Patient-Reported Outcomes With Addition of Combination Treatment to ADT in Newly Diagnosed Metastatic Castration-Naive Prostate Cancer
As reported by Chi et al in The Lancet Oncology, the addition of abiraterone and prednisone to androgen-deprivation therapy (ADT) in the phase III LATITUDE trial was associated with improved patient-reported outcomes in patients with newly diagnosed metastatic castration-naive prostate cancer. The trial showed improved overall survival with the addition of abiraterone (Zytiga) and prednisone vs placebos to ADT.
Study Details
In the trial, 1,199 patients were randomly assigned to ADT plus abiraterone and prednisone (n = 597) or ADT plus placebos (n = 602). Median follow-up was 30.9 months vs 29.7 months.
Patient-reported outcome analyses were an exploratory endpoint and were performed in the intention-to-treat population. Patient-reported outcome data were collected at clinical sites during screening and before any other visit procedure on day 1 of cycles 1 to 3, monthly during cycles 4 to 13, and then every 2 months until the end of treatment. The findings presented are from the first preplanned interim analysis (October 2016).
Patient-Reported Outcomes
Median time to worst pain intensity progression assessed by Brief Pain Inventory-Short Form score was not reached in either the abiraterone plus prednisone or control groups (25th percentile = 11.07 months vs 5.62 months, hazard ratio [HR] = 0.63, P < .0001). Median time to worst fatigue intensity on the Brief Fatigue Inventory was not reached in either group (25th percentile = 18.4 vs 6.5 months, HR = 0.65, P = .0001). Median time to deterioration of functional status assessed by Functional Assessment of Cancer Therapy-Prostate total score was 12.9 vs 8.3 months (HR = 0.85, P = .032). Overall health-related quality of life assessed by EuroQol questionnaires showed consistently greater improvement from baseline in the abiraterone plus prednisone group.
The investigators concluded, “The addition of abiraterone acetate plus prednisone to ADT in patients with newly diagnosed, high-risk metastatic castration-naive prostate cancer improved overall [patient-reported outcomes] by consistently showing a clinical benefit in the progression of pain, prostate cancer symptoms, fatigue, functional decline, and overall [health-related quality of life].”
The study was funded by Janssen Research & Development.
Kim N. Chi, MD, of the Clinical Trials Unit, BC Cancer-Vancouver Centre, is the corresponding author for The Lancet Oncology article.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
