Abiraterone acetate plus prednisone and androgen-deprivation therapy (ADT) are linked to improved patient-reported outcomes (PROs) compared with ADT plus placebos among patients with metastatic castration-naive prostate cancer, according to research published in The Lancet Oncology.1
While effective, ADT is associated with a number of health-related quality of life (HRQoL) issues and usually leads to castration-resistant disease within about a year of treatment initiation. While adding docetaxel to ADT can improve overall survival (OS) and progression-free survival (PFS), chemotherapy increases toxicity, and is not recommended for frail patients.
The ongoing phase 3 LATITUDE (ClinicalTrials.gov Identifier: NCT01715285) showed that — compared with ADT plus placebos — abiraterone acetate, prednisone, and ADT improve a number of outcomes in this patient population, including PFS, OS, and time to chemotherapy initiation. Whether this combination improves PROs and HRQoL was previously unknown.
Patients enrolled in LATITUDE between February 2013 and December 2014 were randomly assigned to the abiraterone group (597 patients) or to the ADT-only group (602 patients). Patients completed the following questionnaires by electronic device at pre-established time points: the Brief Pain Inventory — Short Form (BPI-SF), Brief Fatigue Inventory (BFI), Functional Assessment of Cancer Therapy Prostate scale (FACT-P), and the EuroQol (EQ-5D-5L).
Compliance was 90% or higher. After a median follow-up of 30.9 months, median time to worst pain intensity progression by BPI-SF and median time to worst fatigue intensity were not reached in either group. Patients in the 25th percentile of the abiraterone group, however, had a longer median time to worst pain intensity progression (11.07 months) and to worst fatigue intensity (18.4 months) than did those in the 25th percentile of the ADT-only group (5.62 months and 6.5 months, respectively).
Time to deterioration of functional status was also longer in the abiraterone group (median, 12.9 months) than in the ADT-only group (median, 8.3 months; hazard ratio, 0.85; P = .032).
The authors concluded that “treatment with ADT plus abiraterone acetate and prednisone could be considered a new option for standard of care for patients with metastatic castration-naive prostate cancer.”
- Chi KN, Protheroe A, Rodríguez-Antolín A, et al. Patient-reported outcomes following abiraterone acetate plus prednisone added to androgen deprivation therapy in patients with newly diagnosed metastatic castration-naive prostate cancer (LATITUDE): an international, randomised phase 3 trial. Lancet Oncol. 2018 Jan 8. doi: 10.1016/S1470-2045(17)30911-7 [Epub ahead of print]