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Three-year Safety o...
Three-year Safety of Radium-223 Dichloride in Patients with Castration-resistant Prostate Cancer and Symptomatic Bone Metastases from Phase 3 Randomized Alpharadin in Symptomatic Prostate Cancer Trial
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Parker, Christopher C. (författare)
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Coleman, Robert E. (författare)
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Sartor, Oliver (författare)
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Vogelzang, Nicholas J. (författare)
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Bottomley, David (författare)
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Heinrich, Daniel (författare)
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Helle, Svein I. (författare)
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O'Sullivan, Joe M. (författare)
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Fosså, Sophie D. (författare)
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Chodacki, Aleš (författare)
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Wiechno, Paweł (författare)
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Logue, John (författare)
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Seke, Mihalj (författare)
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Widmark, Anders (författare)
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Johannessen, Dag Clement (författare)
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Hoskin, Peter (författare)
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James, Nicholas D. (författare)
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Solberg, Arne (författare)
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Syndikus, Isabel (författare)
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Kliment, Jan (författare)
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Wedel, Steffen (författare)
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Boehmer, Sibylle (författare)
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Dall'Oglio, Marcos (författare)
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Franzén, Lars (författare)
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Bruland, Øyvind S. (författare)
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Petrenciuc, Oana (författare)
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Staudacher, Karin (författare)
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Li, Rui (författare)
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Nilsson, Sten (författare)
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(utgivare)
- Elsevier 2018
- 2018
- Engelska.
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Ingår i: European Urology. - 0302-2838. ; 73:3, 427-435
Abstract
Ämnesord
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- Background: In Alpharadin in Symptomatic Prostate Cancer (ALSYMPCA) trial, radium-223 versus placebo prolonged overall survival with favorable safety in castration-resistant prostate cancer patients with symptomatic bone metastases. Long-term radium-223 monitoring underlies a comprehensive safety and risk/benefit assessment. Objective: To report updated ALSYMPCA safety, including long-term safety up to 3 yr after the first injection. Design, setting, and participants: Safety analyses from phase 3 randomized ALSYMPCA trial included patients receiving >= 1 study-drug injection (600 radium-223 and 301 placebo). Patients (405 radium-223 and 167 placebo) entered long-term safety follow-up starting 12 wk after the last study-drug injection, to 3 yr from the first injection. Forty-eight of 405 (12%) radium-223 and 12/167 (7%) placebo patients completed follow-up, with evaluations every 2 mo for 6 mo, then every 4 mo until 3 yr. Outcome measurements and statistical analysis: All adverse events (AEs) were collected until 12 wk after the last injection; subsequently, only treatment-related AEs were collected. Additional long-term safety was assessed by development of acute myelogenous leukemia (AML), myelodysplastic syndrome (MDS), aplastic anemia, and secondary malignancies. Data analysis used descriptive statistics. Results and limitations: During treatment to 12 wk following the last injection, 564/600 (94%) radium-223 and 292/301 (97%) placebo patients had treatment-emergent AEs (TEAEs). Myelosuppression incidence was low. Grade 3/4 hematologic TEAEs in radium-223 and placebo groups were anemia (13% vs 13%), neutropenia (2% vs 1%), and thrombocytopenia (7% vs 2%). Ninety-eight of 600 (16%) radium-223 and 68/301 (23%) placebo patients experienced grade 5 TEAEs. Long-term follow-up showed no AML, MDS, or new primary bone cancer; secondary non-treatment-related malignancies occurred in four radium-223 and three placebo patients. One radium-223 patient had aplastic anemia 16 mo after the last injection. No other cases were observed. Limitations include short (3-yr) follow-up. Conclusions: Final long-term safety ALSYMPCA analysis shows that radium-223 remained well tolerated, with low myelosuppression incidence and no new safety concerns.
Ämnesord
- Medical and Health Sciences (hsv)
- Clinical Medicine (hsv)
- Urology and Nephrology (hsv)
- Medicin och hälsovetenskap (hsv)
- Klinisk medicin (hsv)
- Urologi och njurmedicin (hsv)
- Cancer and Oncology (hsv)
- Cancer och onkologi (hsv)
Nyckelord
- ALSYMPCA
- Bone metastases
- Castration-resistant
- prostate cancer
- Long-term safety
- Radium-223
- Follow-up
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Parker, Christop ...
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Coleman, Robert ...
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Sartor, Oliver
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Vogelzang, Nicho ...
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Bottomley, David
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Heinrich, Daniel
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visa fler...
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Helle, Svein I.
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O'Sullivan, Joe ...
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Fosså, Sophie D.
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Chodacki, Aleš
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Wiechno, Paweł
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Logue, John
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Seke, Mihalj
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Widmark, Anders
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Johannessen, Dag ...
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Hoskin, Peter
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James, Nicholas ...
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Solberg, Arne
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Syndikus, Isabel
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Kliment, Jan
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Wedel, Steffen
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Boehmer, Sibylle
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Dall'Oglio, Marc ...
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Franzén, Lars
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Bruland, Øyvind ...
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Petrenciuc, Oana
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Staudacher, Kari ...
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Li, Rui
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Nilsson, Sten
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