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  • Nilsson, S.Karolinska Institutet,Karolinska Hospital, Stockholm, Sweden, Karolinska Institute, Stockholm, Sweden (författare)

Bone-targeted radium-223 in symptomatic, hormone-refractory prostate cancer: a randomised, multicentre, placebo-controlled phase II study

  • Artikel/kapitelEngelska2007

Förlag, utgivningsår, omfång ...

  • 2007

Nummerbeteckningar

  • LIBRIS-ID:oai:gup.ub.gu.se/53902
  • https://gup.ub.gu.se/publication/53902URI
  • https://doi.org/10.1016/S1470-2045(07)70147-XDOI
  • https://lup.lub.lu.se/record/645562URI
  • https://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-54164URI
  • http://kipublications.ki.se/Default.aspx?queryparsed=id:115688596URI
  • https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-49310URI

Kompletterande språkuppgifter

  • Språk:engelska

Ingår i deldatabas

Klassifikation

  • Ämneskategori:ref swepub-contenttype
  • Ämneskategori:art swepub-publicationtype

Anmärkningar

  • BACKGROUND: The alpha-emitter radium-223 ((223)Ra) is a bone-seeking radionuclide studied as a new treatment for patients with bone metastases from hormone-refractory prostate cancer. We aimed to study mature outcomes from a randomised, multicentre, phase II study of (223)Ra. METHODS: Patients with hormone-refractory prostate cancer and bone pain needing external-beam radiotherapy were assigned to four intravenous injections of (223)Ra (50 kBq/kg, 33 patients) or placebo (31 patients), given every 4 weeks. Primary endpoints were change in bone-alkaline phosphatase (ALP) concentration and time to skeletal-related events (SREs). Secondary endpoints included toxic effects, time to prostate-specific-antigen (PSA) progression, and overall survival. All tests were done at a 5% significance level, based on intention to treat. FINDINGS: Median relative change in bone-ALP during treatment was -65.6% (95% CI -69.5 to -57.7) and 9.3% (3.8-60.9) in the (223)Ra group and placebo groups, respectively (p<0.0001, Wilcoxon ranked-sums test). Hazard ratio for time to first SRE, adjusted for baseline covariates, was 1.75 (0.96-3.19, p=0.065, Cox regression). Haematological toxic effects did not differ significantly between two groups. No patient discontinued (223)Ra because of treatment toxicity. Median time to PSA progression was 26 weeks (16-39) versus 8 weeks (4-12; p=0.048) for (223)Ra versus placebo, respectively. Median overall survival was 65.3 weeks (48.7-infinity) for (223)Ra and 46.4 weeks (32.1-77.4) for placebo (p=0.066, log rank). The hazard ratio for overall survival, adjusted for baseline covariates was 2.12 (1.13-3.98, p=0.020, Cox regression). INTERPRETATION: (223)Ra was well tolerated with minimum myelotoxicity, and had a significant effect on bone-ALP concentrations. Larger clinical trials are warranted to study (223)Ra on the prevention of SREs and on overall survival in patients with hormone-refractory prostate cancer. Bone-targeting properties of (223)Ra could also potentially be used for treating skeletal metastasis from other primary cancers.

Ämnesord och genrebeteckningar

Biuppslag (personer, institutioner, konferenser, titlar ...)

  • Franzén, LarsFranzén, L., Länssjukhuset Sundsvall-Härnösand, Sundsvall, Sweden(Swepub:umu)lafr0004 (författare)
  • Parker, C.Institute of Cancer Research, Royal Marsden Hospital, Sutton, United Kingdom (författare)
  • Tyrrell, C.Plymouth General Hospital, Plymouth, United Kingdom (författare)
  • Blom, R.Östergötlands Läns Landsting (författare)
  • Tennvall, JanLund University,Lunds universitet,Bröstcancer-genetik,Sektion I,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Breastcancer-genetics,Section I,Department of Clinical Sciences, Lund,Faculty of Medicine,University Hospital Lund, Lund, Sweden(Swepub:lu)onk-jte (författare)
  • Lennernäs, Bo,1963Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper,Institute of Clinical Sciences,Lennernäs, B., Sahlgrenska University Hospital, Gothenburg, Sweden(Swepub:gu)xlennb (författare)
  • Petersson, U.Centrallasarettet i Västerås, Västerås, Sweden (författare)
  • Johannessen, D. C.Haukeland University Hospital, Bergen, Norway (författare)
  • Sokal, M.Nottingham City Hospital, Nottingham, United Kingdom (författare)
  • Pigott, K.Royal Free Hospital, London, United Kingdom (författare)
  • Yachnin, J.Karolinska Institutet,Karolinska Hospital, Stockholm, Sweden (författare)
  • Garkavij, MichaelLund University,Lunds universitet,Bröstcancer-genetik,Sektion I,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Breastcancer-genetics,Section I,Department of Clinical Sciences, Lund,Faculty of Medicine,University Hospital Lund, Lund, Sweden(Swepub:lu)onk-mga (författare)
  • Strang, P.Karolinska Institutet,Karolinska Institute, Stockholm, Sweden (författare)
  • Harmenberg, J.Karolinska Institute, Stockholm, Sweden, Algeta ASA, Oslo, Norway (författare)
  • Bolstad, B.Algeta ASA, Oslo, Norway (författare)
  • Bruland, O. S.Bruland, Ø.S., University of Oslo, Norwegian Radium Hospital, Oslo, Norway (författare)
  • Karolinska InstitutetKarolinska Hospital, Stockholm, Sweden, Karolinska Institute, Stockholm, Sweden (creator_code:org_t)

Sammanhörande titlar

  • Ingår i:Lancet Oncol8:7, s. 587-5941470-20451474-5488
  • Ingår i:The Lancet Oncology8:7, s. 587-5941474-5488

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