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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. (author)
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Coleman, Robert E. (author)
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Sartor, Oliver (author)
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Vogelzang, Nicholas J. (author)
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Bottomley, David (author)
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Heinrich, Daniel (author)
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Helle, Svein I. (author)
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O'Sullivan, Joe M. (author)
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Fosså, Sophie D. (author)
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Chodacki, Aleš (author)
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Wiechno, Paweł (author)
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Logue, John (author)
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Seke, Mihalj (author)
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- Widmark, Anders (author)
- Umeå universitet,Onkologi
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Johannessen, Dag Clement (author)
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Hoskin, Peter (author)
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James, Nicholas D. (author)
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Solberg, Arne (author)
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Syndikus, Isabel (author)
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Kliment, Jan (author)
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Wedel, Steffen (author)
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Boehmer, Sibylle (author)
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Dall'Oglio, Marcos (author)
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Franzén, Lars (author)
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Bruland, Øyvind S. (author)
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Petrenciuc, Oana (author)
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Staudacher, Karin (author)
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Li, Rui (author)
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- Nilsson, Sten (author)
- Karolinska Institutet
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(creator_code:org_t)
- Elsevier, 2018
- 2018
- English.
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In: European Urology. - : Elsevier. - 0302-2838 .- 1873-7560. ; 73:3, s. 427-435
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Abstract
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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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Urologi och njurmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Urology and Nephrology (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
Keyword
- ALSYMPCA
- Bone metastases
- Castration-resistant
- prostate cancer
- Long-term safety
- Radium-223
- Follow-up
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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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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show more...
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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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show less...
- 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 Urology and Neph ...
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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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European Urology
- By the university
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Umeå University
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Karolinska Institutet