCISCO DALL'OGLIO
hcfmusp.description.beginpage213
hcfmusp.description.endpage223
hcfmusp.description.issue3
hcfmusp.description.volume369
hcfmusp.origemWOS
hcfmusp.origem.pubmed23863050
hcfmusp.origem.scopus2-s2.0-84880428467
hcfmusp.origem.wosWOS:000321945800007
hcfmusp.publisher.cityWALTHAM
hcfmusp.publisher.countryUSA
hcfmusp.relation.referenceAdami S, 1997, CANCER, V80, P1674, DOI 10.1002/(SICI)1097-0142(19971015)80:8+<1674::AID-CNCR18>3.0.CO;2-X
hcfmusp.relation.referenceBruland OS, 2006, CLIN CANCER RES, V12, p6250S, DOI 10.1158/1078-0432.CCR-06-0841
hcfmusp.relation.referenceCella D, 2009, VALUE HEALTH, V12, P124, DOI 10.1111/j.1524-4733.2008.00409.x
hcfmusp.relation.referencede Bono JS, 2010, LANCET, V376, P1147, DOI 10.1016/S0140-6736(10)61389-X
hcfmusp.relation.referenceDe Bono JS, 2011, NEW ENGL J MED, V364, P1995, DOI 10.1056/NEJMoa1014618
hcfmusp.relation.referenceFinlay Ilora G, 2005, Lancet Oncol, V6, P392, DOI 10.1016/S1470-2045(05)70206-0
hcfmusp.relation.referenceFizazi K, 2009, J CLIN ONCOL, V27, P1564, DOI 10.1200/JCO.2008.19.2146
hcfmusp.relation.referenceFizazi K, 2011, LANCET, V377, P813, DOI 10.1016/S0140-6736(10)62344-6
hcfmusp.relation.referenceHarris V, 2011, CLIN ONCOL-UK, V23, P706, DOI 10.1016/j.clon.2011.04.014
hcfmusp.relation.referenceHenriksen G, 2002, CANCER RES, V62, P3120
hcfmusp.relation.referenceHenriksen G, 2003, J NUCL MED, V44, P252
hcfmusp.relation.referenceKerr C, 2002, LANCET ONCOL, V3, P453, DOI 10.1016/S1470-2045(02)00835-5
hcfmusp.relation.referenceLAN KKG, 1983, BIOMETRIKA, V70, P659, DOI 10.2307/2336502
hcfmusp.relation.referenceLange PH, 1998, CANCER METAST REV, V17, P331, DOI 10.1023/A:1006106209527
hcfmusp.relation.referenceLewington VJ, 2005, J NUCL MED, V46, p38S
hcfmusp.relation.referenceLi Yong, 2004, Expert Rev Anticancer Ther, V4, P459, DOI 10.1586/14737140.4.3.459
hcfmusp.relation.referenceLiepe K, 2009, CURR OPIN INVEST DR, V10, P1346
hcfmusp.relation.referenceLipton A, 2010, SEMIN ONCOL, V37, pS15, DOI 10.1053/j.seminoncol.2010.10.002
hcfmusp.relation.referenceMcDevitt MR, 1998, EUR J NUCL MED, V25, P1341, DOI 10.1007/s002590050306
hcfmusp.relation.referenceNilsson S, 2007, LANCET ONCOL, V8, P587, DOI 10.1016/S1470-2045(07)70147-X
hcfmusp.relation.referenceNilsson S, 2005, CLIN CANCER RES, V11, P4451, DOI 10.1158/1078-0432.CCR-04-2244
hcfmusp.relation.referenceNilsson S, 2012, EUR J CANCER, V48, P678, DOI 10.1016/j.ejca.2011.12.023
hcfmusp.relation.referenceOBRIEN PC, 1979, BIOMETRICS, V35, P549, DOI 10.2307/2530245
hcfmusp.relation.referenceOKEN MM, 1982, AM J CLIN ONCOL-CANC, V5, P649, DOI 10.1097/00000421-198212000-00014
hcfmusp.relation.referenceParker CC, 2013, EUR UROL, V63, P189, DOI 10.1016/j.eururo.2012.09.008
hcfmusp.relation.referencePerlroth DJ, 2012, AM SOC CLIN ONC GEN
hcfmusp.relation.referenceRoodman GD, 2004, NEW ENGL J MED, V350, P1655, DOI 10.1056/NEJMra030831
hcfmusp.relation.referenceSartor O, 2011, CLIN GENITOURIN CANC, V9, P1, DOI 10.1016/j.clgc.2011.08.001
hcfmusp.relation.referenceSartor O, 2011, ASIAN J ANDROL, V13, P366, DOI 10.1038/aja.2011.23
hcfmusp.relation.referenceSartor O, 2011, ASIAN J ANDROL, V13, P783, DOI 10.1038/aja.2011.120
hcfmusp.relation.referenceScher HI, 2012, NEW ENGL J MED, V367, P1187, DOI 10.1056/NEJMoa1207506
hcfmusp.relation.referenceSilberstein EB, 2000, SEMIN RADIAT ONCOL, V10, P240, DOI 10.1053/srao.2000.6592
hcfmusp.relation.referenceTannock IF, 2004, NEW ENGL J MED, V351, P1502, DOI 10.1056/NEJMoa040720
hcfmusp.remissive.sponsorshipAstraZeneca
hcfmusp.remissive.sponsorshipBayer
hcfmusp.remissive.sponsorshipBristol-Myers Squibb
hcfmusp.remissive.sponsorshipJanssen
hcfmusp.remissive.sponsorshipNovartis
hcfmusp.remissive.sponsorshipPfizer
hcfmusp.remissive.sponsorshipRoche
hcfmusp.remissive.sponsorshipSanofi-Aventis
hcfmusp.remissive.sponsorshipJohnson and Johnson
hcfmusp.scopus.lastupdate2024-04-12
relation.isAuthorOfPublication0349f82a-1538-4caa-908f-f81634bd6256
relation.isAuthorOfPublication.latestForDiscovery0349f82a-1538-4caa-908f-f81634bd6256
Arquivos
Pacote Original
Agora exibindo 1 - 1 de 1
Nenhuma Miniatura disponível
Nome:
art_DALL'OGLIO_Alpha_Emitter_Radium_223_and_Survival_in_Metastatic_2013.PDF
Tamanho:
1 MB
Formato:
Adobe Portable Document Format
Descrição:
publishedVersion (English)
Baixar
Coleções
Artigos e Materiais de Revistas Científicas - FM/MCG
Artigos e Materiais de Revistas Científicas - HC/ICESP
Artigos e Materiais de Revistas Científicas - HC/ICHC
Artigos e Materiais de Revistas Científicas - LIM/55
Artigos e Materiais de Revistas Científicas - ODS/03