dc.contributor.author | Saad, F | |
dc.contributor.author | Shore, N | |
dc.contributor.author | Van Poppel, H | |
dc.contributor.author | Rathkopf, DE | |
dc.contributor.author | Smith, MR | |
dc.contributor.author | de Bono, JS | |
dc.contributor.author | Logothetis, CJ | |
dc.contributor.author | de Souza, P | |
dc.contributor.author | Fizazi, K | |
dc.contributor.author | Mulders, PFA | |
dc.contributor.author | Mainwaring, P | |
dc.contributor.author | Hainsworth, JD | |
dc.contributor.author | Beer, TM | |
dc.contributor.author | North, S | |
dc.contributor.author | Fradet, Y | |
dc.contributor.author | Griffin, TA | |
dc.contributor.author | De Porre, P | |
dc.contributor.author | Londhe, A | |
dc.contributor.author | Kheoh, T | |
dc.contributor.author | Small, EJ | |
dc.contributor.author | Scher, HI | |
dc.contributor.author | Molina, A | |
dc.contributor.author | Ryan, CJ | |
dc.date.accessioned | 2018-07-31T15:14:15Z | |
dc.date.issued | 2015-10-01 | |
dc.identifier.citation | European urology, 2015, 68 (4), pp. 570 - 577 | |
dc.identifier.issn | 0302-2838 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/2238 | |
dc.identifier.eissn | 1873-7560 | |
dc.identifier.doi | 10.1016/j.eururo.2015.04.032 | |
dc.description.abstract | BACKGROUND: Metastatic castration-resistant prostate cancer (mCRPC) often involves bone, and bone-targeted therapy (BTT) has become part of the overall treatment strategy. OBJECTIVE: Investigation of outcomes for concomitant BTT in a post hoc analysis of the COU-AA-302 trial, which demonstrated an overall clinical benefit of abiraterone acetate (AA) plus prednisone over placebo plus prednisone in asymptomatic or mildly symptomatic chemotherapy-naïve mCRPC patients. DESIGN, SETTING, AND PARTICIPANTS: This report describes the third interim analysis (prespecified at 55% overall survival [OS] events) for the COU-AA-302 trial. INTERVENTION: Patients were grouped by concomitant BTT use or no BTT use. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Radiographic progression-free survival and OS were coprimary end points. This report describes the third interim analysis (prespecified at 55% OS events) and involves patients treated with or without concomitant BTT during the COU-AA-302 study. Median follow-up for OS was 27.1 mo. Median time-to-event variables with 95% confidence intervals (CIs) were estimated using the Kaplan-Meier method. Adjusted hazard ratios (HRs), 95% CIs, and p values for concomitant BTT versus no BTT were obtained via Cox models. RESULTS AND LIMITATIONS: While the post hoc nature of the analysis is a limitation, superiority of AA and prednisone versus prednisone alone was demonstrated for clinical outcomes with or without BTT use. Compared with no BTT use, concomitant BTT significantly improved OS (HR 0.75; p=0.01) and increased the time to ECOG deterioration (HR 0.75; p<0.001) and time to opiate use for cancer-related pain (HR 0.80; p=0.036). The safety profile of concomitant BTT with AA was similar to that reported for AA in the overall intent-to-treat population. Osteonecrosis of the jaw (all grade 1/2) with concomitant BTT use was reported in <3% of patients. CONCLUSIONS: AA with concomitant BTT was safe and well tolerated in men with chemotherapy-naïve mCRPC. The benefits of AA on clinical outcomes were increased with concomitant BTT. PATIENT SUMMARY: Treatment of advanced prostate cancer often includes bone-targeted therapy. This post hoc analysis showed that in patients with advanced prostate cancer who were treated with abiraterone acetate and prednisone in combination with bone-targeted therapy, there was a continued trend in prolongation of life when compared with patients treated with prednisone alone. TRIAL REGISTRATION: ClinicalTrials.gov NCT00887198. | |
dc.format | Print-Electronic | |
dc.format.extent | 570 - 577 | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | ELSEVIER SCIENCE BV | |
dc.rights.uri | https://www.rioxx.net/licenses/all-rights-reserved | |
dc.subject | Humans | |
dc.subject | Bone Neoplasms | |
dc.subject | Prednisone | |
dc.subject | Antineoplastic Agents, Hormonal | |
dc.subject | Antineoplastic Combined Chemotherapy Protocols | |
dc.subject | Disease-Free Survival | |
dc.subject | Treatment Outcome | |
dc.subject | Proportional Hazards Models | |
dc.subject | Odds Ratio | |
dc.subject | Risk Factors | |
dc.subject | Retrospective Studies | |
dc.subject | Time Factors | |
dc.subject | Aged | |
dc.subject | Middle Aged | |
dc.subject | Male | |
dc.subject | Bone Density Conservation Agents | |
dc.subject | Multicenter Studies as Topic | |
dc.subject | Randomized Controlled Trials as Topic | |
dc.subject | Clinical Trials, Phase III as Topic | |
dc.subject | Kaplan-Meier Estimate | |
dc.subject | Bisphosphonate-Associated Osteonecrosis of the Jaw | |
dc.subject | Prostatic Neoplasms, Castration-Resistant | |
dc.subject | Steroid Synthesis Inhibitors | |
dc.subject | Abiraterone Acetate | |
dc.title | Impact of bone-targeted therapies in chemotherapy-naïve metastatic castration-resistant prostate cancer patients treated with abiraterone acetate: post hoc analysis of study COU-AA-302. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2015-04-21 | |
rioxxterms.versionofrecord | 10.1016/j.eururo.2015.04.032 | |
rioxxterms.licenseref.uri | https://www.rioxx.net/licenses/all-rights-reserved | |
rioxxterms.licenseref.startdate | 2015-10 | |
rioxxterms.type | Journal Article/Review | |
dc.relation.isPartOf | European urology | |
pubs.issue | 4 | |
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/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 | 68 | |
pubs.embargo.terms | Not known | |
icr.researchteam | Prostate Cancer Targeted Therapy Group | |
dc.contributor.icrauthor | De Bono, Johann | |