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Two-Year Survival F...
Two-Year Survival Follow-Up of the Randomized, Double-Blind, Placebo-Controlled Phase II Study of Radium-223 Chloride in Patients With Castration-Resistant Prostate Cancer and Bone Metastases
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- Nilsson, Sten (author)
- Karolinska Institutet,Karolinska University Hospital, Sweden
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- Franzén, Lars (author)
- Umeå universitet,Onkologi,Länssjukhuset Sundsvall-Härnösand County Hospital, Sundsvall, Sweden, Umeå University Hospital, Sweden
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- Parker, Christopher (author)
- Institute of Cancer Research and Royal Marsden Hospital, Sutton, UK
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- Tyrrell, Christopher (author)
- Derriford Hospital, Plymouth, UK
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- Blom, Rene (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,Lund University, Sweden
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- Lennernäs, Bo (author)
- Sahlgrenska University Hospital, Gothenburg, Sweden
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- Petersson, Ulf (author)
- Centrallasaretteti Västerås, Sweden
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- Johannessen, Dag C. (author)
- Haukeland Hospital, Bergen, Norway
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- Sokal, Michael (author)
- Nottingham City Hospital, UK
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- Pigott, Katharine (author)
- Royal Free Hospital, London, UK
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- Gillies O'Bryan-Tear, Charles (author)
- Algeta ASA, Oslo, Norway
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- Thuresson, Marcus (author)
- Statisticon, Uppsala, Sweden
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- Bolstad, Björg (author)
- Algeta ASA, Oslo, Norway
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- Bruland, Öyvind S. (author)
- University of Oslo, Norway
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(creator_code:org_t)
- Elsevier, 2013
- 2013
- English.
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In: Clinical Genitourinary Cancer. - : Elsevier. - 1558-7673 .- 1938-0682. ; 11:1, s. 20-26
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Abstract
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- In this 24-month follow-up of a phase II study in patients with castration-resistant prostate cancer (CRPC) and bone metastases, radium-223 (4 injections of 50 kBq/kg every 4 weeks [n = 33]) improved median overall survival vs. matching placebo (n = 31) (65.3 vs. 46.4 weeks, respectively; log-rank P = .056), with no long-term safety concerns. Data suggest that treatment of bone disease with radium-223 has survival benefits. less thanbrgreater than less thanbrgreater thanBackground: This phase II randomized, placebo-controlled study was conducted to evaluate efficacy and safety of radium-223 in patients with castration-resistant prostate cancer (CRPC) and painful bone metastases. Twelve-and 18-month survival results were reported previously. Here we report 24-month overall survival (OS) and safety data from the period 12 to 24 months after the first injection of study medication. Methods: Patients with CRPC and bone pain were randomized 1: 1 to receive 4 injections of radium-223 (50 kBq/kg [n = 33]) or placebo (n = 31) after external-beam radiotherapy; each injection was given every 4 weeks. Endpoints for this report were 24-month OS, long-term safety, and treatment-related adverse events (AEs) occurring in the 12- to 24-month period. Results: After 24 months, 10 (30%) patients were alive in the radium-223 group compared with 4 patients (13%) in the placebo group. Patients who received at least 1 dose of study medication had a median OS of 65 weeks in the radium-223 group vs. 46 weeks in the placebo group (log-rank P = .056). The hazard ratio (HR) for OS, adjusted for baseline covariates, was 0.476 (95% confidence interval [CI], 0.258-0.877; Cox regression P = .017). The most frequent cause of death for both arms was disease progression. There were no reports of treatment-related AEs or long-term hematologic toxicity during the 12- to 24-month follow-up. Conclusion: Radium-223 had a highly favorable safety profile, with no evidence of second malignancies at 24-month follow-up. The significant improvement in OS observed in patients receiving radium-223 vs. placebo suggests that treatment of bone disease with radium-223 has survival benefits. Clinical Genitourinary Cancer, Vol. 11, No. 1, 20-6
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
Keyword
- Alpha-pharmaceutical
- Castration-resistant prostate cancer
- Overall survival
- Targeted alpha-emitter
- Alpha-pharmaceutical
- Castration-resistant prostate cancer
- Overall
- survival
- Targeted alpha-emitter
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Nilsson, Sten
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Franzén, Lars
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Parker, Christop ...
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Tyrrell, Christo ...
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Blom, Rene
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Tennvall, Jan
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Lennernäs, Bo
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Petersson, Ulf
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Johannessen, Dag ...
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Sokal, Michael
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Pigott, Katharin ...
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Gillies O'Bryan- ...
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Thuresson, Marcu ...
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Bolstad, Björg
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Bruland, Öyvind ...
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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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Clinical Genitou ...
- By the university
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Linköping University
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Lund University
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Karolinska Institutet
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Umeå University