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Cabazitaxel versus Abiraterone or Enzalutamide in Metastatic Prostate Cancer

Open access
de Wit, Ronald, de Bono, Johann, Sternberg, Cora N., Fizazi, Karim, Tombal, Bertrand, Wülfing, Christian, Kramer, Gero, Eymard, Jean-Christophe, Bamias, Aristotelis, Carles, Joan, Iacovelli, Roberto, Melichar, Bohuslav, Sverrisdóttir, Ásgerður, Theodore, Christine, Feyerabend, Susan, Helissey, Carole, Ozatilgan, Ayse, Geffriaud-Ricouard, Christine, Castellano, Daniel·2019·New England Journal of Medicine

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.).

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Metadata

Authors
de Wit, R., de Bono, J., Sternberg, C. N., Fizazi, K., Tombal, B., Wülfing, C., Kramer, G., Eymard, J.-C., Bamias, A., Carles, J., Iacovelli, R., Melichar, B., Sverrisdóttir, Á., Theodore, C., Feyerabend, S., Helissey, C., Ozatilgan, A., Geffriaud-Ricouard, C., & Castellano, D.
Venue
New England Journal of Medicine
Published
2019-12-26
Volume
381
Issue
26
Pages
2506-2518
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W2977469640
Cited by
663
References
10
FWCI
53.04
Type
journal article
Language
en
Open access
bronze

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CoChat. (2026). Citation check: Cabazitaxel versus Abiraterone or Enzalutamide in Metastatic Prostate Cancer. https://app.cochat.ai/papers/10.1056/nejmoa1911206
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de Wit, R., de Bono, J., Sternberg, C. N., Fizazi, K., Tombal, B., Wülfing, C., Kramer, G., Eymard, J.-C., Bamias, A., Carles, J., Iacovelli, R., Melichar, B., Sverrisdóttir, Á., Theodore, C., Feyerabend, S., Helissey, C., Ozatilgan, A., Geffriaud-Ricouard, C., & Castellano, D. (2019). Cabazitaxel versus Abiraterone or Enzalutamide in Metastatic Prostate Cancer. New England Journal of Medicine. https://doi.org/10.1056/nejmoa1911206

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.