Abiraterone in "High-" and "Low-risk" Metastatic Hormone-sensitive Prostate Cancer.
Eur Urol
; 76(6): 719-728, 2019 12.
Article
em En
| MEDLINE
| ID: mdl-31447077
ABSTRACT
BACKGROUND:
Abiraterone acetate received licencing for use in only "high-risk" metastatic hormone-naïve prostate cancer (mHNPC) following the LATITUDE trial findings. However, a "risk"-related effect was not seen in the STAMPEDE trial. There remains uncertainty as to whether men with LATITUDE "low-risk" M1 disease benefit from androgen deprivation therapy (ADT) combined with abiraterone acetate and prednisolone (AAP).OBJECTIVE:
Evaluation of heterogeneity of effect between LATITUDE high- and low-risk M1 prostate cancer patients receiving ADTâ¯+â¯AAP in the STAMPEDE trial. DESIGN, SETTING, ANDPARTICIPANTS:
A post hoc subgroup analysis of the 2017 STAMPEDE "abiraterone comparison". Staging scans for M1 patients contemporaneously randomised to ADT or ADTâ¯+â¯AAP within the STAMPEDE trial were evaluated centrally and blind to treatment assignment. Stratification was by risk according to the criteria set out in the LATITUDE trial. Exploratory subgroup stratification incorporated the CHAARTED criteria. OUTCOME MEASUREMENTS AND STATISTICALANALYSIS:
The primary outcome measure was overall survival (OS) and the secondary outcome measure was failure-free survival (FFS). Further exploratory analysis evaluated clinical skeletal-related events, progression-free survival (PFS), and prostate cancer-specific death. Standard Cox-regression and Kaplan-Meier survival estimates were employed for analysis. RESULTS ANDLIMITATIONS:
A total of 901 M1 STAMPEDE patients were evaluated after exclusions. Of the patients, 428 (48%) were identified as having a low risk and 473 (52%) a high risk. Patients receiving ADTâ¯+â¯AAP had significantly improved OS (low-risk hazard ratio [HR] 0.66, 95% confidence interval or CI [0.44-0.98]) and FFS (low-risk HR 0.24, 95% CI [0.17-0.33]) compared with ADT alone. Heterogeneity of effect was not seen between low- and high-risk groups for OS or FFS. For OS benefit in low risk, the number needed to treat was four times greater than that for high risk. However, this was not observed for the other measured endpoints.CONCLUSIONS:
Men with mHNPC gain treatment benefit from ADTâ¯+â¯AAP irrespective of risk stratification for "risk" or "volume". PATIENTSUMMARY:
Coadministration of abiraterone acetate and prednisolone with androgen deprivation therapy (ADT) is associated with prolonged overall survival and disease control, compared with ADT alone, in all men with metastatic disease starting hormone therapy for the first time.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Neoplasias da Próstata
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Prednisona
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Antineoplásicos Hormonais
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Antagonistas de Androgênios
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Androstenos
Tipo de estudo:
Diagnostic_studies
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Etiology_studies
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Observational_studies
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Prognostic_studies
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Risk_factors_studies
Limite:
Aged
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Eur Urol
Ano de publicação:
2019
Tipo de documento:
Article
País de afiliação:
Reino Unido