dc.contributor.author | de Wit, R | |
dc.contributor.author | de Bono, J | |
dc.contributor.author | Sternberg, CN | |
dc.contributor.author | Fizazi, K | |
dc.contributor.author | Tombal, B | |
dc.contributor.author | Wülfing, C | |
dc.contributor.author | Kramer, G | |
dc.contributor.author | Eymard, J-C | |
dc.contributor.author | Bamias, A | |
dc.contributor.author | Carles, J | |
dc.contributor.author | Iacovelli, R | |
dc.contributor.author | Melichar, B | |
dc.contributor.author | Sverrisdóttir, Á | |
dc.contributor.author | Theodore, C | |
dc.contributor.author | Feyerabend, S | |
dc.contributor.author | Helissey, C | |
dc.contributor.author | Ozatilgan, A | |
dc.contributor.author | Geffriaud-Ricouard, C | |
dc.contributor.author | Castellano, D | |
dc.contributor.author | CARD Investigators, | |
dc.date.accessioned | 2020-11-11T12:13:03Z | |
dc.date.issued | 2019-12-26 | |
dc.identifier.citation | The New England journal of medicine, 2019, 381 (26), pp. 2506 - 2518 | |
dc.identifier.issn | 0028-4793 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/4220 | |
dc.identifier.eissn | 1533-4406 | |
dc.identifier.doi | 10.1056/nejmoa1911206 | |
dc.description.abstract | BACKGROUND: 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.format | Print-Electronic | |
dc.format.extent | 2506 - 2518 | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | MASSACHUSETTS MEDICAL SOC | |
dc.rights.uri | https://www.rioxx.net/licenses/all-rights-reserved | |
dc.subject | CARD Investigators | |
dc.subject | Humans | |
dc.subject | Taxoids | |
dc.subject | Phenylthiohydantoin | |
dc.subject | Androstenes | |
dc.subject | Prednisone | |
dc.subject | Androgen Antagonists | |
dc.subject | Antineoplastic Combined Chemotherapy Protocols | |
dc.subject | Infusions, Intravenous | |
dc.subject | Aged | |
dc.subject | Aged, 80 and over | |
dc.subject | Middle Aged | |
dc.subject | Male | |
dc.subject | Kaplan-Meier Estimate | |
dc.subject | Prostatic Neoplasms, Castration-Resistant | |
dc.subject | Progression-Free Survival | |
dc.title | Cabazitaxel versus Abiraterone or Enzalutamide in Metastatic Prostate Cancer. | |
dc.type | Journal Article | |
rioxxterms.versionofrecord | 10.1056/nejmoa1911206 | |
rioxxterms.licenseref.uri | https://www.rioxx.net/licenses/all-rights-reserved | |
rioxxterms.licenseref.startdate | 2019-12 | |
rioxxterms.type | Journal Article/Review | |
dc.relation.isPartOf | The New England journal of medicine | |
pubs.issue | 26 | |
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 | 381 | |
pubs.embargo.terms | Not known | |
icr.researchteam | Prostate Cancer Targeted Therapy Group | |
dc.contributor.icrauthor | De Bono, Johann | |