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dc.contributor.authorde Wit, R
dc.contributor.authorde Bono, J
dc.contributor.authorSternberg, CN
dc.contributor.authorFizazi, K
dc.contributor.authorTombal, B
dc.contributor.authorWülfing, C
dc.contributor.authorKramer, G
dc.contributor.authorEymard, J-C
dc.contributor.authorBamias, A
dc.contributor.authorCarles, J
dc.contributor.authorIacovelli, R
dc.contributor.authorMelichar, B
dc.contributor.authorSverrisdóttir, Á
dc.contributor.authorTheodore, C
dc.contributor.authorFeyerabend, S
dc.contributor.authorHelissey, C
dc.contributor.authorOzatilgan, A
dc.contributor.authorGeffriaud-Ricouard, C
dc.contributor.authorCastellano, D
dc.contributor.authorCARD Investigators
dc.date.accessioned2020-11-11T12:13:03Z
dc.date.issued2019-12
dc.identifier.citationThe New England journal of medicine, 2019, 381 (26), pp. 2506 - 2518
dc.identifier.issn0028-4793
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/4220
dc.identifier.eissn1533-4406
dc.identifier.doi10.1056/nejmoa1911206
dc.description.abstractBackground The efficacy and safety of cabazitaxel, as compared with an androgen-signaling-targeted inhibitor (abiraterone or enzalutamide), in patients with metastatic castration-resistant prostate cancer who were previously treated with docetaxel and had progression within 12 months while receiving the alternative inhibitor (abiraterone or enzalutamide) are unclear.Methods We randomly assigned, in a 1:1 ratio, patients who had previously received docetaxel and an androgen-signaling-targeted inhibitor (abiraterone or enzalutamide) to receive cabazitaxel (at a dose of 25 mg per square meter of body-surface area intravenously every 3 weeks, plus prednisone daily and granulocyte colony-stimulating factor) or the other androgen-signaling-targeted inhibitor (either 1000 mg of abiraterone plus prednisone daily or 160 mg of enzalutamide daily). The primary end point was imaging-based progression-free survival. Secondary end points of survival, response, and safety were assessed.Results A total of 255 patients underwent randomization. After a median follow-up of 9.2 months, imaging-based progression or death was reported in 95 of 129 patients (73.6%) in the cabazitaxel group, as compared with 101 of 126 patients (80.2%) in the group that received an androgen-signaling-targeted inhibitor (hazard ratio, 0.54; 95% confidence interval [CI], 0.40 to 0.73; P<0.001). The median imaging-based progression-free survival was 8.0 months with cabazitaxel and 3.7 months with the androgen-signaling-targeted inhibitor. The median overall survival was 13.6 months with cabazitaxel and 11.0 months with the androgen-signaling-targeted inhibitor (hazard ratio for death, 0.64; 95% CI, 0.46 to 0.89; P = 0.008). The median progression-free survival was 4.4 months with cabazitaxel and 2.7 months with an androgen-signaling-targeted inhibitor (hazard ratio for progression or death, 0.52; 95% CI, 0.40 to 0.68; P<0.001), a prostate-specific antigen response occurred in 35.7% and 13.5% of the patients, respectively (P<0.001), and tumor response was noted in 36.5% and 11.5% (P = 0.004). Adverse events of grade 3 or higher occurred in 56.3% of patients receiving cabazitaxel and in 52.4% of those receiving an androgen-signaling-targeted inhibitor. No new safety signals were observed.Conclusions Cabazitaxel significantly improved a number of clinical outcomes, as compared with the androgen-signaling-targeted inhibitor (abiraterone or enzalutamide), in patients with metastatic castration-resistant prostate cancer who had been previously treated with docetaxel and the alternative androgen-signaling-targeted agent (abiraterone or enzalutamide). (Funded by Sanofi; CARD ClinicalTrials.gov number, NCT02485691.).
dc.formatPrint-Electronic
dc.format.extent2506 - 2518
dc.languageeng
dc.language.isoeng
dc.rights.urihttps://www.rioxx.net/licenses/all-rights-reserved
dc.subjectCARD Investigators
dc.subjectHumans
dc.subjectTaxoids
dc.subjectPhenylthiohydantoin
dc.subjectAndrostenes
dc.subjectPrednisone
dc.subjectAndrogen Antagonists
dc.subjectAntineoplastic Combined Chemotherapy Protocols
dc.subjectInfusions, Intravenous
dc.subjectAged
dc.subjectAged, 80 and over
dc.subjectMiddle Aged
dc.subjectMale
dc.subjectKaplan-Meier Estimate
dc.subjectProstatic Neoplasms, Castration-Resistant
dc.subjectProgression-Free Survival
dc.titleCabazitaxel versus Abiraterone or Enzalutamide in Metastatic Prostate Cancer.
dc.typeJournal Article
rioxxterms.versionofrecord10.1056/nejmoa1911206
rioxxterms.licenseref.urihttps://www.rioxx.net/licenses/all-rights-reserved
rioxxterms.licenseref.startdate2019-12
rioxxterms.typeJournal Article/Review
dc.relation.isPartOfThe New England journal of medicine
pubs.issue26
pubs.notesNot 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-statusPublished
pubs.volume381
pubs.embargo.termsNot known
icr.researchteamProstate Cancer Targeted Therapy Groupen_US
dc.contributor.icrauthorDe Bono, Johannen


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