Prostate cancer agent delays pain progression, QoL deterioration

Abiraterone acetate (ZYTIGA) significantly delays progression of pain and quality of life deterioration when taken in conjunction with prednisone, the authors of a multicenter study reported.

In their study, published online in Lancet Oncology (Sept. 25, 2013), researchers measured the pain and quality of life impact of abiraterone when administered to 1,088 patients with metastatic castration-resistant prostate cancer at 151 sites in the U.S., Europe, Canada, and Australia. The randomized trial enrolled patients who had experienced little or no pain at the outset, prescribing abiraterone and prednisone to 546 of the enrollees and placebo plus prednisone to the remainder.

“The majority of men with metastatic prostate cancer experience pain that is often debilitating and can have a profound impact on their ability to function, sleep, work, and their enjoyment of life. Pain is a central problem in prostate cancer and managing pain remains a major challenge,” said first author Ethan Basch, MD, of the University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill.

The design of the study emphasized the importance of patient-reported outcomes in evaluating new treatments. In previous publications, Dr. Basch has shown the importance of evaluating how treatments impact how people feel and function during drug development.

The study tracked the progression of pain intensity, the time until patients needed opiates to control pain, and patients’ quality of life using validated questionnaires. Patients reported their pain intensity on a scale of one to 10 as well as the amount that pain interfered with their sleep, mood, and ability to conduct daily activities via the Brief Pain Inventory.

The combination of abiraterone and prednisone significantly prolonged the time until clinically meaningful worsening of pain intensity (26.7 vs. 18.4 months) as well as quality of life deterioration (12.7 vs. 8.3 months) compared to placebo plus prednisone. Patients reported a more than 8-month delay in progression of pain and a more than 4-month delay in quality of life deterioration. Significant improvements were also seen in how pain interferes with daily activities and time until opiate use.

“The design of this study provides a path forward for future research to utilize patient-centered endpoints. Not only does it provide essential information about the properties of abiraterone acetate, but it demonstrates the feasibility of rigorously measuring symptoms in a large multinational study. It also helps identify areas of needed future methodological research,” Dr. Basch said.

Employees of Janssen Research & Development participated in trial design, data monitoring and collection, data analysis, data interpretation, and writing of the report.

To get weekly news from the leading news source for urologists, subscribe to the Urology Times eNews.