Adding abiraterone acetate plus prednisone to androgen deprivation therapy (ADT) improves patient-reported outcomes and health-related quality of life in patients with newly diagnosed, high-risk, metastatic castration-naive prostate cancer, according to a new analysis from the LATITUDE study.
The trial previously showed that adding abiraterone plus prednisone to ADT significantly extends overall survival and radiographic progression–free survival along with other outcomes. “Although overall survival and disease progression outcomes are used to evaluate new treatment approaches, to be truly valuable to patients, new treatment approaches should not only improve symptoms but also improve or maintain quality of life,” wrote study authors led by Kim N. Chi, MD, of BC Cancer-Vancouver Centre in Canada.
The trial included 1,199 patients randomized to receive either ADT plus abiraterone acetate and prednisone (597 patients) or ADT plus placebo (602 patients). All patients had newly diagnosed, high-risk, metastatic castration-naive prostate cancer, and they were assessed using the Brief Pain Inventory—Short Form (BPI-SF), the Brief Fatigue Inventory, the Functional Assessment of Cancer Therapy Prostate scale (FACT-P), and the EuroQol questionnaires. Results were published in Lancet Oncology.
The abiraterone patients were followed for a median of 30.9 months, and the placebo patients were followed for a median of 29.7 months. Though the median was not reached in either group, patients in the abiraterone plus prednisone group had a longer time to worst pain intensity progression according to the BPI-SF, with the 25th percentile at 11.07 months compared with 5.62 months with placebo, for a hazard ratio (HR) of 0.63 (95% CI, 0.52–0.77; P < .0001).
Similarly, the median time to worst fatigue intensity was not reached in either group, but favored the abiraterone group. The 25th percentile was 18.4 months with the therapy, compared with 6.5 months with placebo, for an HR of 0.65 (95% CI, 0.53–0.81; P = .0001). Other measures of fatigue also favored abiraterone plus prednisone.
The median time to deterioration based on the FACT-P total score was 12.9 months with abiraterone and 8.3 months with placebo, for an HR of 0.85 (95% CI, 0.74–0.99; P = .032). Healthy utility scores were also better with abiraterone plus prednisone, and those differences were “observed throughout the study,” the authors noted.
“Our patient-reported outcome analysis from the randomized, phase III LATITUDE study shows that ADT plus abiraterone acetate and prednisone consistently improves pain and fatigue symptoms, and overall health-related quality of life, when compared with those for ADT plus placebo,” the authors concluded. “Our findings in combination with the efficacy results…indicate 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.”