Newly diagnosed patients with metastatic, castration-sensitive prostate cancer may have significantly prolonged overall survival (OS) and radiographic progression-free survival (PFS) when treated with abiraterone, prednisone, and androgen-deprivation therapy, according to a study published in The New England Journal of Medicine.1
In the phase 3 LATITUDE trial (ClinicalTrials.gov Identifier: NCT01715285), researchers randomly assigned 1199 patients to receive androgen-deprivation therapy plus abiraterone 100 mg once daily and prednisone 5 mg once daily or androgen-deprivation therapy plus 2 placebos. The primary endpoints were OS and radiographic PFS.
At a mean follow-up of 30.4 months, 406 patients had died. The median OS was significantly longer for the abiraterone arm vs the placebo arm (not reached vs 34.7 months, respectively; hazard ratio [HR], 0.62; 95% CI, 0.51-0.76; P < .001).
Patients in the abiraterone group had a median radiographic PFS of 33.0 months vs 14.8 months in the placebo group (HR, 0.47; 95% CI, 0.39-0.55; P < .001).
The results led to study unblinding, allowing patients receiving placebo to cross over to the abiraterone arm.
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Grade 3 to 4 hypokalemia and hypertension were the most frequently reported adverse events (AEs), which occurred more frequently in the study group.
The authors concluded that “the addition of abiraterone plus prednisone to androgen-deprivation therapy was associated with longer [OS] and longer radiographic [PFS] than was androgen-deprivation therapy alone.”
- Fizazi K, Tran N, Fein L, et al. Abiraterone plus prednisone in metastatic, castration-sensitive prostate cancer. N Eng J Med. 2017 Jul 27. doi: 10.1056/NEJMoa1704174 [Epub ahead of print]