dc.contributor.author | Fizazi, K | |
dc.contributor.author | Chi, KN | |
dc.contributor.author | de Bono, JS | |
dc.contributor.author | Gomella, LG | |
dc.contributor.author | Miller, K | |
dc.contributor.author | Rathkopf, DE | |
dc.contributor.author | Ryan, CJ | |
dc.contributor.author | Scher, HI | |
dc.contributor.author | Shore, ND | |
dc.contributor.author | De Porre, P | |
dc.contributor.author | Londhe, A | |
dc.contributor.author | McGowan, T | |
dc.contributor.author | Pelhivanov, N | |
dc.contributor.author | Charnas, R | |
dc.contributor.author | Todd, MB | |
dc.contributor.author | Montgomery, B | |
dc.date.accessioned | 2017-03-01T13:00:35Z | |
dc.date.issued | 2016-09-01 | |
dc.identifier.citation | European urology, 2016, 70 (3), pp. 438 - 444 | |
dc.identifier.issn | 0302-2838 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/453 | |
dc.identifier.eissn | 1873-7560 | |
dc.identifier.doi | 10.1016/j.eururo.2016.02.035 | |
dc.description.abstract | BACKGROUND: 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.format | Print-Electronic | |
dc.format.extent | 438 - 444 | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | ELSEVIER SCIENCE BV | |
dc.subject | Humans | |
dc.subject | Hyperglycemia | |
dc.subject | Weight Gain | |
dc.subject | Prednisone | |
dc.subject | Antineoplastic Combined Chemotherapy Protocols | |
dc.subject | Time Factors | |
dc.subject | Adult | |
dc.subject | Aged | |
dc.subject | Aged, 80 and over | |
dc.subject | Middle Aged | |
dc.subject | Male | |
dc.subject | Prostatic Neoplasms, Castration-Resistant | |
dc.subject | Abiraterone Acetate | |
dc.title | Low 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.type | Journal Article | |
dcterms.dateAccepted | 2016-02-10 | |
rioxxterms.versionofrecord | 10.1016/j.eururo.2016.02.035 | |
rioxxterms.licenseref.startdate | 2016-09 | |
rioxxterms.type | Journal Article/Review | |
dc.relation.isPartOf | European urology | |
pubs.issue | 3 | |
pubs.notes | No 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-status | Published | |
pubs.volume | 70 | |
pubs.embargo.terms | No embargo | |
icr.researchteam | Prostate Cancer Targeted Therapy Group | |
dc.contributor.icrauthor | De Bono, Johann | |