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PEACE-1

Abiraterone plus prednisone added to androgen deprivation therapy and docetaxel in de novo metastatic castration-sensitive prostate cancer (PEACE-1): a multicentre, open-label, randomised, phase 3 study with a 2 x 2 factorial design

Phase 3N = 1,173NCT01957436

Population
Men with de novo metastatic castration-sensitive prostate cancer, ECOG performance status 0-1 (or 2 due to bone pain); 1173 enrolled, one later withdrew consent for analysis of data
Design
Open-label phase 3 study with a 2 x 2 factorial design at 77 hospitals in seven European countries: 1:1:1:1 randomization to standard of care (ADT alone or with docetaxel 75 mg/m2 every 3 weeks), standard of care plus radiotherapy, plus abiraterone (1000 mg daily with prednisone 5 mg twice daily), or plus both. Co-primary end points radiographic progression-free survival and overall survival; abiraterone efficacy was assessed first in the overall population, then in the population who received ADT with docetaxel (the population of interest).
Primary endpoint
OS, rPFS
Arms
  • Standard of care (control, n = 296): ADT alone or with docetaxel
  • Standard of care plus radiotherapy (experimental, n = 293): Standard of care plus radiotherapy
  • Standard of care plus abiraterone (experimental, n = 292): Standard of care plus abiraterone 1000 mg daily and prednisone 5 mg twice daily
  • Standard of care plus radiotherapy plus abiraterone (experimental, n = 291): Standard of care plus radiotherapy plus abiraterone and prednisone
People
Fizazi K, PEACE-1
OSHR 0.75rPFSHR 0.5OSHR 0.82rPFSHR 0.54
Show the numbers
Results reported for PEACE-1
EndpointAnalysisStandard of care plus radiotherapy / Standard of care plus abiraterone / Standard of care plus radiotherapy plus abirateroneStandard of careEffect
OSADT with docetaxel population (355 patients with and 355 without abiraterone), the population of interestprimarymedian follow-up 4.4 yearsFizazi 2022——HR 0.75P=0.017Abiraterone versus no abiraterone, pooled across the radiotherapy factor (no interaction was found). The abstract gives the 95.1% CI as 0.59 to 0.95, not a 95% interval. Median follow-up applies to overall survival in the whole trial.
rPFSADT with docetaxel population (355 patients with and 355 without abiraterone), the population of interestprimarymedian follow-up 3.5 yearsFizazi 2022——HR 0.5P<0.0001Abiraterone versus no abiraterone, pooled across the radiotherapy factor. The abstract gives the 99.9% CI as 0.34 to 0.71, not a 95% interval. Median follow-up applies to radiographic progression-free survival in the whole trial.
OSOverall population: 583 patients receiving abiraterone and 589 not receiving abirateroneprimarymedian follow-up 4.4 yearsFizazi 2022——HR 0.82P=0.030Abiraterone versus no abiraterone, pooled across the radiotherapy factor. The abstract gives the 95.1% CI as 0.69 to 0.98, not a 95% interval.
rPFSOverall population: 583 patients receiving abiraterone and 589 not receiving abirateroneprimarymedian follow-up 3.5 yearsFizazi 2022——HR 0.54P<0.0001Abiraterone versus no abiraterone, pooled across the radiotherapy factor. The abstract gives the 99.9% CI as 0.41 to 0.71, not a 95% interval.
Results reported for PEACE-1
EndpointAnalysisStandard of care plus radiotherapy / Standard of care plus abiraterone / Standard of care plus radiotherapy plus abirateroneStandard of careEffect
OSADT with docetaxel population (355 patients with and 355 without abiraterone), the population of interestprimarymedian follow-up 4.4 yearsFizazi 2022——HR 0.75P=0.017Abiraterone versus no abiraterone, pooled across the radiotherapy factor (no interaction was found). The abstract gives the 95.1% CI as 0.59 to 0.95, not a 95% interval. Median follow-up applies to overall survival in the whole trial.
rPFSADT with docetaxel population (355 patients with and 355 without abiraterone), the population of interestprimarymedian follow-up 3.5 yearsFizazi 2022——HR 0.5P<0.0001Abiraterone versus no abiraterone, pooled across the radiotherapy factor. The abstract gives the 99.9% CI as 0.34 to 0.71, not a 95% interval. Median follow-up applies to radiographic progression-free survival in the whole trial.
OSOverall population: 583 patients receiving abiraterone and 589 not receiving abirateroneprimarymedian follow-up 4.4 yearsFizazi 2022——HR 0.82P=0.030Abiraterone versus no abiraterone, pooled across the radiotherapy factor. The abstract gives the 95.1% CI as 0.69 to 0.98, not a 95% interval.
rPFSOverall population: 583 patients receiving abiraterone and 589 not receiving abirateroneprimarymedian follow-up 3.5 yearsFizazi 2022——HR 0.54P<0.0001Abiraterone versus no abiraterone, pooled across the radiotherapy factor. The abstract gives the 99.9% CI as 0.41 to 0.71, not a 95% interval.
Primary publication: Fizazi K, Foulon S, Carles J, Roubaud G, McDermott R, Fléchon A, et al. Abiraterone plus prednisone added to androgen deprivation therapy and docetaxel in de novo metastatic castration-sensitive prostate cancer (PEACE-1): a multicentre, open-label, randomised, phase 3 study with a 2 × 2 factorial design. Lancet. 2022;399(10336):1695-1707. PubMedDOI

Appears in

Sources

  1. Fizazi K, Foulon S, Carles J, Roubaud G, McDermott R, Fléchon A, et al. Abiraterone plus prednisone added to androgen deprivation therapy and docetaxel in de novo metastatic castration-sensitive prostate cancer (PEACE-1): a multicentre, open-label, randomised, phase 3 study with a 2 × 2 factorial design. Lancet. 2022;399(10336):1695-1707.

    PubMedDOI