Absolute Benefit of ADT + Abiraterone Therapy in Metastatic Hormone-Sensitive Prostate Cancer

Survival Benefits

The addition of abiraterone acetate plus prednisone to ADT in patients with metastatic hormone-sensitive prostate cancer provides a 14% absolute improvement in 3-year survival and a 28% absolute improvement in 3-year progression-free survival compared to ADT alone 1, 2, 3
A systematic review and meta-analysis using the Framework for Adaptive Meta-Analyses (FAME) pooled data from 2,201 men with metastatic disease from the STAMPEDE and LATITUDE trials, showing that adding abiraterone to ADT reduced the risk of death by 38% (HR, 0.62; 95% CI, 0.53 to 0.71), resulting in a 14% absolute improvement in 3-year survival 1, 2, 3

The addition of abiraterone to ADT reduced the risk of radiographic or clinical progression by 55% (HR, 0.45; 95% CI, 0.40 to 0.51), resulting in a 28% absolute improvement at 3 years 1, 2, 3

ADT plus abiraterone showed significant improvements in quality of life measures compared to ADT alone, including a 37% risk reduction in pain intensity progression (BPI-SF) (HR, 0.63; 95% CI, 0.52 to 0.47; p<0.001) 1
ADT plus abiraterone also showed a 53% risk reduction in fatigue (BFI) (HR, 0.65; 95% CI, 0.53 to 0.81; p=0.0001) 1
ADT plus abiraterone showed a 15% risk reduction in overall quality of life deterioration (FACT-P) (HR, 0.85; 95% CI, 0.74 to 0.99; p=0.0322) 3

The American Society of Clinical Oncology (ASCO) recommends abiraterone combination with ADT for men with newly diagnosed metastatic non-castrate disease on the basis of prolonging life relative to ADT alone 1, 4
The National Comprehensive Cancer Network (NCCN) strongly recommends ADT with treatment intensification (including abiraterone) for patients with metastatic castration-sensitive prostate cancer, and discourages the use of ADT monotherapy unless there are clear contraindications to combination therapy 5, 6

More grade 3-4 acute cardiac, vascular, and hepatic toxicities were seen with abiraterone plus ADT, but there was no statistically significant excess of deaths 1, 2, 3
Common side effects (>5%) include joint swelling or discomfort, hypokalemia, edema, muscle discomfort, hot flushes, diarrhea, hypertension, and fatigue 9, 10

The absolute benefit of abiraterone plus ADT must be weighed against the increased risk of side effects and the cost of treatment 4
Regular monitoring is essential for liver function tests, serum potassium and phosphate levels, and blood pressure readings 8