Abiraterone in M1 hormone-naïve prostate cancer

Long-term results from metastatic (M1) patients in the STAMPEDE trial showed a sustained and substantial improvement in overall survival with androgen deprivation therapy (ADT) plus abiraterone, irrespective of burden of disease.

Previous, the STAMPEDE trial has shown that, among men with locally advanced or metastatic prostate cancer, ADT plus abiraterone and prednisolone was associated with significantly higher rates of overall and failure-free survival than ADT alone [1]. Now, long-term outcomes in subset of patients in STAMPEDE who had metastatic disease (M1) at the start of the treatment were presented [2].

Of 1,917 enrolled patients, 1,003 (52%) had M1 disease. They were 1:1 randomised to receive ADT versus ADT plus abiraterone (1,000 mg daily) plus prednisolone (5 mg daily). At a median follow-up of 6.1 years, median overall survival (OS) in the abiraterone arm was 6.6 years versus 3.8 years in the control arm (HR 0.60; P<0.00001). Median failure-free survival (including PSA failure) was 4.3 versus 0.96 years (HR 0.34; P< 0.00001). In line with these findings, median progression-free survival (PFS), metastatic PFS, and skeletal-related events were in favour of treatment with abiraterone (HR 0.58, HR 0.60, and HR 0.56, respectively). The relative effect of abiraterone was similar in low-burden and high-burden patients.

1. James ND, et al. N Engl J Med 2017;377:338-351.
2. James ND, et al. Abiraterone acetate plus prednisolone for hormone-naïve prostate cancer (PCa): Long-term results from metastatic (M1) patients in the STAMPEDE randomised trial (NCT00268476). ESMO 2020 Virtual Meeting, abstract 611O.

Posted on 25 November, 202023 December, 2021