Chi KN, et al. - An analysis was performed to examine the effects of androgen deprivation therapy (ADT) plus abiraterone acetate and prednisone vs ADT plus placebos on patient-reported outcomes (PROs) and health-related quality of life (HRQOL) in patients in the LATITUDE study. Among patients with newly diagnosed, high-risk metastatic castration-naive prostate cancer, the addition of abiraterone acetate plus prednisone to ADT improved overall PROs by consistently showing a clinical benefit in the progression of pain, prostate cancer symptoms, fatigue, functional decline, and overall HRQOL.

Methods

• The designe of this phase 3 LATITUDE trial was a multicentre, international, randomised research.
• For this study, eligible patients were aged 18 years or older, who had newly diagnosed, high-risk, metastatic castration-naive prostate cancer confirmed by bone scan (bone metastases) or by CT or MRI (visceral, soft tissue, or nodal metastases), and an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less.
• The researchers randomly assigned patients (1:1) from 235 clinical sites in 34 countries following a country-by-country scheme done by permuted block randomisation (with 2 blocks) and stratified by the presence of visceral metastasis and ECOG performance status to receive ADT plus 1000 mg oral abiraterone acetate and 5 mg oral prednisone once daily or ADT plus placebos.
• Selection of ADT (chemical or surgical) was at the investigator's discretion.
• They published co-primary endpoints of the trial, overall survival and radiographic progression-free survival.
• They collected PRO data directly on electronic tablet devices at the clinical sites during screening and before any other visit procedure on day 1 of cycles 1–3, monthly during cycles 4-13, and then every 2 months until the end of treatment, by use of 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) questionnaires.
• PRO analyses were an exploratory endpoint.
• Analyses were by intention-to-treat.
• Here, outcomes were presented from the first pre-planned interim analysis (Oct 31, 2016).

Results

• The researchers randomly assigned 1,199 patients between Feb 12, 2013, and Dec 11, 2014: 597 to ADT plus abiraterone acetate and prednisone and 602 to ADT plus placebos.
• In the ADT plus abiraterone acetate and prednisone group, the median follow-up was 30·9 months (IQR 21·2–33·2) vs 29·7 months (1·4-43·5; 16·1-31·3) in the ADT plus placebos group.
• BPI-SF score revealed that the median time to worst pain intensity progression was not reached in either group (ADT plus abiraterone acetate and prednisone, not reached [95% CI not reached to not reached]; 25th percentile 11·07 months [95% CI 9·23-18·43]; ADT plus placebos group, not reached [95% CI not reached to not reached]; 25th percentile 5·62 [95% CI 4·63-7·39]; hazard ratio [HR] 0·63 [95% CI 0·52-0·77]; p<0·0001).
• As per the outcomes, median time to worst fatigue intensity was not reached in either the ADT plus abiraterone acetate and prednisone group (not reached [95% CI not reached to not reached]; 25th percentile 18·4 months [95% CI 12·9-27·7]) or the ADT plus placebos group (not reached [95% CI not reached to not reached]; 25th percentile 6·5 months [95% CI 5·6-9·2]; HR 0·65 [95% CI 0·53-0·81], p=0·0001).
• Using the FACT-P total score scale, the median time to deterioration of functional status was found to be 12·9 months (95% CI 9·0-16·6) in the ADT plus abiraterone acetate and prednisone group vs 8·3 months (7·4-11·1) in the ADT plus placebos group (HR 0·85 [95% CI 0·74-0·99]; p=0·032).