Abstract | BACKGROUND: PATIENTS AND METHODS: Eligible men with nmCRPC, PSA doubling time ≤10 months and PSA ≥2 ng/mL with continued ADT use were randomised 2:1 to enzalutamide 160 mg or placebo. OS and safety were examined by age (<70 vs ≥70 years) and region (North America, Europe, Asia or the rest of the world). The impact of prior and subsequent therapy was also examined. RESULTS: In total, 1401 men were enrolled (median age, 74 years). Enzalutamide plus ADT reduced the risk of death, independent of age or region. Multivariate analyses identified Eastern Cooperative Oncology Group (ECOG) status (P < 0.0001), log (PSA; P = 0.0002) and subsequent therapy (P < 0.0001) as statistically significant factors impacting OS. Safety was consistent across age and regional subgroups. Any grade treatment-emergent adverse events were similar across age groups, were more common in the placebo group and had regional variation. CONCLUSIONS: In men with nmCRPC and rapidly rising PSA, the benefit and safety of enzalutamide were consistent across age and regional subgroups. Variables impacting OS included ECOG status, log (PSA) and subsequent therapy. CLINICALTRIALS. GOV IDENTIFIER: NCT02003924.
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Authors | Ugo De Giorgi, Maha Hussain, Neal Shore, Karim Fizazi, Bertrand Tombal, David Penson, Fred Saad, Eleni Efstathiou, Katarzyna Madziarska, Joyce Steinberg, Jennifer Sugg, Xun Lin, Qi Shen, Cora N Sternberg |
Journal | European journal of cancer (Oxford, England : 1990)
(Eur J Cancer)
Vol. 159
Pg. 237-246
(12 2021)
ISSN: 1879-0852 [Electronic] England |
PMID | 34784577
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved. |
Chemical References |
- Androgen Antagonists
- Benzamides
- Nitriles
- Phenylthiohydantoin
- enzalutamide
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Topics |
- Age Factors
- Aged
- Aged, 80 and over
- Androgen Antagonists
(administration & dosage)
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use)
- Benzamides
(administration & dosage)
- Humans
- Male
- Middle Aged
- Nitriles
(administration & dosage)
- Phenylthiohydantoin
(administration & dosage)
- Prostatic Neoplasms, Castration-Resistant
(drug therapy)
- Treatment Outcome
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