LATITUDE Trial: Final Survival Data on Abiraterone Acetate and Prednisone Plus ADT
Posted: Monday, July 8, 2019
The addition of abiraterone acetate plus prednisone to androgen-deprivation therapy (ADT) led to improved survival outcomes in patients with recently diagnosed metastatic castration-sensitive prostate cancer, according to the final overall survival analysis of the LATITUDE trial, published in The Lancet Oncology. The investigators concluded that their results support the use of this combination therapy as a standard of care in this patient population.
“The combination of abiraterone acetate plus prednisone with ADT was associated with significantly longer overall survival than placebos plus ADT in men with newly diagnosed high-risk [metastatic, castration-sensitive prostate cancer] and had a manageable safety profile,” concluded Karim Fizazi, MD, PhD, of the University of Paris Sud in France, and colleagues.
The study included 1,199 patients who were randomly assigned to receive daily treatment with either 1,000 mg of abiraterone acetate and 5 mg of prednisone plus ADT (n = 597) or placebos plus ADT (n = 602). Following the results of the first interim analysis, patients in the placebo group were allowed to begin receiving abiraterone acetate and prednisone plus ADT therapy in an extension phase. Thus, the final analysis occurred at a median follow-up of 51.8 months and 618 deaths (275 treated with abiraterone acetate plus prednisone, 343 treated with placebo). Patients in the abiraterone-acetate-plus-prednisone group experienced significantly improved overall survival of a median of 53.3 months, compared with 36.5 months in the placebo group.
A total of 192 patients (32%) receiving abiraterone acetate plus prednisone, 151 patients (25%) receiving placebo, and 4 patients (6%) who crossed over from placebo to the combination therapy experienced serious adverse events. Hypokalemia was the most common treatment-related serious adverse event, with four patients receiving combination treatment experiencing it. A total of six treatment deaths occurred: three treated with abiraterone acetate plus prednisone and three treated with placebo.
Disclosure: The study authors’ disclosure information may be found at thelancet.com.