Τίτλος:
Efficacy and Safety of Cabazitaxel Versus Abiraterone or Enzalutamide in
Older Patients with Metastatic Castration-resistant Prostate Cancer in
the CARD Study
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
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/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
>= 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.
Conclusions: Cabazitaxel improved efficacy outcomes versus
abiraterone/enzalutamide in patients with mCRPC after prior docetaxel
and abiraterone/enzalutamide, regardless of age. TEAEs were more
frequent among older patients. The cabazitaxel safety profile was
manageable across age groups.
Patient summary: Clinical trial data showed that cabazitaxel improved
survival versus abiraterone/enzalutamide with manageable side effects in
patients with metastatic castration-resistant prostate cancer who had
previously received docetaxel and the alternative agent
(abiraterone/enzalutamide), irrespective of age. (C) 2021 Published by
Elsevier B.V. on behalf of European Association of Urology.
Συγγραφείς:
Sternberg, Cora N.
Castellano, Daniel
de Bono, Johann and
Fizazi, Karim
Tombal, Bertrand
Wuelfing, Christian
Kramer,
Gero
Eymard, Jean-Christophe
Bamias, Aristotelis
Carles,
Joan
Iacovelli, Roberto
Melichar, Bohuslav
Sverrisdottir,
Asgerdur
Theodore, Christine
Feyerabend, Susan
Helissey,
Carole
Poole, Elizabeth M.
Ozatilgan, Ayse and
Geffriaud-Ricouard, Christine
de Wit, Ronald
Περιοδικό:
European Urology
Λέξεις-κλειδιά:
Elderly; Cabazitaxel; Metastatic castration-resistant; prostate cancer;
Prostate cancer
DOI:
10.1016/j.eururo.2021.06.021
