MADRID — The addition of abiraterone acetate plus prednisone to androgen deprivation therapy improved health-related quality of life among men with high-risk metastatic prostate cancer, according to data from the LATITUDE trial presented at the European Society for Medical Oncology Congress.
“[The regimen] provided consistent, statistically significant and clinically relevant benefits in patient-reported outcomes compared with ADT plus placebos,” Kim N. Chi, MD, BCCA, medical oncologist and associate professor of medicine at University of British Columbia, said during his presentation. “There was a delay in time to pain intensity and pain interference progression, a delay in time to worst fatigue intensity and fatigue interference progression, and a prolonged time to quality-of-life deprivation. Health status was also statistically improved.”
The LATITUDE study included 1,199 men with newly diagnosed, metastatic, high-risk castration-resistant prostate cancer.
Researchers randomly assigned half of the patients to androgen deprivation with abiraterone acetate (Zytiga, Janssen) — an oral adrenal inhibitor — and prednisone. The other half received androgen deprivation alone.
Efficacy results presented at this year’s ASCO Annual Meeting showed the addition of abiraterone acetate and prednisone to androgen deprivation therapy led to a 38% reduced risk for death. The regimen also doubled median time to prostate cancer progression, from 14.8 months to 33 months.
At ESMO, Chi presented patient-reported outcome data from LATITUDE, including symptom and health-related quality-of-life measures.
Patients completed Brief Fatigue Inventory, Brief Pain Inventory — Short Form, Functional Assessment of Cancer Therapy — Prostate (FACT-P), and EQ-5D-5L questionnaires at baseline, on day 1 of cycles 2 through 13, and then every 2 months until treatment discontinuation. They continued to complete EQ-5D-5L questionnaires every 4 months until 12 months after treatment discontinuation.
Researchers reported a questionnaire compliance rate greater than 90%.
Patients assigned abiraterone acetate and prednisone reported significant delays in time to pain and fatigue intensity and interference progression.
FACT-P results showed abiraterone acetate and prednisone significantly delayed degradation of total score and symptom subscales.
Patients assigned abiraterone reported delayed time to worst pain progression (HR = 0.63; P < .0001) and fatigue progression (HR = 0.65; P < .0001), as well as median time to pain interference (HR = 0.67; P < .0001).
Researchers also reported delayed degradation of quality of life in the abiraterone arm (median, 12.9 months vs. 8.3 months; HR = 0.85; P = .032).
Chi and colleagues also reported significant improvement in general health status and health utility scores for men assigned abiraterone acetate and prednisone. The improvements emerged as early as the fifth treatment cycle and persisted throughout the study period.
“In addition to the improvements in survival and disease progression, these results demonstrate that the addition of abiraterone and prednisone to ADT also improves the patient-reported experience and should be considered a new standard of care,” Chi said. – by Chuck Gormley
Chi K, et al. Abstract 783O. Presented at: European Society for Medical Oncology Congress; Sept. 8-12, 2017; Madrid.
Disclosures: Janssen Research & Development funded this study. Chi reports a consultant or advisory role with Janssen. Please see the abstract for a list of all other researchers’ relevant financial disclosures.