dc.contributor.author | Parker, CC | |
dc.contributor.author | Coleman, RE | |
dc.contributor.author | Sartor, O | |
dc.contributor.author | Vogelzang, NJ | |
dc.contributor.author | Bottomley, D | |
dc.contributor.author | Heinrich, D | |
dc.contributor.author | Helle, SI | |
dc.contributor.author | O'Sullivan, JM | |
dc.contributor.author | Fosså, SD | |
dc.contributor.author | Chodacki, A | |
dc.contributor.author | Wiechno, P | |
dc.contributor.author | Logue, J | |
dc.contributor.author | Seke, M | |
dc.contributor.author | Widmark, A | |
dc.contributor.author | Johannessen, DC | |
dc.contributor.author | Hoskin, P | |
dc.contributor.author | James, ND | |
dc.contributor.author | Solberg, A | |
dc.contributor.author | Syndikus, I | |
dc.contributor.author | Kliment, J | |
dc.contributor.author | Wedel, S | |
dc.contributor.author | Boehmer, S | |
dc.contributor.author | Dall'Oglio, M | |
dc.contributor.author | Franzén, L | |
dc.contributor.author | Bruland, ØS | |
dc.contributor.author | Petrenciuc, O | |
dc.contributor.author | Staudacher, K | |
dc.contributor.author | Li, R | |
dc.contributor.author | Nilsson, S | |
dc.date.accessioned | 2017-08-02T14:35:26Z | |
dc.date.issued | 2018-03-01 | |
dc.identifier.citation | European urology, 2018, 73 (3), pp. 427 - 435 | |
dc.identifier.issn | 0302-2838 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/756 | |
dc.identifier.eissn | 1873-7560 | |
dc.identifier.doi | 10.1016/j.eururo.2017.06.021 | |
dc.description.abstract | 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. PATIENT SUMMARY: Updated Alpharadin in Symptomatic Prostate Cancer (ALSYMPCA) trial findings show that radium-223 remained well tolerated during treatment and up to 3 yr after each patient's first injection. | |
dc.format | Print-Electronic | |
dc.format.extent | 427 - 435 | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | ELSEVIER SCIENCE BV | |
dc.rights.uri | https://creativecommons.org/licenses/by/4.0 | |
dc.title | 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. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2017-06-13 | |
rioxxterms.versionofrecord | 10.1016/j.eururo.2017.06.021 | |
rioxxterms.licenseref.uri | https://creativecommons.org/licenses/by/4.0 | |
rioxxterms.licenseref.startdate | 2018-03 | |
rioxxterms.type | Journal Article/Review | |
dc.relation.isPartOf | European urology | |
pubs.issue | 3 | |
pubs.notes | Not known | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Prostate and Bladder Cancer Research | |
pubs.organisational-group | /ICR/Primary Group/Royal Marsden Clinical Units | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Prostate and Bladder Cancer Research | |
pubs.organisational-group | /ICR/Primary Group/Royal Marsden Clinical Units | |
pubs.publication-status | Published | |
pubs.volume | 73 | |
pubs.embargo.terms | Not known | |
icr.researchteam | Prostate and Bladder Cancer Research | |
dc.contributor.icrauthor | James, Nicholas | |