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dc.contributor.authorFizazi, K
dc.contributor.authorChi, KN
dc.contributor.authorde Bono, JS
dc.contributor.authorGomella, LG
dc.contributor.authorMiller, K
dc.contributor.authorRathkopf, DE
dc.contributor.authorRyan, CJ
dc.contributor.authorScher, HI
dc.contributor.authorShore, ND
dc.contributor.authorDe Porre, P
dc.contributor.authorLondhe, A
dc.contributor.authorMcGowan, T
dc.contributor.authorPelhivanov, N
dc.contributor.authorCharnas, R
dc.contributor.authorTodd, MB
dc.contributor.authorMontgomery, B
dc.date.accessioned2017-03-01T13:00:35Z
dc.date.issued2016-09
dc.identifier.citationEuropean urology, 2016, 70 (3), pp. 438 - 444
dc.identifier.issn0302-2838
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/453
dc.identifier.eissn1873-7560
dc.identifier.doi10.1016/j.eururo.2016.02.035
dc.description.abstractBackground Abiraterone acetate (AA) is the prodrug of abiraterone, which inhibits CYP17A1 and testosterone synthesis and prolongs the survival of patients with metastatic castration-resistant prostate cancer (mCRPC). AA plus prednisone (P) (AA+P) is approved for the treatment of patients with mCRPC.Objective To investigate whether long-term use of low-dose P with or without AA leads to corticosteroid-associated adverse events (CA-AEs) in mCRPC patients.Design, setting, and participants The study included 2267 patients in COU-AA-301 and COU-AA-302. We used an inclusive Standardized MedDRA Queries-oriented approach to identify 112 preferred terms for known CA-AEs, and assessed the incidence of CA-AEs during 3-mo exposure intervals and across all P exposure levels.Intervention All 2267 patients received 5mg of P twice daily, and 1333/2267 received AA (1g) plus P.Results and limitations The CA-AE incidence after any P exposure was 25%, 26%, and 23% for any grade, and 5%, 5%, and 4% for grade ≥3 CA-AEs for all patients and the AA+P and P alone groups, respectively. The most common any-grade CA-AEs were hyperglycemia (7.4%, 7.8%, and 6.9% for all patients, AA+P, and P alone, respectively) and weight increase (4.3%, 3.9%, and 4.8%, respectively). When assessed by duration of exposure (3-mo intervals up to ≥30 mo), no discernable trend was observed for CA-AEs, including hyperglycemia and weight increase. The investigator-reported study discontinuation rate due to CA-AEs was 11/2267 (0.5%), and one patient had a CA-AE resulting in death.Conclusions Low-dose P given with or without AA is associated with low overall incidence of CA-AEs. The frequency of CA-AEs remained low with increased duration of exposure to P.Patient summary We assessed adverse events in patients with metastatic castration-resistant prostate cancer during long-term treatment with a low dose of a corticosteroid. We found that long-term treatment with this low-dose corticosteroid is safe and tolerable.
dc.formatPrint-Electronic
dc.format.extent438 - 444
dc.languageeng
dc.language.isoeng
dc.subjectHumans
dc.subjectHyperglycemia
dc.subjectWeight Gain
dc.subjectPrednisone
dc.subjectAntineoplastic Combined Chemotherapy Protocols
dc.subjectTime Factors
dc.subjectAdult
dc.subjectAged
dc.subjectAged, 80 and over
dc.subjectMiddle Aged
dc.subjectMale
dc.subjectProstatic Neoplasms, Castration-Resistant
dc.subjectAbiraterone Acetate
dc.titleLow Incidence of Corticosteroid-associated Adverse Events on Long-term Exposure to Low-dose Prednisone Given with Abiraterone Acetate to Patients with Metastatic Castration-resistant Prostate Cancer.
dc.typeJournal Article
dcterms.dateAccepted2016-02-10
rioxxterms.versionofrecord10.1016/j.eururo.2016.02.035
rioxxterms.licenseref.startdate2016-09
rioxxterms.typeJournal Article/Review
dc.relation.isPartOfEuropean urology
pubs.issue3
pubs.notesNo embargo
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/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Prostate Cancer Targeted Therapy Group
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/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Prostate Cancer Targeted Therapy Group
pubs.publication-statusPublished
pubs.volume70
pubs.embargo.termsNo embargo
icr.researchteamProstate Cancer Targeted Therapy Groupen_US
dc.contributor.icrauthorDe Bono, Johannen


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