Erleada Combo Shows Comparable Quality of Life Outcomes in Prostate Cancer

Among patients with advanced castration-sensitive prostate cancer, health-related quality of life was not statistically different between those receiving Erleada (apalutamide) alone or in combination with Zytiga (abiraterone acetate) and prednisone compared with those receiving androgen-deprivation therapy (ADT) plus Zytiga and prednisone, according to findings in JAMA Network Open.

Health-related quality of life was evaluated using the Functional Assessment of Cancer Therapy–Prostate (FACT-P) questionnaire and its subscales. The questionnaire was completed at baseline and every four weeks until week 25. FACT-P scores range from 0 to 156, with higher scores indicating better quality of life, according to study authors.

There were no significant differences in baseline mean FACT-P total scores or subscales across the three treatment groups: ADT plus Zytiga and prednisone, 118.5; Erleada, 116.1; and Zytiga and prednisone plus Erleada, 114.9.

Health-related quality of life was maintained during the treatment period, with no statistically significant differences at 25 weeks in mean FACT-P total scores or subscales: ADT plus Zytiga and prednisone, 122.3; Erleada monotherapy, 119.5; and Zytiga and prednisone plus Erleada, 119.9.

The Erleada monotherapy and Zytiga and prednisone plus Erleada groups did not experience meaningful improvements in health-related quality of life compared with the ADT plus Zytiga and prednisone group, except in time to deterioration of the emotional well-being score. This outcome was more favorable in those who received Erleada alone, with a 63% reduction in risk compared with the ADT plus Zytiga and prednisone group, which had a 44% reduction in risk.

Additional Efficacy and Safety Data

A prostate-specific antigen level of 0.2 nanograms per milliliter or lower at week 25 was observed in 31 of 41 patients (75.6%) in the ADT plus Zytiga and prednisone group, 24 of 40 patients (60%) in the Erleada monotherapy group and 31 of 39 patients (79.5%) in the Erleada plus Zytiga and prednisone group. The two-year overall survival rates were 92.5% for the ADT plus Zytiga and prednisone group, 87.9% for the Erleada monotherapy group and 92.7% for the Erleada plus Zytiga and prednisone arm.

Treatment-related side effects of any grade were reported in 30 of 42 patients (71.4%) in the ADT plus Zytiga and prednisone group, 34 of 42 patients (81%) in the Erleada monotherapy group and 36 of 44 patients (81.8%) in the Erleada plus Zytiga and prednisone group.

Grade 3 (severe) and 4 (life-threatening) treatment-related side effects occurred in eight of 42 patients (19%) in the ADT plus Zytiga and prednisone group, seven of 42 patients (16.7%) in the Erleada monotherapy group and 10 of 44 patients (22.7%) in the Erleada plus Zytiga and prednisone group. Lower rates of hot flashes and hypertension were reported in patients who received Erleada monotherapy.

Gynecomastia affected 23 of 42 patients (54.8%), and breast pain was reported by six of 42 patients (14.3%) in the Erleada monotherapy group, both higher than rates observed in the other two groups. No new safety signals were detected in
the study.

Reference

“Androgen Receptor Pathway Inhibitor Therapy for Advanced Prostate Cancer: Secondary Analysis of a Randomized Clinical Trial” by Dr. Diogo Assed Bastos et al., JAMA Network Open.

For more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here.