Sökning: onr:"swepub:oai:DiVA.org:umu-145355" >
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
-
Parker, Christopher C. (författare)
-
Coleman, Robert E. (författare)
-
Sartor, Oliver (författare)
-
visa fler...
-
Vogelzang, Nicholas J. (författare)
-
Bottomley, David (författare)
-
Heinrich, Daniel (författare)
-
Helle, Svein I. (författare)
-
O'Sullivan, Joe M. (författare)
-
Fosså, Sophie D. (författare)
-
Chodacki, Aleš (författare)
-
Wiechno, Paweł (författare)
-
Logue, John (författare)
-
Seke, Mihalj (författare)
-
- Widmark, Anders (författare)
- Umeå universitet,Onkologi
-
Johannessen, Dag Clement (författare)
-
Hoskin, Peter (författare)
-
James, Nicholas D. (författare)
-
Solberg, Arne (författare)
-
Syndikus, Isabel (författare)
-
Kliment, Jan (författare)
-
Wedel, Steffen (författare)
-
Boehmer, Sibylle (författare)
-
Dall'Oglio, Marcos (författare)
-
Franzén, Lars (författare)
-
Bruland, Øyvind S. (författare)
-
Petrenciuc, Oana (författare)
-
Staudacher, Karin (författare)
-
Li, Rui (författare)
-
- Nilsson, Sten (författare)
- Karolinska Institutet
-
visa färre...
-
(creator_code:org_t)
- Elsevier, 2018
- 2018
- Engelska.
-
Ingår i: European Urology. - : Elsevier. - 0302-2838 .- 1873-7560. ; 73:3, s. 427-435
- Relaterad länk:
-
https://doi.org/10.1...
-
visa fler...
-
https://umu.diva-por... (primary) (Raw object)
-
http://www.europeanu...
-
https://urn.kb.se/re...
-
https://doi.org/10.1...
-
http://kipublication...
-
visa färre...
Abstract
Ämnesord
Stäng
- 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
- 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)
Nyckelord
- ALSYMPCA
- Bone metastases
- Castration-resistant
- prostate cancer
- Long-term safety
- Radium-223
- Follow-up
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
Hitta via bibliotek
Till lärosätets databas
- Av författaren/redakt...
-
Parker, Christop ...
-
Coleman, Robert ...
-
Sartor, Oliver
-
Vogelzang, Nicho ...
-
Bottomley, David
-
Heinrich, Daniel
-
visa fler...
-
Helle, Svein I.
-
O'Sullivan, Joe ...
-
Fosså, Sophie D.
-
Chodacki, Aleš
-
Wiechno, Paweł
-
Logue, John
-
Seke, Mihalj
-
Widmark, Anders
-
Johannessen, Dag ...
-
Hoskin, Peter
-
James, Nicholas ...
-
Solberg, Arne
-
Syndikus, Isabel
-
Kliment, Jan
-
Wedel, Steffen
-
Boehmer, Sibylle
-
Dall'Oglio, Marc ...
-
Franzén, Lars
-
Bruland, Øyvind ...
-
Petrenciuc, Oana
-
Staudacher, Kari ...
-
Li, Rui
-
Nilsson, Sten
-
visa färre...
- Om ämnet
-
- MEDICIN OCH HÄLSOVETENSKAP
-
MEDICIN OCH HÄLS ...
-
och Klinisk medicin
-
och Urologi och njur ...
-
- MEDICIN OCH HÄLSOVETENSKAP
-
MEDICIN OCH HÄLS ...
-
och Klinisk medicin
-
och Cancer och onkol ...
- Artiklar i publikationen
-
European Urology
- Av lärosätet
-
Umeå universitet
-
Karolinska Institutet