medwireNews: Adding abiraterone acetate plus prednisone to androgen deprivation therapy (ADT) continues to provide an overall survival (OS) advantage in the first-line treatment of men with high-risk metastatic castration-sensitive prostate cancer (mCSPC), report the LATITUDE investigators.
In the final analysis of the phase III trial – conducted at a median follow-up of 51.8 months – OS was a median of 53.3 months for the 597 patients who were randomly assigned to receive abiraterone acetate 1000 mg/day plus prednisone 5 mg/day alongside ADT and was 36.5 months for the 602 men who instead received placebos together with ADT. This equated to a significant hazard ratio of 0.66 in favor of the active treatment.
Lead author Karim Fizazi (Institut Gustave Roussy, Villejuif, France) and collaborators highlight that men in the placebo group were allowed to crossover to the abiraterone arm after the first interim analysis showed significant improvements in outcomes with the anti-androgen.
Noting that no new safety signals were observed over the longer follow-up, the team concludes: “These findings thus reinforce the use of abiraterone acetate plus prednisone as a standard of care for patients with high-risk mCSPC.”
The trial results are published in The Lancet Oncology.
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