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SUO 2018

SUO 2018: Long-term PROS with Abiraterone Acetate+prednisone Added to ADT in Newly-diagnosed Metastatic Castration-naïve Prostate Cancer: Second Interim Analysis of the Latitude Study

Phoenix, Arizona (UroToday.com) The LATITUDE study, published in July 2017, was a phase III randomized, clinical trial that evaluated the efficacy of abiraterone acetate and prednisone    with androgen deprivation therapy (ADT) in men with newly-diagnosed, castration sensitive, metastatic prostate cancer.      1199 men were randomized to receive ADT with abiraterone and prednisone, versus ADT with dual placebos. The primary endpoints of this study were overall survival and radiographic progression-free survival. This study showed that ADT+ abiraterone and prednisone did confer both a survival benefit over ADT alone, but also showed that there was an improvement in patient-reported outcomes (PROs) over the course of the trial.

As part of the oral abstract podium session at the 2018 meeting of the Society of Urologic Oncology (SUO), Dr. Kim Chi from the British Columbia Cancer Agency presented a second interim analysis of long-term PROs from the LATITUDE trial. For this analysis, the median follow-up was 41 months, as opposed to 30.9 months in the initial interim analysis. To measure these patient-reported outcomes, surveys were administered to the men enrolled in this trial at baseline (before initiation of treatment), monthly during cycles 2-13, and then every 2 months until treatment discontinuation. These surveys included the Brief Pain Inventory-Short form (BPI-SF), Brief Fatigue Inventory (BFI), and Functional Assessment of Cancer Therapy – Prostate (FACT-P). Changes in these patient-reported outcomes from baseline were then measured and compared.

Chi and colleagues found that treatment was still ongoing in 34% of patients in the ADT + abiraterone + prednisone group, while only 12% of the ADT + placebo group had ongoing treatment. Over 90% of patients in both groups participated in the PRO questionnaires. Patients that were in the ADT + Abiraterone + Prednisone group showed a statistically significant decrease in the risk of progression for pain intensity, pain interference, fatigue intensity, and fatigue interference as compared to the ADT + Placebo group. Additionally, there was a delay in the time to health-related quality of life degradation in the ADT + abiraterone + prednisone group as compared to the ADT + placebo group. Chi also noted that there was a significantly greater improvement from baseline in all PRO measures in the ADT + abiraterone + prednisone group as compared to the ADT + placebo group. He concluded that patients with newly-diagnosed, castrate-sensitive, metastatic prostate cancer who use ADT + abiraterone + prednisone fare better in PROs than patients taking ADT + a placebo. These findings, combined with the demonstrated survival benefits supports the use of ADT + abiraterone + prednisone in men with newly-diagnosed metastatic castrate-sensitive prostate adenocarcinoma.

Presented By: Kim Chi, MD, British Columbia Cancer Agency, Vancouver, British Columbia

Written by: Brian Kadow, MD, Society of Urologic Oncology Fellow, Fox Chase Cancer Center, Philadelphia, PA, at the 19th Annual Meeting of the Society of Urologic Oncology (SUO), November 28-30, 2018 – Phoenix, Arizona