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Bone-targeted radiu...
Bone-targeted radium-223 in symptomatic, hormone-refractory prostate cancer: a randomised, multicentre, placebo-controlled phase II study
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- Nilsson, S. (author)
- Karolinska Institutet,Karolinska Hospital, Stockholm, Sweden, Karolinska Institute, Stockholm, Sweden
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- Franzén, Lars (author)
- Franzén, L., Länssjukhuset Sundsvall-Härnösand, Sundsvall, Sweden
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- Parker, C. (author)
- Institute of Cancer Research, Royal Marsden Hospital, Sutton, United Kingdom
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- Tyrrell, C. (author)
- Plymouth General Hospital, Plymouth, United Kingdom
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- Blom, R. (author)
- Östergötlands Läns Landsting
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- Tennvall, Jan (author)
- Lund 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
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- Lennernäs, Bo, 1963 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper,Institute of Clinical Sciences,Lennernäs, B., Sahlgrenska University Hospital, Gothenburg, Sweden
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- Petersson, U. (author)
- Centrallasarettet i Västerås, Västerås, Sweden
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- Johannessen, D. C. (author)
- Haukeland University Hospital, Bergen, Norway
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- Sokal, M. (author)
- Nottingham City Hospital, Nottingham, United Kingdom
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- Pigott, K. (author)
- Royal Free Hospital, London, United Kingdom
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- Yachnin, J. (author)
- Karolinska Institutet,Karolinska Hospital, Stockholm, Sweden
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- Garkavij, Michael (author)
- Lund 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
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- Strang, P. (author)
- Karolinska Institutet,Karolinska Institute, Stockholm, Sweden
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- Harmenberg, J. (author)
- Karolinska Institute, Stockholm, Sweden, Algeta ASA, Oslo, Norway
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- Bolstad, B. (author)
- Algeta ASA, Oslo, Norway
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- Bruland, O. S. (author)
- Bruland, Ø.S., University of Oslo, Norwegian Radium Hospital, Oslo, Norway
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(creator_code:org_t)
- 2007
- 2007
- English.
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In: Lancet Oncol. - 1470-2045 .- 1474-5488. ; 8:7, s. 587-594
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Abstract
Subject headings
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
Keyword
- Adenocarcinoma/radiotherapy/secondary
- Aged
- Aged
- 80 and over
- Alkaline Phosphatase/blood
- Bone Neoplasms/*radiotherapy/secondary
- Double-Blind Method
- *Drug Resistance
- Neoplasm
- Humans
- Male
- Middle Aged
- Placebos
- Prognosis
- Prostate-Specific Antigen
- Prostatic Neoplasms/pathology/*radiotherapy
- Radium/*therapeutic use
- Survival Rate
- NATURAL SCIENCES
Publication and Content Type
- ref (subject category)
- art (subject category)
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To the university's database
- By the author/editor
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Nilsson, S.
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Franzén, Lars
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Parker, C.
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Tyrrell, C.
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Blom, R.
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Tennvall, Jan
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show more...
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Lennernäs, Bo, 1 ...
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Petersson, U.
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Johannessen, D. ...
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Sokal, M.
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Pigott, K.
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Yachnin, J.
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Garkavij, Michae ...
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Strang, P.
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Harmenberg, J.
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Bolstad, B.
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Bruland, O. S.
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Cancer and Oncol ...
- Articles in the publication
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Lancet Oncol
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The Lancet Oncol ...
- By the university
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University of Gothenburg
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Lund University
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Umeå University
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Karolinska Institutet
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Linköping University