Efficacy and Safety of Cabazitaxel Versus Abiraterone or Enzalutamide in Older Patients with Metastatic Castration-resistant Prostate Cancer in the CARD Study

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F61989592%3A15110%2F21%3A73608732" target="_blank" >RIV/61989592:15110/21:73608732 - isvavai.cz</a>

Výsledek na webu

<a href="https://reader.elsevier.com/reader/sd/pii/S0302283821018625?token=5772464FB9F2892D5D3BA783C6988C9287ADB9CBA23C8A71B839318B796609DD5E3574825EEBCC2BF6F1F26EF18293F9&originRegion=eu-west-1&originCreation=20220310093953" target="_blank" >https://reader.elsevier.com/reader/sd/pii/S0302283821018625?token=5772464FB9F2892D5D3BA783C6988C9287ADB9CBA23C8A71B839318B796609DD5E3574825EEBCC2BF6F1F26EF18293F9&originRegion=eu-west-1&originCreation=20220310093953</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.eururo.2021.06.021" target="_blank" >10.1016/j.eururo.2021.06.021</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Efficacy and Safety of Cabazitaxel Versus Abiraterone or Enzalutamide in Older Patients with Metastatic Castration-resistant Prostate Cancer in the CARD Study

Popis výsledku v původním jazyce

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 &lt;= 12 mo on the alternative agent (abiraterone/enzalutamide). Objective: To assess cabazitaxel versus abiraterone/enzalutamide in older (&gt;= 70 yr) and younger (&lt;70 yr) patients in CARD. Design, setting, and participants: Patients with mCRPC were randomized 1:1 to cabazitaxel (25 mg/m(2) 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 &gt;= 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 &lt; 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 &gt;= 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.

Název v anglickém jazyce

Efficacy and Safety of Cabazitaxel Versus Abiraterone or Enzalutamide in Older Patients with Metastatic Castration-resistant Prostate Cancer in the CARD Study

Popis výsledku anglicky

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 &lt;= 12 mo on the alternative agent (abiraterone/enzalutamide). Objective: To assess cabazitaxel versus abiraterone/enzalutamide in older (&gt;= 70 yr) and younger (&lt;70 yr) patients in CARD. Design, setting, and participants: Patients with mCRPC were randomized 1:1 to cabazitaxel (25 mg/m(2) 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 &gt;= 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 &lt; 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 &gt;= 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.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30204 - Oncology

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2021

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

EUROPEAN UROLOGY

ISSN

0302-2838

e-ISSN

—

Svazek periodika

80

Číslo periodika v rámci svazku

4

Stát vydavatele periodika

NL - Nizozemsko

Počet stran výsledku

10

Strana od-do

497-506

Kód UT WoS článku

000696981000020

EID výsledku v databázi Scopus

2-s2.0-85110429381