| Title: |
Abiraterone acetate plus prednisolone with or without enzalutamide for patients with metastatic prostate cancer starting androgen deprivation therapy: final results from two randomised phase 3 trials of the STAMPEDE platform protocol. |
| Authors: |
Attard, G; Murphy, L; Clarke, NW; Sachdeva, A; Jones, C; Hoyle, A; Cross, W; Jones, RJ; Parker, CC; Gillessen, S; Cook, A; Brawley, C; Gilson, C; Rush, H; Abdel-Aty, H; Amos, CL; Murphy, C; Chowdhury, S; Malik, Z; Russell, JM; Parkar, N; Pugh, C; Diaz-Montana, C; Pezaro, C; Grant, W; Saxby, H; Pedley, I; O'Sullivan, JM; Birtle, A; Gale, J; Srihari, N; Thomas, C; Tanguay, J; Wagstaff, J; Das, P; Gray, E; Alzouebi, M; Parikh, O; Robinson, A; Montazeri, AH; Wylie, J; Zarkar, A; Cathomas, R; Brown, MD; Jain, Y; Dearnaley, DP; Mason, MD; Gilbert, D; Langley, RE; Millman, R; Matheson, D; Sydes, MR; Brown, LC; Parmar, MKB; James, ND; STAMPEDE investigators |
| Contributors: |
Parker, Christopher; Abdel-aty, Hoda; Dearnaley, David; James, Nicholas |
| Publisher Information: |
ELSEVIER SCIENCE INC |
| Publication Year: |
2024 |
| Collection: |
The Institute of Cancer Research (ICR): Publications Repository |
| Subject Terms: |
Male; Humans; Abiraterone Acetate; Prostatic Neoplasms; Androgen Antagonists; Androgens; Prednisolone; Docetaxel; Antineoplastic Combined Chemotherapy Protocols; Castration-Resistant; Randomized Controlled Trials as Topic; Clinical Trials; Phase III as Topic; Meta-Analysis as Topic |
| Subject Geographic: |
England |
| Description: |
BACKGROUND: Abiraterone acetate plus prednisolone (herein referred to as abiraterone) or enzalutamide added at the start of androgen deprivation therapy improves outcomes for patients with metastatic prostate cancer. Here, we aimed to evaluate long-term outcomes and test whether combining enzalutamide with abiraterone and androgen deprivation therapy improves survival. METHODS: We analysed two open-label, randomised, controlled, phase 3 trials of the STAMPEDE platform protocol, with no overlapping controls, conducted at 117 sites in the UK and Switzerland. Eligible patients (no age restriction) had metastatic, histologically-confirmed prostate adenocarcinoma; a WHO performance status of 0-2; and adequate haematological, renal, and liver function. Patients were randomly assigned (1:1) using a computerised algorithm and a minimisation technique to either standard of care (androgen deprivation therapy; docetaxel 75 mg/m2 intravenously for six cycles with prednisolone 10 mg orally once per day allowed from Dec 17, 2015) or standard of care plus abiraterone acetate 1000 mg and prednisolone 5 mg (in the abiraterone trial) orally or abiraterone acetate and prednisolone plus enzalutamide 160 mg orally once a day (in the abiraterone and enzalutamide trial). Patients were stratified by centre, age, WHO performance status, type of androgen deprivation therapy, use of aspirin or non-steroidal anti-inflammatory drugs, pelvic nodal status, planned radiotherapy, and planned docetaxel use. The primary outcome was overall survival assessed in the intention-to-treat population. Safety was assessed in all patients who started treatment. A fixed-effects meta-analysis of individual patient data was used to compare differences in survival between the two trials. STAMPEDE is registered with ClinicalTrials.gov (NCT00268476) and ISRCTN (ISRCTN78818544). FINDINGS: Between Nov 15, 2011, and Jan 17, 2014, 1003 patients were randomly assigned to standard of care (n=502) or standard of care plus abiraterone (n=501) in the abiraterone trial. ... |
| Document Type: |
article in journal/newspaper |
| File Description: |
Print; 456; application/pdf |
| Language: |
English |
| ISSN: |
1474-5488; 1470-2045 |
| Relation: |
S1470-2045(23)00148-1; The Lancet Oncology, 2023, 24 (5), pp. 443 - 456; https://repository.icr.ac.uk/handle/internal/6207 |
| Availability: |
https://repository.icr.ac.uk/handle/internal/6207 |
| Rights: |
http://creativecommons.org/licenses/by/4.0/ |
| Accession Number: |
edsbas.F0933993 |
| Database: |
BASE |