دورية أكاديمية
Efficacy and Safety of Cabazitaxel Versus Abiraterone or Enzalutamide in Older Patients with Metastatic Castration-resistant Prostate Cancer in the CARD Study.
| العنوان: | Efficacy and Safety of Cabazitaxel Versus Abiraterone or Enzalutamide in Older Patients with Metastatic Castration-resistant Prostate Cancer in the CARD Study. |
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| المؤلفون: | Sternberg, Cora N, Castellano, Daniel, de Bono, Johann, Fizazi, Karim, Tombal, Bertrand, Wülfing, Christian, Kramer, Gero, Eymard, Jean-Christophe, Bamias, Aristotelis, Carles, Joan, Iacovelli, Roberto, Melichar, Bohuslav, Sverrisdóttir, Ãsgerður, Theodore, Christine, Feyerabend, Susan, Helissey, Carole, Poole, Elizabeth M, Ozatilgan, Ayse, Geffriaud-Ricouard, Christine, de Wit, Ronald |
| المساهمون: | UCL - SSS/IREC/CHEX - Pôle de chirgurgie expérimentale et transplantation, UCL - (SLuc) Service d'urologie |
| المصدر: | European Urology, Vol. 80, no. 4, p. 497-506 (2021) |
| بيانات النشر: | Elsevier Science |
| سنة النشر: | 2021 |
| المجموعة: | DIAL@USL-B (Université Saint-Louis, Bruxelles) |
| مصطلحات موضوعية: | Cabazitaxel, Elderly, Metastatic castration-resistant prostate cancer, Prostate cancer |
| الوصف: | BACKGROUND: In the CARD study (NCT02485691), cabazitaxel significantly improved median radiographic progression-free survival (rPFS) and overall survival (OS) versus abiraterone/enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) who had previously received docetaxel and progressed ≤12 mo on the alternative agent (abiraterone/enzalutamide). OBJECTIVE: To assess cabazitaxel versus abiraterone/enzalutamide in older (≥70 yr) and younger (<70 yr) patients in CARD. DESIGN, SETTING, AND PARTICIPANTS: Patients with mCRPC were randomized 1:1 to cabazitaxel (25 mg/m2 plus prednisone and granulocyte colony-stimulating factor) versus abiraterone (1000 mg plus prednisone) or enzalutamide (160 mg). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Analyses of rPFS (primary endpoint) and safety by age were prespecified; others were post hoc. Treatment groups were compared using stratified log-rank or Cochran-Mantel-Haenszel tests. RESULTS AND LIMITATIONS: Of the 255 patients randomized, 135 were aged ≥70 yr (median 76 yr). Cabazitaxel, compared with abiraterone/enzalutamide, significantly improved median rPFS in older (8.2 vs 4.5 mo; hazard ratio [HR] = 0.58; 95% confidence interval [CI] = 0.38-0.89; p = 0.012) and younger (7.4 vs 3.2 mo; HR = 0.47; 95% CI = 0.30-0.74; p < 0.001) patients. The median OS of cabazitaxel versus abiraterone/enzalutamide was 13.9 versus 9.4 mo in older patients (HR = 0.66; 95% CI = 0.41-1.06; p = 0.084), and it was 13.6 versus 11.8 mo in younger patients (HR = 0.66; 95% CI = 0.41-1.08; p = 0.093). Progression-free survival, prostate-specific antigen, and tumor and pain responses favored cabazitaxel, regardless of age. Grade ≥3 treatment-emergent adverse events (TEAEs) occurred in 58% versus 49% of older patients receiving cabazitaxel versus abiraterone/enzalutamide and 48% versus 42% of younger patients. In older patients, cardiac adverse events were more frequent with abiraterone/enzalutamide; asthenia and diarrhea were more frequent with cabazitaxel. ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 0302-2838 1873-7560 |
| العلاقة: | info:eu-repo/grantAgreement/Sanofi//; boreal:249487; http://hdl.handle.net/2078.1/249487Test; info:pmid/34274136; urn:ISSN:0302-2838; urn:EISSN:1873-7560 |
| DOI: | 10.1016/j.eururo.2021.06.021 |
| الإتاحة: | https://doi.org/10.1016/j.eururo.2021.06.021Test http://hdl.handle.net/2078.1/249487Test |
| حقوق: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.96003423 |
| قاعدة البيانات: | BASE |
| تدمد: | 03022838 18737560 |
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| DOI: | 10.1016/j.eururo.2021.06.021 |