medwireNews: In men with newly diagnosed, high-risk, metastatic castration-naïve prostate cancer (CNPC), patient-reported outcomes (PROs) can be improved with the addition of abiraterone acetate and prednisone to androgen deprivation therapy (ADT), shows the LATITUDE trial.
Study participants who received abiraterone acetate plus prednisone showed improvements in pain and fatigue symptoms, and overall health-related quality of life (HRQoL) relative to patients receiving ADT plus placebo, the investigators report. They add that the PRO benefits are consistent with the previously reported efficacy analysis, which showed significantly longer overall and radiographic progression-free survival with the abiraterone acetate-containing regimen.
Kim Chi (BC Cancer—Vancouver Centre, British Columbia, Canada) and co-researchers believe that the LATITUDE results together with the survival advantage seen in the UK STAMPEDE trial investigating the same combination “indicate that treatment with ADT plus abiraterone acetate and prednisone should be considered as a new option for standard of care” for metastatic CNPC.
In the phase III trial, men with a new diagnosis of metastatic CNPC with at least two high-risk features (including Gleason score ≥8, three or more lesions, or measurable non-lymph visceral metastases) were randomly assigned to receive abiraterone acetate 1000 mg/day plus prednisone 5 mg/day or placebo, in both cases alongside ADT.
Over a median follow-up of 30.4 months, the median time to worst pain intensity, as assessed by the Brief Pain Inventory–Short Form, was not reached in either treatment arm. But this endpoint was reached at a significantly later time by 25% of the group given abiraterone acetate plus prednisone than those given placebo, at 11.07 and 5.62 months, respectively, equating to a hazard ratio (HR) of 0.63.
The results were similar for time to worst fatigue intensity, with the median unreached in the abiraterone acetate and placebo arms, and a significant difference with regard to the time taken by 25% of participants to reach the endpoint, at 18.4 versus 6.5 months, and an HR of 0.65 favoring abiraterone acetate.
Abiraterone acetate-treated participants also fared significantly better in terms of functional decline measured with the Functional Assessment of Cancer Therapy Prostate scale, with a median time to functional deterioration of 12.9 months compared with 8.3 months for men given placebo (HR=0.85). And the abiraterone acetate group also had better general health status and health utility scores on the EuroQol five-dimensions, five-levels questionnaire throughout the study.
In a commentary accompanying the research in The Lancet Oncology, David Penson (Vanderbilt University Medical Center, Nashville, Tennessee, USA) highlights the “significant overall survival advantage” gained by combining abiraterone acetate or docetaxel with ADT in the LATITUDE and CHAARTED trials, respectively.
And he comments that “[t]herefore, the question is no longer whether to add one of these agents to ADT for patients with castration-naïve prostate cancer, but rather which to add first,” a decision that will likely rely on “quality-adjusted life years and the cost-effectiveness of each of the available combination therapies.”
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